Pharmaceutical Serialization: Achieving a reliable implementation process

Serialization projects need sufficient time. The following anonymized example provides important pointers.

A mid-size German company – let’s call it Meyer Pharma AG – whose product range includes painkillers had previously not exported to countries in which serialization is mandatory. However, it planned to change that situation by the beginning of 2016. Meyer Pharma consequently sought to introduce serialization on a total of 15 lines. Initially, an existing packaging line was to be equipped with a track & trace unit that was to print serial numbers on the individual packs, verify them and reject packs with unusable codes. After that, previously bundled individual packs were to be placed in cases by a case packer. All the codes applied to the individual packs were to be recorded in the case by means of a camera. The next require­ment was for a label with the case aggregation code to be automatically printed and applied. Aggregation at pallet level was to be carried out manually. The audit-proof generation, printing, management and archiving of the serialization codes was to be performed by a higher-level software intelligence.

Analysis of needs and definition comes first

Meyer Pharma launched its serialization project in January 2014 with a team of IT, production, purchasing and sales specialists. It took the project team around four months – and that is by no means an excessive amount of time – to determine the actual requirements and to analyse existing and planned processes. The overall plant effectiveness was then defined on this basis. In parallel, the serialization team acquired new knowledge on subjects such as modern coding and camera technologies, security aspects such as tamper-evident packaging and IT issues. The outcome was a user requirement specification (URS), which outlined both external goods and services and internal requirements.

Suppliers are often still unknown

The serialization team quickly realized that choosing a supplier would also be time-consuming as the market is confusing for the uninitiated. A large number of providers are available for individual system components and of course also for the higher-level software.

The team used the Interpack trade fair in May 2014 to get a full overview – particularly with regard to the software, which they recognized as the linchpin of the entire project.

The more flexible the software, the more reliable the operation

Among the products they investigated, the experts accordingly looked in great depth at the MEDTRACKER solution from Atlantic Zeiser. MEDTRACKER is a modular, easy-to-implement software and a flexible and audit-proof solution for generating, distributing, printing, aggregating and tracking codes for all current international regulations – and it includes a full track & trace capability for e-pedigree applications. The software is also easily compatible with machinery supplied by other manufacturers. In autumn 2014, more than ten months after work had started, the team knew exactly what they intended to implement by way of a pilot project and which suppliers met the requirements.

Incidentally, serialization projects involving several plants – maybe even in different countries – are generally even more complex and time-consuming. Meyer Pharma finally decided that Atlantic Zeiser should supply the MEDTRACKER software and MEDILINE T&T coding system and that another manufacturer should provide the case packer.

Component manufacture and reliable acceptance take time

The amount of time needed for the production phase depends to a large extent on the hardware supplier concerned. Machines like case packers are usually made to order or customized within five to six months. As soon as the whole machinery has been assembled, the factory acceptance test (FAT) can take place. Afterwards, process qualification including the site acceptance test (SAT) is carried out on the customer’s premises. Checking the performance data on a pilot line can easily take a whole month.

Two weeks should be set aside for employee training and subsequent familiarization, during which time the plant will not yet be operating at full output. It makes sense to reserve some time for contingencies as unforeseen challenges arise in virtually every serialization project. Against this back­ground, a period of around two-and-a-half years is not extravagant if all the other lines have to be converted accordingly after the first pilot line. Once a serialization project has been successfully completed, however, further lines can be set up much more quickly.

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Stefan Rowinski
Stefan Rowinski
About Stefan Rowinski

Product Management | Atlantic Zeiser