Friday, 9 December 2016

ASME BPE Guidelines for Pharmaceutical Equipment

ASME BPE Guidelines for Pharmaceutical Equipment

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).

The American Society of Mechanical Engineers first published a standard in 1997 for Bio processing Equipment and it has since become a global standard for designing  and building equipment and systems used in the bio processing, pharmaceutical and personal-care products industries. This standard incorporates current best-practices for enhancing product purity and safety. ASME standard covers materials, design, fabrication, inspections, testing and certification of process equipment and system.


ASME BPE standards are developed and maintained by a balanced group of experts and is continuously updated to support industry accepted practices. Updation includes multiple stages of approval before publication. Corrections and clarification of published guidelines can be requested by any one.


This post is an introductory note and will discuss in detail about the ASME BPE standards in upcoming posts......

Much awaited post for ‘Design Requirements of Pharmaceutical Process Piping’ will be published soon.....



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