Labels that are applied to pharmaceutical products, such as vaccines and medicine, often contain various elements, including the necessary manufacturing information to facilitate a recall if necessary. These products are often produced at high volumes at high line speeds, which can create operational challenges when it comes to verifying the label on each product is present, applied in the correct location on the container and has the proper information on it.
HERMA GmbH, based out of Filderstadt, Germany, provides a broad range of labeling products and solutions, including self-adhesive labeling machines used for industrial packaging processes, largely in the pharmaceutical and food industries. The company prides itself on its innovative and sustainable approach to label application system design and working with leading technology partners, such as OCTUM and Cognex, to ensure line speeds and quality requirements are met.
A key component of the labeling machines is inspection—HERMA partners with OCTUM GmbH, from Ilsfeld, Germany, for the label inspection technology within its machines.
HERMA incorporates OCTUM’s software platform, OCTUMISEr, within their machines to verify the label is present, legible, and contains the correct data. ‘label.inspect,’ a software module within OCTUMISEr enables reliable identification and traceability of medical and pharmaceutical products for compliance regulations, such as EU-GMP and CFR Part 11. As integrated components within the ‘label.inspect’ solution, Cognex machine vision systems capture and verify the label information and share it with the labeling machine’s internal monitoring system.
Addressing the unique labeling needs of pharmaceutical manufacturers
HERMA’s customers, who often create products within a regulated industry, such as pharmaceuticals, face various challenges:
- Producing high volumes of products while in a highly regulated environment (i.e., within 21 CFR Part 11, GMP Annex 11, or GMP5 guidelines)
- Preventing labeling mix-ups that can cause harm to consumers
- Achieving high product quality and accurate label verification while running at high-volume production rates
Solving these key challenges involves consistently meeting increased demand by automating the production process, verifying the accuracy of the labels, and designing systems to reject non-confirming labels and products.
HERMA addresses these challenges by building high-quality, innovative pharmaceutical labeling solutions that meet Good Manufacturing Practice (GMP) and 21 CFR Part 11 guidelines. Their labeling machines print and apply labels on surfaces such as folded cardboard boxes, vials, jars, or even injection pens. As part of the overall solution, they integrate label inspection and serialization technology from OCTUM, including Cognex machine vision technology.
Manufacturing pharmaceuticals is usually a high-speed process. All solution components, including the label inspection modules leveraging Cognex machine vision technology, must be optimized to achieve the specified production rate.
According to Patrick Decker-Malaval, Project Manager at HERMA, “Our pharmaceutical customers need a reliable partner that delivers machines that achieve the line speed they are looking for, and OCTUM is the specialist when it comes to vision systems utilizing the Cognex In-Sight systems.”
For example, a pharmaceutical company customer of HERMA that produced vial-based vaccines required a fully automated labeling process that could operate in a controlled pharmaceutical environment. To avoid the risk of product contamination, the manufacturer wanted a process that was free of human intervention, met production volume requirements, and compliant with CFR Part 11. All vial labels required a lot number, which was used to trace back a production lot in case of a recall. The customer also required on-site support for all aspects of the solution.
HERMA, OCTUM, and Cognex team up to meet the customer’s objectives
HERMA’s solution was their 132M HC wrap-around labeling machine, with OCTUMISEr CFR software, a Cognex In-Sight 2D vision system, and lifecycle documentation according to GAMP5 guidelines. The machine printed and applied the labels to the vials and simultaneously verified the printed data. Labels that didn’t meet the set quality criteria are rejected from the labeling process to ensure only good labels are applied. The integrated Cognex vision system inspected labels for accuracy and verified lot code information on vaccine vials. In tandem with HERMA and OCTUM, Cognex's global support ensured the customer received timely service on its vision systems as needed.
A valued partnership – for many reasons
HERMA strives to ensure customer satisfaction, especially after a machine is installed and in production. Because it delivers an integrated solution from multiple companies, it’s important that technology partners, such as Cognex, share their passion for customer satisfaction.
Decker-Malaval explains further, “To achieve that, it is important that we have partners, such as Cognex, that have the same goal to achieve customer satisfaction through quick support response times during unplanned downtime.”
Cognex machine vision systems have been a key part of OCTUM’s 6,000+ successfully installed inspection systems for over 25 years. OCTUM, a Cognex Partner System Integrator (PSI) since 1999, has a development lab featuring a full line of Cognex machine vision solutions and has maintained a close relationship with the Cognex development team.
According to Denis Schmidt, a Director at OCTUM, “Cognex has been a close partner to OCTUM during all its major growth as a company. We fully trust their solutions, especially In-Sight and VisionPro. Our software solutions, OCTUMISEr and CV-Inspect, are used worldwide by leading pharmaceutical, food and beverage, and consumer products brands.”
The three companies enjoy a solid working relationship when it comes to giving HERMA’s customers peace of mind, Decker-Malaval added, “The cooperation between HERMA, OCTUM, and Cognex is really fruitful. Personally, I really enjoy the versatility of the solutions provided by Cognex.”
Working together on the next generation of labeling solutions
What does the future hold with the three-way partnership? HERMA plans on maintaining and strengthening its leading position in the healthcare industry as a labeling machine vendor. HERMA recently redesigned and improved all machines with its new Clean Design. With this new design, HERMA achieved higher performance and increased flexibility for customer needs, and it trusts Cognex and OCTUM to deliver inspection capabilities that are scalable, flexible, and easily retrofitted as needed.