PDA Technical Report No. 27 (TR 27), "Pharmaceutical Package Integrity," is a 1998 guidance document that outlines strategies for assessing the container closure integrity (CCI) of pharmaceutical packaging. It emphasizes protecting sterile products by setting standards for microbial barriers, though it is being superseded by newer guidelines such as TR 86. The report is available for purchase on the PDA Bookstore . Technical Report No. 27: Pharmaceutical Package Integrity
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. pda technical report 27 pdf
Absolutely not. Draft versions contain unapproved language that could mislead your validation work. Only the final published PDF is acceptable for regulatory purposes. PDA Technical Report No
PDA has translated many technical reports. Search the official store for “TR 27 Chinese” or contact PDA Asia Pacific. The report is available for purchase on the PDA Bookstore
PDA reports are generally available through the PDA Bookstore:
Investigators specifically request to see the manufacturer’s gap analysis against TR 27. Having the PDF accessible in your quality system demonstrates due diligence.