Validation & qualification
Inspection of cleaning performance and machine functionality
The cleaning, disinfection and sterilisation of instruments calls for the utmost reliability. Regular inspections of machine functions are indispensable in guaranteeing maximum safety.
Validation
Initial validation
Both applicable laws and guidelines require validated processing methods to guarantee that no health risk can arise to patients, users or any third party from medical devices after reprocessing.
Our expert medical product technicians, specially trained to cover machines and application technology, perform qualification and revalidation work in accordance with the guidelines published by the relevant authorities.
The relevant process parameters are recorded using the latest software programmes and mensuration technology, for example data loggers. The results are evaluated in accordance with all valid guidelines, documented in a report and assessed.
Revalidation
Revalidation is required periodically, even if no changes have been made to the system. Revalidation generally takes place 12 months after initial validation and is repeated on an annual basis. Unscheduled revalidation is also particularly necessary whenever new programmes are introduced, relevant process parameters changed, new chemicals, instruments or loading systems used or the quality of the water supply changes. In the case of the annual revalidation of an unchanged system, defined test loads per machine and reprocessing programme are examined.
Qualification
IQ/OQ qualification by Miele
In the pharmaceutical, food-processing and cosmetics industries, all cleaning systems used in production, quality assurance and R&D must be qualified. Miele's own after-sales service offers qualification as a special service.
Qualification (Installation Qualification / Operation Qualification) is performed by qualified technicians. IQ/OQ documents (standard forms) are provided by Miele.
Annual maintenance and calibration
In addition to maintenance and care, Miele Customer Service calibrates, documents, and performs functional tests on measuring systems and componentry on board both the machine and peripheral units as an extended special service. This ensures that the machine is still in a qualified condition and that the defined machine and programme parameters, which can have an impact on process reliability, are adhered to. The documentation of the IQ/OQ maintenance / calibration (standard forms) is provided by us and handed over to you.
