Serialization Services

 

Serialization Services

Providing flexible serialization solutions to meet all your serialization needs, our partnership with Optel ensures our serialization technology not only meets, but surpasses, current serialization legislation and is adaptable to all upcoming regulations.

Addressing evolving global serialization legislation, Almac’s expert multi-disciplinary serialization team lead the way in supporting our client partners in developing serialization strategies to GS1 standards.

With a decade of experience in developing and delivering serialization solutions to tackle counterfeiting and facilitating traceability throughout the product supply chain; we offer the following solutions from our UK and US commercial packaging facilities:

  • Serialization strategy consultative services

From the initial stage of enquiry, our multi-disciplinary team of serialization experts work with our client partners to outline optimal serialization strategies to meet market requirements for their drug product, determining key considerations such as number generation & integration processes, aggregation and reporting.

  • Design, review & generation of new artwork

Our specialist in-house packaging design team can review current packaging formats and advise if new artwork is required to ensure there is appropriate space on the saleable unit to apply serialized data. Generation of new artwork in-house rather than outsourcing allows Almac to streamline the approval process, saving time and money whilst ensuring that you meet fast approaching regulatory submission deadlines.

  • Technical / prototype testing artwork

Ensuring your packaging and artwork is compatible for processing on our serialization lines, we can generate and test prototype pack formats.

  • Flexible serialization solutions for all pack formats

Our serialization lines in our UK & US commercial packaging facilities can print and verify serialized data on saleable units and secondary packaging of bottles, blisters, wallets, vials, syringes, cartons and complex medical kits.

  • Tamper evidence packaging

Meeting the Falsified Medicines Directive (FMD) requirements to further secure your valuable drug product with enhanced safety features, Almac can apply tamper-evident seals on all secondary packaging.

  • Serialization to 3 levels of aggregation

Our serialization lines in our UK & US commercial packaging facilities generate, allocate and upload unique numbers which are applied to products at each stage of packaging and tracked through the distribution process, from the saleable item level to shipper through to pallet level.

  • Integration with external providers to support serialization management and Government reporting as required

Simplifying the supply chain, our fully flexible level 3 site software can integrate with external enterprise level 4 providers such as Tracelink & Axway providing a central storage location for all serialized data (commissioned, decommissioned and event data), helping in number management and ultimately preventing number duplication.

With EU and FDA approved commercial manufacturing and packaging facilities we are able to provide end-to-end solutions for your drug product, helping you meet commercial supply timelines, mitigate risk and reduce overall product costs whilst helping to secure your supply chain.

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