While PDA TR 84 now leads the way, TR 27 remains a vital part of pharmaceutical history and regulatory compliance. To protect your career and your patients, always obtain the official PDF from PDA, use its principles to build robust CCIT programs, and stay current with new deterministic technologies.
Providing a roadmap for selecting appropriate CCI testing technologies based on the specific dosage form (e.g., liquid, lyophilized, or powder). pda technical report 27 pdf
Defining CCI expectations from initial package design and component selection through to commercial stability testing. Applicable Container Types While PDA TR 84 now leads the way,
The PDA Technical Report 27 is a proprietary document. It can be obtained through the following channels: Defining CCI expectations from initial package design and
| 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. |
Measuring changes in pressure to identify microscopic holes. 3. Component Interaction