The Whole Package Integrity test is intended to determine package integrity of a finished product package. This includes a whole package microbial challenge and subsequent sterility testing on the packaged product to determine penetration of the indicator organism used. Materials tested include pouches, trays, syringes, IV bags, tubing sets, vials, and containers.
The Whole Package Integrity test meets the requirements outlined in ISO 11607 for microbial barrier testing.
- ISO 11607
- AAMI TIR17
- PDA Technical Report 27