ASME BPE Guidelines for
Pharmaceutical Equipment
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ASME BPE - (The American Society of Mechanical Engineers - Bio processing Equipment)
Various regulatory authorities across the globe are taking remarkable efforts to update GMP regulations and standards to improve medicines quality. However these agencies are very non specific about the design/engineering requirements of pharmaceutical process equipment/ system, and here comes the importance of organizations like ISPE (International Society for Pharmaceutical Engineering), ASME (American Society of Mechanical Engineers), ASTM (American Society for Testing and Materials) to setting up the standards which provides the requirements applicable to the design of process equipment/system used in the bio processing, pharmaceutical and personal-care products industries.
Till 1997 there were no industry standards
directed at the needs and requirements of the pharmaceutical industry. Prior to
that time it was a patchwork effort at resourcing and adopting non pharmaceutical-related
codes and standards and then modifying them in order to meet the more stringent
requirements of the Food and Drug Administration (FDA).
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