If you want to place on the market and make available on the market sterile medical devices or you want to offer sterilization service, you have to meet many requirements to guarantee efficiency of the sterilization process and sterility of the product throughout the shelf life. We have experience in all types of sterilization that are conform with the standards: steam, ethylene oxide and irradiation (Gamma and e-beam).
We offer:- Selection of the sterilization method depending on the material/product/complexity
- Evaluation and definition of requirements regarding the microbiological status of raw materials and / or components supplied – specifications
- Microbiological evaluation: clean room, initial product contamination, endotoxins
- Developing the clean room concept, proposition of Hygiene Program (implementation and monitoring)
- Help in Environment Control - according to ISO and GMP
- Consultation during assessment/ validation of sterile barrier system - type of material (selection and suitability) of packaging and packing validation
- Assessment of selected microorganisms to demonstrate the effectiveness of the sterilization process
- Assessment of proper SAL (sterility assurance level)
- Validation and monitoring of the sterilization process (installation, operational and process qualification, re-qualifications), including software validation
- sterilization process audit