Provide an equipment solution for CAR-T manufacturing that could provide a negative or positive pressure environment while also meeting aseptic processing requirements.

The containment system will be used to protect operators during transfer of the lentivirus, as well as provide a controlled environment for IL-2 charging of media, bead addition, and blood bag spiking.

Germfree’s LFGI functions as an aseptic containment isolator and operates under strong negative pressure.  In addition, the unit functions as an aseptic isolator under positive pressure. The operator is completely shielded from the materials being processed by a highly ergonomic glove system. All filters are designed to remove particles and aerosols as small as 0.3 microns with a minimum efficiency of 99.99%. Particles smaller or larger than 0.3 microns are filtered with a higher efficiency.

The containment system had to meet numerous requirements. It shall have one transfer chamber and one main chamber capable of maintaining ISO 5 conditions; shall be capable of maintaining a defined pressure differential between the main chamber and the room during all processes to minimize microbial ingress. The transfer chamber shall provide a barrier to cross-contamination between the main chamber and the room. The containment system shall have airflow from a HEPA supply filter to maintain conditions within the chamber. HEPA exhaust filtration shall be provided to allow air to be returned to the room. The containment system HEPA filters shall be certified to be 99.99% effective for 0.3 micron particle removal. The containment system will accommodate glove ports for operators to perform operations within the unit. Production Period: Equipment shall be designed for continuous 24 hours a day/ 7 days a week operation with periodic use.