Draft of the new DIN 12980 is available

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It is expected that the new DIN 12980 "Laboratory Equipment – Safety Cabinets and Isolators for Cytostatics and Other CMR Drugs" will come into effect by the end of the year. This was announced by Egon Buchta, Chairman of the responsible working committee in the DIN Standards Committee "Laboratory Equipment and Laboratory Facilities" and Managing Director of "Ingenieurbüro & Reinraumservice Egon Buchta GmbH" in Wannweil near Reutlingen. Industry representatives can submit comments on the amended standard until September 30th.

The most significant innovation, according to Buchta, is the integration of isolators into the standard. "Until now, there were no regulations for these devices."
However, since the Pharmacy Operating Regulations have long provided for the manufacture of cytostatics in isolators – also called glove boxes – DIN 12980 had to be adjusted accordingly. This allows manufacturers of isolators to conduct type tests for their devices in the future. "Until now, there was no clear specification for performance criteria when using an isolator for manufacturers and users, which led to a broad interpretation of the criteria," says Egon Buchta. "Now, this openness will be significantly narrowed."

For several small pharmacies, the new regulations may lead to them no longer producing cytostatics at all. The DIN standard, for example, requires the use of special gloves that must be checked daily for leaks. Any necessary replacement not only costs a lot of money but also temporarily halts production. Therefore, Buchta expects that the production of cytostatics will increasingly concentrate in larger pharmacies in the future. They generally have a higher number of devices and staff.

In the area of safety cabinets, the committee, which includes about 20 representatives from manufacturers, service companies, users, professional associations, and testing organizations, has also made changes. Buchta cites the expanded testing of the performance reserves of the airflow at the intended operating points as well as at deviations and the delineations (provocations) related to them as an example. Another innovation is the proof of the backflow-free operation of safety cabinets in conjunction with exhaust air systems within the framework of regular maintenance. Until now, this was only valid for new installations.

The draft can be found online at www.din.de. By searching for "DIN 12980," you can access both the current version and the draft titled "E DIN 12980." To submit comments that will be considered in the working committee's discussions, a free registration is required.