TR 27 has been widely referenced by global health authorities:
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 pda technical report 27 pdf
Pharmaceutical Package Integrity (Technical Report No. 27) Publisher: Parenteral Drug Association (PDA) Current Status: Replaced by Technical Report No. 27-1 (2023) / Revised Version TR 27 has been widely referenced by global
TR 27 introduced a risk-based concept: not every leak must be detectable. The MALL is the largest leak that still ensures sterility over the product’s shelf life. The report guides you to set a MALL based on: The full report is available for purchase at
: TR 27 advocates for an integrity assessment that begins during the design phase and continues through routine manufacturing and shelf-life stability testing.