Sterilization process validation planning skill for EO, radiation, and steam sterilization
The Sterilization Validation Planner Skill supports sterilization process development and validation for medical devices, ensuring sterility assurance levels per ISO standards and FDA guidance.
This skill integrates with the following processes:
sterilization-validation-planner:
methods:
- ethylene-oxide
- gamma-radiation
- e-beam
- steam
- dry-heat
validation-phases:
- IQ
- OQ
- PQ
sal-targets:
- 10-3
- 10-6