GMP Clean Room
Niscell Clean room was designed to meet cGMP standards for aseptic processing of a sterile product (As per NPRA guidance for cell based Industry). All cell culture procedures are performed inside biological safety cabinets (BSCs) that are rated lass 100 or Grade A for air quality. Overall design of the cleanroom suite includes air pressure differentials between inner and outer rooms and double door airlock entry to individual laboratory cleanrooms.
Adjacent space within the cGMP suite include gowning, clean-storage, preparation and corridor areas, each meeting the appropriate air quality standards. Each cleanroom is a self-sufficinet module, containing the range of precision scientific equipment’s to enable cell cultivation, expansion and harvest under highly controlled and reproducible conditions. The multi-lab, modular approach was chosen to minimize the potential for cross-contamination that can accompany large single-laboratory cleanroom designs.
