The core activity of ALVA-TECH is the validation of processes for the sterilization of medical devices and equipment, particularly in the qualification and requalification of sterilizers, washer-disinfectors, thermal sealers and endoscopes, in compliance with applicable standards (EN ISO 15833, EN ISO 11607-2, EN ISO 17665 & 13060).
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Sterilizer Validation
Qualification and requalification of sterilizers, including operational and performance qualification, air-leak testing, Bowie-Dick/Helix testing and reference loads to SN EN 13060 and EN ISO 17665.
Washer-Disinfector Validation
Qualification and requalification of washer-disinfectors to SN EN ISO 15883, including conformity checking and validation of reprocessing processes.
Heat Sealer Validation
Qualification of heat sealers for packaging-process validation, with packaging-integrity checking and dynamometric testing to SN EN ISO 11607.
Validation Documentation
Technical documentation and guides for validating steam sterilization, washing and disinfection processes, and reprocessing medical devices.
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