Washer-disinfectors are often used in medical environments, hospitals and the pharmaceutical industry. They help to control the contamination required in these sectors, and their correct operation must be proven through standardized tests.
The EN ISO15883 standard for washer-disinfectors (LD) specifies the requirements and tests as well as the expected performance for optimum use.
- This equipment requires periodic qualification and inspection to guarantee :
- Optimal operation
- Process control
- Reduced contamination before sterilization
Our services comply with the most stringent health and safety standards, including “Sterilization of healthcare products - dry heat” and “Sterilization of healthcare products - moist heat”, ensuring full regulatory compliance. We will carry out the service using COFRAC or equivalent equipment (members of international recognition agreements), programming and acquisition software compliant with 21 CFR Part 1 requirements, equipment labelling and reports in customer or Intertek formats.
Intertek can support you in the following areas:
- Steam sterilizer qualification
- Autoclave qualification
- In-Place Sterilization (IPS) qualification
- Sterilization/depyrogenation oven qualification
- Sterilization/depyrogenation tunnel qualification
- EN ISO 17665-1 : Requirements for the development, validation and routine control of a sterilization process for medical devices.
- CEN ISO/TS 17665-2 : Guidelines for the application of ISO 17665-1
- EN 285 :2015+A1 :2021 : Steam sterilizers.
- EN ISO 13408-5 : Aseptic processing of healthcare products - Part 5 : In-place sterilization.
- EN ISO 20857: Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Equipment concerned
Heat treatment equipment :
- Autoclave
- Steam sterilizer
- Dry heat sterilizer
- Sterilization / depyrogenation oven
- Sterilization / depyrogenation tunnel
Production equipment :
- Sterilization in place (SEP/SIP)
- Manufacturing equipment and processes (dry, liquid and paste forms)
- Water and steam production and distribution
- Reactors
- Freeze-dryers
Tests carried out
- Drafting of test protocols
- Cycle optimization and development
- Verification of temperature, pressure and time control or recording systems
- Vacuum resistance test (tightness)
- Alarm testing
- Steam diffusion in the sterilizer chamber: Bowie Dick and Dart test
- Steam quality test
- Thermal mapping and homogeneity
- Pressure / Temperature correlation
- Lethality values (Fo / Ft / Fd)
- Heat penetration into the load
- Biological validation (bacterial challenge and/or endotoxins)
- Dryness test
- Measurement of temperature rise rate
- Filter integrity test, air velocity measurement, particle classification (oven and tunnel)
- Speed of descent in vacuum (Freeze-dryer)
- Measurements