感谢共享,准确的说应该是 ISPE Baseline Volume4 :Water and Steam System。
3. WATER OPTIONS AND SYSTEM PLANNING INTRODUCTION. WATER QUALITY OPTIONS SYSTEM PLANNING SYSTEM DESIGN 3. 水选项和系统计划 序论 水质选项 系统计划 系统设计 4. PRETREATMENT OPTIONS INTRODUCTION PROCESS DESIGN OF PRETREATMENT. ...
SYSTEM PLANNING High purity water and steam are the most widely used, and often the most expensive raw material or utility in a pharmaceutical facility. Improper sizing or selection of a steam or water system could limit or even shut down production if under sized. However, system sizing is ...
2.5 cGMP 顺应性问题 2.6 设计范围与操作范围的比较 3. WATER OPTIONS AND SYSTEM PLANNING 3.1 INTRODUCTION.3.2 WATER QUALITY OPTIONS 3.3 SYSTEM PLANNING 3.4 SYSTEM DESIGN 3. 水选项和系统计划 3.1 序论 3.2 水质选项 3.3 系统计划 3.4 系统设计 ...
Where non-engineering issues (e.g., microbiological topics) are covered, the information is included to stress the importance of such topics and the impact they have on water and steam system design.Such non-engineering topics, therefore, are not covered comprehensively, and specific advice from ...
ispe 水和蒸汽指南英文版 English answers: What is ISpe water and steam guide? The ISpe water and steam guide is a set of industry standards for the design, construction, and operation of water and steam systems in power plants. It is developed by the International Society for Power Engineering...
Prove It 良好实践指南: 关键公用系统 GMP合规性 如何做到合规、 并可证明 Disclaimer: This Good Practice Guide is intended to provide guidance on achieving and maintaining critical utility systems compliance, and to be an aid to organizations in preparing and hosting regulatory inspections and audits....
2.1.4Public Water Compliance 公共用水合规 When a public drinking water source is used, the ...
WaterandSteamSystems(SecondEdition)WAT1211/WAT1211DL$200.00$379.00$484.00 CommissioningandQualificationCQ0101/CQ0101DL$200.00$379.00$484.00 BiopharmaceuticalsManufacturingFacilities(SecondEdition)IGBIOMF/IGBIOMFDL$200.00$379.00$484.00 Risk-BasedManufactureofPharmaceuticalProducts(Risk- ...
Items which only indirectly affect the process environment—and,therefore, have no direct patient safety and product quality impact—usuallyinclude Air Handling Units (AHU) pre-filters, fans, coils, humidifiers, and dehumidifiers; ductwork; chilled water; and steam. 仅间接影响工艺环境(因此,对患者安全...