THE PACKAGING VALIDATION PROCESS
[b]Select appropriate package material and design, qualify equipment, validate sealing process, produce test samples
Perform burst test, peel strength creep test on both sterile and non-sterile:
non-accelerated aged product
Place an appropriate number of samples into accelerated aging for the
required period.
After aging, the packaging is tested for physical testing. Device samples
are tested for material problems and whether or not they meet product
specifications.
A portion of the accelerated samples are culled for transportation simulation tests: ISTA /ASTM shipping tests.
Packaging samples are tested for physical parameters as above. A visual
exam is performed to look for holes caused by vibration testing. Device
samples are tested for specification requirements.[/b]
[COLOR=“black”]Combinatory products require strict adherence to ICH guidelines for stability of the drug/biologic throughout the shelf life of the product. For products that have a delivery system (such as needle-less injection systems), storage and shipping parameters are critical to maintaining required potency. For other products that have a drug coating or scaffolding application, the validation program requires a unique perspective into both medical device shelf life studies and ability of the drug/biologic formulation to maintain stability throughout all phases of the manufacturing and sterilization process. Formulation issues are very important prior to FDA filings, and these considerations will be a major portion of the final regulatory filing.
Packaging testing guidelines are listed in ISO 11607. This document describes the available ASTM packaging tests. It also brings together many other key aspects of packaging validation (i.e. material qualification, validation of seal process, whole package seal integrity).
Cell therapy products such as xenografts, allografts, and stem cell products create unusual challenges for the package validation engineer. The FDA offers very little guidance on these issues. Cells must be able to withstand shipment and storage during a finite, defined period. Evaluation of cell lines and tissue implants during a stability program is required prior to FDA submission.[/color]