The interpretation of technical specifications set out in GMP Annex 1 is still in progress, even two years after its publication. The debate has now reached pharmacies and pharmaceutical manufacturing sites where parenterals are typically prepared using safety cabinets. The suitability of these devices as containment for the preparation of individual drug preparations or small batches is still the subject of controversial discussion.

So, what about the suitability of safety cabinets, which are considered state-of-the-art in Germany and many other countries, when individual therapies are to be prepared under controlled conditions? Can their use be sufficiently justified to be an adequate or even better alternative to RABS and isolators? To answer these questions, it is necessary to look at the performance of safety cabinets, but also to evaluate the manufacturing conditions under which they are used. In addition, it is important to include occupational safety requirements that arise from handling highly toxic ingredients, such as CMR substances. Finally, the ability of personnel to operate the devices safely must be considered.

The presentation will introduce and analyse the key aspects of using safety cabinets in the context of the current Annex 1. This will give participants the opportunity to take a perspective that has been neglected in the discussion so far. In addition, the aim is to use the considerations presented here to provide assistance with scientific justifications, as required by Annex 1 for technologies that are not explicitly listed.