Where quality and compliance meet digitalization and design

Builders of tomorrow's smart pharmaceutical factories face new requirements that come with digital transformation. As one of China's leading OEMs for the pharmaceutical industry, SMA has developed a new tablet press that meets these needs by pairing connectivity and transparency with functional design and operator convenience. To bridge the divide between compliance, performance and usability, SMA relied on automation partnership with B&R.

The pharmaceutical industry is no stranger to strict requirements, with some of the most closely monitored regulations and standards around. Yet, as pharmaceutical producers build increasingly digital, connected factories, the technical challenges and resulting solutions are growing more complex than ever. That's why SMA set high goals for its new tablet press – not only for the usual performance metrics – but also in terms of functional, operator-friendly design.

In its evaluation of automation technology for the new press, the company also prioritized total cost of operation, including factors such as software reusability and the availability of remote solutions for machine commissioning, service and diagnostics. After several exchanges with the B&R team about project requirements and functional realization, SMA was confident that B&R and its automation system were more than up to the task, and decided to cooperate with B&R on the new tablet press.

In pharmaceuticals, quality is always priority number one, and so it is the first factor on which pharmaceutical machinery is judged. For a tablet press, quality means the ability to produce tablets of precise and consistent weight and thickness. This is determined in large part by the pressure applied by the upper and lower punches. Getting fast, precise measurements of this pressure is crucial in order to optimize machine performance by making dynamic adjustments to the servo axes of the punches, the upper and lower pre-compression rollers and the fill station.

In the SMA tablet press, this measurement performance is achieved using an X20 analog input module from B&R, which enables 5 kHz / 16-bit sampling with a buffer. Even higher speeds can be achieved using a high-speed FPGA-based processing module featuring B&R's reACTION Technology, which enables cycle times as fast as 1 μs. The reACTION Technology module also supports IEC 61131-3 programming, and eliminates the need for expensive high-speed controllers.

Serving as the automation platform is an Intel Core-i powered, swing-arm mounted B&R Panel PC 3100 that can run Windows and real-time tasks simultaneously. Connected via high-speed real-time Ethernet POWERLINK, two B&R ACOPOS P3 servo drives deliver precise control for six axes in a third of the cabinet space that would be required for conventional single-axis drives.

In addition to processing power and control precision, modern machines also rely on data connectivity. The smarter the factory, the more equipment on the plant floor needs to be connected to MES/ERP systems for tasks such as financial accounting, order scheduling and quality control. With integrated OPC UA servers and support for PackML communication, B&R's X20 control and I/O system makes it easy for the MES system to configure and access the machine to obtain data about production operations, audit trail, quality and maintenance.

In fact, with OPC UA, not only can equipment be interconnected within factories, B&R controllers can also be used as edge devices that aggregate data and send it to the cloud, where sophisticated machine learning algorithms can be applied. The real-time OEE is measured locally and then sent to the production management system or for cloud monitoring. B&R even offers a ready-made software function that makes it easy to send alarms directly to service technicians on their smartphones.

For the FDA/GAMP certification required of all pharmaceutical machinery, SMA was able to rely on B&R's mapp Technology, which encapsulates key functionality in modular, pre-programmed software components. The mapp Audit component made it easy to meet the 21 CFR Part 11 requirements for electronic signature certification and tamper-proof documentation, while mapp User manages user rights and access.

With all configuration and no programming, these mapp functions and others – including recipe management, business intelligence reporting and more – are easy to implement, and substantially accelerated SMA's development process. The mapp View package also gave SMA's developers powerful tools for HMI design. They were able to create a web-based HMI application that displays large amounts of helpful data clearly and intuitively. With OPC UA connectivity, it can be viewed on any PC or smartphone that supports JavaScript and HTML.

With its B&R automation solution, the new SMA machine achieves very high-speed performance, and users enjoy its digital capabilities along with the attractive and intuitive interface. "We really set the bar high for this new machine, but our team of B&R and SMA engineers was more than up to the challenge," says SMA Chairman and General Manager, Yin Wenping. "That has us really excited for future projects, where we will take on even more of the toughest challenges in smart pharmaceutical production."