: Guidance on maintaining barrier quality from product development through its entire life cycle.
– Keep a digital copy on a tablet or laptop for the inspection floor. When an FDA investigator asks, “What leak size does your method detect?” you can instantly reference Table 5.2 of TR 27. pda technical report 27 pdf
: PDA members or corporate subscribers can view the report via the Technical Report Portal . : Guidance on maintaining barrier quality from product
PDA Technical Report No. 27 provides a comprehensive framework for ensuring container/closure integrity, emphasizing a lifecycle approach to prevent sterilization failures. The report guides manufacturers in selecting appropriate test methods, such as vacuum decay, to evaluate the barrier qualities of sterile packaging. For more information, visit Parenteral Drug Association Technical Report No. 27: Pharmaceutical Package Integrity : PDA members or corporate subscribers can view
Within the report, methods are categorized by their reliability:
: Establishing specifications for what constitutes a "leak" for specific product types.