“If I have TR 84, I can ignore TR 27.” Reality: No. If your product was validated between 1998 and 2020, your submission likely references TR 27. You must keep a copy for historical reference during audits.
| Probabilistic Methods (Subjective) | Deterministic Methods (Objective) | | :--- | :--- | | Dye Ingress (Methylene blue) | Vacuum Decay | | Microbial Immersion/Ingress | High Voltage Leak Detection (HVLD) | | Bubble Emission | Pressure Decay | | Results vary based on operator skill and time. | Advantage: Repeatable, quantifiable, automatable. | pda technical report 27 pdf
“TR 27 says dye ingress is dead.” Reality: TR 27 states dye ingress is a “coarse leak test” suitable for quality control sampling, but it is not sensitive enough for small molecule or biologic products that require <1 µm integrity. “If I have TR 84, I can ignore TR 27
PDA has translated many technical reports. Search the official store for “TR 27 Chinese” or contact PDA Asia Pacific. PDA has translated many technical reports
Published by the , Technical Report No. 27, “Pharmaceutical Package Integrity” has served as the industry’s gold-standard reference for developing, validating, and maintaining container closure systems for sterile products.
If you accidentally downloaded an illegal copy, delete it immediately and purchase a legitimate license. Using a pirated PDF during an audit can result in a 483 observation for lack of document control. Are you ready to update your CCIT program? Start with the official PDA TR 84, or secure your archived copy of PDA TR 27 for legacy systems. Quality and patient safety depend on your integrity.