PDA Technical Report No. 27, "Pharmaceutical Package Integrity," provides a comprehensive framework for validating the barrier properties of sterile drug packaging throughout its lifecycle. It emphasizes a science-based, risk-based approach, advocating for deterministic, quantitative leak detection methods over traditional, subjective tests. More information on the report is available through the Parenteral Drug Association (PDA) bookstore.
However, if you are looking for a document to cite in a regulatory filing or to set up a validation protocol for a new line, and USP General Chapter <1207>. TR 27 is the history book; TR 86 is the instruction manual. pda technical report 27 pdf
PDA TR 27 was developed to provide a structured approach to evaluating the ability of a packaging system to maintain a sterile barrier throughout its shelf life. The document addresses three primary objectives: PDA Technical Report No
Protecting the Patient: A Deep Dive into PDA Technical Report 27 More information on the report is available through