Processes incorporating heat sterilisation cycles involve systems such as:
- Steam autoclaves
- Filler lines (SIP/CIP)
- Dry heat ovens
- Depyrogenation tunnels
- Freeze dryers
- Water production and distribution loops
Qualification or requalification consists of controlling the quality of the sterilization process based on normative standards:
- The NF EN 285 standard
- The NF EN ISO 17665 standard
- The NF EN ISO 20857 standard
MAPE intervient pour vous aider à respecter ces normes en effectuant des contrôles périodiques.
CONTROL
- On-site calibration and verification of various quantities: pressure, temperature, time, other...
- Leak test
- Heat distribution studies
- Container mapping
- Heat penetration studies