Within the report, methods are categorized by their reliability:
The report champions the use of instrumentation to detect leaks physically rather than biologically or chemically. It evaluates methods like:
The official, full-text is a proprietary document protected by copyright. It can be purchased and downloaded legally through the official PDA Bookstore. Many pharmaceutical professionals maintain access to TR 27, TR 82, and the USP guidelines as part of their facility's standard regulatory library. pda technical report 27 pdf
: Establishing specifications for what constitutes a "leak" for specific product types.
PDA TR 27 fundamentally changed how the pharmaceutical industry defines a secure package. Rather than looking strictly at the individual physical components (like a glass vial or a rubber stopper), the report looks at the system as a whole. Within the report, methods are categorized by their
How to prove that a packaging system is capable of protecting the drug.
: Submerging containers in a liquid dye solution under a vacuum or pressure cycle, then visually inspecting or using UV-Vis spectroscopy to check for dye inside the container. Deterministic Test Methods Many pharmaceutical professionals maintain access to TR 27,
The is a copyrighted document.
Establishing clear scientific definitions of what constitutes a leak and how gas or liquid transport occurs through microscopic breaches.