Reliable EU FMD compliance for late-starters

Published: 16-Apr-2018

Laetus, an industry leader in inline quality inspection systems, is presenting new last-minute serialisation solutions for the pharmaceutical industry at ACHEMA

The EU FMD deadline is moving inexorably closer and there is not much time left to integrate customised systems into packaging lines and processes. Yet the Alsbach-based provider of solutions for inline quality control and supply chain traceability will be showing how the requirements can be implemented in a timely manner at Stand B 95 in Hall 3.0.

One option for producing the clear identification without significantly interfering with existing packaging processes is machinery for the pre-serialisation of packaging. These place the necessary serialisation data and, where necessary, additional information either on the label roll machinery or on folding boxes and subsequently verify it. The built-in identification software ensures the secure exchange of data with the superordinate IT.

There are reasons why it is necessary to integrate the serialisation process in the packaging line. That is where standardised solutions come in, such as the smart pack handling systems MV-50 and MV-70 from Laetus.

Preconfigured and with short delivery times, these can be implemented in existing processes at comparatively low costs and with less effort. Equipped with high-quality components – including an INSPECT camera system and a Wolke m600 oem printer – both systems reliably cover a range of identification requirements. The MV-70 also offers additional tamper evident labelling.

One alternative to in-house implementation is SaaS+ (Serialisation as a Service). Laetus and MSK Pharmalogistic will show how it works at ACHEMA using a smart MV-50. Since 2017, the two partners have offered their customers tracekey – an option to undertake serialisation on demand or entirely.

The service includes GDP-compliant transport into a temperature-controlled warehouse, storage under quarantine, preparation for dispatch, serialisation and subsequent visual inspection, as well as data management and re-integration into the supply chain.

At ACHEMA, Laetus will show pharmaceutical manufacturers and contract packagers how they can use its carefully considered last-minute solutions to still reliably achieve their compliance objective.

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