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Pharma Packaging Manufacturer Achieves 100% Dimensional Compliance Using PP 300TE Profile Projector

Gauge R&R from 31% to 6.8%. EU customer audit passed. Zero quarantine events in 12 months. Full NABL-traceable records across 12 SKUs.

6.8%
Gauge R&R (from 31%)
100%
Dimensional Compliance
12
SKUs Covered
0
Quarantine Events in 12 Months

The Challenge

A mid-sized pharmaceutical packaging manufacturer in Hyderabad supplies glass vials, ampoules, aluminium closures, and rubber stoppers to formulation companies across India and regulated export markets (EU and US). Incoming quality acceptance required NABL-traceable dimensional inspection records. Inspection was performed with manual gauges across a 12-SKU range — slow (8–10 minutes per sample), highly operator-dependent, and generating no electronic records. Gauge R&R studies returned 31% — well above the 10% threshold required for gauge approval. Three batches were quarantined in a single quarter due to borderline dimensional non-conformances discovered only at the customer's goods-in inspection.

Key Pain Points
  • Gauge R&R at 31% — failing audit threshold
  • Manual gauging with no electronic records
  • 3 batch quarantines in one quarter
  • 8–10 min per sample — too slow for incoming QC
  • No NABL-traceable calibration records

The Solution

Optomech supplied the PP 300TE Optical Profile Projector with the OP1000 computerised metrology software — featuring full geometric element measurement, DXF overlay import, and XML/Excel export. Overlay charts — transparent Mylar templates engraved with nominal profiles and tolerance bands — were custom-fabricated by Optomech for all 12 SKUs, enabling pass/fail decisions in seconds. The system was calibrated against NABL-traceable master glass scales, and SOPs for all 12 product inspection routines were prepared jointly by the Optomech applications engineer and the customer's QA team.

Results

Metric Result
Gauge R&R result Reduced from 31% to 6.8% — passed EU customer gauge approval audit
Inspection time 8–10 min per sample → 2.5 minutes (70% reduction)
Dimensional compliance 100% — zero quarantine events in 12 months post-installation
Traceability Full NABL-traceable records for all 12 SKUs with calibration certificate
EU audit Calibration certificate and SOPs accepted in EU supplier audit
SKUs covered 12 product types with dedicated overlay charts and OP1000 programs
Data export Measurement records exported to Excel — integrated into QMS for trending
Operator training 3 QC operators certified in 3 days

"Our EU customer had flagged our gauge R&R as a major finding. We needed to resolve it before their next audit or risk losing the contract. The PP 300TE with the OP1000 system fixed it completely — 6.8% R&R, NABL traceability, electronic records, and overlay charts our operators can use in under three minutes. Optomech also helped us write the SOPs. We passed the follow-up audit with no observations."

— Head of Quality Assurance, Pharmaceutical Packaging Manufacturer, Hyderabad

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Frequently Asked Questions

What is NABL traceability and why do pharma suppliers need it?
NABL (National Accreditation Board for Testing and Calibration Laboratories) traceability means measurement results can be traced through an unbroken chain of calibrations to national reference standards. Pharma and packaging suppliers to regulated markets (EU GMP, US FDA, ISO 15378) must use measurement equipment calibrated against NABL-traceable masters. Optomech supplies NABL-traceable calibration certificates with all profile projector deliveries.
What is Gauge R&R and what level is acceptable for pharma packaging?
Gauge R&R measures how much variation in your measurement results comes from the measuring system itself versus actual part-to-part variation. For pharma packaging, gauge R&R below 10% is required for gauge approval under GMP standards. Results above 30% mean the measurement system cannot reliably detect real dimensional changes. The PP 300TE reduced Gauge R&R from 31% to 6.8% — well within the acceptable limit.
Can the PP 300TE generate electronic inspection records for EU audits?
Yes. The OP1000 software exports measurement data to XML and Excel in real time. Records include part ID, measurement values, tolerances, pass/fail status, operator ID, date, and calibration reference — providing a full electronic record suitable for EU GMP and ISO 15378 audit requirements.
What are overlay charts and how are they used with a profile projector?
Overlay charts are transparent Mylar templates engraved with the nominal profile and tolerance bands of a component. The component's silhouette is projected onto the screen and compared against the overlay chart — any deviation outside the tolerance band is immediately visible. Optomech custom-fabricates overlay charts for each SKU, enabling rapid pass/fail inspection without software or training.
How quickly can a profile projector be set up for a new SKU?
With the OP1000 software and a saved part program, switching to a new SKU takes under 2 minutes — select the program, load the part, and run. Initial part programming (creating the first program for a new SKU) takes 15–30 minutes using DXF import from the CAD drawing.
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