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At least 19 recordsLinked to original sources
PubMedDate not supplied

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.

Animal Welfare↗
PubMed1987

Recent developments in the design and construction of facilities for the production of human injectables.

The pressures imposed upon pharmaceutical production managers are such that insufficient time is available to plan and develop new pharmaceutical facilities. Standards and codes of practice are available but the relevant data is not presented in a form which would enable the reader to readily access. This paper attempts to highlight the relevant extracts and to visually demonstrate some practical proprietary solutions. It is acknowledged that in some aspects the designer will find it necessary to deviate from the Code and the Standards in the interests of achieving a practical process solution. This paper will provide an awareness of the necessary design parameters such that any deviation judgements have been fully considered.

Drug Industry↗
PubMed2003

Development of guidelines for design and construction of hospitals and health care facilities.

The Guidelines for Design and Construction of Hospitals and Health Care Facilities is the most widely referred to design document in the USA and is influential throughout the world. The Facility Guidelines Institute (FGI) was founded to provide continuity in the guidelines revision process. FGI functions as a contractual, fundraising, and coordinating entity to develop and enhance the content and format of guidelines publications and of ancillary services that encourage and improve their application and use. The Guidelines and the methodology for revising them have been, and still are, in an evolutionary process. It is the desire of the AIA/AAH and FGI to see that the process continues to change and improve with each passing cycle.

Academies and Institutes↗