PDA TR86 药品包装完整性检测的行业挑战和当前技术（全文）-2021（中英）.pdf

PDATechnicalReportNo.86

IndustryChallengesandCurrentTechnologiesforPharmaceutical

PackageIntegrityTesting

PDA86

技术报告第号

药品包装完整性测试的行业挑战和当前技术

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目录

1.0Introduction5

1.1PurposeandScope7

2.0Glossary词汇表8

2.1Abbreviations9

3.0ChallengeswithMethodologies10

3.1PositiveControls11

3.1.1ConsiderationsforSelectingPositiveControls12

3.1.2ConsiderationsWhenUsingPositiveControls13

3.1.3TypesofSimulatedPositiveControls14

3.1.4CalibratedLeaks25

3.1.5AdditionalConsiderationsforControls25

3.2BlockageofLeakPaths26

4.0ChallengeswithPackageDesign28

4.1PrefilledSyringes28

4.1.1Design29

4.1.2Challenges35

4.1.3TestMethodConsideration41

4.1.4AdditionalConsiderationsforSecondaryPackaging43

4.2Single-UseSystems—FlexibleBulkContainers44

4.2.1Design44

4.2.2Challenges46

4.2.3TestMethodConsiderations46

4.2.4AdditionalConsiderationsforFlexibleBulkPackagingSystems50

4.3IVBags—FlexibleFinishedPharmaceuticalContainers50

4.3.1Design51

4.3.2Challenges51

4.3.3TestMethodConsiderations53

4.3.4AdditionalConsiderationsforIVBags54

4.4CryogenicConditions低温条件54

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4.4.1Design设计55

4.4.2Challenges挑战58

4.4.3TestMethodConsiderations测试方法考虑61

4.4.4AdditionalConsiderationsforCryogenicConditions62

5.0InnovativeMethodsforExistingTechnologies62

5.1HeliumTesting氦检62

5.1.1Application应用63

5.1.2TestEquipmentandParameters试验设备和参数64

5.1.3LeakDetectionLimit泄漏检测限65

5.1.4ConsiderationsandChallenges考虑和挑战66

5.2OpticalEmissionSpectroscopy光学发射光谱67

5.2.1Application应用67

5.2.2TestEquipmentandParameters试验设备和参