12月13 Pharmaceutical Manufacturers Are Securely Connected To Prevent Counterfeiting
More and more pharmaceutical manufacturers and their partners and suppliers are using technology to fully leverage the role of the Industrial Internet of Things (IIoT). IIoT’s connectivity capabilities help the industry meet regulatory requirements designed to protect drug safety and prevent counterfeit products from entering the supply chain. As more devices, equipment and production lines are interconnected, it is imperative that these connections are not subject to unauthorized access.
Due to the electronic pedigree and serialization requirements, the pharmaceutical industry has been at the forefront of IIoT data sharing and connectivity breakthroughs over the past few years. The latest trends and technologies in pharmaceutical manufacturing IIoT (sometimes referred to as IIoT-PM) are presented at the same Medical Exposition and at the 2016 International Packaging Machinery Exposition . The Medical Expo is jointly organized by the PMMI and ISPE. Pharmaceutical professionals are able to view a wide range of modern processing and packaging equipment, including anti-counterfeiting, quality control and assurance, tamper-evident packaging, validation and many other technologies.
Robert Muehlfellne, vice president of product strategy and innovation at B & R Automation, said IIoT represents the convergence of Internet technology (IT) and operational technology (OT), with a focus on data processing and security. He believes that the manufacturing sector and IT are closely related, in order to focus on security in the industry to succeed, you need a strong partnership.
“Smaller equipment manufacturers are forced into a connected world but sometimes lack the in-house expertise to make the best use of that connectivity,” says Muehlfellner. “The regulations are becoming increasingly complex and not globally harmonized. We aim to helping customers make better use of these technologies to achieve higher compliance levels. ”
B & R’s automation systems can be used for discrete manufacturing from controllers, I / O systems, motors and drives to human machine interfaces (HMIs) and software. While B & R supports companies of all sizes, Muehlfellner points out that B & R has found a small manufacturer in the face of difficult IIoT technology to be a market niche.
B & R Automation’s production facility in Egelsberg, Austria, has been fully networked since 2006 and is continually updated.
Data access control is one of the industry’s most concerned issues, which in a close collaboration and information sharing era seems a bit contradictory. “In the past decade, all the industry’s focus has been on how machines are connected, and now we are moving from” open “to security measures to prevent unauthorized data access and manipulation, Muehlfellner said.
Data security requirements focus on the type of communication protocol used by the industry. Dayton Thompson, an automation specialist at Beckhoff Automation, points out that the Open Platform Communications Unified Architecture (OPC-UA) protocol has become the standard for smart connectivity and data exchange in the pharmaceutical industry. Developed by the OPC Foundation, OPC-UA is a vendor-independent, industry-leading M2M communication protocol with built-in data encryption.
“Within OPC-UA, you do not need to be a security expert to ensure data exchange security, and it provides interoperability for different vendor installations,” Thompson said,And other open, standardized communication protocols such as MQ Telemetry Transport (MQTT) and Advanced Message Queuing Protocol (AMQP) are becoming increasingly important because they provide fast and efficient data transmission.
Beckhoff Automation’s TwinCAT 3 software helps manage large data inflows while establishing connectivity to EMS and cloud systems.
Managing data security is important, but another key industry requirement is the ability to handle large amounts of data captured by IIoT technology. “Collecting only a large amount of data and transferring data around the world is not the ultimate goal,” Thompson said. “Analysis techniques need insight into data to help make informed and informed business and production decisions.”
So Beckhoff introduced a new software solution called TwinCAT Analytics, capable of recording and analyzing production data in IIoT and “smart” factory settings. When paired with a cloud service or an enterprise server, TwinCAT Analytics can help store large amounts of data when the software workbench performs cycle analysis, energy requirements, and RMS calculations directly on the controller. Beckhoff’s software connects directly to Microsoft Azure and Amazon Web Services (AWS) cloud computing hosting platforms.
Product serialization and the delivery of data to a secure, centralized database are key to drug safety, says Daniel Sanwald, product tracking and tracking product manager for Bosch Packaging Technology. In addition to processing and packaging equipment, Bosch manufactures hardware and software for drug serialization, including printing, validation and inspection weighing technology.
Sanwald said that Bosch has long been engaged in equipment and production line connection business, its long history can be traced back to the company in the automotive industry. “Bosch was the first to use tracking and tracking and sequencing technology in the automotive market 15 years ago, which helped automotive production become the most efficient in the world,” he said. “Today, IIoT is driving new possibilities, “The focus is on serialization, which points to the way we connect machines in the future, affecting our day-to-day business.”
Bosch’s CPI software manages the serialization process from assigning serial numbers to final integration steps, allowing connection of individual components, packaging lines and the entire plant. Software is modular and can be deployed as part of a single source integrated application or in conjunction with third-party vendor hardware.
Full integration and serialization – the ability to track all sales units through the supply chain – will not be fully operational until 2023 in the United States. However, according to Darren Meister, vice president of sales at IMA North America Inc., many drug makers are accelerating that ability because other countries will enforce regulations before the United States.
“Large manufacturers are now trying to meet this standard, because at present or in the near future, in some countries, sales of products must be integrated.” Sturt said. IMA North America, based in Leominster, Massachusetts, supplies automated tablet technology and filling equipment for the pharmaceutical and other industries.
Meister said IMA operates about 20 pharmaceutical serialization projects each year, helping companies to integrate product handling, automation and traceability into their operations. At the Packaging Machinery Expo, IMA showed the serialization of printing and packaging technology.
Glenn Siegele, president of Omega Design in Exton, Pennsylvania, also noted that the sooner an integrated solution is required, the better ahead of regulatory requirements. He said that integration can increase the visibility of products in the pharmaceutical supply chain, while only achieving security levels compared to serialization has also improved.
MGS Machine’s CT200 ™ drug packaging machine combines printing and visual equipment
“Our company focuses on data integrity integrity, and we believe that companies should physically integrate their products before they integrate the data on the packaging line,” Siegele said. “This helps to prevent loopholes in the supply chain.”
Omega provides “fast track” serialization modules for rapid deployment and customization to help companies integrate packaging line equipment with data management software. The company’s Intelli-Pac products enable manufacturers to choose between manual, semi-automatic and fully automatic functions.
Siegele pointed out that in the era of IIoT technology, data access is not the only security issues. When you connect more devices wirelessly, you have to be careful about viruses. Another connection problem is that the amount of data is too large and needs to be properly managed to prevent potential processing slowdowns. However, the increase in data can improve automation and quality control.
Richard Bahr, president and chief executive officer of MGS Machine, in Maple Grove, Minn., Also points out that the pharmaceutical industry is firmly committed to adopting IIoT serialization solutions.Now the mentality of the industry compared to California in the past ePedigree bill issued when the mentality of a significant change.The behavior of the company makes people feel that the latest deadline is real, not just the state of California.
MGS Machine manufactures secondary packaging, product handling and line integration products, including cardboard packaging machines, case packers and labeling machines. Barr said the company’s systems are “neutral” so they can integrate devices with different visual effects and print OEM suppliers to meet customer specifications.
The company’s MatriX ™ cartoner provides a full view of the carton prior to packing.Different from other cartoning machines,MatriX also implements physical integration and visual inspection to ensure all cartons are in the same product line. At the Packaging Machinery Expo, the MGS Machine introduced the new CT200 ™ pharmaceutical packaging machine with print and vision capabilities. Each unit being inspected will have a serial number, which reduces the risk of on-line or off-line products not being tracked, Bahr said.
With IIoT technology changing the manufacturing of each industry, the pharmaceutical industry is particularly well positioned to take advantage of the large number of interconnected industry assets brought about by data collection and OEE improvements. Data Collection Security will continue to drive technology and protocol development to ensure the safety of the global pharmaceutical supply chain.