ASME BPE (2014)

Bioprocessing Equipment

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Annotation and contents

This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification.

ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.

New topics from the last revision include:

• Testing procedures and acceptance criteria for valve diaphragms
• Chromatography requirements
• Polymeric Hygienic Unions
• Steam to/through Connections
• Shelf-life, storage and expiration date requirements for single-use equipment
• Radar Level and Temperature Sensors
• Acceptance criteria for a variance in luster
• Adoption of the CA-1 Standard

ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping.

Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2012 and EP-2012, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance.

Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.

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