One vertical hub for pharmaceutical packaging lines: map Optomech systems from BIS → CIS → LIS → ISIVS → FOSIS, with regulated-software features for 21 CFR Part 11 / EU GMP Annex 11 / GAMP 5, Schedule M & WHO-GMP packaging expectations, and IQ/OQ/PQ documentation as part of commissioning.
Product map
Missing seals, wrong labels, and liner defects in pharma are patient-safety events — not routine QC noise. Use this map to match each packaging station to the Optomech system already documented on our product pages.
100% inline HDPE / PET / PP / glass container inspection — short mould, black spots, seal-surface and zone defects at line speed. Pharma-grade 21 CFR Part 11 software module on BIS-XL / BIS STD+.
Open BIS →Caps and liners before bottling — flash, short mould, no liner, double liner, misalignment, and wad defects. IQ/OQ/PQ validated deployments for pharmaceutical closures.
Open CIS →Wrong-label / SKU mix-up, presence, alignment, and print quality on wrap-around, sleeve, and pressure-sensitive labels — critical at multi-SKU pharma changeovers.
Open LIS →Non-destructive thermal imaging after induction sealing — under/over heat, cut liner, no liner, moon cut, loose cap — with 21 CFR Part 11 records and IQ/OQ/PQ as standard.
Open ISIVS →Injectable vial flip-off seals at up to 600 caps/min, 18+ defect types. Positioned for 21 CFR Part 11, WHO-GMP, and Schedule M pharmaceutical manufacturing.
Open FOSIS →OCR/OCV print verification for batch expiry and lot codes is offered as a LIS capability (vision print check — not full serialization / track-and-trace). See also our OCR verification blog.
Open LIS (OCR capability) →
Dedicated OCR/OCV landing at /vision/products/ocr-ocv-inspection/ is on an unmerged PR and is not yet on main.
Until that page ships, use LIS and the
barcode / batch-code OCR blog.
Validation
Pharmaceutical buyers evaluating vision systems need more than a camera brochure — they need installation, operational, and performance qualification aligned to the installed equipment. Optomech supplies IQ/OQ/PQ documentation as part of commissioning for pharma projects.
Confirm the system is installed as designed: hardware, utilities, network, safety, and configuration baseline for the packaging line.
Prove the system operates within specified ranges — reject logic, access control, audit trail behaviour, and challenge tests for known defects.
Demonstrate consistent performance under real production recipes, SKUs, and line speeds — the evidence auditors expect after go-live.
Use cases
Same regulatory pressure, different defect physics. Match the station to the system instead of forcing one camera to do everything.
Contamination, short mould, ovality, choked neck, sealing-surface damage — BIS before product is filled and capped.
No liner / double liner / half-moon foil defects that later fail induction sealing — CIS Online, CIS Custom, CIS-XL.
Wrong artwork at changeover is a top regulatory risk. LIS catches presence, position, and print issues; OCR/OCV covers lot/expiry print verify under LIS.
Under-heat seals that look intact to the eye — ISIVS thermal imaging after the sealer, with per-bottle electronic records.
Aluminium shell, PP button, and cosmetic/functional defects on vials — FOSIS for high-speed injectable packaging.
FAQ
Send SKUs, line speed (CPM / BPM), and target defects. We’ll recommend BIS / CIS / LIS / ISIVS / FOSIS coverage and outline IQ/OQ/PQ deliverables for your site.