Designing a CGMP Bioprocess Equipment Manufacturing Facility

Designing a CGMP bioprocess equipment manufacturing facility


Fabricating Bioreactors and Fermentors to the ASME Bioprocessing Equipment (BPE) Standard
Ernest L. Stadler, Barbara K. Henon, and David Koiro

GMP facility is, by definition, a facility designed, constructed and operated in accordance with current good manufacturing practices (CGMP) guidelines established by the FDA. By inference, a manufacturing facility that produces CGMP equipment must also meet criteria with respect to SOPs, documentation, and utilities that are involved with product-contact surfaces. Here we describe how one manufacturer has designed and organized its facility and established working procedures for production of GMP bioprocessing equipment. Procedures were developed for orbital welding and documentation for compliance with the most recent ASME Bioprocessing Equipment Standard (BPE 2005) (1).

Planning, preparation, and construction of a new facility gave Sartorius BBI Systems, Inc. (SBBIS, a subsidiary of the Sartorius Group ofGermany) the opportunity to design and organize this facility to improve workflow and efficiency and to streamline procedures. The facility replaces five separate buildings and is “Y”-shaped like an antibody. It has a primary assembly and test floor, feeder shops organized to optimize work flow, and offices housing sales, engineering, production, and QC, all under one roof.

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