Regenerative medicine isolator MCCI

class IIIfor the pharmaceutical industryfor cell culture

Isolation Technology in the pharmaceutical industry and in regenerative medicine provides a physical barrier between a process that may have requirements of asepsis and/or toxicity and the external environment. The physical barrier is usually a fully welded enclosure inside which a specific ventilation and filtration strategy allows a controlled atmosphere. Better safety levels Top class sterilization protocol of the critical areas using VPHP cycle No manual intervention in environmental sanitization brings less risk of human error Efficient space utilization with Glove Boxes Smaller footprint of the classified areas allows a glove box to be installed in smaller facilities A larger Class A space available, compared to the BSC used in the Cleanroom Total sanitizing costs using a glove box: average cost of 1 litre H2O2 cartridge is 7 Euro. Typical consumption is 1 cartridge per 5 cycles Average running cost of a glove box is one third of a small size clean room With a glove box no sterile gowning needed Time savings for operators Easier validation procedure with a glove box The adoption of our Modular Cell Culture Isolator within aseptic processing, compared to the same processes performed in standard clean room environments, has clearly demonstrated the advantages of isolation technology. This newly developed generation of  Isolators designed for Regenerative Medicine application allows Biotech centers as well as Tissue Engineering laboratories to continue to make advancements while still operating within the ever restrictive confines of various regulatory bodies (FDA, EUP, USP) and industry guidelines (GMP, PDA).