Online Sterilization:

· One-step sterilization (suitable for small systems);

· Sterilization in multiple steps, such as: concentrated preparation, diluted preparation, filling, mixing tanks, storage tanks, sterilizing filters; filling machines and multi-pipeline systems, etc.;

· Overlapping areas of sterilization;

Key Points of SIP Validation:

· System air evacuation to ensure all parts of the system are saturated with steam;

· Drain condensate through small pipelines/hoses (e.g., filling nozzles);

· Placement of biological indicators at appropriate locations (e.g., filter screens in pipelines located at the front end of steam valves);

· Sterilization of filters (diaphragm pressure difference);

· Drying of filters after sterilization;

· Non-contaminating integrity testing;

Validation Content for Online Sterilization (SIP):

· Verification of distribution across all parts of the system

· Temperature validation: Sterilization temperature testing

· BI testing: Biological indicator challenge testing

· Pressure validation: Online sterilization pressure testing

· F0 value/kill rate: Microbial lethality rate

· Sterilization time: Validation of effective sterilization time

· Saturated steam conditions (temperature and pressure)

· Sterilization cycle (duration maintained)

· System drying

· Inactivation of all biological indicators

· Integrity of filters post-sterilization

· Pressure increase during cooling with sterile air