MS-451PV Medical Device Packager

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

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.

The Viú® system was designed by our certified packaging engineer to create a non-destructive visual standard in order for quality teams to evaluate possible signs of creep within the packaging program. An included laminated card provides quick reference. This quick reference sheets harmonizes with the ASTM 1886 visual inspection standard. The sealer will then prompt the operator to perform a peel test, which is also designed to harmonize with the ASTM F-88 seal integrity test. If the seal does not pass, the machine will not continue to operate until the supervisor on the operating team inspects possible causation for a seal failure.

This integration is designed to prevent hundreds of thousands of poorly sealed pouches reaching the market, that may prompt a recall. Co-inventor, Charlie Webb states that, "It’s my opinion, after working with literally hundreds of validations from small medical device startups to the nation’s largest medical device makers that output is everything. I believe that many quality teams fail to test in-process regularly and this to me is a huge breach in a cogent quality program."

Integrated Peel Testing

Seal strength is the ultimate arbiter of a packaging program on track. Many companies historically have relied on machine alarms and SOP’s. Under the new sterile barrier system, the standard is shifting towards empirical data such as seal testing.

The MS-451PV medical packager incorporates a peel tester in order to perform an ASTM F-88 peel study. The peel tester further integrates with the machine and allows all seal strength study results to be stored on-board the machine and can later be purged via a USB port to a software program in order to record and manage peel strength records.

The peel tester incorporates two thin-film grips designed to clamp on a variety of films such as TyVek® and clear films such as mylar or poly. These grips have been machined to securely grip thin film in order to thwart slipping during the testing procedure. The peel tester holds at a constant rate of 8.5 in. per minute and quality teams can set the minimum peel strength requirements based on their performance expectation of their film. If the peel test is not compliant to the minimum peel threshold set by your quality team, the MS-451PV will lock-out the continued operation of the machine until a quality team member with a passcode can investigate possible causation for the peel failure. Once remedy has been set in place and the sealer is again producing conforming seal strengths, the machine can regain operation.

Integrating seal strength testing with the machine that created the seals is an excellent way to control possible failures in your sterile packaging program. To find out more about how the MS-451PV medical packager can help you stay compliant, contact technical support at 1-800-550-3854.

The MS-451PV’s microprocessor is fully calibratable to assure NIST traceability to thermal performance as well as pressure performance at the platen, with its calibratable transducer. Also, the peel tester that is integrated with the sealer has a segregated calibration function in order to separate the packaging machine’s performance and the peel tester’s performance. The MS-451PV medical sealer debuted at the MD&M tradeshow this past January in Anaheim at our booth #1953. The response from the quality teams even surprised us. We heard comments like, “gentlemen, you have a home run” to “finally, someone understands the importance of in-process testing” and “brilliant.”

The design and machine quality is absolutely outstanding on this new sealer. Our engineering staff created their magnum opus as this sealer exudes quality throughout its platform, both in its electronic configuration and, as a machine, its mechanical function.

This sealer isn't designed to wholly create a solution for sterile device packaging but rather add an additional level of pouch evaluation during the process of production. We believe utilizing the MS-451PV's unique inspection and testing functions, you will add additional peace of mind that your product will reach the sterile market intact.

PTT-100V Package Testing Unit

Complete package quality lab right on your desktop, the PTT-100V

Quality teams agree - the best way to thwart the risk of a packaging failure in the market is accurate and regular testing and inspection. A product recall due to packaging failures is a senseless risk that can devastate a medical device company.

Van der Stahl Scientific’s package integrity lab understands the value of regular and thorough testing and it is within that spirit that we have developed the all new PTT-100V. This patented medical pouch test and inspection unit has received outstanding reviews from our customers. The PTT-100V’s compact size facilitates the placement of the unit throughout your facility. This system can even be used in the cleanroom for in-process visual inspection of your medical pouches. more

Engineering Support

Just as important as the quality products we offer, our staff of exuberant and talented individuals can guide you through your project.

At Van der Stähl Scientific we have a basic philosophy: If you're in the business of providing machinery that seals sterile packs, you need to have a solid understanding of the integrity of the seal your machine creates. Enter the Van der Stähl Scientific Package Integrity Lab. With an intense interest to provide our customers with exceptional customer

care, we have invested tens of thousands of dollars to create this full service sterile package integrity lab. This state of the art lab allows us to evaluate the pouches and bags that our machinery seals to better understand the total value of the seals that our machines produce. Our laboratory and trained technicians are able to scrutinize sterile packs through a variety of seal strength challenges. Some of these evaluation machines have actually been invented and built by our Sterile Packaging Group. more

Parts and Service Center

Our World Class Engineering Staff and Genuine Machine Replacement Parts, Guaranteed Long, Trouble-Free Performance of Your Equipment

Lisa Durkin Hello and welcome to our parts area. Over the past two years, my staff and I have spent a great deal of time creating and implementing systems designed to be certain our customers have their needed parts.

Customer service is a passion with me and if you are having an issue with your machine, I would be glad to help you identify the correct part to keep your packaging equipment running in peak performance. This year, we instituted the shipped to you in 72 program. This system is designed to get your parts shipped from our parts center within 72 hours and in most cases, much sooner than that.

This year, look for new programs in our parts and service center that will increase your customer experience with Van der Stähl Scientific. During this less for more time we live in, we think you will be pleased with a more for less model that has become our company mantra. best regards, Lisa Durkin, 800-550-3854 x214 more