30、ISPE GPG：温控室温度分布和监控（第1版）-中英-2016.pdf

ISPEGoodPracticeGuide:

ControlledTemperatureChamberMappingandMonitoring1/185

ISPEGoodPracticeGuide:

ControlledTemperatureChamberMapping

andMonitoring

ISPE良好实践指南

温度受控间温度分布和监控

ISPEGoodPracticeGuide:

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Tableofcontents

目录

1.Introduction简介4

1.1.PurposeandObjective目的和目标4

1.2.Scope范围5

1.3.Benefits利益和优势5

1.4.RegulatoryGuidance法规指南6

1.5.KeyConcepts/KeyTerms关键概念/关键术语7

2.RelatedStandards相关标准8

2.1.Standards标准8

3.UserRequirementsSpecification用户需求说明10

4.TypesofControlledTemperatureChamber温度控制室类型11

4.1.Freezers冰柜11

4.2.Refrigerators冰箱14

4.3.ColdRooms冷藏室15

4.4.StabilityChambers,Incubators/IncubatorShakers稳定性试验箱，培养箱/恒温摇床15

5.Commissioning.调试16

5.1.ScopeoftheCommissioning调试的范围16

5.2.TheCommissioningStrategy调试策略18

5.3.Commissioning