Clean rooms are controlled environment work areas used for the production of cellular therapy products, which must be manufactured according to procedures that prevent contamination of the products with infectious agents. In order to significantly reduce particulate matter that can cause contamination, air entering the room is filtered through a series of high-efficiency particulate air (HEPA) filters.  Contaminates created by working in room, such as skin microflora and dust from paper, equipment, or other materials in the room are also removed by recirculating room air through these filters. The actual number of particles in the air varies depending on the pore size of the filters, the number of filters per room volume, and the number of complete air changes that occur through the filters/minute. Clean rooms are classified according to the number and size of particles permitted per volume of air. 

Entry into clean rooms is carefully controlled to prevent unfiltered air from entering. Air pressure in a clean room is usually greater than the surrounding area so that air is pushed out of the room when doors are opened. Staff enters a clean room via an anteroom area in which they can dress in clean or sterile lab coats or jump suits, hoods, shoe coverings or boots, surgical type masks and gloves. This personal protective clothing prevents skin, hair, and dust carried in by staff from contaminating the air. The anteroom also provides an airlock to prevent unfiltered air from flowing into the clean room. This is accomplished with a door locking system that only allows clean room doors to open after the anteroom door to the outside environment is closed. 

We operate Class 10,000/ISO 7 clean rooms which are used to perform contract manufacturing of cellular and immunotherapy products. Please contact us if you are interested in learning more about CCS’s contract manufacturing services.