STRENGTH AND INTEGRITY – The Basics of Medical Package Testing
The release of a terminally sterilized medical device or product to the marketplace is the culmination of monumental design and development effort. Efficient, effective and safe usage characteristics are critical. Once the product has met its own design criteria, the package in which it is enclosed must form a single functional entity with the product that performs to the highest level in the end user’s application. Package testing enables validation of the packaging design and process, and provides documentation of ongoing conformance to specifications. This will in turn assure the maintenance of the sterile barrier around the product, protecting it from contamination.
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