Validation / Qualification

The Qualification Process is usually completed by a Validation. This concept contains a fully documented process to verify and prove the effectiveness of the production process. The process has to pass predetermined acceptance criteria. The Sterilization process with Steam requires a full Qualification Process containing an Operational Qualification (OQ) and a Performance Qualification (PQ) (EN5545).

The Validation service is done by a trained technician using the validation system of Kaye or the Data logging system of Ellab. We consider the standards EN 554/285 and ISO / TS 17665-2 and GMP / FDA guidance. We work on a predefined validation plan for each customer. If desired, we can additionally use biological indicators for testing the Sterilization.

During this process, we also calibrate the temperature probes and the pressure transducers. We also qualify the quality of the Saturated Steam (non con-densable gases, humidity level, overheating…)

The validation documents are very important. Here are some areas the documentation covers:

→ Validation plan
→ Detailed validation protocol of Imtech-Steri
→ Validator protocols such as batch data, graphs, other data
→ Batch-Protocols of the autoclave