Pda Technical - Report 27 Pdf
Technical Report No. 27: Pharmaceutical Package Integrity | PDA
The report famously correlates leak size with microbial ingress:
A key feature of the report is its practical guidance on test method selection. It categorizes the available options and provides a detailed "Decision Tree" to help professionals choose the appropriate tests for their package system. TR 27 specifically describes both physical and microbial integrity tests. This includes probabilistic leak test methods, such as the dye (paint) immersion test and the bacterial immersion test, which have been used in the industry for many years. pda technical report 27 pdf
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Understand why a batch might have failed sterility testing. Technical Report No
Deterministic methods rely on physical or chemical phenomena that can be quantitatively measured. They yield predictable, repeatable results and are less prone to human error.
Revision updates to Annex 1 place stringent emphasis on maintaining and verifying container closure integrity for sterile products, explicitly requiring visual inspection and validated CCI testing for fused containers (like ampoules) and large-volume parenterals. 6. Conclusion TR 27 specifically describes both physical and microbial
It compares microbial test methods against physical test methods, offering clear criteria on when to use specific technologies.
One of TR 27’s most influential contributions is the for CCI. Integrity is not a single test – it must be assured at multiple stages:
The report provides detailed guidance on maintaining an effective microbial and physical barrier against contaminants and reactive gases. Its structure typically includes: