Tuttlingen - The draft of DIN EN ISO 14644-4:2021-11 "Clean rooms and associated clean room areas - Part 4: Planning, execution and initial commissioning" is available: On March 24th, a MedTalk by MedicalMountains GmbH will address the question of which Changes are emerging for users in medical technology. Speaker is Dr. Simon Dietz, Managing Director of the Society for Production Hygiene and Sterility Assurance mbH in Aachen and member of the DIN Committee.
The currently valid version of DIN EN ISO 14644-4 dates from 2003. Accordingly, it can be expected that some developments over the past two decades will be reflected in the new version. The document defines the process from the requirements to the planning, execution and initial commissioning of a clean room. It is aimed at planners and performance testers, but also at users - as in medical technology. A number of companies manufacture or package in this special environment, which means that cleanrooms are among the critical elements in the process chain and deserve special attention.
As a member of the DIN committee, Dr. Simon Dietz is intensively involved with the standard. At the MedTalk, he presents and comments on what innovations are emerging and where the status quo is being maintained. “Certainly, the standard is just one building block alongside GMP requirements and other national documents such as those from the ZLG. However, since no major technical changes are to be expected in the draft, now is a good time to prepare for the revision," says Dr. Simon Dietz. As managing partner of an accredited body for cleanroom monitoring and qualification, he has been able to gain experience in this area for over a decade, which he is now passing on at MedTalk. As a technical expert of the ZLG, he is also active in the audit and can also put on the glasses of the monitoring to point out pitfalls of the regulations.
The Medtalk “Focus on cleanrooms: News about DIN EN ISO 14644-4” begins on March 24 at 4:00 p.m. (online).
