Tuttlingen – "Bioburden", "particle mass", "spectrometry": When it comes to the purity of medical devices, manufacturers are confronted with a multitude of technical terms, processes and ultimately questions. Reason enough for the ExpertTable CleanMed to provide an overview of common analysis methods with the new "Laboratory Guidance". The document can be ordered free of charge from the MedicalMountains GmbH webshop.
Under the organizational leadership of MedicalMountains GmbH, CleanMed has existed since October 2018 as an ExpertTable for technical cleanliness and cleanability in medical technology. The laboratory guidance that has now been published follows the core concern of giving manufacturers of medical devices more clarity in dealing with the various requirements, in this case with regard to analysis methods, parameters and aspects to be observed.
The CleanMed threads come together at Marena Hauser. We asked the project manager at MedicalMountains GmbH why the laboratory guidance was needed and what further plans the ExpertTable was making.
Marena, what made you decide to create the laboratory guidance?
It was important to us to show manufacturers the background of the common analyzes and processes. Why are the analyzes made and for which products? What must be taken into account? The guidance is intended to provide an overview of these and similar issues. References to standards are given for additional information. Corresponding questions have repeatedly been put to the ExpertTable in the past. We collected the points and processed them in the form of the guidance. We are doing a bit of knowledge transfer from experts to the industry.
Who worked on the document?
CleanControlling Medical GmbH & Co. KG, LPW Reinigungssysteme GmbH, Niutec AG and SAS hagmann GmbH & Co. KG were involved. All companies directly related to purity and analysis. So a lot of expertise went into the document.
After the guidance is completed, what further plans does CleanMed have?
Basically, the members of the ExpertTable want to create more transparency with regard to the purity of medical devices and the requirements for them. A next approach is the so-called "CleanTour". We are planning a series of events in which the various aspects will be examined in more detail. And CleanMed always has an open ear for the industry. If companies have questions, they can contact us at any time and possibly also attend a meeting.
Marena Hauser
The laboratory guidance can be obtained free of charge from the MedicalMountains GmbH web shop, https://medicalmountains.de/shop.
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