Counterfeit medicine is a growing challenge for today's pharmaceutical industry. Patients in the European Union are protected by Falsified Medicines Directive 2011/62/EU, which places mandatory serialization and verification requirements on medicinal packaging. To comply, packaging lines need special equipment to print and verify 2D product codes, like the Pharma 2D from Intrex. Equipped with modular automation hardware and software from B&R, the new machines can be quickly adapted to on-site requirements.
For more than a quarter century, Intrex has made a name for itself creating proprietary solutions for marking, labeling, printing and vision control, with customers in nearly every industry. Recognizing the pharmaceutical market's demand for a new serialization and labeling machine, they designed the new Pharma 2D Light and Pharma 2D Pro.
While solving the individual requirements of its pharmaceutical customers, Intrex would also have to ensure that the new machines meet the industry's restrictive standards and guidelines. A prime example is the FDA 21 CFR Part 11 regulation stipulating documentation and tamper-proofing requirements for all electronically stored data. For the operator interface, this means guaranteeing certain functions, such as alarm management, audit trail and user account management.
The variety of different technologies in the machine – from motion control to serialization – meant the control system would have to provide a high level of flexibility, openness and integration. "We've had very positive experiences using B&R automation systems in our other machines," says Automation Manager Mariusz Wojciechowski, "so they were the first place we turned with the requirements of this new project." Intrex was pleased to find that the scalability of B&R's solutions made it possible to use a substantial portion of the software already used in their traditional labelling systems.
The automation hardware is based on a modular X20 control system with a powerful PLC. The system can be easily expanded with I/O modules as the need arises, and its three-part design allows for easy hot-swapping of modules during operation.
The machine conveys the product and applies self-adhesive labels, so electric drives are an important part of the system. Frequency inverters, servo drives and servo motors from B&R ensure that the labeling heads are tightly synchronized with the moving products. Stepper controllers are used for standard applications, while more dynamic applications with labelling speeds up to 100 m/min use compact servo drives. Both versions of the head drives are based on the ACOPOSmicro family, so the software is identical and only the speed parameters need to be adapted.
The main fieldbus network is POWERLINK, which provides convenient wiring and minimum cycle times for efficient communication. In addition, the controller must be able to communicate openly with other devices such as printers, a vision-based verification system or a dedicated serialization system, via a variety of interfaces.
B&R's modular mapp Technology gave Intrex ready-to-use software components specially designed for implementation of FDA 21 CFR Part 11 requirements. With the mapp User component, for example, they were able to quickly set up a system to manage user accounts, access rights and passwords.
The mapp Audit component makes it possible to record events that occur on the machine. Any attempts to gain unauthorized access or change system parameters are logged, archived and can be presented in various forms. PDF reports can be stored locally on the device, on a server, or sent to a specified email address.
"The ability to use these ready-made components compliant with FDA 21 CFR Part 11 significantly reduced the time it took us to complete the project," reports Wojciechowski. "Comparable solutions on the market are usually very expensive, while developing one in house from scratch would involve a huge amount of work and be burdened with a significant risk of error." The ability to use off-the-shelf automation hardware compatible with solutions used in simpler Intrex machines further contributed to the fast implementation.
Thanks to the versatile communication capabilities of Pharma 2D machines, they can be operated either as standalone units or as an integral part of a packaging line. It is also possible to use the description of modes and machine operating states defined in the PackML standard, making it easy to exchange data with other devices in the line from other manufacturers.
The machine's software makes it possible to trace the box with the product at any moment along its journey. The motion control solutions deliver high precision product transport, which translates into reduced waste and high quality printing, reading and verification. Replacing a component – whether a controller, drive or panel – is as simple as connecting the new device. After the next start-up, the system will recognize the device and send it the program and parameters it needs.
Pharma 2D is a complete solution for serialization of pharmaceutical products, enabling printing of high-quality 2D codes, alphanumeric markings, vision control and security labelling. The machines are made according to Good Manufacturing Practice (GMP) quality assurance guidelines. B&R's scalable control system and modular software make it easy to adapt the machine to the needs of the factory where it will be installed – allowing INTREX to provide its customers the highest quality solution in the shortest possible time.
For more information: www.intrex.pl
Automation Manager, Intrex
"B&R's mapp Technology made it quick and easy to implement the software functions we needed to comply with FDA 21 CFR Part 11."