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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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