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Water treatment systems and thermal disinfectors: documentation & publication

 

The Medical Device Operator Ordinance (MPBetreibV) in §4(2) for the processing of medical instruments requires that the results of cleaning, disinfection and sterilization must be guaranteed in a comprehensible manner. This means that a quality management system can only be established if the associated processes run reproducibly and are documented. Without documentation, there can be no proof of a successful process.

The documentation for a thermal disinfector includes parameter monitoring as well as routine monitoring. The parameter monitoring takes place in the device itself using measuring devices and sensors. All data is recorded, evaluated and stored through internal monitoring. Routine monitoring must be organized and carried out by the operator, using work instructions that specify daily monitoring and longer-term monitoring. Our certified service technicians are equipped with the most modern, currently calibrated measuring and testing devices. We work according to the recognized valid rules such as GLP, cGMP issued by the FDA or other regulatory authorities.

Documentation & publication in one hand


The documentation & publication of water technology systems in the pharmaceutical and medical sectors includes, among other things, the following key points:

  • Qualification Plan (QP):
    Detailed description of how to achieve validation of a specific system
  • Installation Qualification (IQ):
    Methodical testing of various installation requirements, particularly for feed water and ambient conditions
  • Operational Qualification (OQ):
    Documented evidence that the system is operating as designed in the various modes of operation, including specific procedures such as cleaning and disinfection
  • Performance Qualification (PQ):
    Evidence that the product water quality meets the desired specification


The reprocessing of medical devices ends with the documented release for the system to be used again. Before the water treatment system or thermal disinfector is put into operation, some routine checks must be carried out and documented. We supply operating instructions for your systems. Our competent employees create your documentation for your individual water treatment systems.

Image Documentation & Publication Maria Seidel

Validation
Ms Maria Seidel
fon: +49 (0) 3 72 07/4 07-25
fax: +49 (0) 3 72 07/4 07-40
mail: validation[at]hartmann-gmbh.eu



     

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