Serialization and FMD-compliant reporting?
We print a GS1 Data Matrix with GTIN, batch, expiry and a unique serial on every carton, with data from your ERP and in-line verification.
Pharmaceutical & medical industry
Compliant marking and traceability for pharma and medical devices
Serialization, legible Data Matrix codes and in-line inspection — from blisters and leaflets to the secondary pack, in line with the FMD directive and UDI requirements.
Context
Marking and traceability in the pharmaceutical industry
The pharmaceutical industry requires permanent, legible and verifiable codes on every packaging level, plus the serialization mandated by European legislation. Imark Sistem integrates laser, inkjet (CIJ and TIJ) and thermal-transfer marking, label applicators, inspection systems and code management software into a single compliant line.
From the batch code and expiry date on the blister to a serialized GS1 Data Matrix on the folding carton and the logistics label on the pallet, we cover the whole flow — tested on your product and integrated with ERP/MES, for complete, auditable traceability.
Real challenges
What we solve in pharma production
Legible codes on blisters, vials and leaflets?
Ink-free laser marking or precision inkjet, on small surfaces and sensitive materials, at line speed.
Risk of foreign bodies or non-conforming product?
Metal detection, X-ray inspection and vision systems in line, with automatic rejection of non-conforming products.
Protection against counterfeiting?
Hard-to-copy dynamic codes and brand-protection solutions, verifiable across the distribution chain.
Applications
What we mark in pharma
Blisters and foils
Batch, date and serial on the foil, via TIJ or laser, contact-free and without migrating inks.
Folding cartons (secondary pack)
Serialized GS1 Data Matrix, printed and verified in line, with variable data from the ERP.
Vials and ampoules
Laser or CIJ marking on glass and plastic, resistant to handling and sterilization.
Labels and leaflets
Print & apply with variable data and reconciliation, for compliant labels.
Medical devices (UDI)
Permanent laser marking, legible long term, in line with UDI requirements.
Pallets and bundles
SSCC logistics labels applied automatically, for traceability in distribution.
Technologies
Which marking technology to choose
The choice depends on the substrate, line speed and compliance requirements. We recommend the right technology after a test on your product.
| Technology | Suited in pharma for |
|---|---|
| Laser (CO₂ / fiber) | Folding cartons, vials, devices (UDI) — permanent, no consumables |
| Inkjet CIJ | Vials, ampoules, foils — high speed, contact-free |
| Thermal inkjet (TIJ) | Cartons and foils — high-resolution 2D codes |
| Thermal transfer (TTO) | Flexible films and labels — clear variable data |
| Print & apply labeling | Cartons, vials, pallets — compliant labels + serial |
Imark solutions
Relevant solutions for pharma
Compliance
Compliance and traceability in pharma
We prepare your line for serialization and identification requirements, with legible codes and correct, auditable data across the distribution chain.
- Serialization per Directive 2011/62/EU (FMD) and Reg. (EU) 2016/161
- GS1 Data Matrix with GTIN, batch, expiry and serial
- Tamper-evidence on the secondary pack
- UDI for medical devices (Reg. (EU) 2017/745)
Why Imark Sistem
Solutions that work. A partnership that lasts.
In industrial production, every detail counts. That is why we do not stop at supplying the equipment: we analyse the application, test the solution and integrate it into your process, with support after commissioning too.
01
We test before we implement
We verify the technology on your parts and materials to find the right solution and reduce uncertainty before you invest.
Decisions based on real tests
02
We integrate, we do not just deliver
We connect equipment, identification systems and software to your existing flow, including the ERP/MES, per the project requirements.
One partner for the whole project
03
We stay with you after installation
We provide service, consumables and genuine parts for the equipment supplied, supporting production continuity.
Long-term support
04
Experience built in the industry
Over 20 years of integrations in Romanian factories, with world-leading brands. We know the technical challenges and the demands of industrial roll-outs.
Experience applied in real projects
FAQ
Frequently asked questions about pharma marking
What does pharmaceutical serialization involve?
Printing a unique GS1 Data Matrix code (GTIN, batch, expiry, serial) on every secondary pack and reporting it to a verification system, per Directive 2011/62/EU and Reg. (EU) 2016/161.
Which technology suits blisters?
Usually thermal inkjet (TIJ) or laser, for legible codes on the foil, contact-free and without inks that migrate into the product.
Can you permanently mark medical devices (UDI)?
Yes, by laser marking, with durable, long-term legible marks per the UDI requirements of Reg. (EU) 2017/745.
Do you integrate the equipment with our ERP/MES?
Yes, we pull the variable data (batch, expiry, serial) directly from your systems and verify it in line, with no manual typing.
How do you check a code is legible?
With inspection cameras that validate every printed code and automatically reject products with unreadable or wrong codes.
Let us discuss your project
Have a technical challenge? Let us find the right solution together.
A hard-to-mark part, a new traceability requirement or a line that needs upgrading? Show us the application and the Imark specialists will help you identify the right technical options.