The Clean Room consists of a vinyl soft-walled enclosure installed by bioBUBBLE (http://biobubble.com), incorporating the architectural features in the room to create a seamless barrier design. The four vinyl walls are a combination of floor length vinyl along with vinyl attached to the counter sides and top. The bioBUBBLE HEPA Power Units and an A2 Biosafety Cabinet (BSC) docked to the clean room side walls allow staff access to the BSC work surface, while keeping the BSC and Power Unit maintenance outside the clean room.
Four HEPA Power Units deliver a total volume of 2400 CFM, resulting in 107 Air Changes Per Hour (ACPH) within the Clean Room. The unique bioBUBBLE air delivery system takes the large volume of air and converts it into a gentle stream of diffused air entering the Clean Room. While a small percentage of the total air volume inside the enclosure exhausts out through the biosafety cabinet and under the vinyl walls near the floor, around 80% flows through the anterooms and into the macro environment outside the Clean Room. The Clean Room exhaust air mixes with the conditioned HVAC supply air, with a portion exhausting out of the room and the remainder going through a recirculation process through the HEPA filters similar to a recirculating BSC.
Access to the Clean Room is provided through a 2-stage opaque anteroom system. The Stage 1 Anteroom is equipped with an Air Shower that provides 200 ACPH of high velocity HEPA filtered air to remove particles from staff prior to donning of personal protective equipment (PPE) in the Stage 2 Anteroom. The Stage 1 Anteroom also serves as preparation area for materials being transferred into the Clean Room.
The Clean Room’s laboratory equipment allows work with bacterial samples to generate plasmid material according to cGMP standards as regulated by the Standard Operating Procedures (SOPs) of the facility. Clean Room’s classification according to ISO and US FED STD 209E standards is validated externally and also routinely monitored by following the facility’s SOP on particle counting.
The laboratory space surrounding the bioBUBBLE Clean Room is a controlled-not-classified GLP area, with specific equipment for cell culture, nucleic acid characterization and storage in -80oC and liquid nitrogen freezers. It also includes a dedicated office where all compliant documentation regarding operation of the facility is stored in digital and physical copies. A third copy of all relevant documents is stored at a Mount Sinai dedicated server.
Personnel can only access the NAPS facility through a code-locked door located in the main corridor of the floor. A second door which is only opened from inside provides a mandatory fire safety secondary exit to the laboratory in compliance to NYC regulations.