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Validation FAQ
Common questions about autoclave validation, requalification, and steam quality testing.
Within the framework of quality assurance, validation is to be divided into three stages: Installation Qualification (IQ), Functional Qualification (OQ) and Performance Qualification (PQ), as defined by Swiss Good Practice for the Reprocessing of Medical Devices.
- Testing of water/steam quality
- Testing of the sterilizer installation
- Structural and technical requirements
- Testing of the manufacturer's documentation
- Description of the programs
- Description of the process parameters and tolerances
- Description of the product family(s) that can be sterilized and their limitations with regard to size and/or weight
- Description of the reference load/sterilizer loading plan/list of instruments
The IQ and OQ are each part of the installation of a new system. Risk Analysis
- Calibration of the system pressure/temperature
- Testing for air leaks: Checking the cycle parameters and the test
- Steam penetration test (B&D test): Checking the cycle parameters and the test
- Steam penetration test with hollow body systems (Process Challenge Device, PCD) according to SN EN 28
- Thermometric testing of a minimum load
- Thermometric testing of three reference loads per program
- Interpretation of physical parameters (time, temperature, pressure, theoretical temperatures)
- Assessment of the dryness of the reference load
- Visual inspection of the integrity of packaging and sterilized medical devices
Following the detailed validation, requalification must be carried out annually. This consists of the following qualification stages, as defined by Swiss Good Practice for the Reprocessing of Medical Devices.
- Testing the quality of the water and steam condensate
- Calibration of the system: Pressure/Temperature
- Testing of the safety and fault detection systems
- Air leakage testing
- Steam penetration testing (B&D test)
- Steam penetration testing with hollow body systems (Process Challenge Device, PCD) according to SN EN 28
We perform the IQ and OQ revalidation as part of our annual maintenance. Maintenance
- Thermometric testing of a minimum load
- Thermometric testing of a reference load per program
- Testing of the reproducibility and interpretation of the physical parameters (time, temperature, pressure, theoretical temperatures) in comparison to the previous validation
- Assessment of the dryness of the load
- Visual inspection of the integrity of the packaging and the sterilized goods
Non-condensable gases (NCG) in the sterilizing steam such as air and/or CO2 can seriously jeopardize the efficiency of steam sterilization processes under certain conditions. These gases are found in steam for various reasons.
Small quantities of NCGs in the steam are not critical for the respective process, as long as the steam or water can mix with the NCGs and this mixture reaches all surfaces to be sterilized. The quantities of NCGs that become critical depend on the goods. For example, a 7 kg Bowie Dick laundry package shows errors via inserted indicator sheet or the growth of inserted biological indicators. This way it can be detected if 150-200 ml of air accumulated inside the package.
Due to the high steam consumption when heating the sterilized items from room temperature to sterilization temperature, even though the concentration of NCGs in the steam is low, such quantities of NCGs accumulate that sterilization safety can be compromised. Therefore, the NCG content is an important quality characteristic of sterilizing steam.
The limit value for NCGs in DIN EN 285 of 3.5% is used to assess the performance of sterilization processes for standardized sterilization items. Tolerable NCG quantities in practice must be determined during process validation.
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