
The Viu® 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 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.”
The MS-450-NG’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-450-NG 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. The engineering staff at Fuji Impulse 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-450-NG's unique inspection and testing functions, you will add additional peace of mind that your product will reach the sterile market intact.
To find out more on how the new MS-450-NG can serve your medical device packaging program, call now and speak with a certified packaging engineer at 1-800-550-3854.
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