Serialization

To meet the increasing requirements for traceability, we have developed a modular platform for inline solutions as well as a simple mobile printer station for serialization and aggregation.

EU & US compliant

The serialization solution is a mobile printer station for serialization in compliance with the EU and US regulations. We provide you with a complete solution for serialization and verification of UI and ATD as well as aggregation up to level 2 (item and bundle).

We can also advise you on ATD adaption and integration of the system into existing packaging lines. The serialization system is available in a manual and a semi-automatic version.

Watch the video to learn more about our serialization solution.

Benefits

• An all-in-one solution
• Minimal burden on employees
• Authentication of products
• Supply chain transparency
• Improved product quality
• Reduction in non-conformities

Serialization

Falsified Medicine Directive

“To reduce the occasions on which falsified medicines enter the legitimate supply chain” is the aim of the EU Falsified Medicines Directive (2011/62/EU). The safety measures require wholesale distributors and pharmacists to verify the authenticity and tamper integrity of the medical product and identify individual packs. By 9th February 2019, all prescription products must be labeled with a UI and an ATD.

Unique Product Identifier (UI)
A two-dimensional barcode and human-readable information providing identification and authentication of the individual unit.

Anti-tampering Device (ATD)
Product sealings that make it possible to visually verify whether the outer packaging has been tampered with.

Interested in a serialization solution?

Contact us if you would like to hear more about how we can help you implement a serialization solution.

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GMP & Compliance

We specialize in GMP-regulated manufacturing environments. Our capable and highly experienced GMP consultants provide expert advice on quality management, production, and processes within GxP-regulated environments.

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