MMM Header

Validation & testing

Process validation

MMM furnishes the proof that your machines - be it MMM machines or other - will continuously deliver good results.

Our validations are carried out in compliance with approved standards, directives and guidelines and cover all kinds of processes involved in a CSSD, i.e. disinfection, sterilization, heat sealing, etc

With more than 1000 process validations, MMM is market leader in Europe. In Germany, more than 38 technicians specialized in validation are equipped with the necessary high-quality measuring instruments. 

MMM staff members participate in many committees active in the preparation and publishing of guidelines and standards. We know, what's going on.

Tests
Apart from validations we are happy to be your partner if legally required tests are to be carried out (e.g. pressure vessel tests, steam generator tests) etc.

  • MMM is your partner when it comes to proving that your equipment and processes correspond with the given specifications. During validation of steam sterilization processes, the parameters affecting the sterilization result are checked: steam supply, sterilization goods and packaging of a load.

    During commissioning (part1 of validation, testing of the technical conditions) the installation conditions, the functions and the empty sterilization chamber are checked. During performance qualification (part2 of the validation, testing of the sterilization results) the sterilizer is tested with the goods to be sterilized and the special conditions of the user (e.g. steam quality or specific packaging). Various parameters, such as steam pressure, temperature and equalization and holding time are measured by calibrated measuring instruments.

    Operators of steam sterilizers are legally obliged to prove reproducibility of sterilization results, the procedure of which is described in various German and European standards (EN 554, EN 285, DIN 58946 T6). MMM offers different service packages to cover different this procedure whichDieses aufwändige, gesetzlich vorgeschriebene und in verschiedenen europäischen und deutschen Normen (EN 554. EN 285, DIN 58946 T6) beschriebene Verfahren führen wir für unsere Kunden in verschiedenen umfangreichen Leistungspaketen durch, über die wir Sie gerne detailliert informieren. 

  •  The preparation of medical devices must be carried out by means of a suitable, documented and validated process (MPBetr.V §4 para. 2). This requirement is also valid for low temperature sterilization methods such as steam-formaldehyde processes.

    Sterilization processes of existing FO sterilizers can be validated after upgrading them to the state of the art. MMM offers special upgrade kits for validation. 

    MMM is your service partner when it comes to validation according to DIN 58948 T16 and prEN 14180 of formaldehyde sterilization processes. 

  • MMM is your partner when you need to prove that your machines and processes constantly correspond to the given specifications.

    We offer various packages for validation and for preparatory measures such as calibration and optimization of processes and machines. 

    We validate according to the current directives of the German DGKH, DGSV and AKI and on demand according to DIN EN ISO 15883 part 1 and 2. 

  • In cooperation with the manufacturer and external test laboratories, MMM carries out examinations relating to process validation. 

  • MMM is your partner when you need to prove that your heat sealing processes constantly correspond to the given specifications.

    We offer validation according to DIN EN 868-5 annex D and simple peel checks.