ISO 11607 applies to terminally sterilized medical device packaging. TR 27 covers aseptically filled and terminally sterilized drug products, with greater emphasis on microbial ingress correlation.
One of the most challenging aspects of CCI is determining what constitutes an "acceptable" leak rate. TR 27 provides guidance on how to define and establish these specifications. It emphasizes understanding the relationship between hole size, leak rate, and the risk of microbial ingress (often referred to as the Maximum Allowable Leak Limit or MALL). 3. Test Method Selection and Validation
| 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 technical report 27 pdf
The air in the sterile processing lab was thick with the hum of the autoclave and the scent of pressurized steam. Elias, a veteran validation engineer, held a worn, printed copy of PDA Technical Report No. 27 (TR 27) —the industry bible for Pharmaceutical Package Integrity Testing
The most significant contribution of TR 27 (and its revision) was moving the industry away from probabilistic testing toward deterministic testing. ISO 11607 applies to terminally sterilized medical device
The is structured into several key sections, providing a logical flow from foundational concepts to practical application. A review of its table of contents reveals the following core chapters:
(A specific type of liquid tracer test, often called the "dye ingress" method) TR 27 provides guidance on how to define
| Pitfall | TR 27 Solution | |---------|----------------| | Using dye ingress as a sole release test | Use dye ingress only for development; switch to deterministic for routine. | | No correlation between leak size and microbial ingress | Perform microbial ingress studies with calibrated leaks (e.g., microcapillaries, laser holes). | | Testing only at time zero | Test at stability points and after shipping. | | Ignoring headspace gas ingress | Consider oxygen/moisture ingress for sensitive products (requires additional testing). | | Destructive testing of all samples | Implement non-destructive 100% testing for high-value biologics. |
Established foundational concepts for pharmaceutical package integrity.
Utilizes electrical conductivity. If a liquid-filled container has a micro-crack, the electrical resistance drops sharply, indicating a leak.
PDA has translated many technical reports. Search the official store for “TR 27 Chinese” or contact PDA Asia Pacific.