PDA 隔离器中无菌药品的无菌加工考虑要点Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in lsolat（中英文）

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隔离器中无菌药品的无菌加工考虑要点

parenteral DrugAssociation

Points to Consider for the Aseptic Processing of

Sternile Phammaceutical Products in lsolators

隔离器中无菌药品的无菌加工考虑要点

PDA Points to Consider for the Aseptic Processing of Sterile Pharmaceutical

Products in Isolators Task Force

PDA 隔离器中无菌药品的无菌加工考虑要点工作组

Authors

作者

Guenther Gapp, Gapp Quality GmbH (Chair)

Shelley Preslar,Azzur Group (Chair)

Marcia Cristina Baroni,Eli Lily and Company

Harold Baseman, Valsource,Inc.

Jette Christensen, Novo Nordisk

Richard Denk,SKAN

Phil DeSantis,DeSantis Consulting Associates

Dawn Downey, PhD,Eli Lilly and Company

Sabina Lancaster, Novartis

Jahanvi Miller, Parenteral Drug Association

Alexandra Staerk, Novartis

Stephen C.Yang,PhD,Merck &Co.,Inc.

Table of Contents

1. Introduction and Scope 引言和范围......................................................................................................................................................... 5

2. Glossary 术语................................................................................................................................................................................................ 8

Topic 1: Isolator Design

主题1: 隔离器的设计 .................................................................................................................................................................................. 12

Q1-1: What should the pressure differential be between the isolator interior and the surrounding area?

问题1-1:隔离器内部与周围区域之间的压差应该是多少? ........................................................................................13

Q1-2: What are the design considerations for isolator gloves?

问题1-2:隔离器手套设计的考虑要点是什么? ..................................................................................................................................... 15

Q1-3: How should the isolator be designed to minimize risk posed by interventions?

问题1-3:隔离器应怎样设计以尽量减少干预措施带来的风险? ........................................................................................................18

Topic 2: PhysicalEnvironment

主题 2: 物理环境 ......................................................................................................................................................................................... 21

Q2-1: What should the classification of the room surrounding the isolator be?

问题2-1:隔离器周围房间应该是什么级别? ............................................................................................................................................. 2

Q2-2: Should the isolator fill zone have unidirectional flow?

问题2-2:隔离器的灌装区是否应该有单向流? ..................................................................................................................................... 25

Q2-3: Should airflow pattern visualization /demonstration be peformed in an isolator?

问题2-3:是否应该对隔离器内进行气流流型可视化/演示? ..................................................................................................................25

Q2-4: Should the isolator environment qualification runs (at rest and in operation ) include the sample sites established

according to ISO 14644-1 or can a reduced sampling plan be followed based on a risk assessment?

问题2-4:隔离器环境确认(静态和动态)是否应包括根据ISO14644-1建立的取样点，或者根据风险评估减少取样计划?30

Q2-5: What techniques should be used to identify , track , and evaluate air flow during qualification and maintenance of thee

isolator?

问题2-5:在隔离器确认和维护过程中，应使用什么技术来识别、跟踪和评估气流?.................................................................. 32

Topic 3: Personnel

主题 3 : 人员 .................................................................................................................................................................................................. 36

Q3-1: How should personnel be gowned when working in the isolator or the background environment area during aseptic

processing?

问题3-1:人员在使用隔离器工作时或在无菌加工期间的背景环境区域工作时，应如何更衣? .................................................. 37

Q3-2: Should operator gloves be disinfected prior to entering isolators gloves?

问题3-2:操作员的手套在进入隔离器手套前应当消毒吗?..................................................................................................................39

Topic 4: Integrity Testing of Isolator and Gloves

主题4:隔离器和手套的完整性测试 .........................................................................................................................................................40

Q4-1: What methods should be used for integrity testing of isolators and gloves?

问题4-1:隔离器和手套的完整性测试应使用什么方法? ..................................................................................................................... 41

Q4-2:What should the maintenance program be for gloves?

问题4-2:手套的维护保养计划应该怎么做? ............................................................................................................................................ 43

Q4-3: What is the response to a glove integrity failure?

问题4-3:手套完整性失败该作何处理?.....................................................................................................................................................45

Topic 5: Environmental Monitoring

主题 5 : 环境监测 ......................................................................................................................................................................................... 47

Q5-1: What should the environmental monitoring frequency be in an Isolator?

问题5-1:隔离器内环境监测的频率应如何规定? ....................................................................................................................................48

Q5-2: Which surfaces should be monitored in an isolator ? 问题5-2:隔离器中哪些表面需要监测? ......................................52

Q5-3: Should environmental monitoring excursions in isolators be treated differently compared to excursions in

conventional filling lines?

问题5-3:隔离器中的环境监测偏离与传统灌装线环境监测偏离相比，是否应区别处理? .......................................................... 54

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摘要：

隔离器中无菌药品的无菌加工考虑要点parenteralDrugAssociationPointstoConsiderfortheAsepticProcessingofSternilePhammaceuticalProductsinlsolators隔离器中无菌药品的无菌加工考虑要点1PDAPointstoConsiderfortheAsepticProcessingofSterilePharmaceuticalProductsinIsolatorsTaskForcePDA隔离器中无菌药品的无菌加工考虑要点工作组Authors作者GuentherGapp,GappQualityGmbH(Chai...

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