New Recommended Practice for Flexible Packaging Material Selection
The Institute of Environmental Sciences and Technology (IEST; Arlington Heights, IL) has published a new Recommended Practice (RP) for the selection of flexible packaging materials for use in contamination-critical applications. The RP includes references to FDA, ISO, and other pharmaceutical and medical device packaging standards.
IEST-RP-CC032.1: Flexible Packaging Materials for Use in Cleanrooms and Other Controlled Environments is written in general terms and is applicable to many industries in addition to pharmaceutical and medical. It outlines acceptable materials, seals, material properties, and compatibility of packaged product environments.
The portion of the document on testing packaging materials includes procedures that pertain to pharmaceutical and medical packaging. IEST-RP-CC032.1 also discusses test methods for particle release, biological tests, organic and inorganic extractable matter, and nonvolatile residue.