Featuring over 54,000 entries, this thoroughly updated Sixth Edition contains the medical terminology used in over 30 of today's fastest growing health profession areas-plus comprehensive inclusion of entries suited for the nursing field. The book includes 1,000 enriched color images and photographs,...
1.1 Purpose/Scope 目的/范围 This Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries. This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements ...
1.1 Purpose/Scope目的/范围 (5)2.0 Glossary of Terms术语 (8)3.0 Sterilization Processes灭菌过程 (19)3.1 Saturated Steam Processes 饱和蒸汽程序 (19)3.1.1 Gravity Displacement Process 重力置换程序 (20)3.1.2 Pre-Vacuum Process 预真空程序 (22)3.2 Air Overpressure Processes空气加压程序 (22...
美国FDA 和欧洲药监局认定PV 在现行GMP 指南的综述和具体条框中都是必要条件 和药品质量保证的必需元素(2,3,5 )。 The PV lifecycle concept links product and process development, the qualification of the commercial manufacturing processes, and maintenance of the commercial production process in a ...
2010TechnicalReportNo.48MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualifcationandMaintenance.pda/bookstoreMoistH t..
1.1 Purpose/Scope目的/范围 (5)2.0 Glossary of Terms术语 (8)3.0 Sterilization Processes灭菌过程 (19)3.1 Saturated Steam Processes 饱和蒸汽程序 (19)3.1.1 Gravity Displacement Process 重力置换程序 (20)3.1.2 Pre-Vacuum Process 预真空程序 (22)3.2 Air Overpressure Processes空气加压程序 (22...
PDA TR48(湿热灭菌)
PDA TR48(湿热灭菌)
Processvalidationlifecycleterminologydiffersglobally.Some termsmay be used differentlyfrom company to used. 工艺验证生命周期术语在全球范围内有所不同。有些术语可能会因公司而异,有些可能会在将来发生变化。 组织必须选择将在其验证程序中使用的术语,明确定义这些术语,并在检查和注册文件、公司内部和监管文 件中...
Content 目录 1.0 Introduction 引言 ... 4 1.1 Purpose/Scope 目的/范围 ... 5 2.0 Glossary of Terms 术语 ...