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The official, authorized version of TR 27 is available for purchase directly from the Parenteral Drug Association bookstore. PDA members often receive significant discounts on digital PDF downloads and print copies.
The primary objective of Technical Report 27 is to provide a scientific framework for assessing .
: Strategies for assessing package integrity during development, in-process controls, and final product testing.
It outlines exactly what constitutes "integrity" and provides guidance on setting appropriate leak rate specifications.
Pharmaceutical Package Integrity (Technical Report No. 27) Publisher: Parenteral Drug Association (PDA) Current Status: Replaced by Technical Report No. 27-1 (2023) / Revised Version
What is your specific (e.g., glass vials, pre-filled syringes, or blisters)? What method are you currently using for leak detection?
While applicable to many packages, it emphasizes those intended for sterile pharmaceutical products Parenteral Drug Association Where to Access the PDF
Unlike earlier methods that relied heavily on visual inspection, TR 27 emphasizes a science-based approach. It encourages the use of deterministic leak testing methods over older, probabilistic ones to achieve more reliable and reproducible results. Core Objectives of the Report
When a customer reports an empty syringe or a leaking vial, TR 27 provides a decision tree for root cause analysis:
Regulators often ask for the rationale behind chosen leak test methods. Citing TR 27 provides a recognized industry justification.
What are you using (e.g., vials, syringes, IV bags)?
Yes—for any new product or new equipment validation. However, for legacy products already on the market, maintain your existing TR 27-based methods unless you identify a failure trend.
The official, authorized version of TR 27 is available for purchase directly from the Parenteral Drug Association bookstore. PDA members often receive significant discounts on digital PDF downloads and print copies.
The primary objective of Technical Report 27 is to provide a scientific framework for assessing .
: Strategies for assessing package integrity during development, in-process controls, and final product testing.
It outlines exactly what constitutes "integrity" and provides guidance on setting appropriate leak rate specifications.
Pharmaceutical Package Integrity (Technical Report No. 27) Publisher: Parenteral Drug Association (PDA) Current Status: Replaced by Technical Report No. 27-1 (2023) / Revised Version
What is your specific (e.g., glass vials, pre-filled syringes, or blisters)? What method are you currently using for leak detection?
While applicable to many packages, it emphasizes those intended for sterile pharmaceutical products Parenteral Drug Association Where to Access the PDF
Unlike earlier methods that relied heavily on visual inspection, TR 27 emphasizes a science-based approach. It encourages the use of deterministic leak testing methods over older, probabilistic ones to achieve more reliable and reproducible results. Core Objectives of the Report
When a customer reports an empty syringe or a leaking vial, TR 27 provides a decision tree for root cause analysis:
Regulators often ask for the rationale behind chosen leak test methods. Citing TR 27 provides a recognized industry justification.
What are you using (e.g., vials, syringes, IV bags)?
Yes—for any new product or new equipment validation. However, for legacy products already on the market, maintain your existing TR 27-based methods unless you identify a failure trend.
