Ethylene Oxide
Services Qualification (IQ, OQ, PQ) Ethylene oxide sterilisation equipment, in compliance with the standards UNI EN ISO 11135 and UNI EN 1422:
(sterilisation systems using steam, peracetic acid, hydrogen peroxide)
- Verification of purchasing, design and installation documentation
- Verification of mechanical and process requirements (control panel, alarms, cycle execution)
- Testing and calibration of critical on-board instruments
- Sterilisation chamber seal test
- Temperature increase test, pressure and humidity test of empty chamber
- Ethylene oxide penetration testing: measuring uniformity, temperature, pressure and humidity (3 consecutive runs for half-time cycle)
- Sterilisation cycle efficiency testing: insertion of biological indicators
- Short-time testing
- Medical devices analysis: Bioburden (bacterial count)
- Medical devices analysis: Sterility
- Medical devices analysis: Bacterial endotoxins (Pyrogens)
- Ethylene oxide penetration testing in full-time cycle: Medical Device Ethylene Chlorohydrin analysis
- Ethylene oxide penetration testing in full-time cycle: Medical Device Ethylene Glycol analysis
- Ethylene oxide penetration testing in full-time cycle: Medical Device ETO Residue analysis
- ETO residue degassing curve
Validation of ETO sterilisation process
Physical and microbiological qualification and chemical analysis
ETO STERILISATION Biocompatibility Analysis
- Direct Contact Cytotoxicity Testing (in conformance with ISO 10993-5 EC)
- MEM Elution Cytotoxicity Testing (in conformance with ISO 10993-5 EC) – when the method of the previous point cannot be applied
- Skin irritation testing on rabbits (ISO 10993-10 EC)
- Allergic sensitization using closed-patch testing (Buherer test in conformance with ISO 10993-10 EC) performed on sample as received
Validation of ETO packaging systems
ETO sterilization service