Europhartech Implements Holistic Fully Integrated Serialization Project

For several years, Europhartech has been implementing a continuous investment policy, firstly to make its production ever more agile and, secondly, to comply with future demands and legislation. Therefore, in order to anticipate new serialization regulation in February 2019, it has devoted more than 40% of its investments to the implementation of a serialization solution on its medicine packaging lines – a significant investment for an SME with a turnover of 20 million euros.

Founded 20 years ago in Auvergne region, France, the company develops and produces medicines and food supplements for pharmaceutical and veterinary laboratories around the world. It provides complete support for projects, from production through to shipment of the finished product. All of these activities are spread over two sites, with a total area of over 10,000 m². Each year, 400 million tablets are manufactured and more than 30 million cases and jars are packaged.

Europhartech differentiates itself through its ability to produce small and medium batch sizes to meet specific needs, such as fragile and niche products. It also possesses expertise in the production of medicines for healthcare centres, for which it designs pre-cut blister packs that facilitate unit dispensing.

Serialization and tamper-proofing will concern 10 to 12 million boxes a year – 70% of Europhartech's activity – all destined for the European market. For this project, Europhartech turned to leading automation and information solutions supplier, Rockwell Automation and serialisation machine specialist H²M Technologies.

CHALLENGE

Each of the five production lines covered by this project manufactures both medicines and food supplements, with manufacturing orders varying in nature and volume. The manufacture of a batch of medicines, to which the serialization and tamper-proofing system will apply, may be followed by the manufacture of a batch to which only one operation applies, or, indeed, neither. The solution therefore needed to adapt to the demands of each order.

Marking is currently performed by a conventional ink jet printer, and then read and verified by an obsolete camera. This system is poorly optimized for the production line, as some boxes were not marked. This caused their rejection, generating extra costs. Finally, the specifications impose a reduction in the rate of production line failures in order to increase productivity. The new serialisation solution will mitigate this marking problem, with a marking-rate target of 100%.

Project success will also depend on the smooth running of serial number exchanges. Its good execution will impose an irreproachable interfacing between Europhartech's computer networks and those of its customers. The solution must therefore assure data integrity.

SOLUTION

Europhartech was advised and supported by Rockwell Automation and by H²M Technologies, a specialist company, which offers a variety of machines for track & trace solutions for pharmaceutical packaging lines, delivering serialization, aggregation and tamper-evident printing capabilities. In addition to the new production line configuration – now with two horizontal conveyors – new cameras with OCR capabilities have been deployed to greatly reduce or even eliminate rejects.

Rockwell Automation proposed a configurable and pre-validated base solution, which significantly reduces implementation time. The serialization solution is based on its Rockwell Software® PharmaSuite® MES platform, using a client-server architecture running FactoryTalk® View Site Edison (SE). The Product Management Client (PMC) is designed as a module of the PharmaSuite MES and acts as an operator-interaction screen. Unlike many solutions designed and developed from Tier 1 systems, the Rockwell Automation serialization solution is designed as a Tier 3 specific module. It therefore benefits from the ability to interface with other ERP and MES suites, as well as line controllers and lower-tier machines.

From an automation perspective, the project employs an Allen-Bradley® ControlLogix® programmable automation controller (PAC). This is powerful processor that is specified due to the large amounts of serialisation data it needs to store. Should the serialisation server fail, the PAC can run autonomously using the pre-downloaded data. Allen-Bradley CompactLogix™ PACs can also be used if a full batch download is not required. Due to the Logix range’s scalability, very little effort is required to change controllers.

Visualisation and operator interaction is provided by an Allen-Bradley VersaView® industrial computer, Although FactoryTalk View does not normally need a computer equipped HMI, in this instance more functionality was required as was the need to run parts of the PharmaSuite client on screen. The PLC and motion solution can also be controlled from this interface.

For product movement and orientation, the serialisation solution deploys several Allen-Bradley Kinetix® servo drives. These are used to control both the upper and lower belt rotation, the vertical position of the upper belt (to cater for varying box sizes) and the two-axis printer head. Servo delivered accuracy is important to synchronise printing and the application of the tamper evidence solution. This accuracy is coupled to the flexibility need to cater for a variety of box sizes, with simple re-programming or recipe selection via the HMI.

The Rockwell Automation solution is also scalable, and can adapt depending on the needs of Europhartech. For example, centralized serial number management and tamper-proofing, which the PMC allows, can be extended to aggregation. The randomized serial numbers, supplied by the company's ERP system, are sent to the workshop via the MES where the PMC module will process them. The PMC also supports main recipes and packing orders.

Europhartech also chose a predictive maintenance solution from Rockwell Automation, which will be used to reduce or even eliminate faults, a major boost for the group, whose production is performed on a just-in-time basis, operating on a 3 x 8-hour shift basis, sometimes seven days a week.

This new data architecture, delivering more robust internal and external communication, has taken Europhartech into the arena of the Rockwell Automation Connected Enterprise, an approach which converges plant (OT) and enterprise (IT) networks, and securely connects people, processes and technologies. As well as addressing upcoming serialisation regulations, it also covers all primary facets of an Industry 4.0 approach and, in this instance, Pharma 4.0.

RESULTS

Of the five lines to be modernised, the first was upgraded in March 2018, with final roll-out scheduled for November 2018. Europhartech started with serialization and tamper-proofing, preferring to postpone aggregation until it is more familiar with the new tool. It also wished to test its potential in order to refine the settings under varying real-life conditions, comprising successive batches of different medicines.

Europhartech will be ready to meet all the requirements of current and future regulations by June 2018, giving it a significant competitive and commercial advantage, and improving serialization information exchange with its partner customers. Its maintenance teams already appreciate the design of the module, including front-facing label projection. They also welcome the line's agility, which manufacturing/process line switching easier than before.