PDA Technical Report No. 27 (TR 27), titled Pharmaceutical Package Integrity
Specific methods for proving that a container-closure system prevents microbial ingress. Industry Status and Updates Member Access: PDA members can view the full report on demand through the PDA Technical Report Portal pda technical report 27 pdf
Published by the Parenteral Drug Association (PDA) , Technical Report No. 27, “Pharmaceutical Package Integrity” has served as the industry’s gold-standard reference for developing, validating, and maintaining container closure systems for sterile products. PDA Technical Report No
| Aspect | PDA TR 27 (2014 Rev) | PDA TR 86 (2021) | |--------|----------------------|------------------| | Focus | Fundamental methodology | Emerging challenges & case studies | | Leak size guidance | ≥0.2 µm equivalent | Covers down to sub-micron | | Technologies | Traditional methods | Includes laser-based, microcurrent, and headspace analysis | | Regulatory alignment | Precedes USP <1207> shift | Fully aligned with USP <1207> (2016-on) | | Practical examples | Limited | Extensive industrial case studies | PDA TR 27 is the historic standard for
The most significant contribution of TR 27 (and its revision) was moving the industry away from probabilistic testing toward deterministic testing.
PDA Technical Report No. 27, "Pharmaceutical Package Integrity," provides comprehensive guidance on Container Closure Integrity Testing (CCIT) to ensure the barrier quality of pharmaceutical packaging, particularly for sterile products. It outlines strategies for establishing integrity standards and selecting appropriate test methods, such as helium mass spectrometry and microbial challenge, throughout the product lifecycle. The full report is available for purchase at the PDA Bookstore. Technical Report No. 27: Pharmaceutical Package Integrity