For over two decades, TR 27 was the industry's go-to reference for package integrity. However, the pharmaceutical landscape has evolved dramatically, with more complex packaging systems like pre-filled syringes, auto-injectors, and large-volume flexible containers for biologics becoming standard. In 2021, the PDA formally recognized this evolution by publishing .
Understanding PDA Technical Report 27 (TR 27): Pharmaceutical Package Integrity
TR 27 advocates for deterministic methods where possible, while acknowledging the historical use of dye ingress for many products. pda technical report 27 pdf
To address this, the PDA released (often referred to as the revised TR 27).
While older testing paradigms relied heavily on qualitative, destructive methods, TR 27 helped pave the way for a more quantitative, science-based approach to packaging validation. Core Objectives of TR 27 The primary goals of PDA Technical Report 27 include: For over two decades, TR 27 was the
– Require all QC analysts who perform leak testing to read specific sections of TR 27 (e.g., Chapter 4 on method selection, Appendix C on validation statistics).
"TR 27 says we don't just fix the one vial," Elias explained, pointing to the section on Maintenance of Sterility . "We find the root cause in the capping pressure." Core Objectives of TR 27 The primary goals
: A review of various leak detection methodologies, including a Decision Tree to help users select appropriate methods for their specific needs.