The Challenge
A cap and closure manufacturer in Baddi — one of India's most densely concentrated pharmaceutical manufacturing zones — produces polypropylene caps with induction-seal liners and foil wads at 22,000 caps per hour across three moulding and assembly lines. Their customer base includes formulation companies exporting to the US and EU under FDA and EMA oversight. As a direct packaging component supplier, the manufacturer falls within scope of their customers' supplier qualification programmes.
During a supplier qualification audit conducted by a US-based pharmaceutical customer, the FDA representative identified the cap inspection process as a critical control gap. The existing process used periodic offline sampling: a trained quality inspector pulled 200 caps per hour from each line and manually checked for visible defects. Liner inspection was particularly problematic — missing liners, half-moon liner defects, and foil wads placed at an angle are invisible until the cap is inverted and examined individually. At 22,000 caps per hour, the inspector was physically checking 0.9% of output.
The audit finding stated: "Inspection method provides insufficient statistical confidence that 100% of product meets specification. Risk of liner-deficient caps reaching the drug product line." The manufacturer was placed on a CAPA plan requiring validated 100% inspection within 90 days as a condition of continued supplier qualification — the customer representing 34% of annual revenue.
The Solution
Optomech installed the CIS (Cap Inspection System) inline on all three cap assembly lines, rated at 22,000 caps per hour — matching production speed exactly. The CIS uses a multi-camera vision system to inspect every cap in motion across two inspection zones: a top-face station (cap exterior, diameter, ovality, flash, and short-moulding) and an inverted station (liner/wad presence, alignment, foil integrity, half-moon, double liner, and missing foil). Rejected caps are ejected automatically via an air-blast rejection mechanism calibrated to 99.97% ejection efficiency.
The Optomech applications engineer worked with the customer's QA team to define acceptance criteria for all defect classes — translating pharmacopoeial and customer-specific specification requirements into measurable tolerance parameters within the CIS software. A full IQ/OQ/PQ protocol was executed and documented, providing the validation evidence package required for FDA CAPA closure.
All rejection events are logged with timestamp, defect category, and stored image — accessible via the CIS console and exportable to Excel for batch records. The 3-level password access control system prevents operators from modifying inspection tolerances without QA authorisation. Remote connectivity allows Optomech to support software updates without disrupting production.
Each line was commissioned in under 8 hours — with no lost production shift during installation.
Defects Detected by the System
Results Achieved
| Metric | Result |
|---|---|
| CAPA closure | FDA CAPA closed within 75 days — 15 days ahead of the 90-day deadline |
| Inspection coverage | 100% of all caps inspected at full production speed of 22,000 cph |
| Liner defects caught | Avg. 1,140 liner-defective caps rejected per line per shift — previously completely undetected |
| Customer defectives | Zero defective caps reported at any customer goods-in over 10 months post-installation |
| Supplier qualification | All three customers renewed annual supplier qualification — one upgraded to preferred supplier status |
| Validation documentation | Full IQ/OQ/PQ package accepted by FDA audit team at follow-up inspection |
| Shift reporting | Automated defect reports generated every shift — no manual data entry required |
| Downtime for installation | Each line commissioned in under 8 hours — zero lost production shifts |
"The FDA finding was a crisis for us — 34% of our revenue was at risk. Optomech delivered the CIS, the validation documentation, and the IQ/OQ/PQ package in time for us to close the CAPA. When the auditor came back, he reviewed the system and the records and had no further observations. The liner defect numbers shocked us — we had no idea how many defective liners were going out under our old process."— Director – Quality & Regulatory Affairs, Cap Closure Manufacturer, Baddi
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