Isolator for API dispensing and aseptic operations
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).
Used inFill Finish ManufacturingForDispensingAsepsis
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.
Fully PLC controller
Software GAMP5 compliant
Friendly Operator Interface
Double filtration stage H14 inlet and double stage outlet
Sensors for monitoring the oxygen level
Humidity and temperature sensors for each chamber
Circuit with VPHP integrated, also usable with other VPHP generators.