b+b automation and control technology: modular software architecture for serialisation

The various serialisation requirements call for software structures that can be flexibly configured. Odenwald-based b+b Automations- und Steuerungstechnik has therefore developed intelligent concepts for the reliable serialisation of pharmaceutical packaging.

Serialisation requirements vary greatly from country to country. By the beginning of 2019, the pharmaceutical industry in more than 40 countries must Serialisation and track & trace regulations for medicinal products implement. This is based, among other things, on the statutory regulatory provisions of the DSCSA (USA) and the EU-FMD for Europe (2011/62/EU). All pharmaceutical manufacturers as well as their contract manufacturers (CMO) and contract packers (CPO) with thousands of packaging lines are affected.

Flexible architecture

The centrepiece of the b+b solution is a Modular software architecturewhich Compiled according to requirements and can also be Adapt to future requirements can be used. It can be used to manage production lines or sites, to adapt to new coding and aggregation regulations or to expand machinery. The modular software architecture is customised by the expert team at b+b Automations- und Steuerungstechnik according to the individual requirements of pharmaceutical manufacturers, drug importers or contract packers, integrated on site and also supported. The service package is complemented by the company's own machine and plant construction in Beerfelden. Not only modern labelling systems, but also devices for serialisation applications have been manufactured here for more than 30 years.

The most important modules

The central database b+b-SiteServer acts as the control centre for the complete software modules with the management of databases and user authorisations, data exchange with the production lines, licence management of the b+b software modules (production/workplace PCs) and the exchange of data and messages with various external repository databases (e.g. EU Hub) on an XML basis. The central administration software for the b+b SiteServer database is the b+b-SiteManager with the user interface for managing all production orders. It can be used by all authorised users (e.g. in a network) and controls the feeding of the production lines with the production data. At the end of the batch, the collected data, including the lists of serial numbers, are automatically reported back from the line to the b+b SiteManager.

Display

For serialisation tasks on the production line, the b+b-LineManager used. It enables convenient camera and printer operation. The jobs received via b+b-LineLink are displayed here for selection. The user starts an order. The corresponding serial numbers are printed, validated, collected and, if required, aggregated (up to aggregation level 2-3) and then reported back to the b+b site server for further management. Products with serial numbers that are to be aggregated are identified with the b+b-AggregationModule either manually or automatically, either in pure or randomised form on the line. At the end of aggregation, depending on the aggregation level, a outer carton or pallet label generated.

Behind b+b-ERPLink hides the bi-directional interface between b+b SiteServer and the ERP system. Order-related information such as expiry dates and batch and serial numbers are provided by the ERP system for production. The b+b-GlobalServer collects data from b+b site servers located at different sites.

Application in practice

One example of the successful combination of b+b hardware and software is EurimPharm Arzneimittel GmbH, headquartered in Saaldorf-Surheim. It is regarded as a pioneer in the import of pharmaceuticals and as the first provider of low-cost imported pharmaceuticals in Germany. In order to be able to fulfil the requirements of the new FMD guidelines in the future, the company is preparing to offer its customers the entire serialisation process from goods receipt to goods issue as a service to offer.

[infotext icon]For the past 40 years EurimPharm its market segment with a consistently high standard of drug safety. 350 employees produce around 1,800 different articles. Around 130 production orders are processed per day in two-shift operation on currently six finishing and inspection units. This corresponds to a daily quantity of around 25,000 medicine packs.[/infotext]

LSS transport unit with integrated serialisation module attracts attention: The basic version of the LSS combines a printer, camera, ejection station and IPC touch panel on a conveyor belt that is just 1,200 millimetres long. The products are printed on the conveyor belt, read by a camera and analysed. Products with unreadable data are automatically ejected by the integrated ejection unit.

„The ease of operation and convenient control of the entire system are very important features for us. We would particularly like to emphasise the supplier's high level of process understanding and results-oriented implementation,“ evaluates Thomas Valerius, Head of Human Resources and Corporate Development at EurimPharm, on the experience gained with b+b following the successful launch.

EurimPharm opted for the LSS-V without a printing unit, as the pharmaceutical packs are already labelled with all variable data (batch, date and serial number) in an upstream work step. The system has now been successfully installed and has been linked to the local database as well as to the b+b Line Manager and b+b Site Server software modules. In the process, b+b demonstrated a high level of expertise in both mechanical engineering and system integration. Those responsible at EurimPharm also praised the punctuality with which this project was completed. Further expansion stages have already been firmly planned in co-operation with b+b.