Pharma treasures is an informatory site, which shares pharma related articles. The ultimate goal of this site is to become a knowledge hub by gathering all pharma related technical information under one roof......
This blog mainly talks about QMS,cGMP,Regulatory Filings & Guidelines,Validation & Qualifications,Drug Stability,FDA 483s &Media Fill.
Hope this blog will cater the needs of both fresher’s and experienced professionals.
Friday, 9 December 2016
ASME BPE Guidelines for Pharmaceutical Equipment
ASME BPE Guidelines for
ASME BPE - (The American Society of Mechanical
Engineers - Bio processing Equipment)
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).
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.....