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&A:
There are many considerations to take into account when qualifying a top web material. Factors include:
- bottom web specifications
- required material performance characteristics
- package size and application
- sterilization method
- marketing requirements
- distribution cycle
- shelf life
- device attributes
- user needs research
For more detailed information, review Consider the Basics when Developing Packaging, by Randy Troutman, former Technical Director and part of the Oliver-Tolas Answer Team.
Also, consider reviewing these documents for more information:
ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems
ANSI/AAMI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes
ASTM F2097-05 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Available for purchase here
FPA SPMC 011-03, Guide for Design and Evaluation of Primary Packaging for Medical Products
Contact Oliver-Tolas for a complimentary copy of the SPMC Standards, including FPA SPMC 011-03.
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