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Research ArticleTechnology/Applications

Microbiological Validation of a New Manufacturing Complex for an Injectable Biological Product

Michael C. Carroll, Marjorie Van Pala and Linda Vollherbst
PDA Journal of Pharmaceutical Science and Technology July 1992, 46 (4) 107-110;
Michael C. Carroll
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Marjorie Van Pala
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Linda Vollherbst
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Abstract

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 pharmaceuticals 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.

  • Received September 14, 1990.
  • Accepted February 13, 1992.
  • Copyright © Parenteral Drug Association. All rights reserved.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 46, Issue 4
July-August 1992
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Microbiological Validation of a New Manufacturing Complex for an Injectable Biological Product
Michael C. Carroll, Marjorie Van Pala, Linda Vollherbst
PDA Journal of Pharmaceutical Science and Technology Jul 1992, 46 (4) 107-110;

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Microbiological Validation of a New Manufacturing Complex for an Injectable Biological Product
Michael C. Carroll, Marjorie Van Pala, Linda Vollherbst
PDA Journal of Pharmaceutical Science and Technology Jul 1992, 46 (4) 107-110;
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  • Bacterial Adhesion: Considerations Within A Risk-Based Approach To Cleaning Validation
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