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Pharmaceutical Technology Europe
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
The pharmaceutical industry was an early adopter of machine vision, as these optical inspection systems aid in guaranteeing product safety and integrity. With the introduction of more stringent regulations throughout the industry, such as the European Union’s Falsified Medicines Directive (EU FMD), optical inspection is now, more than ever, an integral part of the industry.
To find out more about these essential systems within pharma, the challenges of safety regulations, and the future of packaging technology, Pharmaceutical Technology Europe interviewed Dietmar Karepin, business development manager healthcare of Vitronic.
PTE: As a machine vision systems provider, what significant transformations have you seen in the pharma during the past three decades?
Karepin (Vitronic): Thirty years ago, industrial machine vision was a new technology that became established over the years. Prior to the introduction of this technology, quality inspections in the pharma industry were performed using statistical process controls-basically with manual spot checks. The first machine vision systems were often elaborately produced even if the camera resolution and computing power were quite basic compared to today’s standards.
Vision systems have changed significantly over the past 20 years, however, not only in size, but also in components. Today, automated optical inspection systems are designed to meet the requirements of the pharma industry and also feature an optimized and compact design, which can be easily integrated in filling and sealing processes, making these systems an important and integral part of pharma manufacturing.
Machine vision technologies have developed rapidly as production has increased, automation has expanded, and cyclic output has risen in the pharma industry. Nowadays, automated optical inspection systems perform extremely complex inspection tasks while also collecting high volumes of data. Take vials, for example, they are inspected at a high rate of 10 vials per second. To ensure that inspections meet demanding requirements in terms of reliability and speed, extremely powerful and intelligent inspection equipment is required. This inspection equipment must comprise hardware and software components that are tailored to the inspection requirements at hand.
One area that has grown in significance is documentation. Currently, the industry requires extensive documentation to ensure that the systems and machines are qualified to meet pharmaceutical industry standards. Great emphasis is also placed on system compliance to regulatory guidance such as the US Code of Federal Regulations (CFR) 21 Part 11-electronic records and electronic signatures.
Furthermore, the link between machine vision and data technology has changed significantly over the past five to six years. Automated inspection processes require systems to be increasingly flexible, with the ability to access much more data.
PTE: With the introduction of stricter safety regulations, such as the EU FMD, what challenges do pharma companies face?
Karepin (Vitronic): To be able to comply with the EU FMD regulation, the industry had to ensure that as of February 2019 drugs requiring a prescription were sold only in packaging with a serial number and with their original seal. The data must also be saved to a central IT database. For international pharma companies, current challenges include the number of regulations set forth by each individual market. These regulations can vary greatly and include the United States e-pedigree and Chinacoding, for example.
Medical safety is the number one priority. Not only the quality of the product but also other relevant data, including packaging information, must be protected from misuse and fraud and documented thoroughly. Furthermore, tamper evidence is required to ensure that unauthorized tampering and changes to the product are recognized immediately. In short, the product must arrive at the pharmacy in its original packaging completely intact. In this context, pharmaceutical packaging includes more and more information such as labels, codes, and special safety data, which is sometimes invisible to the human eye. All of this information must then be captured by the optical inspection.
In addition to typical optical quality inspections, supplementary solutions must be implemented in the pharmaceutical packaging process for traceability purposes. Customers are, therefore, seeking end-to-end solutions, preferably from a single source.
PTE: What are your future predictions for inspection technology improvements that may lead to a paradigm shift in pharmaceutical packaging?
Karepin (Vitronic): Processing smaller batches is becoming more common in the pharma packaging industry. This requires that lines are more flexible and can be reconfigured quickly, and as such, inspection systems need to be more flexible too. On the one hand, they must be scalable to the different product types, and on the other hand, they must be easy to reconfigure even by the user if necessary.
Additionally, personalized healthcare is requiring new approaches to production and, in turn, to automated quality control. Intelligent and interconnected systems that can manufacture for batch size one are a clear trend, and not just in the pharma industry.
Data captured by automated inspection systems offer huge possibilities. One of the greatest challenges of the future is to use the data even more intelligently. One promising application is what is known as closed loop, which can be used to help us draw conclusions about machine parameter settings based on findings from the inspection process. In the automated application, data from the inspection [are] fed back directly to the machine control unit, which can automatically make corrections to machine parameters there. Furthermore, we are exploring applications for deep learning methods in specific inspection environments so that we can continue to improve processes and defect detection results.
Pharmaceutical Technology Europe
Vol. 31, No. 8
When referring to this article, please cite it as F. Thomas, “Farther Than the Eye Can See,” Pharmaceutical Technology Europe 31 (8) 2019.