首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 CI-81-05-4
收藏跟踪
购买正版
Clean Room Applications in Pharmaceutical Manufacturing 洁净室在制药中的应用
制药行业对洁净室的要求与其他设施不同。食品和药品管理局(FDA)及其质量控制部门(Q.C.)实施了设计标准,使该设施成为高度专业化的空间。必须忽略传统的空气流速。满足冷却负荷的足够空气不足以用于其他用途,而典型的洁净室空气量可以大大减少,以达到预期效果。 本文为制药洁净室的设计提出了经济可行的解决方案。引文:俄亥俄州辛辛那提ASHRAE学报第87卷第2部分研讨会
The pharmaceutical industry has requirements for its clean rooms which are alien in other facilities. The F.D.A. (Food and Drug Administration) and its own Q.C. (Quality Control) Department impose design criteria which make the facility a highly specialized space. Traditional air flow rates must be disregarded. Sufficient air to satisfy the cooling load is inadequate for other purposes, while typical clean room air quantities can be considerably reduced to attain the desired effect.This paper suggests economically feasible solutions for the design of a pharmaceutical clean room.
分类信息
关联关系
研制信息
相似标准/计划/法规
现行
GB 50457-2019
医药工业洁净厂房设计标准
Standard for design of pharmaceutical industry clean room
2019-08-12
现行
NY-87-13-4
Enthalpy Recovery in Low-Humidity Pharmaceutical Clean Rooms
低湿度制药洁净室的焓回收
现行
NY-87-13-4
Enthalpy Recovery in Low-Humidity Pharmaceutical Clean Rooms
低湿度制药洁净室的焓回收
现行
CI-81-05-1
Clean Room Design for Microelectronics Manufacturing
微电子制造业的洁净室设计
现行
CI-81-05-1
Clean Room Design for Microelectronics Manufacturing
微电子制造业的洁净室设计
现行
YBB 00412004-2015
药品包装材料生产厂房洁净室(区)的测试方法
Test for Clean Rooms (Areas) Producing Pharmaceutical Packaging Materials
2015-08-11
现行
GB/T 16292-2010
医药工业洁净室(区)悬浮粒子的测试方法
Test method for airborne particles in clean room(zone) of the pharmaceutical industry
2010-09-02
现行
GB/T 16294-2010
医药工业洁净室(区)沉降菌的测试方法
Test method for settling microbe in clean room(zone) of the pharmaceutical industry
2010-09-02
现行
GB/T 16293-2010
医药工业洁净室(区)浮游菌的测试方法
Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
2010-09-02
现行
LA-74-10-4
The Approach to "Class 10" Clean Rooms for the Manufacture of Semiconductors
半导体制造“10级”洁净室的探讨
现行
LA-74-10-4
The Approach to "Class 10" Clean Rooms for the Manufacture of Semiconductors
半导体制造“10级”洁净室的探讨
现行
CI-81-05-3
Clean Room Equipment and Laboratory Biohazard Safety Applications
洁净室设备和实验室生物危害安全应用
现行
SME MS900680
Design Criterion Of End Effectors For Clean Room Application
洁净室用末端执行器的设计准则
1990-06-01
现行
CI-81-05-3
Clean Room Equipment and Laboratory Biohazard Safety Applications
洁净室设备和实验室生物危害安全应用
现行
ASTM E2968-23
Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
制药工业中连续制造(CM)应用的标准指南
2023-01-01
现行
ASTM E2537-16(2024)
Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
连续过程验证应用于制药和生物制药的标准指南
2024-10-01
现行
ASTM E2891-20
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
药物开发与制造应用中多变量数据分析的标准指南
2020-07-01
现行
ASTM E3418-23e1
Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
制药和医疗器械制造设备及医疗器械清洁用残留物科学合理限值计算的标准实施规程
2023-11-01
现行
ASTM E3051-16
Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
一次性系统在制药和生物制药制造中的规范 设计 验证和应用标准指南
2016-02-01
现行
YY/T 1809-2021
医用增材制造 粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法
Additive manufacturing for medical applications—Verification methods of cleaning and cleaning effectiveness of metal powder used in powder-bed fusion process
2021-09-06