PDA Technical Report No. 27 provides a comprehensive framework for assessing pharmaceutical package integrity, with a key Decision Tree for selecting appropriate leak test methods. The report offers detailed guidance on integrity assurance, establishing leak rate specifications, and evaluating various test methods throughout the product life cycle. Non-members can purchase digital or paper copies via the PDA Bookstore . PDA Tech-Report-27 98 Packaging Integrity | PDF - Scribd

1. Introduction and Significance

  1. The Official PDA Store (pda.org): The primary source. As of 2025, PDA TR 27 is listed as "archived" or "historical," but you can often purchase the PDF for historical reference (cost approx. $250–350 USD for members, $400–500 for non-members).
  2. PDA Technical Report 84 (Current): If you don't specifically need TR 27 for legacy documentation, buy TR 84 instead. It includes all updated methods (e.g., laser-based headspace analysis, mass extraction).
  3. Corporate Subscriptions: Many large pharma companies (Pfizer, Roche, J&J) hold site-wide PDA licenses. Ask your internal librarian or quality document control for access.
  4. Academic Access: Universities with pharmaceutical engineering programs may have institutional access.

Leak Test Methods

: Technical details on specific testing procedures. Accessing the Full Document