EU directives require the serialization and verification of pharmaceutical packaging. With the help of B&R hardware and software, Intrex 's new Pharma 2D machine can quickly adapt to field requirements.
Counterfeit drugs are a growing challenge facing the pharmaceutical industry today. Patients in the European Union are protected by the Anti-counterfeiting Medicines Directive 2011/62/EU, which mandates serialization and verification requirements for medicine packaging. To comply with this, packaging lines need specialized equipment to print and verify product QR codes, such as Intrex 's Pharma 2D . The new machine, equipped with B&R's modular automation hardware and software, can be quickly adapted to on-site requirements.
B&R Drive Technology ensures synchronized movement for precise label application.
For 25 years, Intrex has been known for creating proprietary solutions for marking, labeling, printing, and vision control, serving customers across various industries. Recognizing the pharmaceutical market's need for new serialization and labeling machines, they designed the new Pharma 2D Light and Pharma 2D Pro .
Advancing serialization in the pharmaceutical industry: Intrex Pharma 2D Pro .
Personalized needs and restrictive standards
While meeting the personalized needs of pharmaceutical clients, Intrex must also ensure that its new machines comply with industry-restrictive standards and guidelines. FDA 21 CFR Part 11 regulations are a prime example, specifying documentation and tamper-proofing requirements for all electronically stored data. For the user interface, this means ensuring certain functionalities such as alarm management, audit trails, and user account management are guaranteed. Various technologies are used in the machines. – From motion control to serialization – This means the control system must offer a high degree of flexibility, openness, and integration. “We have extensive experience using B&R automation systems on our other machines,” said Mariusz Wojciechowski, Automation Manager . “Therefore, it was our first choice when it came to meeting the requirements of our new project.” Intrex was pleasantly surprised to find that the scalability of B&R solutions allowed them to utilize much of the software already used in traditional labeling systems.
Scalable hardware
The automation hardware is based on the modular X20 control system, which features a powerful PLC . The system can be easily expanded with I/O modules as needed, and its three-piece design facilitates easy hot-swapping of modules during operation.
The rocker-mounted touchscreen panel provides convenient and intuitive operation.
This machine can transport products and affix self-adhesive labels, making electronic drive an essential component of the system. B&R's frequency converters, servo drives, and servo motors ensure close synchronization between the labeling head and the moving products. Stepper controllers are used for standard applications, while compact servo drives are used for high-dynamic applications with labeling speeds up to 100 meters per minute. Both labeling head drives are based on the ACOPOSmicro series, so the software is identical; only speed parameters need to be adjusted. The primary fieldbus network is POWERLINK , which provides convenient wiring and minimizes cycle time for efficient communication. Furthermore, the controller must be able to communicate openly with other devices via various interfaces, such as printers, vision-based verification systems, or dedicated serialization systems.
Advanced medicine functions that are ready to use right out of the box
B&R's modular mapp technology provides Intrex with ready-to-use software components specifically designed to meet FDA 21 CFR Part 11 requirements. For example, the mapp User component allows them to quickly set up the system to manage user accounts, access permissions, and passwords. The mapp Audit component logs events occurring on the machine. Any unauthorized access attempts or changes to system parameters are logged, archived, and presented in various formats. PDF reports can be stored locally on a device or server, or sent to a designated email address. "Being able to use these off-the-shelf FDA 21 CFR Part 11 compliant components significantly reduced the time we spent completing the project," said Wojciechowski . "Similar solutions on the market are often very expensive, and developing a solution from scratch would involve a lot of work and carry a significant risk of errors." The availability of off-the-shelf automation hardware compatible with the solutions used in the simpler Intrex machines further facilitated rapid implementation.
B&R's mapp technology provides Intrex with a ready-made set of modular software components.
Comprehensive benefits
Because Pharma 2D machines have multiple communication capabilities, they can operate both as standalone units and as part of a packaging production line. They can also easily exchange data with other equipment in other manufacturers' production lines using the modes and machine operating status descriptions defined in the PackML standard.
The machine's software can track the packaging boxes containing the products in real time. Motion control solutions provide high-precision product delivery, meaning reduced waste and high-quality printing, barcode reading, and verification. Component replacement – Whether it's the controller, the driver, or the panel – It's as simple as connecting a new device. Upon the next startup, the system will recognize the device and send it the necessary procedures and parameters. Pharma 2D is a complete solution for drug serialization, enabling high-quality QR code printing, alphanumeric labeling, visual control, and security labeling. The machine is manufactured in accordance with Good Manufacturing Practices ( GMP ) for pharmaceuticals.
B&R's scalable control systems and modular software make it easy to adapt machines to factory needs . This enables INTREX to provide customers with the highest quality solutions in the shortest possible time.
