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Articles from 2003 In July


Computer System Validation Course Goes On-Line

Originally Published MPMN July 2003

INDUSTRY NEWS

Computer System Validation Course Goes On-Line

Laura Angela Bagnetto

Click to go to site.

Managing the validation of computer systems is part of a new on-line course made available through EduNeering Inc. (Princeton, NJ) and ISPE (Tampa, FL). Reviewed by FDA's Office of Regulatory Affairs, the second course in a four-part series is now available to private sector companies. It will become part of an on-line training program for FDA staff at state and local levels.

This is the first time that FDA has engaged in such a vast outreach program and made its training courses available to the regulated community, says Stephen Gerard, senior vice president at EduNeering. Providing industry and government employees access to the same information base "promotes consistency and excellence in the life sciences industry," adds Jerry Roth, vice president of education at ISPE.

This and other courses are available at www.eduneering.com for companywide contracts and at www.ispe.org for individual use.

Copyright ©2003 Medical Product Manufacturing News

Couplings Tool Generates 3-D CAD Data

Originally Published MPMN July 2003

INDUSTRY NEWS

Couplings Tool Generates 3-D CAD Data

Laura Angela Bagnetto

Click to go to site.

A new on-line tool translates raw data on flexible couplings into usable CAD drawings. The Configurator from Lovejoy Inc. (Downers Grove, IL) can be accessed at www.lovejoy-inc.com.

The database stores data on more than 200,000 couplings used in power-transmission applications. Configurable curved-jaw, torsional-LM, and disc couplings are available in engineering CAD drawings on the site. More styles are being added. The tool accepts both inch and metric data, and computes parameters such as torque. "While the company actively partners with customers on product engineering, the Configurator offers our customers an easy, interactive consultation," says president Michael Hennessy. "Often, it provides a final solution for their coupling requirements."

The drawings can be downloaded and e-mailed to colleagues. They can be saved and recalled at a later session. Definitions of coupling styles are provided, as are custom configurations of selected types. A software package is required to manipulate the 3-D models.

Copyright ©2003 Medical Product Manufacturing News

Alloy Company Goes Worldwide

Originally Published MPMN July 2003

INDUSTRY NEWS

Alloy Company Goes Worldwide

Erin Bradford

Shown here is a knee joint made from Sandvik Bioline's High-N material.

Sandvik Bioline, a business unit of Sanvik Materials Technology, (Scranton, PA; www.sandvik. com/bioline) has recently restructured its marketing and distribution of metal materials to support global markets. The United States and Europe are currently the largest markets for medical products. However, manufacturers outside these countries may find it harder to get the supplies and technical support they need.

Sandvik Bioline's new organization will ensure that the same quality of materials is available worldwide as it is in the United States, and will also provide technical support. Large companies and consolidated groups will have access to the same products in all locations.

"The development cycles will be easier," says John Petry, vice president and general manager of Sandvik Bioline. "All of the material expertise will be concentrated into one place. There will be a high level of 
expertise."

Supplies will be sold and marketed through one organization. In this way, customers will find metal materials and production support from a single company.

"There is now more of an applications focus," explains Petry. "Instead of manufacturers looking for support on one particular product at a time, we will help develop the product in terms of material choice and other specifications."

Copyright ©2003 Medical Product Manufacturing News

Implantable Silicones Business Changes Hands

Originally Published MPMN July 2003

INDUSTRY NEWS

Implantable Silicones Business Changes Hands

Norbert Sparrow

Nusil Technology (Carpinteria, CA; www.nusil.com) has acquired the long-term implantable silicones business from Rhodia Silicones. NuSil made the announcement on June 3 at the MD&M East show in New York City.

Long-term implantable silicones are used in medical devices that are implanted for 29 days or longer. More than 30 former Rhodia products are now under the NuSil umbrella as a result of the sale. The material is used in cochlear implants, stomach elastic bands, and pacemaker lead coatings, among other medical devices.

Manufacturing and customer support services are being transferred to NuSil's headquarters near Santa Barbara, CA. The firm will continue to service existing global customers from there. It has also announced that it will honor the pricing on all purchase orders made prior to the acquisition.

"This sale allows us to remain focused on the growth opportunities of our healthcare business," says John Foley, general manager for Rhodia Silicones North America. "Rhodia had a fairly small position in the long-term implantables market." By withdrawing from this sector, the company will be able to better support the growth of its liquid-silicone-rubber business, adds Foley.

Copyright ©2003 Medical Product Manufacturing News

Watlow Introduces Thermal Systems Consulting Service

Originally Published MPMN July 2003

INDUSTRY NEWS

Watlow Introduces Thermal Systems Consulting Service

Norbert Sparrow

Shown here is a thermal profile of a contrast medium during the in situ heating of an infusion syringe. By using computer modeling techniques, Single Iteration can rapidly and cost-effectively find solutions to thermal heating problems. Click to enlarge.

Watlow (St. Louis; www.watlow.com) has been supplying industrial heaters, sensors, controllers, and related software for more than 80 years. During that time, it has acquired considerable expertise in providing thermal solutions to a range of industries. Well aware of this knowledge base, customers frequently turn to the company for answers to complex thermal heating problems. Watlow has built on that tradition by introducing its Single Iteration Div. (Fenton, MO; www.singleiteration.com), a team of scientists and engineers experienced in the use of predictive modeling techniques.
"This group is composed of highly trained thermal experts with doctorates or masters' degrees in physics, computer science, and controller theory," says business director Ray Derler. "They form the backbone of the division. We are not simply working on the component level," he stresses. "Single Iteration is involved in the entire heating, sensing, and control loop."

As the name indicates, one of the division's core goals is to help clients avoid multiple design iterations. The staff achieves this by using computational modeling techniques and applying its years of experience in the design and manufacture of thermal parts. "Our assumptions are based on our downstream knowledge of manufacturing requirements and how our products perform in the field," says Derler. By the use of modeling, alternative concepts and technologies are quickly evaluated. When a solution has been found, the subsystem can be rapidly prototyped and integrated into a product for validation. "We manage the project in a holistic fashion. We look at it from a systems perspective," explains Derler.

Although it is part of the Watlow group, Single Iteration routinely seeks expertise elsewhere, as needed. "Our systems approach means that we may require knowledge that is not available at Watlow," says Derler. He cites polymer chemistry as one example. To fully meet the needs of its customers, the firm currently has affiliations with third parties, and it continues to seek more. "We have our tentacles out in the field for various disciplines," says Derler.

Partnering with the division can take a number of forms. "We can be an extension of a company's internal engineering team," says Derler. "Or the OEM can outsource the function entirely to us." Firms adopting the latter approach avoid the added cost and training associated with hiring internal staff, Derler notes. In either case, he stresses, the sooner Single Iteration is brought into a project, the better. "That's when we can do our best work and keep costs low. We want to be a partner, not a crisis manager."

Copyright ©2003 Medical Product Manufacturing News

Hi-Tech Rubber Offers Cross-Functional Collaboration Program

Originally Published MPMN July 2003

INDUSTRY NEWS

Hi-Tech Rubber Offers Cross-Functional Collaboration Program

Erin Bradford

How often have you seen this before: An engineer designs an innovative product and sends it to manufacturing. Then manufacturing sends it back, saying that it can't be built. The specs, size, or materials of the design made the assembly impossible. How much time was wasted?

The people at Hi-Tech Rubber (Anaheim, CA; www.hi-techrubber.com) have seen this problem all too often. To help its customers avoid this trap, the company has put together the Premier Collaboration Assistance Program (PCAP). This effort is meant to help customers through every stage of design and construction by connecting designers and manufacturers. In addition, customers can speak with Hi-Tech's internal engineering and technical team. Once customers are equipped with technical advice and current industry and supplier information, they will be able to find the best possible materials and strategy for their designs.
"What we're hoping to do is help the design engineers on the front end of their projects," says Dave Mabie, senior product and marketing manager for Hi-Tech. "Often, engineers will submit a project to manufacturers only to find that the project needs to be modified or redesigned. With this program, engineers will work with the manufacturer up front on the design of the product." 

PCAP will focus on advancing the use of silicone and thermoplastic elastomers in medical device applications. Such materials have a number of uses, ranging from fluid-pump diaphragms to check valves and other peripheral equipment.

Users can access the program through Hi-Tech's toll-free customer service number, 800/475-9790, or log on to the company's Web site. --Erin Bradford

Copyright ©2003 Medical Product Manufacturing News

MSI Puts Catheter and Stent-Delivery Products to the Test

Originally Published MPMN July 2003

INDUSTRY NEWS

MSI Puts Catheter and Stent-Delivery Products to the Test
A view of the IDTE showing the tortuous path submerged in water.

Susan Wallace

Data gathered during testing of catheters and stent-delivery products can have a direct impact on a manufacturer's product design. Also, end-users such as interventional cardiologists or radiologists will use this information in employing the devices. Realizing the value of accurately measuring performance criteria, Machine Solutions Inc. (MSI; Flagstaff, AZ; www.machinesolutions.org) recently introduced its Interventional Device Tracking Equipment (IDTE) at the MD&M East 2003 trade show in New York City.

The IDTE from Machine Solutions Inc. measures performance characteristics of catheters and stent-delivery products.

A PC controls the IDTE, which has an adjustable PFA track that enables both 2- and 3-D testing. "The track can be configured to simulate the different parts of a patient's anatomy," says James P. Kasprzyk, the company's director of global marketing. Typical configurations mimic the aortic arch for coronary procedures, or the superficial femoral artery or iliac branches for peripheral applications. Stepper motors push catheters through the tortuous path. The path is submersed in water maintained at body temperature.

A data-collection feature samples up to 100 data points per centimeter of the product being tested. The information is saved in a spreadsheet format for further analysis. It can be used in FDA submissions, pre-clinical-trial testing, marketing literature, competitive product testing, or product-design calculations. 

The IDTE measures catheter characteristics including push efficiency, guidewire movement, device crossability, trackability force, catheter flexibility, and device lubricity. Stents will be tested for device lubricity, expansion force, and retention force.

Copyright ©2003 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN July 2003

E-NEWS

My Favorite Bookmarks

The Engineering Staff of Intuitive Surgical

The following engineers from Intuitive Surgical contributed to this article (clockwise): Stacey Chang, Bruce Baker, Andy Ramans, Steve Blumenkranz, 
Roman Devengenzo, Art Gwerder, and Tom Cooper. Not pictured: Maggie Nixon, Chris Anderson, Joe Orban, and Randy Goldberg.

Online Conversion (www.onlineconversion.com) covers every imaginable unit-to-unit conversion. I don't bother with printed charts anymore. This is more convenient and simple to use.

MatWeb (www.matweb.com) is a thorough database on material properties for just about everything. It's very useful for finding and comparing material properties that, otherwise, would take several sources.

Century Spring (www.centuryspring.com) has a tremendous stock of all kinds of springs. A catalog search allows you to specify the physical dimensions of springs or their functional requirements.

Find Chips (www.findchips.com/ avail) is a good resource for searching multiple distributors of electronics components . . . and it's free! The search engine gets the search results directly from the distributors, and provides links to those sites.

Vishay Strain Gage Technology (www.vishay.com/brands/measurements_group/guide/index.htm) has extensive theoretical information that allows you to determine the best sensor for your application. It also has practical technical papers that assist in areas such as bonding techniques and data acquisition methods.

The Goal of Engineers Edge (www.engineersedge.com) is to be a "total solutions design, engineering, and manufacturing resource." There are good references for hardware data, material properties, design equations, and even some Web-based design calculators. I've used this site a lot for application and theoretical information.

Stock Drive Products (www.sdpsi.com) is great for specifying gears and general drive components. Plus the site has 3-D CAD models that can be downloaded for free in several different formats.

Engineering Toolbox (www.engineerstoolbox.com/index.html) is a browser-based application. It allows engineers to do real-time calculations such as beam design, column design, spring design, pressure vessels, interference fits, spring mass systems, and so forth. The Java-based software has a great user interface that supplies both numerical and graphic outputs. The interface allows the user to quickly run through what-if scenarios for various technical problems.

McMaster Carr (www.mcmaster.com) is a distributor of pretty much anything you need for your facility. Even with an offering of more than 400,000 items, the Web site is very easy to navigate and use. The search engine usually hits very close to the intended products, and the ordering process is fairly straightforward. The entire transaction can be completed on-line, and the order tracking process is easy.

Two reference sites (fonsg3.let.uva. nl/Service/Statistics.html and www.soc.surrey.ac.uk/uss/index.html) provide an overview of statistical tests and explain the usefulness of each analysis. You can also perform analyses. Both sites are fairly basic but effective. The second site also provides additional statistical information, including some tables, for those who don't have access to any.

How Stuff Works (www.howstuffworks.com/index.htm) is a general information Web site that will provide fundamental knowledge on how just about anything works. You can explore topics more deeply.

Steven Henderson's Web site (www.shender4.com) is an engineering site I use a fair amount. It contains several different conversion calculators as well as commonly needed reference information about stuff like threads and metal finishes.

And what about Yahoo Maps (maps. yahoo.com/)? Who doesn't use this when you have to go from here to there?

Intuitive Surgical (Sunnyvale, CA; www.intusurg.com) develops products and technologies designed to provide surgeons with the flexibility of traditional open surgery while operating through tiny ports. These technologies may aid in reducing trauma, postoperative pain, and surgical complications for patients. The firm has developed and commercialized the Da Vinci Surgical System.--Laura Angela Bagnetto

Copyright ©2003 Medical Product Manufacturing News

Coating Technologies: The Latest in Device Wear

A quality inspection being done on catheters treated with the Lubrilast coating from AST Products.

The advanced features that are being designed into medical devices vastly improve patients' diagnoses and treatments. However, some of these products "are often made with materials that bring undesirable complications to the body including bacterial infection, blood clots, and tissue trauma caused by device insertion," says AST Products Inc.
The challenge for manufacturers is to make the devices more compatible with human tissues. This is often achieved by modifying device surfaces without significantly changing the underlying material.

Although the category of surface-treatment technologies is broad, MPMN focuses this article on different types of device coatings.

Environmentally friendly coating technologies are available from AST Products Inc. The solvent-free processing technique can be used with either dry or water-based formulations. One of its advantages is that no special solvent handling is required. Another benefit is that there is no risk of damage to solvent-sensitive substrates. 

LubriLast, one of the company's products, is a nonthrombogenic, biocompatible, lubricious hydrophilic polymer coating. It is formulated as an aqueous-based solution. It provides lubricity on device surfaces, it is durable, and it can incorporate bioactive agents that are released in vivo. According to the company, the material overcomes many of the limitations associated with other commercially available hydrophilic coatings, such as poor adhesion, UV curing, or solvent processing. It does this by using no organic solutions.

An atomic force microscopy image of a coated stent showing the topography of the coating.

Another of the company's products, VascuLast has reportedly been shown to be effective in reducing restenosis with certain stent designs and bioactives. It can be made of compounds that act by inhibiting angiogenesis, inflammation, smooth-muscle-cell proliferation, or the clotting cascade. The material strongly and uniformly adheres to substrates with no bridging, flaking, or delamination even when the devices are fully expanded. 
SurModics Inc. also offers a technology that improves medical device surface characteristics in such areas as lubricity, hemocompatibility, infection resistance, and tissue integration. PhotoLink works to modify surfaces in two ways. Passivation prevents unwanted biological responses. Activation includes specific functionalities into the device and environment interface. 

PhotoLink can be easily integrated into manufacturing lines. In the first step, reagents are dissolved in water or a water-and-alcohol mixture. Then the mixture is applied to a cleaned device surface and activated by ultraviolet light. The exposure to UV light takes seconds to minutes to initiate the chemical bonding reaction at the surface. Metals and ceramics may require a separate surface-priming step.

PhotoLink technology uses no harsh chemicals and produces no hazardous by-products. With this process, surface-expanding pretreatment that can often affect a device's physical properties is not necessary. Additionally, no environmental equipment, vacuum control equipment, or curing ovens are required. 

The surface topography of a stent 
using a Leica microscope in Differential Interference Contrast mode.

PhotoLink is the core technology used by Johnson & Johnson's Cordis Div. to coat its drug-eluting coronary stent. FDA approved the device for commercial use in the United States in April 2003. 

Some other uses include coating and matrix technologies for tissue engineering applications such as islet cell encapsulation, and genomics and proteomics products such as activated slides for DNA. 

The company also offers a combination of coatings for the same product. For example, a device may need both a lubricious coating for ease of use and a hemocompatible coating to reduce the likelihood of clotting. 

A Leica Differential Interference Contrast mode image of a coating that has been dewetted.

Parylene Coating Services Inc. supplies parylene thin-film conformal coatings. They can be deposited on most biomedical devices or substrates. The process begins when the dimer is heated and converted into a vapor. The pervasive vapor passes over and around the various configurations to be coated. Deposition takes place at room temperature. Any object that can withstand medium vacuum can be parylene coated.

The coated substrates or devices are stable, and show little or no change in their response characteristics, according to the company. Typical applications are forming mandrels, catheters, guidewires, stents, sensors, transducers, and probes. All of these products have reportedly been used or implanted and found to be compatible with body tissue.

Thickness tolerances are typically held to ± 20% from nominal. Tolerances as tight as ± 5% are possible when necessary. Parylene is inert and insoluble in most solvent systems within its useful range of temperatures. Parylene C may be used up to 125°C continuously in the presence of oxygen. Parylene D is useful up to 140°C in the presence of oxygen.

Copyright ©2003 Medical Product Manufacturing News

Eye-Level Panel Makes Control of Steam Sterilizers Easy

Originally Published MPMN July 2003

EQUIPMENT NEWS: PACKAGING AND STERILIZATION

Eye-Level Panel Makes Control of Steam Sterilizers Easy

Operators can conveniently access the PSS500 control panel from Primus Sterilizer Company, Inc.

The operator-friendliness of a line of steam-pressure sterilizers from Primus Sterilizer Company, Inc., has been increased with the introduction of a control panel placed at eye level. The PSS500 control panel is placed adjacent to the opening of the sterilization chamber and provides both convenient access to controls and clear visibility of cycle display information. Also featured on the sterilizers so equipped are automatic takeup reels for tidy compact storage of batch reports generated.
The control panel also is available with a serial data port for sending electronic batch-data reports to storage and to
a local PC for viewing. This feature provides an integral history of all cycles and complete associated run data, including cycle settings, run parameters, error messages, and a record of any operator interventions. A management option involving an operator number and personal identification number enables operation to be restricted to only trained and authorized users. 

Primus Sterilizer Company, Inc., 17 S. 25th St., Omaha, NE 68131.


Compact Cartoner Provides High Productivity, Saves Floor Space

A German-built cartoning machine supplied by Technik Packaging Machinery LLC places relatively small medical devices and other products into cartons at speeds up to 60 cartons per minute. Available in vertical and horizontal models, the versatile Carton King cartoner offers this high performance while occupying only 40 ¥ 38 in. of floor space. The compact machine has many features that can benefit packagers of pharmaceuticals, cosmetics, and small device parts.

The cartoner has a rotating turret and modular components that enable it to accommodate a wide range of carton blank sizes, and it easily incorporates such quality control functions as bar code verification. It also offers many options for printing, embossing, labeling, and leaflet insertion. The machine can provide hot-melt or tuck-in closures. Several degrees of automation are available, ranging from semiautomatic hand feeding of product to a fully automated system of product infeed, leaflet insertion, and discharge handling of the completed carton. 

Technik Packaging Machinery LLC, 8141 Technology Dr., Covington, GA 30014.


Sterilization Systems Meet Any Requirement

Quetzal offers complete automated sterilization process tunnels or 
stand-alone sterilization chambers.

The globally oriented sterilization equipment specialist Quetzal International Inc. makes both standard systems and custom-configured processors designed to meet specific application requirements. Sterilization systems employing steam and ethylene oxide are marketed to large- and small-volume medical device and pharmaceutical manufacturers, hospitals, laboratories, and research institutions.

Complete automated sterilization processing systems, or tunnels, are offered, as well as stand-alone sterilization chambers. All systems are designed to accord with current codes and standards, including those issued by ASME, IEEE, ISO, and NFPA. The company has produced sterilization equipment for 40 years. 

Quetzal International Inc., 116 Village Blvd., Ste. 200, Princeton, NJ 08540.


Fully Servo-Controlled Wrapper Can Handle Difficult Products

The Revolution IP inverted full-servo polywrapper from Campbell Wrapper is designed for difficult-
to-handle products.

An inverted polywrapper available from Campbell Wrapper Corp. is configured to handle a wide variety of products unsuited for a conventional upright horizontal wrapper. 

The completely servo-controlled Revolution IP is designed to transfer products to be wrapped directly onto the film web that is introduced to the film-forming plow from beneath the product infeed conveyor. The modular machine has a sanitary design with cantilevered components. With a standard sealing head, it can operate at speeds up to 200 packages per minute. Machine functions are managed by Allen-Bradley servomotor and drive controllers in combination with a ControlLogix 5000-series programmable logic controller. Servomotors with timing-belt drives to the cutting head, film-feed roll, film tubing section, and infeed conveyor provide reliable operation requiring no maintenance. The electrical system includes UL- and CE-approved touch-safe components and quick-disconnect sensors and actuators.

The user-friendly touch screen interface has fault, production speed, and totalizer displays. As many as 20 stored product records may be retrieved via the touch screen. The machine is quickly and easily adjusted for changeover of product or wrapping material. 

Campbell Wrapper Corp., 1415 Fortune Ave., De Pere, WI 54115.


High-Throughput Bag Sealer Leads Sealing Machine Line

A high-speed industrial bag sealer from Emplex Systems Inc. can seal heavy-duty bags of any style and heat-sealable material at production rates. Made of mostly stainless steel for operation in harsh environments, the MPS 14000 bag sealer features 25 in. of heat and 10 in. of water cooling, and can easily switch among bags of different thickness. The PLC-based machine alternatively can be configured for a variable speed to 1500 in./min to seal any heat-sealable bags in manufacturing environments emphasizing throughput. It comes standard with a removable sealing module that facilitates change out of Teflon bands, cleaning, and maintenance. The user can control each sealing parameter through a touch screen.

The established MPS 6000 series of band sealers from the same manufacturer has meanwhile been upgraded with a new band-tensioning system, and an easily and repeatably installed and removed front-end trimmer. A master/ follower electrical drive system for the conveyor allows more weight to be run through the machine. All sealers are offered with many optional add-ons.

Emplex Systems Inc., 2045 Midland Ave., Toronto, ON M1P 3E2, Canada.


Analyzer Measures Chamber EtO and Water Vapor Simultaneously

An EtO and H2O analyzer from Sensor Electronics monitors EtO and water-vapor levels in sterilization chambers through an entire cycle. 

A sensitive analyzer able to simultaneously measure the levels of ethylene oxide gas and water vapor in sterilization chambers provides real-time readouts of both measurements to satisfy FDA requirements. Offered by Sensor Electronics, the EtO and H2O analyzer reads the levels of these chamber atmosphere constituents separately and concurrently through the entire cycle for a continuous dual overview. It also can determine levels of propylene oxide gas.

In addition, the analyzer can drive remote monitors, plotters, printers, and computers to create a permanent record of conditions inside the sterilization chamber. It uses no mirrors or lenses, and thus experiences no problems relating to dust, dirt, airborne contaminants, or misalignment. The device is impervious to toxic and corrosive atmospheres and temperature and humidity extremes. With self-correcting circuitry, it can work for years without significant adjustment or recalibration. Self-diagnostic capability enables the analyzer to warn the user when an internal problem may develop, and to explain its nature.

Sensor Electronics, 5500 Lincoln Dr., Minneapolis, MN 55436.


Heavy-Duty Pass-Through Sealers Offer Dependability, Customization

Heavy-duty tabletop and floor-standing pass-through sealers are designed to meet demanding flexible packaging needs. 

Packaging Aids Corp. produces a family of heavy-duty tabletop and floor-standing sealers for medical and pharmaceutical applications. This Vertrod/TechnaSeal line of pass-through sealers, recognized for their ruggedness and dependability, 
is available as a complement to the manufacturer's extensive range of sealing machines that are designed to meet the most demanding requirements of medical device and drug industry companies for flexible packaging.

The equipment supplier also specializes in custom engineering, and welcomes the opportunity to work with clients in developing package sealers to fulfill specific packaging needs.

Packaging Aids Corp., 25 Tiburon St., P.O. Box 9144, San Rafael, CA 94912.

Copyright ©2003 Medical Product Manufacturing News