Packaging Seal Integrity Test Lab

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. The efficaciousness of our seal packaging inspection tools are so unique we were granted a patent in September, 2007 on our technology. Our laboratory can perform a variety of tests such as burst testing, peel analysis, and dye penetration studies and will do so with precise resolution. All the data collected during these robust seal integrity studies are extrapolated via our computer interface systems that allow us to provide comprehensive real time data logging with NIST traceable equipment.

Your IQ starts with machinery designed to meet the rigors of the new sterile barrier system requirements. Speak with technical support about our IQ pack and how it can help you at the threshold of your sterile device packaging program. It's important not to discount the weight of a solid IQ under the ISO 11607. Qualified machinery supported by regulatory girth equals a solid sterile device packaging program. Technical support 1-800-550-3854

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Obviously, in an empirical laboratory, we take very serious the accuracy and analytical nature of our jobs. However, there is no shortage of right-brain thinking as not only is a playful free-thinking model allowed, it is encouraged. Our innovative group continues to evaluate new and better ways to manage sterile packaging. Our staff is excited that our seal integrity device, the VIU has been so widely accepted and utilized and we will continue to evaluate other new technologies, such as our MS-451PV medical pouch sealer. Keep an eye on the in the news area of our website as our prolific team continues to innovate to better serve our customers and market.

Our latest patent-pending technology is our MS-400-10 medical pouch sealer. Our design group has synthesized down the most basic functions of a medical device packaging machine in order to manage cost for our medical device startup firms. Many of these firms have been forced to take shortcuts on less than validatable packaging equipment in order to meet budgetary needs. Although our basic unit was designed with a low cost mandate, there was never a discussion of cutting corners qualitatively. Keep your eye on our sites for this exciting machine and be certain to stop by the upcoming MD&M tradeshow in Anaheim, CA.

Charlie A. Webb, CPP, CMC With an ophthalmic surgical background, Charlie understands not only the technical aspects of complex medical devices, but as a device technologist also understands the rigors of compliance to 3rd part regulatory agencies.

Charlie also is a certified packaging engineer as well as a former independent management consultant. His unique background has gained great praise from our customers.

Just as important as the advanced equipment we utilize in our package integrity lab is the people that interpret the data. Whether it's the metrology department or the seal integrity lab, all data is evaluated and interpreted by a degreed technician.

And all of these reports are ultimately reviewed and interpreted by our in-house certified packaging professional, CPP. This process assures that you will receive the most relevant feedback on your machine's calibration or package integrity study.

Process guidance Call and speak with Charlie regarding your packaging program for key regulatory and technology advice.

Package integrity As the director of our empirical laboratory, Charlie can help you discover needed machine processes for compliant seals.

800-550-3854 x112

During the development of this device, we have had the opportunity to inspect hundreds of sample seals from medical device manufacturers throughout North America and abroad.

Frustrated with the lack of available visual inspection equipment, we developed the Viú® in our packaging integrity lab. Even when utilizing the best available microscopes with both back and front lighting, we were unable to develop the needed visual acuity.

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Van der Stähl Scientific and HAWO are excited to bring you this powerful sterile packaging validation tool.

In accordance with ISO 11607, Part 2, the sealing seams must show the following quality characteristics within the Operational Qualification (OQ):

1. intact seal for a specified seal width
2. no channels or open seals
3. no punctures or tears
4. no material delamination or separation.

With the hawotest Seal Check, an indicator strip shows whether these quality features are fulfilled. A subjective interpretation of the seal seam is excluded, regardless of the type of sealing device.

An optimum seal seam can only be guaranteed if such critical parameters as sealing temperature and sealing pressure are correctly set and adjusted to the material to be sealed. If one of these parameters shows a deviation, this is visible on the indicator strip.

When used daily, the Seal Check can ensure that the sealing device is working at optimum efficiency and is performing correctly.