Equipment News

Sharp Safety

2008-01-05T11:12:00.000+08:00

At least 800,000 accidental needlesticks are reported in the United States each year according to the
Centers for Disease Control and Prevention. Some estimates place the number of accidental needlesticks as high as 2.5 million. Whatever the true number, it’s clear home syringe users and the healthcare industry face continuing challenges from sharps incidents.

The best solution? That’s difficult to say. In an ideal world we’d find a way to avoid using syringes. But since that’s not going to happen any time soon, other options must be explored. Safety syringes are the best real-world option. However, their higher costs, coupled with the array of options on the market, have dampened enthusiasm among some home users. Although home users have not adopted the use of safety syringes, I strongly encourage their use in the home care setting. I recently was diagnosed with drug-induced diabetes. I had to worry about using safety lancets, blood glucose monitors and being injected with insulin. All of a sudden the disposal of my sharps at home became a real issue. My wife and I talked about the proper way to dispose of these products to keep our family,
sanitation workers, landfill workers and others safe from my blood.

Many home users and healthcare professionals wrestle with similar challenges of safety, economy, disposal, ease of use and compliance. I recently had the opportunity to review an innovative product in a totally new safety product category. It addresses the home healthcare market and the apparent preference of home users to use the standard traditional syringe. This new product is called the Sharpsfree Syringe Management System. Available in models for home users and healthcare professionals, this point-of-use system is simple and easy. Just insert the syringe and the machine does the rest, automatically separating the needle from the syringe. The used needles are stored inside the machine in a puncture-resistant cartridge for safe, convenient disposal. The remaining syringe can either be deposited into household trash or recycled as normal waste.

There are three key benefits associated with these kinds of devices.

First, they greatly reduce the post-use handling of syringes, resulting in a significantly reduced chance of accidental needlesticks during disposal for syringe users as well as those who handle the waste.
Second, these systems are simple, fast and easy to use, increasing the probability of implementation. No product is effective if it’s complicated or slow because people don’t want to take the trouble to learn complicated and slow systems.
Third, these systems save money. They allow use of regular syringes, if that’s what users prefer, and they allow for the separation of the sharps from the plastic waste, which can then be disposed of more economically.

What is BLOGRUSH?

Design Students Create Innovative Medical Equipment

2008-01-03T18:08:00.001+08:00

Good design won't cure illness, but a group of art students in Halifax are trying to prove that it can make you feel better.

Since January 2003, design students from NSCAD University have worked with hospital staff and patients at Halifax's QEII Health Sciences Centre to improve the hospital's medical equipment and public spaces. Their creations were exhibited at the health centre this week.

NSCAD teacher Carlo Testa helped conceive Design for Health after visiting a family member in hospital.

"You feel like you are in a very depressing place - the choice of colours, poor air quality, poor lights, poor furniture," Testa said of his experience.

"You find extremely committed staff, [who do] everything possible to make you better, [in] an environment that does everything possible to make you worse."

The project's goal was to design more practical hospital equipment and more welcoming physical environments. Students created a range of prototypes, including a spill-proof cup for patients with failing hands, an ergonomic, football-shaped reflex hammer and an easily adjustable, padded lifting belt.

All designs were tested and evaluated by health professionals, some of whom are already using the instruments.

What is BLOGRUSH?

Lung Flute – new device to obtain high quality sputum samples

2007-12-29T17:48:00.000+08:00

Medical Acoustics presented the Lung Flute®, a cost effective and easy-to-use device to quickly and effectively gather sputum samples. The Lung Flute has FDA-clearance and was recently successfully registered as a Class 1 medical device for sale in the European Union and qualified for the application of the CE mark for diagnostic and therapeutic applications.

"The Lung Flute provides EU clinicians with a safe, easy-to-use means of obtaining high quality sputum samples for the improved diagnosis and treatment of a myriad of lung and respiratory diseases," explains Terence Cryan, President of Medical Acoustics.

The Lung Flute is Medical Acoustics’ first product and shaped like a flute that creates a specific low-frequency sound when the user blows into it. The hand-held, disposable device creates vibrations in the lung which cause secretions to thin and be expelled. The device is very comfortable for the patient and could greatly enhance testing significantly as the procedure can be repeated every 20 minutes.

"The applications for our device are far-ranging. They include, for example, public health officials using the Lung Flute® to quickly and effectively gather sputum samples to screen for tuberculosis (TB), or even health clinics using it to clear the lungs of asthma patients. Our novel technology is now accessible to over 300 million people throughout the European Union," concludes Cryan.

What is BLOGRUSH?

Quick Change Lancets

2007-12-29T17:44:00.001+08:00

Although taking a tiny blood sample for self-monitoring should be as easy as possible for the diabetic patient, this has not been an easy task because changing a used lancet has proved a fiddly and often daunting job.

Now a blood testing kit named Accu-Chek Multiclix has been launched Roche Diagnostics, and this has an integrated, replaceable lancet drum that carries six lancets. After using one, the diabetic rotates the integrated drum, which moves a fresh lancet into position. In addition, there are eleven settings for the pricking depth, to suit individual skin types and make contact gentler.

What is BLOGRUSH?

Innovation Solution for Hearing Loss

2007-12-29T17:38:00.000+08:00

Otologics’ Carina could improve the quality of life for patients suffering from hearing loss. The fully implantable hearing device uses a transducer to move the middle ear bones - much like the eardrum causes the middle ear bones to vibrate in response to sound wave. Carina implantation surgery takes about three hours and is an easy procedure with low surgical risks.

What is BLOGRUSH?

Safety Blood Collection Set

2007-12-22T15:44:00.000+08:00

The VACUETTE® SAFETY BLOOD COLLECTION SET improves safety for blood collection personnel as well as increasing patient protection. Even when dealing with patients with difficult vein conditions, this product is a safer alternative to other conventional blood collection sets; it aims at
simplified handling and maximal flexibility. The vein puncture proceeds as normal, and blood flashback is clearly seen through the translucent shield.

However, following completion of the blood collection, the safety mechanism can be easily activated
by pressing in both sides of the security lock. The translucent needle shield is then pulled over the cannula until it is locked in place. An audible click indicates that the safety mechanism has been correctly activated. The cannula is completely isolated and securely locked into a closed system. The needlestick risk is reduced to an absolute minimum.

There are three versions of the VACUETTE® Safety Blood Collection Set available:

Standard version (without Luer adapter)—21 or 23 G
Standard version (with Luer adapter)—21 or 23 G
Version with Luer adapter + tube holder—21 or 23 G

What is BLOGRUSH?

Criteria for Medical Device Automation Builders

2007-12-21T23:55:00.000+08:00

Medical Device Assembly Automation Validation Documentation:

Machine Builders has prepared Design Qualification Reports, Installation Qualification protocols and Operational Qualification protocols for our medical device assembly automation customers.
They also participated in the execution of the IQ and OQ protocols at our medical assembly customers’ facilities.
Machine Builders must understands our medical assembly customers’ needs for a successful Performance Qualification and designs our automation assembly systems with this in mind.

Medical Device Assembly Automation Support Documentation:

Machine Builder develops a Functional Design Specification from our customers’ User’s Requirements Specification and equipment specification proposal.
Every change to the scope of the project is documented with a signed Engineering Change Order.
We work with customers on their FEMA to insure the equipment identifies all critical assembly issues.

Medical Device Assembly Automation Data Collection and Storage:

Machine Builder incorporates all relevant requirements of 21CFR Part 11 in the design of the systems as required for electronic records and signatures. Ensure that they have designed and built automation equipment to print, apply and read unique barcodes. Device Assembly and test data is collected and stored by product ID in a database with batch number, date and time stamp.
Batch records are down loaded to servers and file comparison is used for transfer confirmation.
SPC and process tracking used in the design of the controls systems.

Machine Builder understands the critical issues of custom Medical Device Assembly Automation and will be sure that nothing is missed along the way. They perform this regularly so they know the proper steps required.

What is BLOGRUSH?

MEDICAL DEVICE ASSEMBLY AUTOMATION

2007-12-21T23:53:00.000+08:00

INNOVATIVE has been designing and building custom automation equipment for the medical device assembly industry since our company was founded. We have built many automated medical device assembly systems over the years in accordance with the GMP Guide, and we understand the FDA validation requirements to which our medical device assembly automation equipment and pharmaceutical customers must comply.

Medical Device Assembly Automation Design for Validation:

INNOVATIVE designs automation equipment for installation in clean room environments.
We custom manufacture all contact tooling utilizing only non-contaminating materials.
We design calibration tools and procedures for each online measurement test.
Reject stations are designed with sensors to verify out of specification product is properly removed. Rejected product is often marked or purposely damaged to prevent accidental usage.
Computer programs are written to insure critical sensors function each cycle of the machine.
Computer program structures are written in a format easy to validate.

What is BLOGRUSH?

How Clean Is Your Clean Room?

2007-12-05T23:49:00.000+08:00

After investment in a clean room, cleanliness, sanitisation or sterility is essential to ensuring it operates at the highest standard. This article advises on the products and maintenance procedures to achieve this.

Continuing cleanliness
When a medical device company identifies the need for a clean room, much time, thought and effort go into planning and designing the room, and determining the classification needed and which air filters are required to achieve this standard. But how much thought goes into maintaining the cleanliness of the room thereafter? Once the room is installed and operational, the air filters alone will not ensure that the room maintains its cleanliness. Stringent cleaning measures must also be taken.

There is a wide range of cleaning products on the market, but how does a company determine what is best for it, particularly if it has little prior experience of clean rooms? As a starting point, the company needs to define “clean:” does the room need to be clean, sanitised or sterile?

For a clean room to be clean, not only does the visible dirt need to be removed, but also any contaminants that could have a detrimental effect on the products or materials being worked on. For example, hard particles such as paint, concrete or metal can cause damage to the surface of the product they come into contact with and soft particles such as skin, hair and clothing can interfere with the operation of the device.

Determine acceptable contamination
Different parts of the clean room will be dirtier than others. These areas can be classified as “critical,” “general” and “outside.” For example, surfaces that have more contact from people will be dirtier than those that do not, that is, floors and doors will be dirtier than ceilings and walls. Those high-contact areas will be classified as critical. Once this has been determined, acceptable or tolerable levels of contaminants can then be agreed.

Distinction needs to be made between disinfecting, sanitising or treating with anti-static solutions. There are many different products available, each having a different purpose and level of effectiveness. As a starting point, a vacuum cleaner is effective at picking up larger particles, but an alternative method will be required for particles of 10 μm or smaller. Wet mops, dry wipes with liquid or impregnated wipes are effective because they attract smaller particles. However, there are disadvantages to wipes. Reusable wipes and mops tend to shed the least, but are the most absorbent. Conversely, highly absorbent disposable wipes and mops also tend to shed more. Tacky wipes can be used on smooth or glazed surfaces. These are generally solvent free, which reduces the risk of fumes and resistance build up in bacterial organisms.

Select the cleaning agents
When choosing cleaning agents, consideration needs to be given to the results required, the surfaces being cleaned, other chemicals being used, timescale and temperature. All of these decisions will be determined by the devices being manufactured.

Detergents are used to remove dirt, grease and soil. These will not necessarily kill bacteria, viruses, mould or fungi; therefore, additional products will be required.

Disinfectants reduce or kill bacteria and should only be used on clean surfaces; that is, those that are free from dirt, grease and soil. Many contain other chemicals to assist in the cleaning process, for example, surfactants to control foaming and to improve the wetting properties or alcohol to increase the drying time of the product. They are effective at fighting disease-causing microbes but will not kill spores. Sanitisers act as a detergent and a disinfectant combined.

Antibacterial cleaners will only kill bacteria; antimicrobials will kill bacteria, viruses and moulds; sporicides will kill microbial spores, especially bacterial spores and microbial spores.

Consider consistency
To ensure consistency in cleaning products, diluted disinfectants and detergents (unless sterile) should only be stored for a defined period of time. In clean rooms of grades A and B, disinfectants and detergents must be sterile. These products should be rotated regularly to ensure resistant strains do not develop and regular checks should be undertaken. Clean-room management will need to determine the frequency that rotation takes place and whether to use one or more supplier. If static is an issue, nonionic or cationic detergents diluted with water are suitable. If using alcohol as a sanitiser, consideration needs to be given to the contact time. Alcohols generally evaporate in less than 30 seconds and it may also be necessary to use a microbial inhibitor.

For floors and walls, phenols and quats are generally used; they tend to be avoided on other surfaces because they can be corrosive. Best practice recommends rotating these products regularly to reduce the risk of developing resistant strains of micro-organisms. Care should be taken, however, because soaps and anionic detergents can inactivate quats.

Purchasing decisions may also be influenced by the contact time of the cleaning product. Some products work more effectively if left on a surface for a given length of time. This will not present problems on horizontal surfaces, but may prove difficult on vertical surfaces. Some disinfectants work better at higher temperatures, which will influence the contact time needed. If it is not possible to alter the ambient temperature of a room, the contact time may need to be altered. If a longer contact time is not possible because of operational time constraints, the concentration of the disinfectant can be increased to improve its bactericidal activity. However, the cost implication of this should also be borne in mind.

In addition to the above, the clean-room manager needs to be confident that the products used meet other criteria:

• Has it been through a validated sterilisation process?
• Has it been manufactured under good manufacturing practices?
• How stable is the product?
• What is its shelf life?
• Does the product come with batch certification and traceability?

Follow a good routine
Establishing a cleaning routine will help achieve the best results. General guidelines suggest cleaning from the dirtiest areas to the cleanest and beginning with the highest classification area/room. In a vertical laminar flow room, the room should be cleaned from top to bottom, and a horizontal flow room should be cleaned from back to front. To ensure that all areas are cleaned and none missed, a grid approach is often used. The room can be split into manageable squares of, for example, 30 m². Care should be taken to ensure that all cleaning is done in straight horizontal lines, each one overlapping the previous one by 10–20%, and never in a circular motion.

Establishing and adhering to a well-prepared cleaning programme will considerably help to ensure that the clean room operates to the highest standard. After all, the return on the investment made in setting up the clean room should not be reduced by an inferior cleaning routine.

What is BLOGRUSH?

Catheter Hole Making

2007-12-05T23:44:00.000+08:00

The science and technology of making good quality holes in tubing is an important issue for the success of the application. The process options and their benefits and limitations are examined.

Designing new catheters, or enhancing current designs, is a complex process. Especially now that catheters are getting smaller in diameter, designed for multiple functions, and in some cases steerable or implantable. From simple drainage catheters to complicated neurological and cardiovascular catheters, catheter designs must be robust, they must be able to be produced reliably, and their quality must be reproducible. Bonded junctions must meet pull-test strength requirements; formed tips must be smooth and flash-free; the tubing must be flexible yet rigid enough to avoid kinking; and flow rates through the lumens must meet tight requirements. So, why is the process for placing holes in catheter tubing typically an afterthought in its design?

Even today there are production lines staffed by people who are cutting notches in catheter tubing using straight blades. In some cases, this is sufficient. In most cases, however, hole position, size and quality are critical aspects to the form and function of the catheter design. In addition, because hole cutting is typically conducted at or near the end of the production cycle where unit scrap costs are most significant, it makes sense to consider the best type of hole for the application and the best process to make those holes.

Hole making in catheter tubing is accomplished using one of two methods: laser or mechanical processing. Laser processing is recommended when hole diameters range from 0.1 mm down to the hundreds of microns; this is not the subject of this article. For hole diameters greater than 0.1 mm, mechanical hole making is the most widely utilised and least expensive method for placing holes in catheter tubing. However, the science and technology that goes into mechanical hole making should not be underestimated.

With a few exceptions, the hollow-core cutter is the tool most utilised to create holes in catheter tubing. This seemingly simple and inexpensive tool is designed to cut through the wall of the tube and removed the “plug” with as little distortion or remaining flash as possible. The plug is then ejected from, or fed through, the cutter in preparation for another cut. In reality, these hollow-core cutters are highly engineered tools and selecting the right style could make the difference between success and failure of the application.

Some of the considerations when selecting the right tool for the application includes the style of the cutter tip, that is, the position of the cutting edge in relation to the outside diameter (O.D.) and inside diameter (I.D.) of the cutter, the grade of cutter material (for example stainless steel) and whether or not coating is beneficial. The style of the cutter tip, in combination with the processing method and tubing polymer, determine the resultant hole geometry and quality of the cut. The type of cutter material and coating has an effect on the cutter life and wear characteristics, and also has an impact on the cost of the cutter.

The next consideration when mechanically cutting holes into catheter tubing is the three basic types of processes: drilling, skiving and punching. Within each of these types of hole-making processes, there are nuances that could have a great impact on the resultant quality of the hole and production cycle times.

Drilling is the most commonly employed process for catheter hole making. It is performed using a round, rotating, hollow core cutter to remove the plug and gain access to the lumen. Some of the
benefits of drilling include:

* good hole quality and geometry, the plugs are cylindrical in shape
* drilling can be conducted with or without the use of an I.D. support mandrel
* cutter life is best when employed for drilling.

Some limitations to drilling include the fact that the ratio of tubing wall thickness to hole diameter needs to be less than 2:1 and, with certain polymers, flash can occur in the tubing when not using an I.D. support mandrel.

Skiving is a form of drilling and the process of side porting that most resembles the result of manually using a razor blade to notch the tubing. The resultant hole when skiving is that of an “eye” shape where the major and minor axis dimensions are controlled through cutter diameter and depth of cut. When skiving, there is no need for an I.D. support mandrel and no chance that the removed portion of the tubing wall or “chip” will remain in the tubing. Another benefit to skiving is the ability to access the complete lumen diameter when maximum fluid flow rate or guidewire access is required. The best quality of cut is obtained using a cutter with an O.D. cutting edge and close-tolerance fixtures that stabilise the tubing to minimise flash.

Punching creates a hole using a round or shaped cutter that is not under rotation (Figure 4). The benefits of punching include:

* its ability to make any shaped hole, whether oval, triangular or square
* its suitability for thick-walled tubing with up to 4:1 ratio of wall thickness to hole diameter, or braided tubing.

Punching is preferable for this size tubing for the following reasons. Drilling thick-walled tubing has a higher potential to leave flash because the plug begins to rotate with the cutter before it completes the cut. With braided tubing, the wire braid must be sheared to cut cleanly. Drilling tends to distort the wire (and plastic) before completing the cut resulting in burrs and flash.

A common result when punching, especially in thick-walled or low durometer tubing, is that the resultant hole geometry is typically tapered: the entry is equal to the cutter diameter and tends to be slightly smaller at the exit diameter into the lumen I.D.. To minimise the hole taper and flash in the I.D., punching is usually done with the use of an I.D. support mandrel made from low density polymers such as low density polyethylene. However, when punching without the use of an I.D. support mandrel such as with through-punching, the resultant hole geometry is unique to each application in combination with the cutter tip style selected. For example, in some cases the hole taper will invert with larger hole diameter at the I.D. than at the O.D. of the tubing. In others, the hole through the wall of the tube where the punch entered is conical, but the hole through the exit wall may be cylindrical.

Whatever the application may be, whether the tubing is multilumen or single lumen, shaped or round, tipped, formed or braided, with the proper tools and production equipment, catheter hole making can be done efficiently and effectively. It all starts with selecting the right tool for the job.

What is BLOGRUSH?

FDA Human Factors Requirements

2007-12-05T21:32:00.000+08:00

As a manufacturer, you are required by FDA (and other international regulatory bodies) to demonstrate how human factors considerations were met during your product's development. To assist manufacturers in understanding the regulations, FDA has issued several guidance documents to support its human factors initiative, including

Do It By Design: An Introduction to Human Factors in Medical Devices
and
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.

However, the "teeth" behind their human factors requirements lay in Section 820.30 of the QSR, in paragraphs (c), (f), and (g):

(c) Design Input:
"Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the users and patient."

FDA's goal is to ensure that manufacturers make a systematic assessment of who will be using a device (user population), the conditions under which it will be used (use environment, situational factors), how it will be used (tasks, usage scenarios for the full life of the product), and whether there are use-related hazards (can it be used safely).

Human factors activities for generating design inputs include things like user research studies (focus groups, one-on-one interviews, contextual inquiry), task analysis, Usability & Safety Bench Tests, and usability testing of design concepts.

(f) Design Verification:
"Each manufacturer shall establish and maintain procedures for verifying the design input. Design verification shall confirm that the design output meets the design input requirements."

Verification pertains to inspection, analysis, and testing of your device against requirements. Human Factors techniques for verification include Usability & Safety Bench tests and usability testing.

( g ) Design validation:
"Design validation shall ensure that devices conform to defined user needs and intended uses, and shall include testing of production units under actual or simulated use conditions."

Validation addresses the broader issue of whether the device can be used safely in real-world situations. FDA expects you to conduct usability testing with actual users under simulated (but as real as possible) conditions, using production or pre-production models.

The primary human factors techniques for design validation is usability testing.

Paragraph (g) also references risk analysis:
"Design validation shall include...risk analysis...."

Throughout product design and development, FDA expects manufacturers to engage in risk management. The human factors focus for risk management is on so-called use-related errors. Risk management of use-related errors involves identifying and describing use scenarios that result in hazards, assessing risk, introducing user interface design changes that eliminate or mitigate risk, verifying that design changes do mitigate risk and that no new hazards are introduced, and validating that the final device can be used safely and effectively. These goals can usually be met as part of the task analysis, expert review, and usability testing activities discussed above.

FDA expects investments in human factors by manufacturers to be commensurate with a device's inherent risk: the greater the risk associated with error, the more human factors effort is warranted. However, there are no hard and fast rules (only guidelines) and in the end, it's up to the company to decide what human factors work to conduct during product development. Device manufacturers need to be satisfied that what they have done is sufficient to ensure that their device can be used safely and effectively, and that they can justify their level of human factors effort to FDA if asked.

What is BLOGRUSH?

IVD Sales flourish

2007-12-05T21:28:00.000+08:00

Sales of in vitro diagnostic (IVD) products in Europe reached €9217 million in 2006, according to estimates published by the European Diagnostic Manufacturers Association (EDMA). This figure is based on data combined from EU and European Free Trade Association countries. Average IVD sales in most European countries represented less than 2% of the total health care expenditure (THE), with traditional EU countries spending a lower percentage of THE on IVD products than the new Member States. In terms of spending per capita, however, the two newest EU member states, Bulgaria and Romania, were the lowest, spending €169 and €204, respectively. Switzerland and Norway were the highest spenders, showing €4525 and €4736, respectively. This compares with €5102 spent per capita in the United States.

What is BLOGRUSH?

Powder Injection Molding (PIM)

2007-11-14T22:10:00.000+08:00

Powder injection molding (PIM) is a manufacturing solution for producing intricate parts in medium to high volumes (10,000 to over 2,000,000 parts annually) using fine (<20 µm) metal or ceramic powders.

PIM combines the material flexibility of powder metallurgy and the design flexibility of plastic molding. With properties comparable, or better than, those of wrought steel, the PIM process is ideally suited to producing small and complex-shaped parts with outstanding mechanical properties.

PIM is capable of transforming complex concepts & designs into high precision, high final properties, and net-shaped products from a wide range of materials such as carbon steels, low alloy steels, stainless steels, low expansion alloys (kovar and invar), tool steels, soft magnetic alloys, super alloys, to conductive materials (copper), and ceramics.

PIM is well suited for parts weighing from 0.1gm to 250 gm. Cross sections are typically less than 0.25 in. (6.35 mm). However, parts are not restricted to this combination of mass and cross section. Tolerances are on the order of ±0.3 to 0.5%, albeit specific dimensions can be held as close as ±0.1%.

In addition to cost-effective, high-volume production, other PIM benefits include:

Complex geometries
Close porosity
Excellent surface finish
High performance
High final density (93-99%)

The Process
Mixing
Very fine metal or ceramic powders are mixed with thermoplastic polymer (known as the binder) to form a homogeneous mixture of ingredients that is pelletized and directly fed into a injection molding machine. This pelletized powder-polymer mixture is known as feedstock.

Injection
In this process, the feedstock is heated to melt the binder content in order to form the desired component geometry. The molded part is known as the green part.

Debinding
The polymeric binder is removed from green part by thermal heating to approximately 400°C or 752°F. The result is known as the brown part that still contains its original geometry and size.

Sintering
In this process, the brown part is heated to approximately 85% of the material's melting temperature, allowing densification and shrinking of the powder into a dense solid with the elimination of pores. The sintered density is approximately 98% of theoretical. The end result is a net shape or near net-shape metal or ceramic component, with properties similar to that of bar stock.

Materials

Category Examples of materials processed by PIM
Carbon Steel 1010, 1060
Low Alloy Steel Fe-2Ni, Fe-2Ni-0.5C, Fe-2Ni-0.5C-HT, Fe-8Ni, SAE 4650
Stainless Steel 316L, 430L, 440C, 440C-HT, 17-4PH, 17-4PH -HT,
HK 30, SUS 420J2, SUS 310
Low Expansion Alloy Kovar, Invar
Tool Steel M2
Soft Magnetic Alloy Pure Iron, Fe-3Si, Alloy 52, Permendur, Permalloy
Super Alloy Inconel 718, Hastelloy X, F75
Heat Conductive Copper, W-15Cu
Heavy Alloy 90Fe-Ni, 92W-Fe-Ni, 95W-Fe-Ni
Ceramic Alumina, Zirconia, Spinel

Advantages

PIM enables processing of high melting point metals and ceramics with the following benefits: Attractive cost savings
Wide latitude of part shape, sizes (0.1g to 250g) and design
Ability to combine functions and eliminate sub-assemblies
Good dimensional control with close tolerances of ±0.5%
Net shape production, eliminating or minimizes machining
Wide range of available alloys, composites and properties
Cost efficient for moderate-to-high production volume
Suitable for intricate and complex geometries
High material density and strength Design flexibility Produce good surface finishes

What is BLOGRUSH?

Kohjinsha laptop. PDA or UMPC?

2007-11-13T23:59:00.000+08:00

Kohjinsha laptop. PDA or UMPC?

While the recent trend has been to launch high performance laptop, Kohjinsha sport an impressive notebook that combine high features with a low price. I'd never wanted to have an laptop like the Kohjinsha SA1F00.

Launched in Japan this compact laptop are similar to Flybook, but smaller, and both have an rotating display, up to 180 degree. It comes with all the usual features you'd expect from a laptop computer, smaller of an classic notebook but larger than a pda it measures 218 x 163 x 25.4mm and weigh 960g. It pack 500MHz Goede LX800 processor 1GB of memory, up to 40GB hard drive and With an full plastic jacket, silvery keypad, still make it an attractive laptop.

With only 800x480 pixel resolution, it includes audio ports, a VGA connector and a single battery allows up to 5 hours of continuous use. It also equipped Bluetooth 2.0, 802.11b.g Wi-Fi, SD card slot, two USB ports, and speakers. Price starts from $750 with 40gb of hard drive to $930 with 80gb Hard drive.

Now, showed here is a images of the Kohjinsha SH-series UMPC bumped to Intel A110 processor.

The new SH8-series eases the processor up a notch to an 800MHz Intel A110 while stiffening the disk to 120GB -- 32GB SSDs still available. Unfortunately, they've somehow managed to decrease battery life from 3.5- to 3.3-hours with the SSD, or 3.1-hours with an HDD -- a real no-no for ultraportables. You'll be looking at ¥238,000 (about $2,047) fully specced with a 1Seg TV tuner and Vista / MS Office pre-load when these hit Japan in September. Docked, white-on-black style after the break.

What is BLOGRUSH?

Laptop Notebook Computers - What Are They?

2007-11-13T23:31:00.000+08:00

A notebook computer, sometimes called a laptop, typically weighs less than 5 pounds and is 3 inches or less in thickness. "Notebook Computers" is another term for the portable computer. Notebook computers are no longer fancy toys; the notebooks are being used as business tools ready to compete with your desktop computer.

With wireless cards you now have entertainment on the go. There's a huge selection of wide-screen, light weight, top-of-the-line, and multimedia notebook computers. Desktop performance in a notebook including wireless features with the versatile range. So you can take your notebook on the road.

Notebook computers generally cost more than desktop computers with the same capabilities because they are more difficult to design and manufacture. Think you can't afford a notebook. Now you can get some at reasonable prices. But before purchasing cheap notebook computers, it is wise to look through reviews to get an idea of the model best suited for your individual needs. You might get a good price just to get it home and find out you can do no more than play games on it.

Your search should include cost and needs. Battery Laptops usually run on a single main battery or from an external AC/DC adapter which can charge the battery while you are using it. Typical battery life for most notebooks is two to five hours with light use, but may drop to as little as one hour with lots of use. And that means you can expect battery life at best touching the five hour mark.

What is BLOGRUSH?

Medical Superbill Software

2007-11-13T23:23:00.000+08:00

The tracking and monitoring of patients' medical information had never been so easy after introduction of Medical Superbill Software popularly called as 2KMobile Link Superbill Software.

This Medical Office Superbill Software is accessible from any normal internet access device such as: cellular phones, PDAs, tablet PCs, laptops and mobile devices. In fact, this Medical Superbill Software enables you to a real time access to a physician's practice management system database. The doctors find this software handy for scheduling appointments, creating superbills, viewing patients' information and connecting to the patients' information database of data. The 2KMobile link software is accessible with any cell phones supporting I.E 5.0 or any higher version and if embedded with Wi-Fi technology then it further enhances the performance.

Basic Requirements
The following are the basic requirements for installing the Medical Superbill Software:

Cellular phones supporting internet access especially Windows Mobile with I.E 5.0 and higher version are recommended
High speed Internet as its not supporting dial-up connections.
One Server (where the superbill software is installed) - The server should have static IP address. The software is compatible with Windows XP Professional, Windows 2000 server or Windows 2003 server. However, it is not supportive with Windows XP Home or Windows Media Edition.
Some Medical Practice Management Softwares such as: Lytec or Medisoft etc. This 2k Mobile Link Superbill Software not only provides the liberty to the medical practitioners to access their patients' database but it also enhances their multi-tasking capability.

The following are some of the activities that can be performed through the Superbill Softwares.

Creating, viewing, copying and printing superbills from anywhere where internet connectivity is available.
Creating, viewing and editing patient information.
Reviewing and editing new information or entries, setting up user rights and patient profiles, and creating Superbill rules to reduce claim denials with the Administrative Panel.
Reading and writing to the Medical Practice Management System Database with ease.
Medical Appointment Scheduling Software enables to create, view and edit patient appointments.
2KMobile Link Patient Scheduling Software not only helps in creating, viewing and editing the diagnosis and cpt codes of patients but also provides refined researching option to the medical practitioners.

This Medical Office Superbill Software also comes up with a customized display option for the superbill screen where the users can view the reports as per their required format. It also provides a search option from the patients' database on patient type or category basis.

The recommended devices for 2K Mobile Link Providers are: the Palm Treo and Treo Smartphone, Mobile Pocket PC phones, Blackberry Mobile phones, Sprint Power Vision Smart Devices (such as: Treo 700wx by palm, PPC 6601, PPC 6700, MOTO Q by Motorola and IP-830 by Samsung), T-Mobile (Wing & Dash), Verizon (Treo 700w by palm, Motorola Q and XV 6700) and AT&T-8525, Cingular-8125, Treo &50 by palm and Blackjack by Samsung. There are lots of attractive offers provided by 2kmobilelink.com .

The tracking and monitoring of patients' medical information had never been so easy after introduction of Medical Superbill Software popularly called as2KMobile Link Superbill Software 2KMobile Link Superbill Software. This Medical Office Superbill Software is accessible from any normal internet access device.
What is BLOGRUSH?

Injection Molding Machine: Body Parts (Part 2)

2007-09-17T22:53:00.000+08:00

Mold Closing Unit
Opens and closes the mold, and during the injection, keeps the mold closed under powerful clamping forces so that the mold is not opened by the resin pressure. Consists of following parts:

Platen (Die Plates) - A pair of plates to which the mold is mounted, consisting of a fixed platen on the nozzle side, and a moving platen that opens and closed the mold.
Tie-Bar - Supports the platens and becomes a sliding guide for the open-close motion of the mold. In case of a straight hydraulic mold clamping system, supports the reaction force of the clamping force, while in case of a toggle type, stretches to generate the clamping force by means of elasticity recovery force.
Mold Clamping Cylinder - A hydraulic cylinder that opens and closes the mold, and generates the clamping force. In the straight hydraulic mold clamping system, the ram is directly connected to the platen, whereas in the toggle type, the toggle mechanism stands between for amplifying the force.
Mold Thickness Adjuster - Available in toggle type only. Actuating position of the toggle type being constant, this device is provided to enable the effective movement of the toggle in accordance with the thickness of the mold.
Ejector - Ejects the product at the time of mold opening for mold removal.
Safety Door - Protects the operator so that he is not caught in the mold. Mold will not clamped as long as this door is opened.

Hydraulic Drive System
Mechanical motions of the mold clamping unit as well as injection unit are actuated by hydraulic cylinder. This is the system that gives such energy to the hydraulic cylinder. Consists of the power source sch as electric motor or pump, control parts such as pressure reducing valve, relief valve, direction switch valve or flow control valve, hydraulic units such as cylinder or hydraulic oil motor, accessories sch as strainer, cooler or filter, and hydraulic oil reservoir and hydraulic pipings, etc.

Electrical Control System
Actuates the various parts in the order of sequence. Consists of selector switches, limit switches, timers and relays to actuate the mold clamping or injection, etc.. The system comprises of the following 3 portions

Temperature controls for the heating cylinder and nozzle. (Heater circuit)
Motion Control (Control circuit)
Power control (Motor circuit)

Injection Molding Machine: Body Parts (Part 1)

2007-09-17T22:30:00.000+08:00

Frame
This is the base of the machine on which injection unit, mold clamping unit and hydraulic drive system, etc. are mounted. In case of hydraulically driven machine, the internal of the frame may also used as an hydraulic oil reservoir. It is normally made of steel plate welded construction, as it is required to have sufficient strength and rigidity so as to maintain the accuracy for long period of time withstanding the forces generated in various part of the machine as well as the vibrations.

Injection Unit
This is the unit that melts the resin, measures the predetermined amount of resin, and inject it into the mold. The system consists of the followings:

Hopper - The storage tank for the plastic material resin to be stored and dropped to the heating cylinder is fitted with a shutter.
Heating Cylinder - The portion that melts and injects the plastics.
Nozzle - Installed at the front end of the heating cylinder, and closely touches to the spool bush of the mold to form a flow-path for the molten resin during injection.
Injection Cylinder - A hydraulic cylinder that advances the screw, generating the injection pressure as well as the injection speed back pressure.
Screw Drive System - The mechanism that gives a rotation to the screw, consisting of a driver (hydraulic motor or electric motor) and a speed redcer.
Injection Table - A base of the injection unit which accomodates the heating cylinder, injection cylinder, screw driving system, etc.

Injection Molding: Fundamental Knowledge of Injection Molding

2007-09-17T22:12:00.000+08:00

Construction of Injection Molding Machine

Injection molding machine for thermoplastic resin, particularly the in-line-screw type machine which is most prevailing today. This type in which a single screw performs the dual functions of plasticizing as well as injection. The advantage of this design is that the homogeneous melt is obtained with smaller area for the resin to dwell and smaller pressure loss.

The injection molding machine can be roughly divided into following portions:

Frame
Injection Unit
Plasticizing Unit
Mold Clampling Unit
Hydraulic Drive System
Electric Control System

Evaluation of The BD Integra 3ml Syringe

2007-09-07T14:16:00.000+08:00

In this age of managed care and escalating health care costs, not only is it important to deliver medications safely but to do so in a cost-effective manner. In an effort to meet these needs, BD has designed a 3ml syringe and needle, known as the BD Integra Syringe with Retracting BD PrecisionGlide Needle.

The BD Integra Syringe with Retracting BD PrecisionGlide Needle is a safety-engineered device which activates when the user continues to press down on the plunger at the end of the injection, triggering the retraction of the needle backwards into the syringe. An added design feature of this system is low waste space volume.

All needles and syringes have waste space. In traditional needles and syringes, the waste space volume is a consequence of residual medication remaining within the syringe tip, needle hub and cannula after injection is complete. The BD Integra Syringe with Retracting BD PrecisionGlide Needle has a specially designed hub and corresponding syringe connection site, known as Tru-Lok. As a result of this innovative design, the BD Integra Syringe with Retracting BD PrecisionGlide Needle has less waste space volume than conventional syringe/needle combinations (data on file).
Two evaluations of the BD Integra 3ml Syringe with Retracting BD PrecisionGlide Needle were conducted in the Fall of 2003 during two Influenza vaccine programs to evaluate the low waste space design when using multidose vials. The first evaluation was conducted at the Employee Health Department at Texas Children’s Hospital in Houston, Texas and the second was conducted at Test-med, an on-site Influenza vaccination provider in San Francisco, California.
By using the BD Integra 3ml Syringe with Retracting BD PrecisionGlide Needle, both Texas Children’s Hospital and Test-med were able to maximize their Influenza vaccine supply and gain, on average, one extra dose per 10 dose vial of Influenza vaccine.

Read More ..........

Innovative Safety Syringe

2007-09-07T13:56:00.000+08:00

Inviro Medical is the maker of the innovative InviroSNAP! Safety Syringe, part of the Inviro Safety System, which includes custom-designed retractable safety syringes and needleless syringes.

The InviroSNAP! Safety Syringe was invented by a nurse and physician practicing at the Center of Excellence for the Treatment of AIDS at St. Paul’s Hospital in Vancouver. The safety feature of our retractable safety syringes is an integral part of the product. It allows the user’s hands and fingers to remain behind the needle, and, once activated, the safety syringe is permanently disabled and cannot be reused.

Push…Pull…Snap! Our Retractable Safety Syringes Are Easy to Use!
Using the InviroSNAP! Safety Syringe is as easy as ... Push. Pull. Snap! Once the dose is given, simply push the plunger fully to engage the safety mechanism. Pull the plunger back to retract the needle inside the barrel, and SNAP! off the plunger. The user’s hands remain behind the needle of our retractable safety syringes during activation of the safety feature.

Alongside our retractable syringes, the Inviro Safety System includes InviroLINK – a needleless vial access device. The Inviro Safety System is compatible with split septum and needlefree connector IV injection sites.

A Better Choice for Infection Control Professionals
Inviro believes, and the 2006 Independent Study of Needlestick Injuries confirms, that as healthcare professionals strive to enhance their safety efforts, they should seek:

New technology, not retrofitted designs.

Retractable safety syringes that immediately protect against needlestick injuries Prevention of the possibility of the reuse of syringes or needles. Ease of use and minimal change in standard filling and injection techniques

The InviroSNAP! Safety Syringe is the cornerstone of the Inviro Safety System. This breakthrough safety syringe was designed by a practicing nurse and surgeon to reduce the potential for needlesticks to healthcare workers. The unique product was engineered with the safety feature integral to its design, unlike most safety syringes that are retro-fitted using add-on pieces.

The InviroSNAP! Safety Syringe takes sharps safety to the next level with a new category of safety syringe that bridges the gap between bulky retro-fitted models and more expensive automatic retractable syringes. Its revolutionary design as a manually retractable syringe places InviroSNAP! in a next generation product category all its own.

Inviro Medical introduces the Inviro Safety System, a comprehensive product line that includes our patented retracting needle syringe as well as needleless access devices that replace conventional syringes. The Inviro Safety System features safety syringes with fixed and exchangeable retractable needles in a wide range of sizes plus vial access plastic cannulae and syringes for split septum or needlefree connector IV injection sites.

The Inviro Safety System is currently divided into two product categories: the InviroSNAP! Safety Syringe Injection System and the Inviro Needleless Vial Access System. Simply click the products in the image below for more information about any of our products in either line.

Cleanroom Packaging: 10 Questions to Ask

2007-08-27T23:05:00.000+08:00

Medical device manufacturers require specific cleanroom performance from their outsourcers.
Here is how to make sure a potential sterile packaging provider is right for you.

In today’s competitive market, many outsourcing companies claim to run top-of-the-line cleanroom facilities for packaging sterile medical devices. But not all cleanrooms are the same.

It is important to understand that fundamental differences exist between cleanrooms for medical device manufacturers and cleanrooms for manufacturers of machinery, optical products, high-end electronics, and other devices not intended to penetrate the skin or interact with open wounds. Medical OEMs that produce orthopedic or spinal implant technologies, for example, require cleanrooms that demonstrate extremely low bioburden rates as well as those that can restrict airborne particles. Airborne particles are the enemy of hard drives and microchips, whereas both particles and microorganisms pose a threat to medical devices.

Medical device OEMs need cleanrooms that have an established platform of technology and biocontamination protocols that extend through component preparation, product assembly, packaging, and testing of sterile medical devices and surgical products.

Since quality is a key factor in the success or failure of many medical device manufacturers, how does a medical device maker search out a facility that packages a product to current rigorous standards? This article presents 10 questions that medical device manufacturers should ask potential partners and themselves when choosing a cleanroom service provider.

1. Does the Cleanroom Actually Exist, or Is It Simply a Marked-Off Area?

Many outsourcing companies recognize the value of cleanroom services to their customers. However, some have not invested the time, attention, and financial resources necessary to build a cleanroom facility that meets the sterilization standards required by medical device manufacturers. Cleanrooms must be constructed with the proper components in order to meet these standards. These components include a separate air-conditioning system and sealed, particle-free ceiling tiles. Also important are plenum grids that enable proper placement of HEPA filtration units at optimal locations as well as hollow-wall air returns that allow previously cleaned air to be recycled. Such returns extend the life of the HEPA filters cleaning the air.

Ideally, cleanrooms should employ technologically advanced systems that control airflow direction and rates. They should also use calibrated and validated equipment to measure pressure, relative humidity, particles, and temperature within the operating space. Equipment, workspace fixtures, and accessories and supply bins can all be cleanroom certified, meaning that each item reduces particle production and can be thoroughly cleaned to limit biocontamination. Cleanroom specialists wear protective garments and are trained in sterilized packaging techniques, cleaning protocols, and system-monitoring practices. Personnel and packaging materials enter the cleanroom through air-lock doors on entrances and exits that maintain the appropriate room pressure and temperature.

The best way for an OEM to know whether a cleanroom is truly clean is to audit the facility. Ask the outsourcing partner to provide an in-depth tour, and then ask to see the outsourcer’s annual cleanroom calibration data and quarterly bioburden test results.

2. Is the Cleanroom Fully Integrated into the Quality System?

The integration should include comprehensive corrective and preventive action protocols to thoroughly address all cleanroom excursions. Outsourcers have a responsibility to their customers to measure, track, and realign any potentially harmful conditions in the cleanroom. Outsourcing companies that take this responsibility seriously are always on the lookout for opportunities to improve their cleanroom systems.

The outsourcer should have a written plan that it can provide to OEMs. Such a plan should provide for revision procedures for aberrant excursion measures and have defined alert and action limits (similar to those for any other department). The plan should also cover cleanroom maintenance and technician training and include up-to-date drawings for equipment placement within the cleanroom. As part of the response plan, any equipment or gauges used to measure cleanroom contaminants must be regularly calibrated and recorded in a calibration log. The best cleanrooms develop their protocols so the parameters dovetail with the standards for their class of cleanroom.

An OEM should engage an outside auditor to assess the validity of the outsourcer’s overall plan. The auditor should also perform regular evaluations of how well the outsourcer is adhering to its own processes and how effectively it responds to any quality concerns.

In addition, the cleanroom’s pressure, temperature, and humidity levels must stay within the action limits defined by the revision procedures. The company must also perform quarterly bioburden assessments, track excursions, and record how problems have been addressed and corrected.

Finally, training records for the cleanroom technicians must match up with the current quality control plan, the drawings used to show equipment placement must be current, and the cleaning log should be used and kept up-to-date. If any of these actions are not performed or are underperformed, the OEM should view that as a red flag.

3. Does the Cleanroom’s Layout Promote Efficiency and Reduce Biocontamination?

Cleanrooms are expensive to build and maintain, and for this reason, each square foot of a cleanroom facility is valuable. The more streamlined the packaging progression by way of the assembly process and traffic patterns, the more cost-efficient the overall sterilized packaging service will be for an OEM. Moreover, the design of a cleanroom also contributes to the flow of air in and out of the room, which relates to the number of particles and microorganisms in the air and on work surfaces.

A well-conceived cleanroom layout, including placement of workstations and machines in relation to walls, enables air to move with uniform velocity and along parallel flow lines, also known as laminar flow. Laminar flow reduces turbulence, which in turn reduces particle production and the introduction of microorganisms. OEMs should seek out packaging partners that consider airflow concerns as well as production capacity when designing their cleanroom footprint.

4. Is Cleanroom Maintenance a Priority?

It sounds obvious, but it bears repeating that a cleanroom is only as good as it is clean. Contamination, in the form of particles and microorganisms, can come from spills and leaks, employees’ skin and clothing, cleaning chemicals and debris, and other outside agents. Many providers of cleanroom packaging services build state-of-the-art facilities that could conceivably address the sterilization requirements of medical device manufacturers. But such cleanrooms cannot consistently prevent the contamination of an end product if they are not maintained with strict protocols. In addition to using proper cleaning procedures, outsourcing partners should use only cleaning products, from disinfecting solutions to tools, that are certified for use inside cleanrooms.

Effective management of the cleaning process is also critical. Outsourcers should employ a regular schedule of facility maintenance that is documented, tracked, and trended to prevent quality breaches. Regular testing of potentially contaminated surfaces should be part of these standard operating procedures. OEMs should review the outsourcing company’s maintenance log records to evaluate the strength of the maintenance program and, more importantly, its implementation.

5. Is a Validated Ultrasonic Clean Line Attached to the Cleanroom?

When a product arrives at an outsourcing company’s facility, it is just beginning its journey through a minefield of opportunities for contamination. Without an ultrasonic clean line to give products the once-over before they enter the cleanroom, products bring with them all the biohazards they have picked up along the way. The end result is increased bioburden within the cleanroom and increased risk of product contamination. Companies without clean lines attached to their cleanrooms are often forced to clean products in the machine shop before the products go through processes like receiving, inspection, and etching. With cleaning as the last step before the product enters the cleanroom, much of the variability is removed. The chances of bioburden spikes are limited to the packaging process, which is the easiest to control because it occurs within the cleanroom.

Ultrasonic lines differ, but an effective line might use several deep-water tanks in which devices are submerged for a three-step cleaning process that employs ultrasonic sound waves. In the first tank, products are lowered with a robotic arm into heated water mixed with a mild detergent. Sound waves create implosions as bubbles hit the products and remove particles. The second tank is the first of two rinse tanks. The water in the second tank, also heated, removes the detergent and any remaining particles with sound waves as well as with cascading water that comes from tank three. Products are moved to the third tank for a final rinse and are then air-dried or dried with hot-air dryers. Using a robotic arm throughout the cleaning of a particular product enables the outsourcer to maintain process consistency for all items.

However, having a clean line attached to the cleanroom is only the first step. For outsourcers to effectively utilize their clean lines, they must perform regular validation testing, including bioburden and, specifically, endotoxin levels. Such validation testing confirms that the clean line is actually reducing the potential for contamination. Medical device OEMs should know at which point their product is cleaned prior to packaging. They should seek outsourcing partners with validated clean lines that serve as the last stop on the road to the cleanroom.

6. Has the Cleanroom Been Audited Multiple Times?

Outsourcers should welcome audits, as painful as they might be. They should accept audits from any source, including clients, FDA, and ISO registrars. Audits should be seen as opportunities to consider an objective view of a company’s cleanroom policies and procedures and a possibility to enhance the sterility of its cleanroom facility.

Audits are often performed for a number of reasons. FDA audits may occur as a part of a client’s application to market a new invasive device. Or, an audit may be a spot-check of a particular vendor. The best outsourcing companies will take the opportunity to gain the confidence of FDA by demonstrating both their expertise and their willingness to learn from the experience and further refine their processes.

Gaining ISO cleanroom certification is another important measure for outsourcers to take. Although some ISO auditors are less stringent because they lack expertise in a particular discipline, most have technical experience in auditing sterile packagers and employ microbiologists who specialize in sterilized cleanroom procedures. In any case, outsourcers must ensure that microbiological controls and particulate counts are audited annually by an outside entity, and OEMs should ask how often and by whom a potential outsourcing partner is audited. In addition, it is important for OEMs to examine the observations that resulted from those audits and how those recommendations were incorporated into the outsourcer’s overall quality control plan.

7. Is the Cleanroom Staffed with Experienced Sterile Packaging Technicians?

There are at least three ways cleanroom personnel can affect bioburden levels in a sterile environment. Those ways include what they wear, how they behave, and how they help maintain cleanroom protocols. People in general are a leading dissemination source of particles and microorganisms through their hair, skin, clothing, cosmetics and perfume, and respiratory emissions. Cleanroom specialists are trained to limit cosmetics and perfumes and to wear garments appropriate for specific cleanroom standards, such as gowns, caps, shoe coverings, gloves, and even face masks. Behavioral requirements, including rate of movement, minimize the transfer of microorganisms and particles.

Finally, regular training reinforces the importance of cleaning procedures and facility maintenance. Medical device OEMs should choose outsourcing partners that hire sterile packaging technicians with cleanroom experience and that invest in their personnel by providing specialized training.

8. Is Testing Paramount?

Even with all the necessary pieces in place, a cleanroom can be a toxic environment if a system breaks down. Outsourcers that use testing to remain vigilant can assure their clients that products meet the highest sterilization standards. Tests that should be performed quarterly include testing of bioburden levels, such as microbial air and surface tests, and dose audits to ensure that products meet validation specifications.

Endotoxin levels in the water of the ultrasonic clean line should also be tested regularly to avoid any contamination to products before they enter the cleanroom. And, of course, all test results must be tracked and trended. A cleanroom should have extremely low bioburden levels, meaning that there are low amounts of bacteria and mold in the air and on surfaces.

Outsourcers should maintain the trend reports to document low bioburden levels. Low bioburden counts are generally 5 CFUs (colony-forming units) or fewer for surface readings. For air readings, low bioburden counts are usually 20 CFU or fewer.

Testing offers an outsourcing company the chance to increase the frequency of cleaning, switch cleaning solutions, or modify maintenance protocols if necessary. OEMs should consider the testing performed, as well as the quality of the test results, a make-or-break part of an outsourcing partnership.

9. Does the Cleanroom Run a Particulate-Monitoring System?

Some outsourcers measure particulate levels every minute at each workstation using a particulate-monitoring system (PMS). This additional testing provides the proof that products were packaged within acceptable particulate levels and provides an opportunity to correct an excursion issue before products ship out. A PMS can provide tight real-time monitoring and control.

Until recently, monitoring particulates has been reserved for firms in the pharmaceutical industry. Today, more and more medical device OEMs are in search of companies that run cleanrooms that meet rigorous sanitation requirements. The U.S. standard (Federal Standard 209E) for cleanliness results in a distinction of Class 100,000, Class 10,000, or higher (see Table I). This distinction reflects the number of particulates found in the air. For example, a Class 10,000 cleanroom is one that requires that there be no more than 10,000 particulates in the air at a given time.

A PMS allows for real-time measurement of particulates, relative humidity, pressure, and temperature at one-minute intervals, 24-hours a day, via sensors mounted above workstations throughout the cleanroom. The sensors take readings and report back to computer software that sends an alert if any measurement falls outside of an approved range. Currently, few outsourcing companies use a PMS for sterile medical device packaging. In fact, most outsourcers take quarterly readings and use those results to certify that all products processed within that quarter were packaged at acceptable levels.

The benefit of having a PMS is that if the particulate levels rise significantly, the outsourcer can make an appropriate adjustment right away. Quick adjustments help ensure that all packaged products meet the OEM’s quality specifications.

10. Do I Trust This Company?

To provide its OEM partners with packaged medical devices that come as close as possible to sterilized perfection, an outsourcing company must meticulously plan and construct a cleanroom, establish an interrelated set of protocols, and adhere to strict guidelines. Trusting that an outsourcing partner has the expertise and integrity necessary to run an effective cleanroom can be a tall order for OEMs. There are many opportunities for error throughout the process, and every product that clears the sterile packaging process and is then distributed has the potential to aid or to harm a patient. A single product recall that results from compromised sterility of an improperly packaged device can be catastrophic, in terms of both potential patient risk and the OEM’s financial survival.

Medical device manufacturers, which often must rely on outsource partners to provide outstanding packaging services, should know as much as possible about the cleanrooms that process their products. As OEMs search for an outsourcing partner that they can trust, there are a few factors they should consider carefully. The best outsourcing partners will be those that can demonstrate their cleaning standards and capture the details in their logbooks. In addition, the company’s training of its staff, the frequency of its testing and auditing, and its ongoing improvements to the cleanroom are also critical.

Conclusion

Medical device manufacturers are under both cost pressures and intense scrutiny over quality concerns. The race to enhance market performance often requires OEMs to rely on outsourcers to provide critical functions, such as sterile packaging. Outsourcing can be highly effective but can also jeopardize product quality. Finding the right outsourcing relationship becomes even more important as the standards for sterilized packaging are strengthened in the United States and abroad.

To choose the best outsourcer to provide sterilized packaging services, OEMs must evaluate each potential provider’s approach to cleanroom design and operation. The variety of factors that make a cleanroom service successful boil down to one essential ingredient: the integrity of the outsourcing company. It is the OEM’s responsibility to assess the outsourcer’s level of competence through facility inspections, periodic reviews, and the imposition of specific requirements for testing and reporting. Trust can be earned, but OEMs should make their outsourcing partner earn that trust again and again.

Read-Write RFID Tag Withstands Gamma Sterilization Process

2007-08-27T09:36:00.001+08:00

While promoting a radio-frequency identification (RFID) tag for tracking hoses in pharmaceutical processing plants, AdvantaPure (Southampton, PA; www.advantapure.com) encountered significant interest from other markets desiring the technology for their own tracking needs. The company happily accommodated requests and tailored the tag for use on pumps and valves. But when manufacturers of single-use products expressed interest in an RFID solution for bioprocessing bags, one obstacle stood in the way: compatibility

with gamma sterilization.

Identification of disposables undergoing gamma sterilization has posed a number of problems in the past, according to Jeff Johnson, director of software development. Tracking often requires the labeling of a product prior to sterilization and then again after processing because the tag could not withstand the exposure to gamma rays, he says.

“We put our heads down and said: ‘Oh well, we tried on that application.’ Basically, gamma sterilization and computer chips don’t mix,” says Ken Baker, CEO for AdvantaPure. “Then we started talking to everybody and anybody about this and finally came up with a solution. After discussion, R&D money, and coming up with the right configuration for environmental [compatibility]—not only gamma, but also temperature and cold—we came up with this chip.”

Suited for single-use products, the GammaTag is a gamma-sterilizable RFID chip equipped with read-write capabilities. Measuring 25 mm in diameter and 2 mm thick, the tag withstands gamma radiation up to 45 kGy and temperatures ranging from –20° to 85°C. Using silicone tape, a watchband-style holder, pouch, or lamination, the tag attaches to such disposable products as sample and production bags, manifolds, tubing and hose, filters, and single-use systems.

It also enables the gamma sterilization of a single-use process system as a complete unit.

“By having a tag that can actually go through the process and retain its data, you can have a fully sterilized, yet fully identifiable, lot-traceable item,” Johnson explains. “We can write information on the tag relating to the part number, the serial number, the lot number, or any of the manufacturer’s information and it doesn’t get separated from the product at any point throughout production or sterilization.”

Whereas bar codes and tags are read-only identification products, GammaTag allows manufacturers to write data directly on the tag for accurate and updated product tracking. The chip accommodates 2 Kb of memory. Using a handheld tag reader and software, users can also access such data as certifications, instructions, warning notices, and disposal procedures.

“Right now, the best way of tracking items going through gamma sterilization is through a log book, or with paper, which is fundamentally flawed on many different levels,” Baker says. “This allows an end-user to really have that confidence in removing the risk of tracking a disposable—whether it is a bag, a filter, or a medical device—all the way through from manufacture to sterilization to end use.”

Injection Moulder Earns Accolade for Injection Device

2007-08-27T09:33:00.001+08:00

Top Clean Injection (Peschadoires, France) received the Prix Pharmapack 2007 in the medical products category at the Paris trade show earlier this year.

A subsidiary of Top Clean Packaging, which is headquartered in nearby Thiers, the company was singled out for its M’Jet intraocular-lens injection device. Designed for the treatment of cataracts, the device was developed, and is now manufactured, packaged, and sterilized, solely at the company’s facility.The award caps an especially dynamic period for the firm, which specializes in injection moulding.

In 2006, Top Clean Injection obtained approval to place the CE mark on the Class IIa M’Jet device and achieved ISO 9001:2000 and ISO 13485:2003 certification. It operates ISO Class 7 and Class 8 cleanrooms on-site.

Noncontact System Accurately Gauges Thickness of Medical Tubing and Balloons

2007-08-27T09:29:00.000+08:00

A new nondestructive optical system can determine the thickness of transparent and translucent materials while largely removing the human element from the procedure. Capable of calculating the width of tubing and balloon walls individually, the OptiGauge system from Lumetrics (Rochester, NY, USA) provides detailed analyses of translucent single- or multilayer surface components.

The most commonly used method for measuring medical tubing involves using a pin gauge to determine its inner diameter. “The main disadvantages of this method are that it is normally destructive and the accuracy of the data largely depends on the operator,” says Rob Vlosky, the firm’s director of marketing and sales. Determining the dimensions of angioplasty balloons is similarly limited by physical testing. “To measure angioplasty balloons, a technician generally crushes the balloon between a micrometer and divides the total thickness in half to estimate the individual wall thickness,” Vlosky explains. “The obvious fallacy in this method is an inability to tell if one wall is too thick or the opposite wall is too thin,” he adds.

Accurate to 0.1 µm, the OptiGauge is suited for measuring solid material as thick as 8 mm and tubing up to 10 mm in diameter. The system can be used for product testing on manufacturing lines, as well as in quality assurance laboratories. In addition, the OptiGauge simultaneously supports as many as eight probes that can be positioned up to 1000 m apart. The resulting data are integrated into a quality control database, where comparisons with the expected dimensions are used to generate pass or fail recommendations in real time.

Based on patented technology originally developed by Eastman Kodak, the unit projects an infrared light beam from an LED onto a transparent or translucent material. A PC equipped with proprietary software instantly analyzes light reflecting back from the material. If the evaluated object is comprised of layers, light reflecting from the layers is analyzed individually to determine their individual thicknesses. Advanced processing algorithms then display the widths of the individual layers using a graphical user interface.

The unit is available in Europe from the medical sales organization 2Spring (Tilburg, Netherlands).

Welding Technology Fuses Nitinol to Stainless Steel

2007-08-27T09:26:00.000+08:00

For three years, engineers at Creganna Medical Devices (Galway, Ireland) scratched their heads over how to join nitinol to stainless steel to produce a catheter that exhibited the performance of nitinol without the associated high costs. For the past year, the company has actually been developing the nitinol–to–stainless-steel tube-welding technology that provides the elusive answer to a question posed for years by manufacturers.

“They’re such dissimilar materials in terms of metallurgy,” says Creganna product manager Maura Leahy. “Whenever you read about nitinol and challenges in manufacturing, one of the issues is how difficult it is to weld to any sort of dissimilar type of material.”

Welding nitinol to stainless steels tends to be extremely difficult due to the formation of intermetallics in the weld zone, which results in brittle joints. As an alternative, nitinol can be joined to dissimilar metals by way of such mechanical processes as crimping or swaging, bonding, or heat shrinking. However, such operations do not create the join-zone strength achieved by welding, according to the company. Creganna’s Fusion Technology incorporates a filler material in the join zone, thus avoiding the interference of intermetallics and ensuring strong joints.

“We’ve developed the capability, which has been a holy grail for design engineers for quite some time, to be able to put these two materials together,” says Alan Crean, business developer for Creganna.

When designing a catheter, engineers often pass over nitinol in favor of a more economical material, despite its desirable properties for the application. However, Creganna’s joining technology may enable catheters to benefit from the nickel-titanium alloy without the high cost.

In addition to its shape-memory characteristics, nitinol offers crush resistance, superelasticity, and flexibility. Because of these properties, the alloy is suited specifically for use in the distal section of a catheter, which is the end that first enters the patient’s body. Fusion Technology enables engineers to employ nitinol solely at the distal end of the catheter. Reducing materials costs, this design approach requires only about 100 mm of nitinol out of the 1 or 2 m of material that makes up the catheter, according to the company. The remaining proximal section of the device can consist of such cost-effective alloys as stainless steel, joined to the nitinol through the company’s technology.

As the only firm currently offering this capability, Creganna has remained tight-lipped as to how the dissimilar metals can be fused. However, the company does reveal that the welded material in the middle is a common medical-grade material, so it will not present any new challenges to OEMs. Fully biocompatible in a single-use implantable device, the technology offers pull forces ranging from 300 to 370 Mpa, joint strain ranging from 0.5 to 1.5%, and a joint hardness of 410 Hv maximum.

Gear Up Your Fitness Goals with the Best Gym Equipment in the Market

2007-08-27T07:51:00.000+08:00

There are many types of gym equipment and when choosing it is important to understand the fitness goal that you are working toward, because each piece of equipment focuses on different fitness outcomes.

At every aging event in life, we tend to make new resolutions related to weight loss, increasing cardiac output and a slimmer look. The media helps by creating images and stories of success with various exercise equipments. Impressed by these stories, we start dreaming about the results and finally work toward getting a brand new fitness equipment promising a perfect shape. These promises fade shortly, due to lack of interest and time. That is the reason that it is so important to choose the most appropriate gym equipment to help you stay interested and obtain your goal.

The fitness market has to many different equipments and various models that have great health benefits. A good review of the types of exercise equipment and end result will help you make your decision. After spending only a few minutes reviewing equipment, you will find a plethora of treadmills, elliptical machines, stair steppers, exerciser bikes and many more. All of these pieces of equipment function differently, working different areas of the body.

A treadmill is indoor equipment that keeps your body in motion to obtain greater cardiovascular benefits along with weight loss. Treadmills are available in both steel and aluminum frames and have a cushion system that absorbs all the force created during the workout. This in turn reduces the impact that the machine puts on joints and the rest of the body.

New electronic treadmills available have an automatic stop system with a good electronic display that monitors your heart rate, calories burned and distance covered. Its incline system makes workouts more efficient and beneficial. Most have a guarantee of one year for its belts and sports a lifetime guarantee for its frame. Though they may be a bit more expensive, it is a true bargain for health and fitness.

Elliptical machines are small foldable exercise equipment that enables you to have all the benefits of aerobic and running exercises. Its workouts are easy, comfortable, non- strenuous and non-jarring. Rowing firmly with this equipment reduces the impact to your lower joints making workouts safe and comfortable. Its priced from about two hundred to one thousand dollars making it an affordable way to stay in shape.

An exercise bike is another type of gym equipment that is a compact and improved model over the old types of bikes. These bikes make your exercising a fat burning programs that is comfortable and effective. Like many of your daily weight bearing exercise such as running and bicycle ridding, it also offers an increased cardiovascular circulation with minimal stress to your knees, ankles and hips. Its inbuilt feature offers various resistances giving the benefit of bicycling over uneven surfaces.

So, redefine your fitness goals and try to understand what you actually need from your body, whether is it weight loss, better cardiac output or a perfectly sculpted body. After outlining your goals then, you will be able to choose the correct piece of gym equipment. that fits your definition of fitness.

Author: Jones Wright

Benefits of Owning A Rowing Machine

2007-08-27T07:46:00.000+08:00

Rowing machines are an excellent way to increase the overall health of your body, inside and out. A rowing machine is specifically designed to imitate actual boat rowing so that it feels as if you are pushing oars through water. The rowing machine is the perfect tool to aid with weight loss and improve stamina. It is really a great machine to have.

Rowing Machine Workouts
A workout on a rowing machine creates a muscle and cardiovascular workout. Suprisingly, the legs get about 70% of the workout, leaving about 30% to the arms. Rowing machines can help burn up to 15 calories per minute, which means you can maintain a good fitness level with just 20 minutes of exercise!

Muscle Groups Worked by Rowing Machines
The muscle groups in the legs, arms and back are worked by the rowing machine. Muscle mass burns calories more efficiently than fat, so as your muscle mass increases from rowing your body weight will naturally decrease.

In conclusion, a rowing machine is the best machine to simulate rowing a boat. They are versatile in the fact that they can be used as a warmup because of the full body and cardiovascular workout offered. Rowing machines are also great for strengthening your back and core-strength in general! Rowing machines are great for people of all ages and really deliver where promised.

Make sure to use correct technique, a straight back, to avoid stress on the lower back. If you have back problems, you should consult a physician before you start rowing, or any exercise plan for that matter, to avoid further damage.

Rowing Machines are an excellent way of achieving physical fitness.

Rowing Machines: Are They for You?

2007-08-26T22:46:00.001+08:00

Rowing machines offer one of the best aerobic fitness workouts. A workout on a rowing machine or rowing ergometer achieves two things: a cardiovascular and muscle workout. If you are keen on developing your cardiovascular systems, but also your muscular system, then a rowing machine could well be what you have been looking for.

A full body workout on one machine Other cardio machines, such as exercise bikes, stair climbers, and treadmills do wonders for your legs and butt, but do not give an adequate workout to your upper body. Rowing machines, believe it or not, actually work both upper and lower body. In fact, workout analysts say that your legs get up to 70% of the workout benefits, but your upper body gets the rest. This basically translates to getting a full body workout on just one machine.

Rowing not only burns a ton of calories, it exercises all major muscle groups while strengthening your back and improving flexibility. Impact-free, smooth motion is achieved via the dual piston technology and is an ideal choice if you're looking for a space-saving, inexpensive and effective piece of exercise equipment for your home.

Rowing machines are low impact The other major plus is that the rowing machine offers a safer alternative to jogging. Jogging, whether you do it on a treadmill or in the outdoors, is a high impact exercise and is not suitable for everyone. Each time you jog you are in danger of trauma to your bones and joints. Rowing machines offer a low impact workout, which is a very safe way to increase your overall health and fitness.

Which rowing machine is for you?
There are a number of rowing machines on the market today. A hydraulic machine is a good choice if you don't want to spend too much. Air or flywheel rowing machines have a real outdoor rowing feel. Air and flywheel rowing machines feel natural and smooth, while hydraulic machines don't. The magnetic resistance machine is a very popular rowing machine because it is very smooth and quiet. Whatever machine you choose, you will get your full body aerobic workout that is low impact and the best thing for your muscles and your heart.

How to Choose the Best Fitness Equipment

2007-08-26T22:38:00.000+08:00

There is an old saying health is wealth. If we do not have good health all the things in the world have no importance. Staying healthy is must for everyone. But these days scenario is that intake of calories is much more than their consumption. Thus these calories start depositing in our body in form of fats. Deposited fats are always a problem for everyone. Along with an unattractive physique the fats are major cause of many diseases. Obesity causes a person to be lethargic and inactive. Thus everyone should be conscious about his or her health and stay fit. Exercising regularly is the best way to stay fit. We can make our body exercise by various techniques. Some people prefer to walk while others opt for rigorous exercise. Aerobics is a very entertaining and good method of exercising. Now a day many different types of exercising equipment are available in the market. Deciding upon a good exercising machine is a difficult process.

One should always think about the type of exercise he or she wants to do. Like for body building the exercising equipments are different while for aerobics the exercising equipments needed are different. The metabolism rate of the body is raised by the aerobic exercises. The equipments available for the aerobic exercises include tread mills, stationary exercising cycle, a stair stepper, rowing machine etc. and this list is endless. A tread mill for exercising has various features to increase its utility and reducing its maintenance cost. A treadmill has back legs along with the handles which have their center section upwards. The control panel of the tread mill is just like the control panel of any electronic equipment. It's very easy to operate. The embedded buttons on the control panel can be easily pushed with a soft touch even while jogging. The liquid crystal display keeps on showing the speed at which one is walking or jogging. In this way we can easily keep a track of our speed and distance walked.

Exercising bike is also common equipment. It has been invented for the gymnastic purposes. This bike resembles the typical bicycle which was invented years ago. The bike includes a hand exercising and a foot exercising mechanism. Both are mounted on the bike frame. The hand exercising mechanism is above the bike frame while the foot exercising mechanism is mounted below the bike frame. The gear mechanism is also mounted on the bike frame. All these mechanisms work hand in hand to give the user's full body a good exercise. This is a stationary bike which also has a speed control settings. By adjusting the knob one can always increase or decrease the amount of energy one wants to put in while exercising.

About the Author: Bekie Cohner is a health and wellness professional with 16 years experience helping people make the right decisions for everything from Exercise Equipment

Thinking out of the box brings success

2007-08-24T01:08:00.000+08:00

SINGAPORE'S small and medium enterprises (SMEs) are sometimes accused of lacking creativity and entrepreneurial spirit. But Microwave Packaging, for one, has built its business around a product of its own design.

Microwave Packaging was founded by managing director Leonard Lau, who has more than 35 years' worth of experience in packaging and design. During a visit to Taiwan more than 20 years ago, Mr Lau noticed that food vendors were using grease-proof paper boxes for takeaway meals - a more sophisticated form of packaging than what was available in Singapore at the time.

Yet these boxes had one flaw: they could not be closed without a rubber band. Mr Lau wondered if the design could be improved, so that the box could close securely by itself. Although Mr Lau's friends in Taiwan said that such a design was impossible, this merely made Mr Lau more determined to find a solution.

After almost 10 years of development, Mr Lau patented his box design in 1999. But that was only the beginning, for he then had to design his own manufacturing equipment. It took two scrapped machines before Microwave Packaging finally developed its first functional, semi-automatic machine in 2003.

In 2004, it secured its first big contract - with the Singapore Armed Forces (SAF). Singapore's National Servicemen now eat their out-ration meals out of Mr Lau's patented boxes. The box has a maximum compression strength of 37 kg, allowing many such boxes to be stacked for easy storage and delivery.

The SAF contract has since given rise to many smaller ones. Some National Servicemen who started their own food businesses after their time in the army remembered Mr Lau's boxes and are now Microwave Packaging's customers.

Some customers have seen business increase up to three-fold in the few years since they switched to his packaging, added Mr Lau. The advantage of Microwave Packaging's product is that takeaway meals can be refrigerated and microwaved in the same box.

The product design also ensures that food remains fresh and tasty, with features that have won several awards, including a World Star Packaging Award from the World Packaging Organisation in 1999.

The box is also washable, reusable, and biodegradable, since it is made from waterproof, food-grade paperboard. Microwave Packaging has since achieved the Singapore Green Label, and won at least one environmentally concerned customer: Raffles Girls' School, which now uses Microwave Packaging's boxes in its canteen.

Despite such a successful design, however, Mr Lau has not found it easy. He describes the experience as 'a very hard climb'.

'For start-ups like us, it is very difficult to get financing,' he said. 'Money is our biggest hurdle.'

Even when Microwave Packaging clinched the SAF order, said Mr Lau, they found it hard to raise enough money for the required machinery. One option they explored was taking loans from Spring Singapore.

Since then, Spring has also helped Microwave Packaging in other areas, such as providing networking opportunities with venture capitalists, and involving the company in trade fairs or business mission.

A Spring-organised trip to Japan last year, for example, may have opened new doors for the company. Microwave Packaging is now in talks with partners in Japan, for cross-licensing of their design.

However, overseas expansion may not be possible without Microwave Packaging having first built a strong foundation, said Mr Lau. And in Singapore's small market, 'it is very difficult to build a foundation of wealth'.

Still, Microwave Packaging has big plans. It hopes to clinch large contracts with customers such as the Singapore Prison Service and airlines, as well as diversify its product range by moving into lower-end products.

Mr Lau hopes that new, cheaper product ranges will appeal to customers such as small hawkers, who might not be able to afford the original product with full functionality. 'We are on the move,' said Mr Lau.

The company also hopes to leverage on an existing product feature to spin off a new business: its boxes provide a good avenue for branding, as high-quality printing is possible.

Now, Microwave Packaging's direct customers may not be the only ones who will benefit from this, as Mr Lau has plans to sell advertising space on his boxes.

Not only would Microwave Packaging earn more revenue, its food vendor customers would have their costs subsidised by third-party advertisers. Mr Lau describes the idea as 'a very effective advertising tool, where the hit rate is one-to-one'.

Yet for this - as for all other development plans - Microwave Packaging will need financial strength to begin and sustain this new business, said Mr Lau.

Embroidery Designs

2007-08-23T09:38:00.000+08:00

Embroidery is an art of materials (mostly fabrics) with designs stitched with together with yarn.
This can be done either by hand or by machine.

The thread that you use is a special one made only for embroidery work. It comes in many colors also yarn can be used but this is used mostly for embroidery work called crewel and you will usually use a heavier fabric. When doing crewel this can be framed and hung on the wall as a picture or for a decorative pillow on a sofa or for the seat covering of chairs. When embroidering the use of the right needle is very important.

Needles are available in many types and different sizes. When doing embroidery the needles should be changed every 20 hours. A necessary skill for any embroiderer is to select the appropriate needles. Example for crewel a medium length needle is used with a very sharp point. All purpose needles can be used f or most embroidery projects. For beginners an assorted needle package would be the best purchase for beginners.

Sewing machines can also be used to create machine embroidery designs. This type of embroidery is very popular for designs on jackets, sweatshirts, and sports wear etc. Mostly these embroidery designs machines are computerized that read digital embroidery designs files made by some specific software. Many machine embroidery designs can be found on internet and one can easily work on those by downloading designs. There are some machines only for embroidery designs purposes while others are combination of embroider design and sewing.

Embroidery Machinery & Software Advancement

2007-08-22T12:08:00.000+08:00

Embroidery machinery has come a long way from ancient methods. Now embroidery technology allows the most complex designs to be completely automated. Here is a look at embroidery advancements throughout history.

There are two types of machine embroidery. One is using sewing machines and hand stitches, known as manual machine embroidery. The other type uses machinery designed specifically for embroidery and is automated to create designs from pre-purchased design that are read in a digital format. This more advanced type of embroidery is currently the most popular. It is a much more cost-effective method for embroidery.

Current embroidery machinery relies on digital formats of designs. In 1980, a computerized embroidery system was designed. It was however, somewhat limited and not affordable for the consumer. However, advances in technology have allowed the prices of computers and embroidery software to drop drastically, making it available to the embroidery enthusiast.

Embroidery machinery on the commercial market can range in price from anywhere to $2,000 to $125,000 for the largest models. Large factories can run embroidery machines for up to 24 hours a day for large-scale production. Smaller factories can simply run several small machines to meet production demands.

All types of commercial embroidery factories need essential embroidery software. This software puts the embroidery design into a digitized format that can be read by embroidery machines. These embroidery file formats include ART, SEW, VIP, JEF, among others. Embroidery software at the entry level can range in price from free to several thousand dollars. High ends software can cost upward of $5,000. However, these software programs are equipped with great advanced features and are necessary for quality embroidery designs.

Digitizing embroidery designs is a very complicated process that requires hours of training for good results. Even with professional level quality software, problems can still occur if essential digitizing practices are not applied.

Embroidery is a beautiful method for embellishing and customizing apparel and accessories. Thanks to advances in technology, large quantities of products can be created in a fraction of the time and at a fraction of the cost.

Best Embroidery Design Software

2007-08-22T11:40:00.000+08:00

The creation of the digital embroidery technology has brought in the ability for everyone who is not good with embroidery to have a good experience with the fine parts of this craft. This better technology has created new ways for anyone who is interested in embroidery but is too shy to try it. It takes away the long hours of hard work that was necessary for finishing a design that was in its simplest form. Now with a few buttons pushed, the most intriquite of designs can be made in a minute or two and be correct and with the right quality that can only be finished with the new technology.

There are much digital embroidery that is out on the market that comes in many varieties of sizes and shapes. The cost will also differ from one model to the other and from one product brand to the next. The cost will depend on the things that the particular machine features and what it can do.

Those who have already purchased there machines for embroidery within the past year will fell very aggravated because their machine does not have all the features that todays machines have. If you are working into the embroidery business, you will want to make yourself aware of the newest technologies and designs or they may experience the bad times that will cause them to loose clients because of the designs being old. Some of the ones that are made to upgrade the machines they have may need to decide on an upgrade or to get a new machine.

The newest technology does not need for a person to get themselves a new machine but to easily download a new software design for embroidery that is offered online with a cheaper cost. Many of the software designed for embroidery lets a person change an image in digital form to a pattern for embroidery that can be uploaded on the machine.

One of the more famous software that is out there today is the PE-Design from the Brother Company that is based in Australia. It will not make a difference if the design is drawn by you or if it is digitally made better by using Adobe Photoshop or some software the will let you download on the internet. You can even use a digital camera picture.

When using the embroidery machine software, you can add a picture to anything that can be embroidered on in a second. The design software for embroidery can make the quality of the products you make much better. It will also give you the chance for a woman who has a busy schedule to create their own embroidery designs in a new fad way. Many of the machines can cost you around a thousand to twelve hundred each.

The great things about it is that the machine you choose will definitely pay for yourself if you find out from the dealer if they are going to release any upgrades for it. If they are, it might be right for you to wait until the new software comes out before you make your sale. Small upgrades will usually be given free if you are using that particular version of the software.

Different And Unique Embroidery Designs

2007-08-22T11:38:00.000+08:00

Are you constantly searching for new and unique embroidery designs? If you are then you will be happy to find out the embroidery designs are found in great numbers in the marketplace to fit any occasion or personality. You will be able to go online and also to the store to find them. May stores will give you a large group of designs for you to pick from. The designs for embroidery are created with a certain theme or subject in mind. You can find designs that are made for specific holiday like Christmas, Valentine's Day, birthdays, etc... Some are also available in easy to follow themes. Examples of this type of designs would new flowers, shapes, or colors. You will be able to find many styles and colors to fit any personality. Whatever you are looking for or want, you will find available in an embroidery design.

How Embroidery Designs are made?

Making a design for embroidery can be hard at times and can be harder if you are not experienced. You will need to have some creativity, time, effort, and an interest in the craft. The beginning designer may think that it is very hard but, the experienced designers find it easy. The experts can bring a single design about in a few hours and with the assistance of the latest technology, may even be able to shorten that time to a few seconds. The designs for embroidery are created with two designs in mind. The first one is created to finish the borders and corners of the design. The second one is made to cover and finish the remaining fabric. The designers usually make the design into a draft, using a pencil to finish the designs. When the design is drawn out, it has color added to it and a style that will fit with the persons needs in mind.

Embroidery Designs - Advantages and Disadvantages

Embroidery designs have good and bad things about them. The good things include the fact that many people the designs make a piece of material or clothing can look much better than before embroidery. It can give that piece a more professional look to it. Sophistication can be brought to a specific product. Your garment can be pleasing to the eye and bold also. It will make it more attractive and wonderful. The way the garment will change will depend on the design chosen.

The bad things about embroidery are that when you are creating a specific design, it can waste your time because it may not be what you wanted it to be. This means that the time you have spent is not for anything. Another bad thing about embroidery is that it can take person hours to come up with a design if they are a beginner. The designs can be hard to get digitally enhanced and you may not have the delicate nature for this part of the marketplace. the really bad part of embroidery is that there can be times when the designs that are made are slowed down in making them and also in the time that it takes the products t be purchased. For anyone in the embroidery business, this must be avoided.

Brother Brand - Embroidery Sewing Machine

2007-08-22T11:35:00.000+08:00

Brother is a name well known for making products that will make your household better. This company also makes commercial products. Brothers have a plant that is in the heart of the technological country of Japan. You can be sure that you are getting what you pay for with these products.

When you buy an embroidery machine from the rich collection, you may be confused when you about the machines because each one is as different and unique as the next one. To make shopping easier, you will need to find out what it is that you want the machine to do and then that will give you an idea of what machine to start looking at.

NV-700EII Dedicated Embroidery Machine

This new and improved embroidery machine with large embroidery area has 136 built in designs for you to choose from so you can customise your projects and personalise them too with 6 different styles of lettering.

If you are looking for a Brothers machine that does not have but a few stitch functions than you will want the SE270D machine. This machine will automatically load your thread into the needle with a system called cassette. The cassette is not a music cassette like you thing it is and unfortunately, no machine has the ability to play music while you work. It may be something for the future. The Brothers machine is part of the rich collection because it has a rich amount of designs for you to pick through.

Another Brothers machine is the PR600II. This machine offers the user a blueprint that will show you the many different colors that can be used for the design. This special tool will help you to have more time to do other things because of the six needles and thread that can be loaded at one time. Before you stat with a project that requires hemming, this machines program will let you program the color exchange before hand.

The IN2500D is another of the Brothers embroidery machines. This model will allow you to look for more designs through the internet. You can comment your machine to your computer by the use of a USB port. The monitor on this machine is LCD and it works like a touch screen. You can use the screen to choose the designs and alter them with your fingertips. This machine allows you to use the software to scale the image, work with the layout of the image, and to number some of them.

The PE700 model of Brothers embroidery machines can run at a fast 650 stitches per minute. Even if you have a small work area, the machine will give you the decorations and embellishments you want. This machine is perfect for every housewife that believes strongly about making sure the family's clothing is taken care of.

Patchwork Quilting - A History Summary

2007-08-22T10:55:00.000+08:00

Patchwork Quilting goes back many years. Examples of quilting have been found in tombs of Pharohs dating back to 3400BC. Joseph's coat of many colors was probably patchwork. Even armour was made by quilting heavy fabrics together. Quilted bed covers were recorded in household inventories from the 17th century. Patchwork quilting has even evolved into an art form known as art quilts. The Amish have developed the quilting traditions of other immigrants into America, into their own style.

Emigrants from Europe took their traditions of making quilts from scraps with them to America. Ideas and designs and even fabrics were exchanged across the Atlantic. The Log Cabin Quilt Design that was originally known in Ireland as the Folded Quilt Design, was a good way of using small scraps of fabric to create a very practical piece of art. It is doubtful if women quilters viewed their creations as art, it is much more likely they were simply seen as a quilt to cover a bed and provide warmth, albeit still a beautiful item. Crazy quilts are made from randomly stitching together odd pieces of cloth. In colonial times all cloth had to be shipped from Europe at great expense so nothing could be wasted.

A patchwork quilt was never regarded as being finished until it had been quilted. Quilting combined the three layers of the quilt - the backing, the wadding and the pieced top together, so the woollen or cotton wadding would be held in place. Quilting was a time consuming yet essential task as it provided a hard wearing warm durable quilt that had cost very little as it was made of the scraps from other projects.

Quilting is generally regarded as a female pastime since traditionally men did not learn to sew, while sewing was an essential skill for a young woman. Quilting was also a social pastime. Women would gather together to piece the top together and while they worked they would exchange gossip and tales. Sometimes after a quilting party the men would join the women for supper and often romances would begin.

Lives are displayed in traditional patchwork quilts. Part of the dress of a dead child or part of a cherished Father's shirt could be pieced in to allow the maker to hold her memories. Quilts have been made over years, lifetimes or even generations. Telling the tales of women's lives though embroidery, color and embellishment.

One group of special mention is the Amish, a religious group who migrated to America in the 1800s'. Quilting was not a skill they bought to America, but rather a skill they learnt from ex-English neighbours in their new land. In Amish societies, a simple life is a core belief and continues to be today avoiding modern mechanisation. While they do use a treadle-operated sewing machine to piece their quilts together the quilting is always done by hand.

The Amish do not use patterned fabrics in their quilts, the piecing patterns they use readily distinguish Amish quilts from other varieties of patchworking. The patterned fabrics are considered to worldly for use in a conservative Amish home. Some Amish quilts do not even use pieced tops; the only pattern is the intricate quilting designs. For an Amish woman an elaborately quilted design is not extra work but a creative outlet.

Traditionally Amish quilts were made from scraps left from clothes or recycled fabrics. This is another Amish value to waste as little as possible. Characteristically Amish quilts will have borders (almost always at least one and usually two) added because they increase the size and frame the pieced design. Borders are cut conservatively on the grain so as not to waste fabric. The inner border is cut from strips of cloth with a square in the corner to join it. Mitre corners or bias cut borders are rarely used as this wastes fabric. Often the quilts are bordered simply by cutting the backing larger, allowing it to be folded over.

Amish quilts are very striking despite their simplicity. This is usually due to the colors used. Although it is commonly believed that there are color restrictions in Amish quilts, this does not appear to be true. The only restriction is what is available to the quilter and the quilter's own color sense. Typically an Amish quilt will feature two or three dominant colors with an accent color, e.g. Slate blue, black and deep mauve. White is not often used as it is hard to keep clean.

For the wider quilting enthusiast population, quilting has evolved into more of an art form. While traditional patchwork relies on pattern and color to create an image. Art quilts (or water color quilts) are more like painting with fabric than traditional patchwork designs.

Art quilts range in size but generally they are more often seen hanging on a wall rather than on a bed. There is no form of embellishment that is forbidden in Art Quilting, if you can imagine it you can use it. Because of these rather vague boundaries this is the perfect art form, for any creative fabric artist.

There are many groups for modern quilters to join and sell their works. The internet provides an excellent medium for groups to collaborate with each other to create a quilt together. Thanks to T.V. shows, Quilting is reaching a wider audience and is no longer viewed solely as a women's pastime. Quilts and quilting have never been more popular.

Eric Sheares

About the Author

Eric Sheares is the fashion designer of Quilting Embroidery Limited. He has a great interest in making quilts. His design has won many international awards for best design.

The Simplest Designs Are Machine Embroidered

2007-08-22T09:37:00.000+08:00

In the fast paced technology world, the success of machine embroidery is rising. You will find that the majority of the embroidery on the market has been done by a machine. You can see it in the T-shirts, caps, towels, and other clothing, that machine embroidery has been used. The clothing and housing industries are using the machine embroidery more and more because of the popularity of it in the marketplace.

In the very early years of using machine embroidery, it was thought to be one of the simplest things to do. It took the use of many colors of thread that was utilized as a top stitch on a special material or fabric piece. The zigzag stitch was used to design it. With the new developments in technology, the embroidery is harder to accomplish. The plain embroidery machine has evolved to the use of computers. Instead of manually creating the designs, the embroidery is now done with the help of computers and the embroidery machines can complete the most intricate designs and also create an exact lace design on the fabric. There are a few different types of software that have been produced. This has made it easier for others to make their own machine embroidery designs from the beginning.

There are two distinct designs in embroidery. These two are the free machine embroidery design and the computer machine embroidery design. The last one is completed with the help of a regular zigzag sewing machine. This type of embroidery also incorporates the hoop into it. This type of design for embroidery using a free machine is good because it allows a person to make a bunch of different patterns easily. It is known as 'free machine embroidery' because of the hoop that is used to make the design. This hoop is controlled by hand and not in any way connected to the sewing machine.

Contrary to this, the computerized machine embroidery designs are completed with the help of a computer. The designs are set into the machine by a computer but, they can also be made by using a plain embroidery card which is sent into the machine. It is very unique to understand that this type of machine embroidery design is digitally created and made better before it is sewn on the fabric. Digitally designed means a picture has been uploaded to the computer and has been changed or altered by using a type of embroidery software, making it into a set of sewing designs. This software can be purchased from the stores by itself or as a package with a particular machine.

With the different kinds of embroidery machine designs, the computer generated kind is the one that everyone likes the best. Many think that it is because of the choices that the computer brings are fun and full of competition. You can surely make wonderful designs and even more so when you digitally design them with the computer before you start you re sewing. It is also precious information to learn that the quality of the machine designs done on the computer are much higher quality than the ones that are made using the zigzag stitch machines. You do not even need to be a great computer user to make the good designs you think of. This type of embroidery design is the easiest you can accomplish when a computer is used.