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Manual Inspection
Process for a new
Fill Finish Facility
• Employ over 2,000 people at sites in Dublin, Carlow, Cork, Tipperary and
Wicklow.
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MSD Ireland (Carlow)
• 200,000 ft2
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•MSD Ireland (Carlow) – Site Overview
•Energy Centre
•Production Support & (11,000 sq ft)
warehousing (95,000 sq ft)
•Admin building
(17,000 sq ft)
•Production Building
(77,000 sq ft)
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•Manufacturing Technology
• Part 1:
– Outline the qualification strategy for manual inspection
at MSD Carlow.
• Fiona Byrne (Technical Operations - Process)
• Part 2:
– Implementation and management of manual inspection
at MSD Carlow.
• Caroline Devery (IPT - Operations)
Qualification strategy for manual inspection at
MSD Carlow
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Content
• Manual Inspection
• Strategy Overview
• Training
• Sensitivity Studies
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Manual Inspection Qualification Strategy
• Objective:
– To outline the qualification strategy for inspection at
MSD Carlow.
• Consists Of:
– Workshop on manual inspection
– 20/20 vision test
– Vision colour acuity and depth perception test
– Read & Understand - Procedures and Work Instructions
– Defect Set Test:
• 80% good product; 20% defective product
• Approx. 120 containers
• 1 gross example of each categorized defect type
• Inspector must catch 100% of defective product
13 • Inspector must not false reject more than 5% of good product
Phase 2: Sensitivity Study
• Consists Of:
– Defect set:
• Those identified during RA (risk assessment)
with varying ranges
• Excludes single presentation defects e.g.
missing stopper
• Approx. 1,500 Samples (20%:80% ratio)
– Raw data will be analyzed to determine min size
value (based on reject zone > 70%)
– Based on analysis of group statistics (min. 10
inspectors)
Rick Watson and Joe Straub (Merck), Manual Inspection Capability to Detect Particulate in Parenterals:
PDA Visual Inspection Forum, 7-8 Oct 2013, Bethesda, MD
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Phase 3: Knapp Manual Baseline
• Consists Of:
– All defect categories:
• Defect ranges determined by Phase 2 Sensitivity Study
• All single presentation defects e.g. missing stopper
– Approx. 1,500 Samples (20%:80% ratio)
– Data compilation
• Determine manual inspection Baseline Reject Zone Efficiency i.e. RZEM
– Inspected by multiple trained inspectors as a blind study to determine
inspector efficiency & effectiveness (RZE value)
– Based on analysis of group statistics (min. 10 inspectors)
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Phase 4b: Manual Inspector Qualification /
Requalification
• Purpose: To successfully qualify / re-qualify manual
inspectors to release them for manual inspection of
finished product
• Consists Of:
– Defect set:
• Same accepts, defect types, ranges, sizes and presentation as those
used in the Phase 3 Manual Baseline
– Compilation of new manual inspector efficiency RZEni
• (Reject Zone Efficiency new inspector)
– Acceptance Criteria:
• RZEni within 3-sigma of baseline
• False Rejectni within 3-sigma of baseline
– Requalification on annual basis
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Strategy Flow Summary Overview
Approved Strategy:
Categorized Defects
• Baseline Qualification:
– If Risk Assessment of new product shows:
• Equivalency to current product – no new baseline will be needed
• Gaps to current product – gap analysis completed to determine
requirements
• Difference to current product - new baseline required
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Matrix / Leveraging Approach
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Summary
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Implementation and management of manual
Inspection at MSD Carlow
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Requirements for Manual inspection at Carlow
• Visual inspection of the statistical sample of accepted material post 100% inspection.
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Material Flow
Fill
Auto Inspection
Cold Store
Manual Inspect
Cold Store
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Manual Inspection Area & Equipment
• 8 Inspection Booth’s
• Eisai-Bosch, MIH-
DX Inspection Hood
• 2000-3750 Lux,
Daily Check
• Multiple Concurrent
Inspections
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Control and Record of Manual Inspection
• Work Station
• Werum PAS-X MES
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Inspection Technique – Standard Work
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Categorisation of Rejects
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Sampling and Reject Trend Monitoring
• Reject Trending
– 1.5 to 1% reject rate manual inspection
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Start-up Challenges
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