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P3-A End Suction Centrifugal Pumps for Active Pharmaceutical Ingredients P3-A活性药物成分用端吸离心泵
发布日期: 2012-02-01
活性药物成分(API)制造商已确定,需要制定更高效清洁的设备设计标准,以提高QA和检验机构的认可度,并推进生产设备的最先进水平。新的制药3-A(P3-A)标准规定了制造活性药物成分的建筑材料和可清洁设备的设计要求。本标准涵盖符合ANSI/ASME B73的机械密封端吸离心泵的卫生设计要求。1、与活性药物成分(API)制造相关,以保持产品完整性。
Active pharmaceutical ingredient (API) manufacturers have identified the need for standards for the design of equipment that is more efficiently cleanable to enhance acceptance by QA and inspection agencies and advance the state-of-the-art for production equipment. The new Pharmaceutical 3-A (P3-A) standards provide the requirements for materials of construction and for the design of cleanable equipment for the manufacture of active pharmaceutical ingredients.This standard covers the sanitary design requirements of mechanically sealed end-suction centrifugal pumps, conforming to ANSI/ASME B73.1, pertinent to active pharmaceutical ingredient (API) manufacturing in order to maintain product integrity.
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