ADVANCED THERAPY ISOLATOR
Producing advanced therapy medicinal products (ATMPs) for therapeutic purposes is a complex task, for which aseptic conditions are only one part of the requirement. Apart from the clean room zone itself, you need trained operators and strict procedures to prepare the room and the people involved to be ready for the process. This requires huge efforts in terms of infrastructures, personnel training and compliance.
BioAir, with its ISOCell PRO Cell Therapy Isolator, can be the answer to your needs by providing a streamlined workflow environment reducing the set up and running costs of cell therapy products preparation while still operating within the restrictive confines of various regulatory bodies (FDA, EUP, USP) and industry guidelines (GMP, PDA).
- Simplicity of the ISO 5 location and easy gowning for most applications since isolator systems dedicated to cell production may be located in a Class D room with restricted access
- Security with validated sterility of the working area and cross-protection of product/operator/ environment
- Traceability for all the steps of the sterile handling process
- The initial sterility is provided by a dedicated H2O2 vapor (HPV) program to bio-decontaminate the work area and the material access area
- The sterility is maintained with the positive pressure of HEPA-filtered air. The outlet HEPA prevents against any return of non-sterile air
- System is designed to be used in validated GMP processes