According to TR 27, ensuring package integrity is not a one-time test but a continuous process:
, titled "Pharmaceutical Package Integrity," is a foundational guidance document published by the Parenteral Drug Association (PDA) that establishes best practices for ensuring the barrier qualities of pharmaceutical packaging. Originally released in 1998 to supersede Technical Information Bulletin No. 4, it remains a critical reference for manufacturers developing strategies to protect sterile products from environmental contamination and maintain product stability throughout their lifecycle. Key Objectives of TR 27
: While it emphasizes packaging for sterile products , the principles are applicable to any nonporous barrier system protecting a pharmaceutical product. pda technical report 27 pdf
For professionals seeking the full technical details, the PDA Bookstore offers the for purchase and download. Technical Report No. 27: Pharmaceutical Package Integrity
: Often considered the gold standard for validating a sterile barrier. According to TR 27, ensuring package integrity is
: Stability studies must include integrity tests to confirm that the package maintains its barrier properties under typical storage conditions until the product's expiration. Methodologies and Validation
: TR 27 advocates for an integrity assessment that begins during the design phase and continues through routine manufacturing and shelf-life stability testing. Key Objectives of TR 27 : While it
: A traditional physical method often correlated to microbial results.
: The report introduced modernized terms, such as "product package" (instead of container/closure system) and "package seal" to encompass diverse sealing technologies. Lifecycle Integrity Assessment
The report primarily focuses on , providing a scientific framework for evaluating how well a package maintains its microbial barrier and prevents the ingress of reactive gases like oxygen or water vapor.