Active pharmaceutical ingredient isolator API

class IIIasepticdispensing

The isolator for API dispensing and aseptic operations was conceived to guarantee suitable safety and aseptic conditions during preparation of a product containing an active ingredient belonging to category OEB 5 (OEL<0,001 mg/m3). Given the high level of toxicity and the extraordinary integration of the preparation process between the inside and outside of the isolator, a careful study was necessary of all the transfer systems both for solids and liquids as well as the interfaces with all of the equipment involved in the chemical/physical process, that is: pressurised preparation tanks, peristaltic pumps, thermostatic baths, homogenisers, powder loading system, scales, etc.