PDA Technical Report No. 27 provides a scientific framework for evaluating nonporous packaging integrity in sterile pharmaceuticals, covering the product lifecycle, Maximum Allowable Leakage (MALL), and test method selection. While a foundational 1998 document, it is largely superseded by modern standards such as USP and EU GMP Annex 1. Purchase the report at PDA Bookstore Parenteral Drug Association Parenteral Drug Association