Yes—for any new product or new equipment validation. However, for legacy products already on the market, maintain your existing TR 27-based methods unless you identify a failure trend.
"...the level of cleaning validation required should be commensurate with the risk to the patient and the product. A risk-based approach to cleaning validation involves identifying and assessing the risks associated with the cleaning process, and then designing and implementing controls to mitigate those risks." pda technical report 27 pdf
Once you have obtained the legitimate , follow these steps to maximize its value: Yes—for any new product or new equipment validation
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. pda technical report 27 pdf
| 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. |
, though it is generally not available for free public download. Succession: