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Certification of the quality management system for organizations manufacturing or supplying tubing and fittings under the scope of the ASME BPE standard, "Bioprocessing Equipment."
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About the ASME Bioprocessing Equipment Certification Program
Products manufactured under the ASME Bioprocessing Equipment (BPE) Certification Program have been created in adherence to the ASME BPE standard, "Bioprocessing Equipment". This standard provides the requirements applicable for 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.
The ASME BPE Certification Program 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 the ASME BPE Certification Program can often achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations. The Certification Mark with a BPE Designator indicates that components bearing the mark have been manufactured and certified by an ASME BPE Certificate Holder.
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ASME CA-1-2014, Conformity Assessment Requirements
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