API Isolator 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 in Fill Finish Manufacturing For Dispensing Asepsis
 

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.

Highlights

  • Fully PLC controller
  • Software GAMP5 compliant
  • Friendly Operator Interface
  • LED Lightings
  • WIP Circuit
  • 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.

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