工艺放大与技术转移案例(PDF 20页)
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ISPE CHINA ANNUAL CONFERENCE 2014
Identify Any Known Risks And Opportunities
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
OEB 2 • Facility and Equipment • Manufacturing Change – Formula and Process changes • Changes to Packaging Materials and Process • Cleaning Process Modifications • Changes to Analytical Methods and Limits
IBC
Containment Valve Metering Volumetic Feed Device Hydraulic System Floating CoRmopllaDcteiosingn SizReolls Reduction Unit (1 or 2 Units)
IBC
•Volumetric control of feed material to the roll nip (HFS) •Pre-compression applied to powder (VFS) •Roll surface •Roll speed •Roll gap (thickness of compact) •Applied roll force
Possible Solutions:
• Adjust feed speed(s) • Roll speed/pressure • Roll cooling • Vacuum De-aeration • Moisture content/ambient humidity • Adjust formulation • Check side seals
Transfer Strategy
Development trials will be completed at approximately 10% of commercial scale Conversion of blender speed Calculation for rotation speed while keeping the peripheral speed constant Compression The dwell time will be kept the same Coating
Documentation
Transfer Project Plan De商vel业op策m略ent report Quality / Technical Agreement(s) Specification-method Critical In-Process check sheets MSDS OEB/OEL Process Hazards Analysis
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Transfer Receiving Team
Quality /Mfg Support
EHS/RA
Project Leader
Mfg
Technology/ Validation
Supply Chain Support
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
Manufacturing/Packaging Facility
Sending Site
Receiving Site
Roller compaction： Compact the blend using a Roller compaction： smooth (top) and a Serrated Compact the blend. Pass the (bottom) roller combination. blend through the screen Pass the blend through the milling system. screen milling system.
21 – 22 April 2014, Shanghai
工艺放大与技术 转移案例
Scaleup & tech transfer case study
于英伟 海正辉瑞制药有限公司
SCALE-UP & TECHwenku.baidu.comTRANSFER OF TABLETS A
Project Charter Technical Transfer Receiving Team Documentation Transfer Identify Any Known Risks And Opportunities Transfer Strategy Manufacturing Submission
Transfer Strategy
Logistics and Finance Plan Stability Strategy Transfer Milestones
Problems:
•Compressibility •Excess fines •Poor dissolution •Low throughput •Instability of ribbon or tablets •Compaction within hopper
Gaps & Rationale
Technical Risk Analysis
Critical Process Parameters - Roller Compaction
Sending SitFeitzpatrick IR220/IRR52e0ceiving Site
Critical/ Non -
Unit Operation
Critical
Control Space Design Space Control Space
Parameter
Pre-compression Feed Screw (VPS)
Multiple Vacuum De-aeration Zones
Containment Valve
Identify Any Known Risks And Opportunities
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
OEB 2 • Facility and Equipment • Manufacturing Change – Formula and Process changes • Changes to Packaging Materials and Process • Cleaning Process Modifications • Changes to Analytical Methods and Limits
IBC
Containment Valve Metering Volumetic Feed Device Hydraulic System Floating CoRmopllaDcteiosingn SizReolls Reduction Unit (1 or 2 Units)
IBC
•Volumetric control of feed material to the roll nip (HFS) •Pre-compression applied to powder (VFS) •Roll surface •Roll speed •Roll gap (thickness of compact) •Applied roll force
Possible Solutions:
• Adjust feed speed(s) • Roll speed/pressure • Roll cooling • Vacuum De-aeration • Moisture content/ambient humidity • Adjust formulation • Check side seals
Transfer Strategy
Development trials will be completed at approximately 10% of commercial scale Conversion of blender speed Calculation for rotation speed while keeping the peripheral speed constant Compression The dwell time will be kept the same Coating
Documentation
Transfer Project Plan De商vel业op策m略ent report Quality / Technical Agreement(s) Specification-method Critical In-Process check sheets MSDS OEB/OEL Process Hazards Analysis
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Transfer Receiving Team
Quality /Mfg Support
EHS/RA
Project Leader
Mfg
Technology/ Validation
Supply Chain Support
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
ISPE CHINA ANNUAL CONFERENCE 2014
Technical Risk Analysis
Manufacturing/Packaging Facility
Sending Site
Receiving Site
Roller compaction： Compact the blend using a Roller compaction： smooth (top) and a Serrated Compact the blend. Pass the (bottom) roller combination. blend through the screen Pass the blend through the milling system. screen milling system.
21 – 22 April 2014, Shanghai
工艺放大与技术 转移案例
Scaleup & tech transfer case study
于英伟 海正辉瑞制药有限公司
SCALE-UP & TECHwenku.baidu.comTRANSFER OF TABLETS A
Project Charter Technical Transfer Receiving Team Documentation Transfer Identify Any Known Risks And Opportunities Transfer Strategy Manufacturing Submission
Transfer Strategy
Logistics and Finance Plan Stability Strategy Transfer Milestones
Problems:
•Compressibility •Excess fines •Poor dissolution •Low throughput •Instability of ribbon or tablets •Compaction within hopper
Gaps & Rationale
Technical Risk Analysis
Critical Process Parameters - Roller Compaction
Sending SitFeitzpatrick IR220/IRR52e0ceiving Site
Critical/ Non -
Unit Operation
Critical
Control Space Design Space Control Space
Parameter
Pre-compression Feed Screw (VPS)
Multiple Vacuum De-aeration Zones
Containment Valve