Project
PRJ-0218
Industry
Pharmaceuticals & Life Sciences
Application
Inspection & controlled handling
Commissioned
May 24, 2024
Status
Supported
6,000 vials/h inspected automatically, with glass breakage at transfer points reduced from 0.12 % to 0.03 %.
Project
PRJ-0218
Industry
Pharmaceuticals & Life Sciences
Application
Inspection & controlled handling
Commissioned
May 24, 2024
Status
Supported
6,000 vials/h inspected automatically, with glass breakage at transfer points reduced from 0.12 % to 0.03 %.
FIG. 1
Inspection & controlled handling
PRJ-0218
01
Commissioning results
Measured outcome
01
Commissioning results
Measured outcome
Inspection rate
6,000
vials/h
Continuous, 2 ml and 10 ml vial formats
Inspection rate
6,000
vials/h
Continuous, 2 ml and 10 ml vial formats
Challenge-set detection
99.4
%
2,484 of 2,500 defect vials · 5 classes, each ≥ 98.0 %
Challenge-set detection
99.4
%
2,484 of 2,500 defect vials · 5 classes, each ≥ 98.0 %
Glass breakage at transfer
0.12
→
0.03
%
3 months after SAT vs. prior 3 months
Glass breakage at transfer
0.12
→
0.03
%
3 months after SAT vs. prior 3 months
Inspectors per shift
3
→
1
One operator for reject review; two redeployed
Inspectors per shift
3
→
1
One operator for reject review; two redeployed
02
Engineering record
Challenge, approach and architecture
02
Engineering record
Challenge, approach and architecture
Challenge
Context. A fill-finish line for injectable products in 2 ml and 10 ml glass vials, operated by a contract manufacturer for several clients.
Existing process. Three inspectors per shift checked vials manually against a light box. Results varied between inspectors, and glass breakage at two manual transfer points created particle risk.
Constraints.
Every requirement traced from the client's user requirement specification to a test.
Reject handling must be segregated and lockable.
The client remains responsible for qualification; our documentation had to support their IQ/OQ.
Challenge
Context. A fill-finish line for injectable products in 2 ml and 10 ml glass vials, operated by a contract manufacturer for several clients.
Existing process. Three inspectors per shift checked vials manually against a light box. Results varied between inspectors, and glass breakage at two manual transfer points created particle risk.
Constraints.
Every requirement traced from the client's user requirement specification to a test.
Reject handling must be segregated and lockable.
The client remains responsible for qualification; our documentation had to support their IQ/OQ.
Engineering approach
We worked from the client's URS to a functional and design specification, then agreed a challenge set of 2,500 defect vials in five classes, with acceptance at ≥ 98.0 % detection per class.
Scope. Star-wheel transfer replacing two manual steps; four-station camera inspection (360° cracks and cosmetic, stopper and crimp, fill level); locked reject bins; batch reports with user management and audit trail; FS, DS, traceability matrix and FAT/SAT protocols.
Engineering approach
We worked from the client's URS to a functional and design specification, then agreed a challenge set of 2,500 defect vials in five classes, with acceptance at ≥ 98.0 % detection per class.
Scope. Star-wheel transfer replacing two manual steps; four-station camera inspection (360° cracks and cosmetic, stopper and crimp, fill level); locked reject bins; batch reports with user management and audit trail; FS, DS, traceability matrix and FAT/SAT protocols.
System architecture
Handling: star-wheel infeed and transfer with guided vial contact.
Inspection: 4 stations, 7 cameras in total — 360° glass inspection, stopper and crimp, fill level — with dedicated lighting per defect class.
Control: safety PLC and HMI with role-based access and audit trail.
Records: batch report per lot with images of rejected vials.
System architecture
Handling: star-wheel infeed and transfer with guided vial contact.
Inspection: 4 stations, 7 cameras in total — 360° glass inspection, stopper and crimp, fill level — with dedicated lighting per defect class.
Control: safety PLC and HMI with role-based access and audit trail.
Records: batch report per lot with images of rejected vials.
Deployment & commissioning
FAT was executed against the agreed protocols with the client's quality representatives in our hall. SAT followed on site, and we supported the client's IQ and OQ execution. Performance qualification and release were carried out by the client.
Deployment & commissioning
FAT was executed against the agreed protocols with the client's quality representatives in our hall. SAT followed on site, and we supported the client's IQ and OQ execution. Performance qualification and release were carried out by the client.
- INInfeedStar-wheel
- CAM 1–2Glass 360°4 cameras
- CAM 3–4Closure & fill3 cameras
- REJRejectLocked bin
- RECBatch recordAudit trail
03
Specification & results
Specification, acceptance and results
03
Specification & results
Specification, acceptance and results
Rate
6,000 vials/h
Rate
6,000 vials/h
Formats
Change parts per format
2 ml · 10 ml
Formats
Change parts per format
2 ml · 10 ml
Stations
7 cameras
4
Stations
7 cameras
4
Challenge set
5 classes × 500
2,500 vials
Challenge set
5 classes × 500
2,500 vials
Records
Audit trail, role-based access
Batch report
Records
Audit trail, role-based access
Batch report
Parameter
Specified
Measured
Result
Detection · cracks / chips
≥ 98.0 %
99.4 %
Pass
Detection · cracks / chips
Specified
≥ 98.0 %
Measured
99.4 %
Result
Pass
Detection · cosmetic scratches
≥ 98.0 %
98.6 %
Pass
Detection · cosmetic scratches
Specified
≥ 98.0 %
Measured
98.6 %
Result
Pass
Detection · stopper position
≥ 98.0 %
100 %
Pass
Detection · stopper position
Specified
≥ 98.0 %
Measured
100 %
Result
Pass
Detection · crimp defects
≥ 98.0 %
99.2 %
Pass
Detection · crimp defects
Specified
≥ 98.0 %
Measured
99.2 %
Result
Pass
Detection · fill level
≥ 98.0 %
99.6 %
Pass
Detection · fill level
Specified
≥ 98.0 %
Measured
99.6 %
Result
Pass
False rejects · 2,000 good vials
≤ 1.0 %
0.55 %
Pass
False rejects · 2,000 good vials
Specified
≤ 1.0 %
Measured
0.55 %
Result
Pass
Results
Measure | Before | After |
|---|---|---|
Inspection | Manual, 3 inspectors per shift | Automated, 1 reviewer per shift |
Rate | Limited by inspectors | 6,000 vials/h |
Transfer | 2 manual steps | Star-wheel transfer |
Breakage at transfer | 0.12 % | 0.03 % |
Detection by class: cracks / chips 99.4 %, cosmetic scratches 98.6 %, stopper position 100 %, crimp defects 99.2 %, fill level 99.6 % (500 vials per class). False rejects on 2,000 known-good vials: 11 (0.55 %).
Results
Measure | Before | After |
|---|---|---|
Inspection | Manual, 3 inspectors per shift | Automated, 1 reviewer per shift |
Rate | Limited by inspectors | 6,000 vials/h |
Transfer | 2 manual steps | Star-wheel transfer |
Breakage at transfer | 0.12 % | 0.03 % |
Detection by class: cracks / chips 99.4 %, cosmetic scratches 98.6 %, stopper position 100 %, crimp defects 99.2 %, fill level 99.6 % (500 vials per class). False rejects on 2,000 known-good vials: 11 (0.55 %).
04
Drawings
Layout and detail drawings
Original technical drawings prepared for this record. Illustrative, not to scale.
04
Drawings
Layout and detail drawings
Original technical drawings prepared for this record. Illustrative, not to scale.
FIG. 1 · Vial transfer and inspection, plan
FIG. 2 · Challenge-set results by defect class
The documentation arrived in the structure our validation team asked for, which is not something we can take for granted.
Validation Lead
Client · contract manufacturer (anonymized)
PRJ-0218
05
Related
Solutions, platforms and resources
05
Related
Solutions, platforms and resources
A
Related solutions
B
Technology stack
C
Related resource
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