Guidance Document - American Association of Tissue Banks

IV. PACKAGINGQ1. Does the immediate package of, or the packaging system for, a tissue needto be verified or validated?A1. No. Process validation or verification only applies to processing. Packaging andshipping are not part of processing [see 1271.3(ff)]. Therefore, packaging andshipping containers are not required to be validated or verified. At a minimum, therequirement for packaging is that the containers be designed and constructed toprotect the tissue from contamination and cross-contamination. Also, you mustestablish appropriate storage parameters and shipping conditions to be maintainedduring transit. So, for example, a shipping container would have manufacturer’sspecifications when packed with gel packs or wet ice, and the tissue establishmentcould ensure that those specifications were followed and resulted in the desiredtemperature range during shipping. Another example would be to have anindicator device placed in shipments that registers what the highest and lowesttemperatures were during shipment, but it would not be required to use such anindicator.Page 24 of 44