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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, technical director and part of the Oliver 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 Medical for a complimentary copy of the SPMC Standards, including FPA SPMC 011-03.
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