Microbiological validation of a new manufacturing complex for an injectable biological product.

The Raritan Biological Production Facility (RBPF) at Ortho Pharmaceutical Corporation, Raritan, NJ, is a unique facility designed and built exclusively for the production of a sterile, injectable biological product of murine monoclonal origin. This product is the first injectable monoclonal antibody product to be licensed by FDA's Center for Biologics-Evaluation and Research (CBER). Thus, Ortho's Biotechnology Division had a unique opportunity to work very closely with CBER throughout all aspects of facility design, construction and validation, including microbiological validation of the facility and its equipment. This paper will address how existing guidelines for pharmaceutical and sterile products were used to develop initial validation protocols for the different areas and applications within the facility, and how the data gathered were used, with the assistance of CBER, to develop operating specifications and monitoring programs, for the operations within the complex.