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现行 P3-A Pharmaceutical Standards Set
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Full Set of P3-A Pharmaceutical Standards 全套P3-A药品标准
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。设置内容:P3-A 001:2008,制药3-A标准中使用的术语通用术语表。本标准为制药3-A®(P3-A)标准和公认实践的用户提供了这些文件中广泛使用的首字母缩写词和术语的定义。P3-A 002:2008,制药3-A工艺设备和系统所用材料的卫生/卫生标准。 本标准规定了制药环境中使用的新设备和组件的最低材料和表面性能要求,包括最低制造相关材料和表面性能要求,这些材料和表面性能可能直接、间接或附带影响强度、特性、安全性,活性药物成分、赋形剂或药品的纯度或质量。P3-A 003:2008,P3-A活性药物成分的端吸离心泵。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。还提供基于网络的多用户订阅服务。 订阅服务允许一个或多个用户以电子格式从任何位置同时访问P3-A药物标准。文件的任何更新都包括在一年的许可期内。点击此处了解更多信息或发送电子邮件至TechStreet。service@thomson.com.
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.Set Contents:P3-A 001:2008, General Glossary of Terminology Used In Pharmaceutical 3-A Standards.This standard provides users of Pharmaceutical 3-A® (P3-A) Standards and Accepted Practices with definitions of acronyms and terms widely used in these documents.P3-A 002:2008, Pharmaceutical 3-A Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems.This standard provides minimum materials and surface property requirements, including minimum fabrication related materials and surface property requirements, for new equipment and components utilized in the pharmaceutical manufacturing environment whereby those material and surface properties may directly, indirectly, or incidentally impact the strength, identity, safety, purity or quality of the active pharmaceutical ingredient, excipient, or drug product.P3-A 003:2008, P3-A End Suction Centrifugal Pumps for 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.A web-based multi-user Subscription Service is also available. The Subscription Service allows one or more users to access the P3-A Pharmaceutical Standards simultaneously from any location in electronic format. Any updates to the documents are included for the one-year license period.Click herefor more information or emailtechstreet.service@thomson.com.
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