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Articles from 2003 In May


Applying 21 CFR Part 11 to Medical Plastics Processing

 

Originally Published MPMN

May 2003

PRODUCT UPDATE

Applying 21 CFR Part 11 to Medical Plastics Processing

A paperless records-management system can give manufacturers a competitive advantage

by
Norbert Sparrow

When PCs began to settle into the workplace, pundits far and wide proclaimed the dawning of the age of the paperless office. Reality intruded, and those prognosticators subsequently went into hiding, joined recently by the new-economy gurus and the Dow 30,000 crowd. All of which is a roundabout way of saying that one might be inclined to take the latest bout of paperless cheerleading--focusing on the manufacturing sector this time--with a grain of salt. Skepticism is healthy, but there are ample reasons why processors of medical plastics and other materials should, in fact, listen up.

For one thing, establishing a paperless records-management system puts the manufacturer in harmony with the precepts of FDA's 21 CFR Part 11. According to Serge Jonnaert, executive vice president in charge of marketing for American MSI Corp., which has developed the CellTrack Pro production records-management system, that is but one of the compelling reasons why medical molders and extruders should kick the paper habit. He recently published a white paper on the topic, titled 21 CFR Part 11 for Medical Plastics Processors.

Medical device manufacturers face increasing FDA oversight related to the documentation and tracking of recipes, processes, and production data, writes Jonnaert. Most companies have long maintained a paper record of basic equipment and process data. This practice is tedious and time-consuming and makes it challenging to adequately meet FDA reporting requirements, according to Jonnaert. It also has a significant impact on overhead and efficiency.

"The cost increases exponentially as paper production records are archived and grow in size," writes Jonnaert. The inherent inefficiencies of paper-based systems are difficult to justify by today's standards, he adds. Increasing federal oversight and product liability issues should also give manufacturers pause. "A paperless batch records-management system provides instant access to detailed production data," writes Jonnaert, enabling a company to respond faster and more comprehensively to product quality and safety issues. Indeed, a paperless system can contribute to an improvement in product quality, he argues. Real-time visibility into all aspects of production can lead to improved employee monitoring and a reduction in operator errors, writes Jonnaert.

An effective production records- management system, according to Jonnaert, should capture batch, equipment, and operator data. 
"The batch information is a given. 

The equipment information should be captured as it relates to the production of a batch. And the operator information should focus on who did what, where, when, and even why, as it relates to equipment operation," stresses Jonnaert. Plastics processors should strive to correlate these requirements with FDA's definition of electronic records, he adds. Jonnaert describes this process in great detail in his white paper, which can be downloaded at www.americanmsi.com/celltrackpro
 
A summary of the points he raises in the document follows.

Aspects of compliance

Electronic records. The system must be capable of recording raw data as well as so-called meta data (raw data translated into a table, graph, or other semantically friendly format). A good batch-recording system should allow the manufacturer to segregate active and completed batches, capture the various steps of downstream processing, and account for partial batches temporarily placed in a staging inventory.

Closed and open systems. The FDA rule defines a closed system as one in which "system access is controlled by persons who are responsible for the content of the electronic records that are on the system." Jonnaert concedes that bringing a manufacturing shop floor into a "closed system" can be a big challenge--industrial equipment was not designed to be part of a larger closed network. It's not impossible, however, and he lists centralized user-rights management, database alteration alerts, automatic and secure time-outs, and algorithm-based record validation as some of the key features of a closed manufacturing system.

Conversely, an open system is one in which access is not controlled by persons responsible for the content of the electronic records. This requires the implementation of additional controls to ensure a record's authenticity, integrity, and confidentiality.

Electronic signatures. The definition of the term in 21 CFR Part 11 makes it very clear as to what an electronic signature is and how it should be used, writes Jonnaert. To quote from the rule, "each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else" and it must "employ at least two distinct identification components, such as an identification code and password." Just as handwritten signatures can be forged, so can electronic signatures. FDA expects paperless systems to meet today's recognized industry-standard security measures. If a system is built on a platform with outdated security safeguards, it should be remedied immediately, suggests Jonnaert.

User rights management. Modern network operating systems already provide the means to manage user rights, which is described as a continuous process that maintains and verifies user identities and passwords. Jonnaert suggests considering adding features such as settings specific to each production cell, role templates that can be customized to grant specific access rights to an individual, and an active/inactive-user function. The rule stipulates that no user information can be deleted, so that an audit trail can always tie a record to an individual. By distinguishing between active and inactive users, writes Jonnaert, a change of status can be logged into the system.

Records management. To best meet the requirements detailed in 21 CFR Part 11, Jonnaert recommends storing the raw data as well as the meta data for each record, ensuring that records cannot be erased or overwritten, separating active from archived data, and choosing a system that can log almost all relevant activities. Flexibility is key when deciding on the means of storing the data. "The application architecture needs to be able to accommodate the various storage media available today including storage area networks, CD-ROMs, and DVD-ROMs, as well as technologies that may become prevalent in the future," writes Jonnaert.

Audit trails. Described as the raison d'être for production records management by Jonnaert, audit trails should include every data point that could be considered relevant to the quality of a part complete with a signature, date, and time stamp. "This includes but should not be limited to cell and equipment configuration changes, changes to recipe and process parameters, personnel activities and changes, batch records, and any reporting activities," he writes.

Reporting. A minimum system requirement should be the ability to output a report in an FDA-approved electronic file format. The ubiquitous Adobe PDF format is perfectly acceptable. Again, advanced security features need to be in place. Generating and printing reports should be limited to authorized users only, and the system should disable the Windows copy, paste, and screen-capture functions.

Data collection. There are few guidelines in the FDA rule relating to data collection on the shop floor. The primary challenge, according to Jonnaert, will be linking a 21 CFR Part 11-compliant application to the end points on the shop floor. "This requires the ability to communicate with both state-of-the-art machines that use complex data interface protocols as well as older equipment that is controlled and monitored using analog gauges and dials," writes Jonnaert. It's not impossible, but it requires a carefully thought-out strategy.

People and procedures. Retrofitting machinery, however, can be a cakewalk compared with changing staff habits. To enlist your employees' help in implementing compliant operating procedures, Jonnaert advocates taking a direct approach. Develop an information strategy early in the process with regular briefings on how the regulation applies to an operation and what the compliance initiative entails, he suggests. Don't neglect to provide plenty of advance warning to staff on what they should expect in terms of new policies, procedures, and management guidelines.

Validation. Once the system and accompanying policies and procedures are in place, FDA requires an audit by a third party to validate systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Validation is a challenging and time-consuming process that should not be underestimated, stresses Jonnaert. The user is also required to show that a "specific electronic signature is the legally binding equivalent of the handwritten signature of the person using the electronic signature."

Achieving convergence

To his credit, Jonnaert doesn't sugarcoat the pill when he describes the challenges involved in implementing a paperless records-management system. "The path to compliance is riddled with many challenges that need to be addressed individually and, in the end, converge into a cohesive solution," he writes. "This implies selecting a solution that was designed first and foremost to meet compliance, and [partnering with] vendors that understand medical plastics processors and the framework of regulatory compliance in which they operate," he writes. Most important, don't lose sight of why you are doing this: to document your company's commitment to quality. Keeping that in mind will help you to get through the inevitable rough patches.

Companies that embark on this mission, stresses Jonnaert, will benefit from an unquestionable image of quality in the marketplace. Implementing a paperless production records-management system that dovetails with CFR Part 11 requirements comes at a substantial cost, both financial and in terms of resource utilization, acknowledges Jonnaert. But the question is, can you afford not to do it?

Copyright ©2003 Medical Product Manufacturing News

Sensor Web Site Offers Notes for Medical Applications

 

Originally Published MPMN

May 2003

E-NEWS

Sensor Web Site Offers Notes for Medical Applications

by Zachary Turke

www.mtsmedicalsensors.com (Click on picture to go to site).

A supplier of magnetostrictive linear displacement technology worldwide, MTS Sensors Corp. (Cary, NC) has launched a new Web site specifically for medical device designers. Hosted at www.mtsmedicalsensors.com, the site explores ways in which the company's products can be used in healthcare position- and level-sensing applications. "We felt that the medical market deserved a quick resource on how our magnetic technology could be applied," explains commercial products manager Jesse Russell. "Our application notes make it easy for designers to consider these sensors in their next design," he adds.

The on-line application notes include hospital beds, dental chairs, infusion pumps, and fluid-handling devices. These materials are downloadable and supplemented with new product information as it becomes available. For people unfamiliar with magnetostrictive products, the notes can be used in conjunction with the page's tutorial section and glossary of common terms. 

The Web site also allows users to access the company's on-line catalog library. Similar to a print catalog, this virtual resource contains the company's entire product line and may be browsed page by page or searched using part number, type, or product description. Each page is available in JPG or PDF format. A product-selector guide is also available to simplify specification. 

Copyright ©2003 Medical Product Manufacturing News

On-Line Seminars Provide Regulatory Compliance Information

 

Originally Published MPMN

May 2003

E-NEWS

On-Line Seminars Provide Regulatory Compliance Information

by Zachary Turke

www.etlsemko.com (click on picture to go to site).

The ETL Semko division of Intertek Testing Services (Boxborough, MA) has announced the opening of the Intertek Education Center, a Web-based resource featuring an ongoing series of live seminars for compliance engineers in the medical field. Accessible through a link on the company's home page at www. etlsemko.com, these seminars are designed to increase the understanding of current regulatory requirements and facilitate transitions to future standards. "By attending these virtual lectures, medical device engineers and manufacturers [are] taking a proactive stance toward understanding this ever-changing field," says director of business and medical technology Don Sherratt.

The first lecture in this series, "The In Vitro Diagnostics Directive: An Inside View," provided a comprehensive look at IVD requirements for CE marking. Originally broadcast on March 20, the seminar was led by Sherratt and offered engineers useful strategies for making the testing process smoother, faster, and more cost-efficient. The lecture was immediately followed by a live question-and-answer session where engineers were allowed to address their specific concerns. The entire broadcast has been archived to allow viewing by parties who were unable to attend.

Other seminars ETL Semko has hosted include "Understanding Bluetooth," and a two-part seminar, "The Basics of Compliance," is scheduled for April 2 and 30. Topics to be covered in the future include ISO 13485:2003 transitioning, FDA 510(k) reviews, and Asian-market entry requirements. All seminars begin at 12:00 p.m. (EDT).

Copyright ©2003 Medical Product Manufacturing News

My Favorite Bookmarks

 

Originally Published MPMN

May 2003

E-NEWS

My Favorite Bookmarks

by Stuart Kingsley, Chief Scientist Srico Inc.

Stuart Kingsley

The Institute of Electrical and Electronics Engineers (www.ieee.org) site is a professional resource containing scientific papers on a variety of engineering topics. Dating from 1960, the papers are searchable by author and journal using the IEEE Xplore function and can be downloaded in PDF format. As a member of IEEE, I receive print copies of some of its publications, but I still use the on-line search function because it's much quicker than looking by hand.

The International Society for Optical Engineering (www.spie.org) is another engineering organization that I belong to. The group's Web page contains industry news, a technical library, conference information, and product data for a number of companies. My firm does a lot of work with optical modulators and sensors, and I find that this site's Photonics Gateway section is a particularly useful resource.

PC Magazine (www.pcmag.com) is where I go when I want to answer general computer-related questions or get an accurate review of the latest hardware and software. In today's high-tech world, it's important to have the right tools for the job, and this page helps to make sure that happens. The best part is that you don't have to have a subscription to view any of the listings.

Expedia (www.expedia.com) is one of the many Web resources for purchasing airline tickets at discounted prices. Because of the way that some airlines handle frequent-flier miles, it may be more cost-efficient in the long run to purchase tickets directly from their individual home pages, but I often come to Expedia first to get a quick overview of the market. You can also use the site to reserve hotel rooms or rent cars. 

Srico Inc. (Columbus, OH; www. srico.com) designs all-optical sensors for measuring and transmitting analog and digital data in electrically noisy or hazardous environments. In the medical field, the company's products include units for electrodiagnostic, patient-monitoring, and functional MRI applications. 

Medical Product Manufacturing News is seeking design engineers to share their Internet expertise with our readers. If you or someone else from your company would like to participate in this column, please contact managing editor Susan Wallace by telephone at 310/445-4265 or via e-mail at susan.wallace@cancom.com

Copyright ©2003 Medical Product Manufacturing News

Manufacturer Etches MEMS Components from Nickel

 

Originally Published MPMN

May 2003

INDUSTRY NEWS

Manufacturer Etches MEMS Components from Nickel

Zachary Turke
Produced under cleanroom conditions, Tecan Components Ltd. offers nickel MEMS components with apertures and fluid channels as small as 1 µm.

Combining experience gained from working with semiconductors, compact discs, and holograms, Tecan Components Ltd. (Weymouth, UK; www.tecan.co.uk) has developed a photochemical etching process to produce microelectromechanical systems (MEMS) components from nickel. In the past, such components have been manufactured from silicon, a material that can be both expensive and brittle. By using nickel, the Tecan process overcomes these inherent shortcomings, offering a finished product that may be more cost-efficient and offer increased mechanical strength, electrical conductivity, and corrosion resistance.

Produced at a new 8000-sq-ft facility, the nickel components can be designed with apertures, fluid channels, and other features as small as 1 µm in size. Customizable to individual requirements, the parts can also be manufactured with surface finishes as smooth as 600 nm and raised areas of a maximum aspect ratio of 5:1. And while the company has no figures on the smallest part the technology can be used to produce, it says that surface areas of up to 144 sq in. can be achieved for non-MEMS applications.

With this list of features, Tecan Components estimates that its nickel components will find numerous applications in the medical, optical, and electronics industries. In the medical MEMS arena, such applications could include sensors, actuators, hearing aids, microlenses, meshes, masks, displays, and microfluidic devices. 


Copyright ©2003 Medical Product Manufacturing News

Valtronic to Develop Battery-Management Circuitry for Medical Implants

 

Originally Published MPMN May 2003

INDUSTRY NEWS

Valtronic to Develop Battery-Management Circuitry for Medical Implants

Zachary Turke

Power-system manufacturer Quallion LLC (Sylmar, CA; www.quallion.com) has selected Valtronic USA Inc. (Solon, OH; www.valtronic.com) to develop a miniaturized battery-management device for its future line of medical implants. Partially funded by a grant from the National Institute of Standards and Technology's Advanced Technology Program, Valtronic's goal is to design a small device capable of adapting Quallion's rechargeable lithium-polymer battery technology for electrical stimulation. If the project is successful, the technology could be used to treat the 6.6 million Americans who suffer from strokes, epilepsy, Parkinson's disease, sleep apnea, limb paralysis, urinary incontinence, and similar maladies.

In business since 1982, Valtronic was selected for this project because of its history of developing novel microelectronics. "Few companies can supply the same level of functionality, microminiaturization, and robust packaging that we can," says Valtronic director of sales and marketing Gary Pinkerton. "For this project, we will use all our experience to develop a power source that fits inside an implant the size of a matchstick, lasts for 10 years or longer, and can be recharged from outside the body with no physical connections," he adds.


Copyright ©2003 Medical Product Manufacturing News

Coded Particles Protect Resins Against Counterfeiting

 

Originally Published MPMN

May 2003

INDUSTRY NEWS

Coded Particles Protect Resins Against Counterfeiting

Zachary Turke
This magnified image shows microtag particles from RTP Co. suspended in a polycarbonate resin.

As more and more manufacturing operations shift to locations outside the United States, the chance that the products they produce will be threatened by counterfeiting increases correspondingly. Patented resins, according to some experts, are particularly susceptible to this threat because the deception is often undetectable without complex chemical analysis. That is why RTP Co. (Winona, MN; www.rtpcompany.com) has developed a process called microtagging. Based on a technique developed to track terrorism in the explosives industry, the microtagging process incorporates minute coded particles into thermoplastic compounds to allow identification and authentication.

"The microtag particle is essentially a unique numeric code sequence supplied in a microscopic multicolor layered format," says product manager Stuart Swain. "A specific sequence is produced for each customer and application, and we never use the same code twice," he adds. To suit a variety of production requirements, the particles are available in sizes of 20-60 µm. RTP offers the option of adding them to the thermoplastic material they protect during compounding or supplying them in concentrate form for use at the molding stage.

And according to Swain, the method used to detect counterfeiting is as simple as the particles themselves. "All you need is an ultraviolet light and a 100¥ magnifying glass, and you can determine definitively if you have the correct resin, compound, or alloy," he says. For those who don't wish to perform visual identification, the company can also imbue the particles with magnetic and other qualities that can be detected by scanners and electronic sensors. 


Copyright ©2003 Medical Product Manufacturing News

Bayer Polymers Upgrades Development Facilities

INDUSTRY NEWS

Bayer Polymers Upgrades Development Facilities

Zachary Turke

This new extruding equipment was installed as part of Bayer Polymers' renovations to its Americas Technical Center facility.

Following similar renovations at its facilities in Germany and China, Bayer Polymers (Pittsburgh; www.bayer.com) has upgraded the research and development capabilities of its Americas Technical Center. 

Located in Pittsburgh, the technical center has been improved with the installation of an environmental testing chamber, a weathering lab, and other specialty research equipment. The new resources will be used to develop and test new plastics, evaluate applications and processes, provide technical support, and research new methods of injection molding, coextrusion, and thermoforming.

"The upgrade to the Americas Technical Center is a major investment in the future of Bayer Polymers," says company spokesman Bob Kumpf. "New technologies and specialized technical capabilities are the key drivers for success in a competitive marketplace, and our upgrading efforts will allow us to service our customers more effectively worldwide," he adds.

The renovations to the testing facility follow a 2002 decision to relocate it from Massachusetts to the company's headquarters. Like the upgrade, Kumpf says the move was geared to improve service for the company's customers. "In its new location, the Center shares space with our plastics, polyurethane, and coating businesses. This colocation allows us to take advantage of the synergy between our divisions, adding more value for our customers who are looking for a one-stop shop for material and technical solutions," he says. 

Copyright ©2003 Medical Product Manufacturing News

Fillers and Dispensers

Originally Published MPMN

May 2003

EQUIPMENT NEWS

Fillers and Dispensers 

Micropump Dispenses Low Volumes in Instrumentation Applications 

A self-priming, fixed-displacement diaphragm pump from Bio-Chem Valve Inc. is suitable for use in scientific and electronic instrumentation.

A miniature self-priming fluid-dispensing pump designed to serve as a compact and reliable component in scientific and electronic instrumentation is available from Bio-Chem Valve Inc. The fixed-displacement diaphragm pump provides programmed precision microdispensing of high-purity or aggressive fluids.

The robust micropump, measuring 3¼4 in. in diameter and 17¼8 in. high, can be factory-set to handle discrete fixed-output flows of 3 to 8 µl per solenoid actuation. It offers an inert fluid path for precise, repeatable dispensing with an accuracy of 0.5 µl. In addition to providing discrete dispense as an alternative to pump-and valve combinations, the pump can be a low-maintenance, long-life substitute for peristaltic pumps in applications requiring continuous pulsating flow.

Bio-Chem Valve Inc., 85 Fulton St., Boonton, NJ 07005.


Valve Deposits Fluid Dots and Beads with Speed and Accuracy

A self-contained fluid-dispensing valve supplied by Techcon Systems Inc. can deposit shots as small as 0.010 in. diam at rates of five per second, or even faster. The TS5000 rotary microvalve also can continuously dispense fluids in beads that are 0.010 to 0.050 in. wide at rates to 4 in./sec. Accurate, repeatable dispensing of both types is achievable in a production environment.

Available in a wide variety of configurations and with a 3- or 6-W motor, the valve dispenses medium- to heavy-viscosity fluids by means of a positive-displacement action based on an auger principle that creates very high pressure at the dispense hub. The amount of material deposited is determined by motor speed, motor running time, feed-screw configuration, material feed pressure, and the size of the dispense tip.

Small-shot precision is best attained by using a shallow-thread 16-pitch feed screw with the 3-W motor. Chrome-plated stainless-steel feed screws are available for dispensing abrasive materials and plastic components for applications where chemical compatibility is a factor. The 6-W motor is offered in an encoder version. The optimal configuration for a particular application can be ascertained through a material test program offered by the manufacturer. 

Techcon Systems Inc., 12151 Monarch St., Garden Grove, CA 92841.

Digital Deposition System Is Designed for Subnanoliter Dispensing

A servo-driven automated dispensing system features powerful proprietary software and a graphics user interface that allows for intuitive programming and control. The Champion 6809 from Creative Automation Co. includes a large, bright, high-contrast color TFT, liquid-crystal display. The system can be configured to match exacting application requirements from dots to underfills with a broad array of options. Placement accuracy of the system is within 3 µm.

Designed for subnanoliter quantities, the unit dispenses dot diameters down to 0.003 in. with bead widths down to 0.003 in. Volumes are below 0.5 nl. True positive displacement is used and volumetric accuracy is ensured regardless of deposit size, viscosity, or temperature. 
The Champion 6809 comes standard with a three-axis brushless servomotor drive, x-axis and y-axis linear encoders, z-axis rotary encoder, and Windows-style software. Its dispense area is 5.5 ¥ 12.0 in. 

Creative Automation Co., 61 Willett St., Passaic, NJ 07055.


High-Pressure Tool Dispenses Very Thick Assembly Fluids

A handheld fluid dispenser from EFD Inc. can generate output as high as 700 psi from 100-psi input.

A handheld dispenser from dispensing system specialist EFD Inc. is designed to maximize productivity in precision medical device assembly applications involving thick adhesives. The HP7x high-pressure dispensing tool is well suited for assembling pacemaker leads and other devices requiring small amounts of very thick assembly fluids to be applied through small-gauge tips.

The handheld tool is able to generate output as high as 700 psi from 100-psi input. The result is easy dispensing of medical-grade adhesives, RTV silicone, epoxy, and other thick fluids from its 3-cm3 syringe.

EFD Inc., 977 Waterman Ave., East Providence, RI 02914.


Filling Systems Offer Versatility and Fast Changeover

A series of digitally controlled liquid-filling systems offered by National Instrument Company, Inc., for medical industry packaging applications can handle many types of fluid. Constructed of stainless steel, the Filamatic DMS Digifil filling systems provide a choice of piston, lobe, gear, peristaltic, ceramic piston, flowmeter, and time-pressure metering systems. Meters of various sizes are designed to accommodate fluids in a range of viscosities. 

Filamatic DMS Digifil filling systems from National Instrument Company, Inc., can handle many types of fluid.

Fill volumes from less than 1 ml up to 5 gal are possible, depending on system design.

In addition to a model with metering systems mounted traditionally to the base frame, the Filamatic DFS is offered in a configuration with the systems mounted on integrated dockable trolleys. This model lets production continue with a second set of fluid-contacting parts and metering systems while the first is being cleaned in place at a remote location. The interchangeable trolleys enable changeover between filling runs to take as little as 5 minutes.

The filling systems are available in standard frame widths of 36, 50, and 72 in., which hold 3 to 5, 4 to 8, and, for highest-productivity filling, 8 to 12 filling heads, respectively. Machines can be equipped with special systems and fluid pathways for temperature-sensitive products, hot fills, fluids with suspended solids, sterile products, and products that are solid at room temperature and liquid at higher temperatures.

National Instrument Company, Inc., 4119 Fordleigh Rd., Baltimore, MD 21215.


Dispenser Quickly, Repeatably Applies UV Adhesive to Parts

A benchtop deep-ultraviolet dispenser 
from TechnoMed Inc. dispenses UV adhesive onto polymeric medical parts quickly and precisely.

A device-assembly adhesive dispenser from TechnoMed Inc. is designed to dispense UV-curable adhesive onto polymeric medical parts quickly and precisely. The benchtop dispenser places adhesive on the internal or external surfaces of tubing, conical parts, needles, connectors, and other components inserted into a custom-made dispensing bush. Bushes are application-specific and easily interchangeable.

Adhesive is continuously recirculated through the bush via an electric pumping system and dispensed uniformly onto the component surface. The component can be pushed into the bush from 1.3 to 8.0 mm deep depending on bush configuration, with a dead stop ensuring that the correct length of surface is uniformly coated. The part is then immediately pulled back for assembly. No rotation or other manipulation 
is necessary. Interior dispensing protects against unwanted polymerization of the adhesive by light.

User training is minimal, as the system is designed for mistake-proof and reproducible operation. Adhesive is dispensed cleanly and without waste. A conveyor system removes adhesives vapors from the working area for operator safety.

TechnoMed Inc., 59 Stiles Rd., Salem, NH 03079.


Industrial Dispenser Features Valveless Piston Design

Fluid Metering Inc. offers a fluid-dispensing and metering unit for use in industrial process environments. The IDS 2000 industrial dispenser features the company's patented CeramPump valveless piston design, provides fixed or multiple-shot dispensing and continuous or variable speed, uses a high-precision long-life stepper motor and control circuit, and accommodates programmable logic control. The stainless-steel, wall-mounted device is rugged and splashproof (IP 65) and can be used for electronic assembly, ultraviolet and solvent adhesive application, and precision lubrication.
The dispenser can produce one to seven shots per dispense, field selectable. Dispense volume is 0.002-1.28 cm3 per shot and precision is 0.5%. Drive speed can be preset at the production line for anywhere from 10 to 1200 rpm. The dispenser runs on 24-32 V dc, 2.0 A minimum; measures 11.4 ¥ 5.2 ¥ 4.3 in.; and weighs 7.1 lb.

Fluid Metering Inc., 5 Aerial Way, Ste. 500, Syosset, NY 11791.


Loading and Filling Module Provides Case-Packing Versatility

The ULF universal loading and filling module from Rovema Packaging Machines LP can be used as a stand-alone unit or be integrated with other machines.

A versatile and efficient packaging system from Rovema Packaging Machines LP offers flexibility in configuration to accommodate a variety of bags to be filled with product and packages to be packed in cases. The ULF universal loading and filling module can fill pillow-style, flat-bottom, and Stabilo Seal bags and single-gusseted stand-up pouches, and can place into the final package boxes, cartons, flow wraps, blister packs, and more. It can operate as a stand-alone machine or be integrated with other of the manufacturer's machines into a complete filling and packaging line.

The ULF allows for single or multiple layers or rows of filled packages, standing upright or lying flat. RSC cases, trays, or plastic containers can be employed as the final package for a wide variety of products, which are collated by product-specific grouping systems and loaded via a programmable handling tool. Size changeover and changes in the grouping system are quickly accomplished. 

The system is controlled from a touch screen. It can handle trays and cases in a wide range of formats and measuring up to 600 ¥ 600 ¥ 400 mm.

Rovema Packaging Machines LP, 650 Hurricane Shoals Rd., Lawrenceville, GA 30045.




Copyright ©2003 Medical Product Manufacturing News

Spotlight on

Originally Published MPMN

May 2003

SPOTLIGHT

Spotlight on Extrusion and Tube Processing

Reinforced fluoropolymer hose

A core layer of PTFE fluoropolymer is overlaid with protective layers of glass fibers and stainless steel to construct strong, flexible hose that handles maximum pressures ranging from 1200 to 4000 psi and does not kink. The smooth, chemically inert, nonstick inner surface of the APFGS hose suits biotechnology, pharmaceutical, and other high-purity applications. The hose's fiberglass layer insulates, and its stainless-steel outer surface contributes durability and abrasion resistance. The hose is available in seven sizes between 0.188 and 0.875 in. ID, with either a white PTFE core or a black conductive PTFE core. AdvantaPure, 145 James Way, Southampton, PA 18966.


Fluoroplastic tubing

PTFE, FEP, PFA, ETFE, and ECTFE can be extruded to create convoluted tubing in sizes from 1.8 to 4 in. ID.
The precision nonstick fluoroplastic tubing is chemical resistant and nonflammable, withstands ambient temperatures to 500°F, and features good dielectric properties. End configurations include no cuff, straight cuff, slightly flared or reduced cuff, specified-degree flared end, and 90° flanged end. The tubing can be supplied in cut lengths with custom cuff dimensions. TexLoc Ltd., 4700 Lone Star Blvd., Fort Worth, TX 76106.





Video option for catheter processing

Live, on-screen video capability is a feature of a programmable catheter-hole-drilling machine. The video is controlled by an on-screen button and appears in a 3 ¥ 4-in. window. The video displays a view of the drilled access hole magnified approximately 12 times. The unit was designed to limit harmful ergonomic effects on operator health, such as eyestrain, muscle strain, neck cramps, headaches, and muscle spasms. Technical Innovations, 20714 Hwy. 36, Brazoria, TX 77422.


Replacement biopsy channels

Standard and custom replacement biopsy channels produced and prepared for endoscope manufacture and repair are available, many for immediate shipment. The channels have a PTFE inner layer and an external polyurethane-encapsulated stainless-steel spring for support and resistance to kinking and puncture. They allow flex angles to 210°. Each channel produced is subjected to rigorous testing for leak resistance, surface quality, and flexibility. International Polymer Engineering, 2445 Medtronic Way, Tempe, AZ 85281.


Tube expander

The arms of a heavy-duty tube expander can accommodate two jaw sets of different sizes, allowing two assembly operations to be performed without time-consuming jaw-set changing. The 995HD-2 tube expander is specialized for expanding large-diameter tubing up to 11¼2 in. diam and heavy-wall or high-durometer tubing. The pneumatically operated device
can expand tubing made of PVC, polyurethane, vinyl, latex, silicone, rubber, and other elastomers. Standard jaws handle tubing from 0.062 to 0.375 in. ID, while larger jaw sets and Teflon-coated jaws are optionally available. Lakeview Equipment Inc., 3382 Commercial Ave., Northbrook, IL 60062.


Polymer extrusions

Tubing with inner diameters as small as 0.0015 in. and walls as thin as 0.0015 in. is extruded from such fluoropolymers and other high-performance engineering resins as PTFE, FEP, PFA, PEEK, MFA, and Pebax. Precision products that are available include special profiles, expanded-PTFE tubing, lay-flat tubing, Sub-Lite-Wall tubing, and tight-tolerance multilumen extrusions. Zeus Industrial Products Inc., P.O. Box 2167, Orangeburg, SC 29116.


Extrusion and assembly

A company creates custom tubing 
for a variety of medical device applications. In-house extruding and braiding capabilities enable extrusion of tubing in a wide variety of polymers, colors, sizes, and lumens. Cost-effective assembly of finished medical devices and the support of an experienced engineering staff are also available. Minnesota Extrusion Inc., 11760 Justin Cir., Ste. B, Maple Grove, MN 55369.

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