Existing cleanroom building composition
The building housing this expansion was comprised of offices, labs, manufacturing and support spaces, with a total of over 220,000 square feet of space. Distinctive air-handling zones existed for the offices, the labs and the manufacturing areas. Offices were served by several packaged single-zone systems. The labs and the manufacturing areas used air handlers utilizing chilled water and hot water coils.
Air handling zoning and air movement
The facility renovation converted around 40,000 square feet of existing non-manufacturing space, mostly composed of non-cGMP storage warehouse, to qualified cGMP production space. Two new air-handling systems and related exhaust fans suitable for cleanroom applications were added. As part of the air-handler zoning plan, all the ISO 7 spaces were supplied from a common air-handler system. This was possible because the facility only produced one drug product at a time. The controlled not classified (CNC) spaces were conditioned by a second and completely separate air-handler system. Air filtration of the ISO 7 areas was through ceiling-mounted HEPA filters providing at least 99.9 percent filtration efficiency. Room exhaust was through low wall grilles. Given the nature of the API, low wall returns in the critical zone contained HEPA filters identical to the supply and had provisions that allowed them to be integrity tested in place by the use of a shroud for the introduction of the challenge media. The CNC spaces, which included the initial level of gowning, were also provided with ceiling supply HEPA filters and ceiling returns without HEPA filters.
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