The only industry where
inspection is written into law.
AI inspection for pharmaceutical production — where 100% visual inspection is mandated, the defect library is controlled, and every result has to be defensible.
Test it on your productThe Hard Case
Regulators already assume
human inspection is inconsistent.
Pharmaceutical is the one domain where EU law fully specifies visual inspection, and the way it does so is instructive. It requires 100% inspection of filled containers — and then requires statistical sampling after that inspection has already happened.
It also requires inspectors to be qualified initially & requalified periodically. Read those requirements together & the regulator's position is explicit: human visual inspection varies between people, degrades over time, and is not treated as complete even at full coverage.
That is the context an automated system enters. It is not being asked to replace a reliable process. It is being asked to be at least as good as a process the law already treats as fallible — and to produce a record that proves it.
Automated systems are held to a defined bar.
Pharmacopoeia practice requires an automated inspection system to equal or exceed qualified human inspection before it replaces it — a validation exercise, not a demonstration.
The defect library is a controlled document.
EU GMP requires a defect library covering the typical defects of the process, with defects classified by criticality and counts trended. A system that logs every unit with its image feeds that directly.
What it checks
The checks a regulated line
actually needs.
Is the container sound?
Container integrity
Cracks, chips and deformation on vials, ampoules, syringes and bottles before filling or after sealing.
Is it sealed correctly?
Closure & seal
Stopper seating, cap crimp, seal condition and closure presence — visual checks that sit alongside, not instead of, container closure integrity testing.
Is the fill within specification?
Fill level
Fill height measured and recorded as a value for every container, not a pass or fail stamp.
Right label, right place?
Label verification
Correct label for the product and strength, applied straight, undamaged and legible.
Is the batch data readable?
Code & batch marking
Batch, expiry and serial marking read and verified against what should be on that unit.
Is the pack complete?
Carton & leaflet
Leaflet presence, carton condition, correct insert and closure before despatch.
Would this be rejected on appearance?
Surface & cosmetic
Surface contamination, residue and marking on the container exterior.
Is everything assembled?
Component presence
Presence, position and orientation of components on assembled devices and combination products.
Is the tray or case correct?
Count & placement
Confirms the product running matches the job, which is where changeover errors are caught before a pallet is built.
Built for the environment
Controlled areas, validated
equipment, documented change.
A pharmaceutical line constrains what you can install and how you can change it. These are the conditions the deployment is designed around.
ENVIRONMENT
Built for stability. Designed for real-world conditions.
- Cleanroom compatibilityMaterials and housings appropriate to the classified area
- Cleaning regimeSurfaces and mounting compatible with your sanitisation procedure
- ValidationInstalled and operated as a documented, qualified system
- Change controlModel and configuration versions recorded, so change is traceable
- Data retentionPer-unit records retained on your infrastructure for your retention period
IMAGING
Clearer vision. Smarter inspection.
- Glass and clear containersBacklight and structured lighting to manage refraction
- Fill levelBacklight for liquid level against container geometry
- Labels and cartonsRGB at resolution matched to the smallest printed character
- Codes and serialisationOCR and OCV against the expected string
- Multiple facesSeveral inspection points with reorientation
- Reflective foil and crimpSeveral inspection points where more than one face matters
On lighting. Printed and filmic packaging is reflective, and reflective surfaces are where lighting geometry decides whether a system works at all. Dome, backlight or structured illumination is specified per application and validated on your material, not assumed from the camera.
Where the record matters
In this industry the record is the
product of the inspection.
Detection alone is not sufficient. What makes an inspection system usable in a regulated environment is what it retains and how defensible that retention is.
Defect library and classification
EU GMP requires a defect library covering typical process defects, with criticality classification and trended counts. Per-unit records with retained images feed that directly.
Batch release linkage
Deviation from typical defect levels must influence batch release. A system that trends every unit makes that relationship visible rather than reconstructed.
Qualification evidence
Where an automated system replaces or supplements human inspection, its performance has to be demonstrated and documented. Complete per-unit logging is what that demonstration is built from.
The platform
Same three components,
tuned to your product.
Standards & codes
The standards your inspection
programme is built on.
The published criteria your customers, auditors and quality team already reference. We train models against your interpretation of these standards — we do not certify conformance to them, and an inspection result is not a conformity assessment.
Ph. Eur. 2.9.20
What it covers
Particulate contamination: visible particles. The European compendial test for visible particulates in parenteral preparations.
Where it applies
Container and fill inspection
Ph. Eur. 5.17.2
What it covers
Recommendations on testing of particulate contamination, including operator qualification and requalification, and sampling applied after 100% inspection has been carried out.
Where it applies
How the inspection programme itself is designed and qualified
USP <790>
What it covers
Visible Particulates in Injections. The US compendial acceptance standard, setting the pass or fail criterion and specifying manual inspection conditions including illumination, background and inspection time.
Where it applies
Container and fill inspection for the US market
USP <1790>
What it covers
Visual Inspection of Injections. Recommendations for the design, qualification, validation and application of a visual inspection programme across the product lifecycle.
Where it applies
Qualification evidence where an automated system is introduced
EU GMP Annex 1
What it covers
Manufacture of sterile medicinal products, including the requirement for a defect library covering typical process defects, criticality classification and trended counts.
Where it applies
Defect library, classification and batch release linkage
Pharmaceutical questions
What regulated producers ask first.
The system is installed and operated as a documented, qualified system, and model versions and configuration changes are recorded so that change is traceable. Validation remains your process — what we provide is a system whose behaviour and changes are fully evidenced.
- Does this replace container closure integrity testing?
- Where is our data retained, and for how long?
- Can it support our defect library and classification?
- How do you demonstrate it performs as well as our inspectors?
Still deciding
The one question this page can't answer:
does it work on your defect?
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