Measures pressure changes inside a test chamber containing the package. A leak causes a predictable rise or drop in pressure over time.
is a landmark document that has guided the pharmaceutical industry for over two decades. It provides a systematic approach to evaluating packaging integrity, from product development to quality control. Its exploration of microbial and physical testing methods, leak rate specifications, and its famous decision tree have provided a structured methodology for countless sterility assurance programs.
The report establishes a critical hierarchy: Physical tests are generally more sensitive and reliable than microbial tests. It argues that you can correlate a physical measurement (e.g., pressure drop) to a microbial risk, saving time and money while increasing safety. pda technical report 27 pdf
A unique logical tool to help manufacturers determine which microbial or physical leak tests are most appropriate for their product Why Integrity Testing Matters
PDA Technical Report No. 27: Pharmaceutical Package Integrity Measures pressure changes inside a test chamber containing
| | Cons | | :--- | :--- | | Foundational Theory: Explains the physics of leaks better than almost any other document. | Dated Technology: Does not cover modern high-speed inspection systems in detail. | | Method Comparison: Offers deep analysis on the pros/cons of various test types. | Superseded: Regulatory inspectors now look to USP <1207> and PDA TR 86 for compliance. | | Paradigm Shift: Captures the moment the industry moved from "testing quality" to "building quality." | Statistical Gaps: Lacks the rigorous statistical acceptance criteria required by modern FDA/EMA guidelines. |
It ensures that the drug product remains safe and stable for the patient, preventing spoilage or contamination. Accessing the PDA Technical Report 27 PDF It provides a systematic approach to evaluating packaging
The report assists manufacturers in picking appropriate testing procedures by balancing several parameters: