Critical Process Parameters
When developing a cleaning process, it is important to consider various factors related to the surface, process cleaner, and cleaner.
January 6, 2021
Key Takeaways:
- The four Critical Process Parameters (CPPs)—Time, Action, Chemistry and Temperature (TACT)—must be optimized to ensure effective and efficient cleaning in pharmaceutical manufacturing.
- Dirty hold time (DHT) and clean hold time are key timing considerations, as longer DHTs increase cleaning difficulty, while clean hold time defines how long equipment remains clean before reuse.
- Mechanical action, such as spray ball impingement or manual scrubbing, is essential for residue removal and must be validated for complete surface coverage.
- Pharmaceutical detergents are engineered to reduce cleaning time, temperature and mechanical force, improving process efficiency while maintaining surface integrity.
- STERIS’s PACE™ program and technical services team members help manufacturers evaluate and optimize cleaning processes across diverse systems.
When developing a cleaning process, it is important to consider various factors related to the surface, process cleaner, and cleaner. Critical Process Parameters (CPPs) are key factors to evaluate during each step of the cleaning cycle. Commonly abbreviated to the acronym TACT, the critical process parameters of a cleaning cycle include cleaning time, cleaning action, cleaning agent concentration, and temperature.
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