Annex 1 | Are insulators mandatory?
- Are only isolator/RABS systems to be used in the manufacture of pharmaceuticals, i.e. are the cleanroom concepts D/C/B/A ("A" class achieved by safety cabinet) obsolete?
- What is an "open isolator" from the point of view of the testing authority? Can this also include a safety cabinet in accordance with DIN 12469?
Speakers:
