Which checks does the solution perform on a tub?

Four families of checks: presence and conformity of the tub itself, integrity of its packaging, positioning of the nest and RTU components inside, and legibility of the printed information. Any detected defect triggers automatic rejection before the tub joins the logistics flow.

Which data are read and traced?

Batch number, product reference, expiry date, barcodes and DataMatrix, along with supplier traceability information. These data are read then validated, which allows full tracking of pharmaceutical components and secure batch management.

What is the tamper-evident label for?

It makes any opening or handling of the tub visible between production and use in the sterile area. That is what protects RTU components across the whole logistics chain: a tub with an altered label is removed before it enters the classified area.

Does the solution accept several tub and nest formats?

Yes. The solution is configurable for the various tub, nest, vial and RTU syringe formats on the market. The formats actually handled and the changeover times are settled during the integration audit, based on your references and your flow.

How does the solution integrate into an existing line?

It is designed to slot into pharmaceutical production and packaging lines that require a high level of accuracy and traceability. The constraints of your environment — ISO class, flow, data interfaces — are reviewed during the preliminary audit. The solution is delivered with its IQ/OQ qualification file.

Ligne de contrôle Contrôle de Tub avec inviolabilité et identification

Packaging machine

SPC MACHINES

Automatic Inspection and Labelling Solution for Pharmaceutical RTU Tubs

Inspection, identification and tamper-evident labelling of pharmaceutical tubs holding RTU vials or syringes, on a single automated line.

Who is it for?

This solution is aimed at pharmaceutical laboratories, prefilled-syringe manufacturers, RTU vial producers and sterile packaging players who must guarantee tub integrity right up to opening in the production area. It replaces manual visual inspection and hand labelling with an automated, traceable and repeatable station, suited to pharmaceutical and biopharmaceutical environments.

How does the solution work?

The line chains inspection, identification and securing on a continuous flow of tubs, with no manual handling between stations. Any non-compliant tub is removed before it reaches the logistics flow. The cycle runs in 5 steps:

Presence and conformity check of the tub and its packaging
Position verification of the nest and RTU components inside the tub
Data reading and validation — batch number, product reference, expiry date, barcodes and DataMatrix
Inspection of printed information and automatic defect detection
Tamper-evident label application, making any later opening visible

Key features

Automatic check of presence, conformity and packaging integrity
Verification of nest and RTU component positioning inside the tub
Barcode and DataMatrix reading: batch, reference, expiry date
Full traceability of components and supplier data
Automatic tamper-evident labelling of every inspected tub
Automatic defect detection and rejection before shipment
Adaptable to different tub, nest, vial and RTU syringe formats
Designed and manufactured in France, IQ/OQ file delivered

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Specifications

Technical specifications

Handled components: tubs holding RTU vials or syringes in nests
Checks performed: tub presence and conformity, packaging integrity, nest positioning
Data read: batch number, product reference, expiry date, barcodes, DataMatrix
Print inspection: reading and validation of printed information, defect detection
Securing: automatic tamper-evident label application
Non-conformity handling: automatic rejection before entering the logistics flow
Indirect contact / structure: 316L stainless steel
Integration: onto an existing pharmaceutical production or packaging line

Compliance

Machinery Directive 2006/42/EC
CE marking (Machinery, EMC, Low Voltage)
Design compliant with GMP
ISO 22716 — Good Manufacturing Practices for Cosmetics
316L stainless steel product-contact parts, PTFE seals
IQ/OQ qualification file delivered with the machine
FAT/SAT documentation + "as-built" file
Designed and manufactured in France

Use cases

Typical use cases

Prefilled-syringe manufacturers: inspection and securing of tubs before shipment to aseptic filling sites.
RTU vial producers: validation of nest positioning and batch data on every tub leaving production.
Pharmaceutical laboratories: inspection of incoming tubs before sterile components enter the classified area.
Sterile pharmaceutical packaging: tamper-evident labelling guaranteeing packaging integrity across the whole logistics chain.
Multi-reference sites: removal of manual visual inspection and its operator errors on flows with high format turnover.