Pharmaceutical isolator for contamination control
Ensuring sterile conditions during pharmaceutical manufacturing involves handling active pharmaceutical ingredients (APIs) and preventing cross-contamination. This is crucial when working with high-potent ingredients in environments demanding stringent contamination control.
Guarantee aseptic conditions during manufacturing
The FCIS pharmaceutical isolator by Fedegari is engineered to ensure clean and sterile conditions during the handling and dispensing of APIs and high-potent ingredients. It employs a barrier system that separates operators working in EU GMP C or D grade areas (ISO7, ISO8) from the operating area, which is maintained at an A grade sterility level (ISO5). The isolator is equipped with Fedegari’s innovative Hydrogen Peroxide Vaporizer (FHPV), ensuring effective bio-decontamination of surfaces. This unit complies with FDA, EMA, WHO, and other international standards. Its configurable design includes features like AISI stainless steel chambers with a bright annealed surface and a double gasket door system for enhanced operator safety. The Thema4 process controller ensures precise control of H2O2 vapor concentration, maintaining it within ± 15 ppm for consistent results.
Benefits
- Operations guaranteed in a grade A environment
- Avoidance of material/operator cross contamination
- Savings on utilities compared to clean rooms
- Integrated Hydrogen Peroxide Vaporizer for reliable decontamination
- Customizable to suit specific customer needs