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Significance and Use
Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.
Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.
The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
1.1 This guide defines the requirements and considerations for flexible barrier materials.
1.2 This guide addresses some critical printing requirements for flexible barrier materials.
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4321 Test Method for Package Yield of Plastic Film
F17 Terminology Relating to Flexible Barrier Packaging
F88 Test Method for Seal Strength of Flexible Barrier Materials
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
F2203 Test Method for Linear Measurement Using Precision Steel Rule
F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
F2251 Test Method for Thickness Measurement of Flexible Packaging Material
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2559 Guide for Writing a Specification for Sterilizable Peel Pouches
TAPPI StandardT437 Dirt in Paper and Paperboard
FDA Document21CFR178 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
ICS Number Code 55.040 (Packaging materials and accessories)