In The News...

With so many new and exciting customer enhancements, we had to create this area on our website big enough to capture these monumental events. Much is on the drawing board in the next few years, including medical pouch rotary sealers that can seal clear film to clear film header bags. We will be exploring new packaging testing machinery designed to help medical device makers deliver their product sterile to market. Also, this coming year, expect great value-added services from our packaging integrity lab. We also are in our third year of development and now finally have a working prototype for our MS-400-JP. This unit will use a proprietary pressure system that will better aid the validation processes, so keep your eye on this area of our website and we will be announcing ship dates for this innovative sealer. Also visit our software area on our website for latest news on our Viu Calibrate software. If you are a member of the press, you can download large images by clicking the link on the bottom right of this page. Feel free to cut and paste press releases from the body of this website and thank you for visiting Van der Stahl Scientific.

New PTT-100V medical pouch testing unit needed to preserve sterility of critical medical devices.

Redlands, Calif. - Non-compliant medical device packaging has been at the tip of the tongue of medical device manufacturers over this past year. Third party agencies such as the FDA and ISO are getting tough with non-compliant packaging programs.

The best way to thwart the devastating blow of a medical device product recall is regular pouch testing, claims Charlie Webb, Van der Stahl Scientific, Inc.’s president.

Webb says, “It’s become increasingly apparent that many medical device companies are simply not testing pouches in process and this breach in quality assurance is a recipe for disaster.”

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Historically, many quality assurance groups have felt that testing machinery is cumbersome to use and because most of the tensile testing equipment is designed to pull test a variety of products and packaging, it is not finely tuned for medical device pouch peel testing.

With the new PTT-100V Testing Unit, this system incorporates a quick load fixture and has been developed and optimized to work in concert with the ASTM-F88 peel test protocol.

The unit also incorporates another important feature, the VIU system. This patented system side lights the medical pouch with a LED light wash at a low angle. With the 3X magnification lens the system allows lay packaging staff to evaluate the basic seal integrity by using this fixed magnification, fixed lighting system. The VIU includes a quick reference card in order for packagers to evaluate visual seal integrity against a known standard. The PTT-100V is a small unit that is right at home in a clean room.

The system is designed to promote regular testing through its ease of use. Perhaps most important, the system will digitally date and time stamp every inspection and testing event. Lot numbers and machine serial numbers can be included at the time of each inspection as well as the inspecting personnel’s name. The PTT-100V ships with included software that allows quality teams to purge inspecting and testing data in order to archive important testing and inspection records. The firm has created a video of this unique product in order to highlight the systems ease of use, visit this URL to view. www.vanderstahl.com/medical_pouch_sealers/ptt-100v-package-testing-unit

Webb says, “This is a paradigm shifting approach to medical pouch inspecting and testing. We have worked hard to include process ergonomics in order to help our medical device packaging customers stay compliant to ISO-11607. We’re passionate about the movement to increase inspection intervals as we truly believe this is the pathway to total quality of a medical device packaging function.”

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientifics’ corporate mission is to provide patented technologies to serve the challenging sterile packaging industry and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

This patented system greatly exaggerates the topography of the flexible pouch seal area and also records each inspection event

Redlands, Calif. - A human eye is an incredible machine. Despite our incredible computer and sensor technologies, we can’t even begin to touch the surface of the human eye’s amazing capabilities. It has a 200 degree viewing angle, can see 2.7 million colors and has a possible contrast ratio of about 1,000,000 to 1 [Wikipedia].  The eye is the ultimate inspection device, and yet we seem to lean away from the human eye’s capability to other empirical data portals. In the medical device packaging industry, inspection and monitoring are king. In order for us to be certain that the medical devices that we cocoon to market are kept viable and efficacious, we need to use all tools available in science.

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In fact, the only broken link in this otherwise spotless methodology is the lack of a repeatble light source and a system of fixed magnification. Because we can visually interpret a host of possible anomalies within the sterile seal, we only then need to assure that a repeatable, mechanized system is in place in order to flatten out possible data scatter due to the inspector’s visual acuity to the sealed area.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientifics’ corporate mission is to provide patented technologies to serve the challenging sterile packaging industry and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

Ten years in product design and development and two US patents later, the MS-451PV is here.

Redlands, Calif. - This innovative new medical device packager will change the way medical device companies manage their sterile packaging program. With advanced integration, medical device quality teams can now manage in-process visual inspection and destructive testing on one integrated packaging machine. The MS-451PV medical pouch sealer controls all critical packaging attributes in order to ensure seal-to-seal consistency. An advanced transducer manages platen pressure that electronically feeds back data to the microprocessor in real time.

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The MS-451PV medical device bag sealer also manages the platen’s thermal environment with a K-type thermocouple that is configured to sample pouch environment. But the MS-451PV does much more. This advanced system allows quality teams to program required stop and test functions into the machine. This function will automatically stop production, prompting the operator to perform first a visual seal inspection with our low angle of light 3x magnification visual inspection tester.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientifics’ corporate mission is to provide patented technologies to serve the challenging sterile packaging industry and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

SC-1 Specimen Cutter speeds, simplifies testing process to help medical device companies keep their product sterile to the point of use.

Redlands, Calif. – Under the new spirit of increasing test intervals for medical device pouch testing, Van der Stahl Scientific has created a quick cut specimen cutter in order to speed up and simplify the ASTM F-88 seal strength test.

Historically, medical device packagers have had to manually cut the one edge specimen with scissors.

Company spokesman Charlie Webb says, “The arduous process of cutting each specimen out with scissors has created two problems. First and foremost, the process is very slow. But also, most importantly, the specimens’ widths vary from specimen to specimen. This is completely counter to the testing process as unless the specimens are of uniform width, data will be deeply skewed.”

The SC-1 has just been released and already medical device packaging engineers are singing its praises. Its compact size makes it easy to stow when not in use and its heavy base plate and rubber feet assure a solid grip on the table top.

To see more information on the SC-1 specimen cutter visit this link.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

Van der Stahl Scientific keeps packaging community current with new blog centered around medical device packaging.

Redlands, Calif. – Van der Stahl Scientific has been committed to medical device packaging for nearly two decades. It is within the spirit of that commitment that Van der Stahl Scientific has released an open forum blog expressly for the discussion of the challenges facing sterile device packaging compliance.

Company spokesman Charlie Webb says, “This informative interactive area on our expanded website is a terrific boon for medical device manufacturing companies as it is an open forum for sterile device packaging engineers to read about current issues and sterile device packaging.”

The company plans to blog regularly as a no-cost educational service to their medical device customers.

Blog editor Jennifer Dean says, “The Van der Stahl Scientific blog, an excellent resource for individuals searching for sterile medical device packaging news, is full of updates on packaging standards and useful advice from experts on the frontline of the complex industry.”

To learn more about this informative blog visit www.vanderstahl.com/blog/

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

New online radio Validation Report keeps engineers up to speed on Medical Device Pacakaging

Redlands, Calif. – Van der Stahl Scientific puts its money where its mouth is with a new validation report radio online. Medical device packaging engineers can listen in at any time to the “validation report radio” and stay up to speed with the constantly evolving medical device packaging regulatory changes and climate.

According to company spokesman Charlie Webb, “Knowledge is everything in our business. We have seen many companies receive a 483 or non-compliance letter simply because they did not understand completely the 11607 guidelines for the packaging of terminally sterile medical devices.”

The firm plans to expand into several new programs this year featuring regulatory experts as well as certified packaging engineers. To find out more information or to listen in to the validation report online radio program visit, www.vanderstahl.com/validation- report.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

VIU Calibrate Software improves equipment maintenance efficiency

Redlands, Calif. – Van der Stahl Scientific announces the release of their new software program VIU Calibrate Software. This data collection software works with many data logging systems in order to capture data from electronic thermometers and thermal data loggers, etc. The system was also designed for use with the company’s proprietary medical device packaging machinery and medical pouch testing machinery.

Also, this software will expand to integrate with the company’s maintenance cast software that allows medical device packagers to schedule and monitor maintenance on critical packaging machinery.

To find out more about this innovative new data capture software visit www.vanderstahl.com/viu-calibrate.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

Van der Stahl IPhone App Simplifies Maintenance Schedules

Redlands, Calif. – Coming soon, Van der Stahl Scientific will roll out the iPhone version of Maintenance Cast, an intuitive, simple preventative maintenance-scheduling app specific to Van der Stahl Scientifics’ machine models. With Maintenance Cast, quality engineers and maintenance personnel can schedule important tasks such as perform periodical maintenance such as replacing heating elements, glass cloth, silicone rubber, etc. It will also prompt users with its integrated alarm function to perform vital inspections of key components such as temperature sensors and micro switch positions.

“This is an excellent way for maintenance personnel to stay on top of the exceedingly important function of preventative maintenance,” says Charlie Webb, Van der Stahl Scientifics’ president.

This intuitive app will also allow users to receive blog feeds on current issues surrounding sterile device packaging. We’ll also incorporate a database of useful tips on better packaging. Many medical device companies have fallen short on maintaining critical packaging machinery and the FDA and ISO have taken notice. Don’t risk a 483 from a non-compliant PM program. Stay on track with Maintenance Cast.

This app will be available soon. Return to this page for updates regarding this unique iPhone app.

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.

Van der Stahl Scientific expands into Medical Pouch testing equipment

Redlands, Calif. – Van der Stahl Scientific has been providing medical device and critical packaging machinery to North America for nearly two decades. Because most of the equipment sold by Van der Stahl Scientific is scrutinized through testing equipment, it seemed a natural fit for the firm to begin offering testing machinery for medical device pouches.

Company spokesman Charlie Webb says, “You can no longer make claims that your package machinery is creating repeatable seals. It’s absolutely vital that you test your pouches regularly in order to stay compliant to third parties such as the FDA and ISO.”

The company, frustrated with the limits of testing and inspection machinery in the market, made the choice to develop their own patented technology that is more finely tuned for the testing and inspection of medical pouches and medical bags.

Expect to see much more from our medical pouch testing innovation group this coming year,” says Webb.

The firm is currently developing two more patented systems for dye penetration testing and burst testing.

Webb goes on to say, “Clunky, difficult to use and oftentimes, marginally accurate testing systems will no longer meet the advancing rigors of medical device packaging compliance. We have seen a lot of pouch failures out in the market and expect to see a crackdown by regulatory agencies in the coming decade. It’s time we get serious about regular, in-process testing and inspection and our firm is dedicated to partnering with medical device manufacturers to that aim.”

To find out more about these innovative new testing devices visit www.vanderstahl.com/test-equipment

Van der Stahl Scientific is an innovative medical device packaging technology group based in Redlands, California. Van der Stahl Scientific’s corporate mission is to provide patented technologies to serve the challenging sterile packaging technology and regulatory requirements of the food and Drug Administration and ISO. Van der Stahl Scientific serves most of the major medical device manufacturers such as Medtronics and Boston Scientific as well as non-medical firms such as the Department of Defense and NASA.