SEAL STRENGTH AND PACKAGE INTEGRITY – (密封强度和包的完整性).pdfVIP

SEAL STRENGTH AND PACKAGE INTEGRITY – (密封强度和包的完整性).pdf

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SEAL STRENGTH AND PACKAGE INTEGRITY – (密封强度和包的完整性)

SEAL STRENGTH AND PACKAGE INTEGRITY – The Basics of Medical Package Testing Stephen Franks TM Electronics, Inc. “Seal Strength and Package Integrity: The Basics of Medical Package Testing” Stephen Franks © 2006 TM Electronics, Inc. Part 1: Seal Strength Testing The objective of package testing for medical packages is twofold: first, to ensure the integrity of the sealed package, and second, to assure that no weaknesses in the sealed areas of the package permit leaks to develop during sterilization, normal handling, transportation and storage. Testing of a medical package must yield a comprehensive view of its ability to provide and maintain a sterile barrier around the medical device or product. According to ANSI/AAMI/ISO11607-1997 Packaging for terminally sterilized medical devices, both seal strength testing and package integrity testing are needed in order to properly validate your design and document your conformance to specifications. In this article we will look closely at seal strength testing. Seal strength testing evaluates the mechanical strength of the seal, assuring proper bonding to maintain package integrity throughout the life of the package. Package integrity implies the maintenance of the sterile barrier property of the package. It is important to understand that seal strength and package integrity are distinctly separate objectives of the package testing process. Seal strength is a package attribute; data acquired can be used to validate the package design as adequate for maintenance of integrity, to monitor process performance, and to confirm shelf life

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