Critical Process Parameters
When developing a cleaning process, it is important to consider various factors related to the surface, process cleaner, and cleaner.
2021-01-06
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.
