Labels on medications are critical for patients and pharmaceutical manufacturers. Labels, barcodes, VR codes and other identifiers on raw materials, end products, equipment and instruments are becoming even more important as track-and-trace and validation requirements ramp up. Many manufacturers are seeking help organizing their labels and labeling technologies to help ensure accurate, high-quality production.
"Labels have a special meaning in pharmaceutical manufacturing. If you don't have a good label, you can potentially lose your whole business," said Choon Teo, corporate vice president and deputy general manager at Zhejiang Medicine Co. (ZMC), parent company of Changhai Biological Co. in Shaoxing, China, south of Shanghai.
"Label requirements from the U.S. Food and Drug Administration (FDA) and European Union regulators require pharmaceuticals to be identified with distinctive codes for each shipment, including product name, material, lot number, strength, batch number, weight and other information answering the primary 'what, who, time and batch code' questions about how it was made," Teo said. “A label isn't just its physical paper, but is really the ability to carry its required information forward."
Teo presented "What's in a Label? PharmaSuite Application in a Finished Dosage Form (FDF) Project" on the second day of Rockwell Automation TechED 2015 in San Diego, Calif.
Also read: Learn more about PharmaSuite.
Zhejiang Medicine Company was established in 2011, but it occupies one of the oldest and largest pharmaceutical plants in China, covering more than 8,500 acres, where more than 1,500 employees manufacture anti-infective, anti-viral and anti-fungal additives and ingredients for animal feed, as well as vitamins and anti-diabetic medicines for humans. Teo says it's the largest worldwide manufacturer of Vitamin E. The company operates two large power-injection facilities, an active-feed production line, oral-solid tablet, soft-gel and chewable applications, and other processes.
Besides maintaining labeling for raw materials and products, Zhejiang Medicine also uses numerous labels for container and equipment identification and status, weighing, material status, instrument calibration and other equipment and production assets.
"These labels are more transient because we add and remove them every time we clean, sterilize, dispense, switch components, or get them ready for use," Teo said. "Our status quo was using handwritten labels attached to equipment or batch records, which was simple and didn't require any capital expenditures or IT involvement."
But, Teo said, the usual paper labels are easily damaged. They can be hard to remove once stuck on and yet risk falling off, especially when wet. They also increase the risk of mixing and rendering the wrong materials and products.
"We need to know who does what at all manufacturing stages, including sterile filtration, aseptic spray drying, sterile powder transfer, inspection and labeling, primary/secondary packaging and warehousing." Teo said.
"Our next step is to integrate 2D labeling with our manufacturing execution system (MES) and warehouse management system (WMS) solutions; go to having no handwritten or physical labels; have our MES and WMS automatically print labels for raw materials and quality-control samples; and have unique identifiers that allow us to digitize all our former labels with engraved barcodes on our equipment, which can the be scanned with mobile devices."
As a result, Zhejiang Medicine and its staff have been working with the China-based division of Rockwell Automation to develop an Internet protocol (IP) address-enabled labeling system and a mobile app, which can help scan products and equipment, and bring back essential data. This solution works with the plant's existing Rockwell Software PharmaSuite, and will be expanded to the company’s FactoryTalk Batch software in the future. Teo reported that the Zhejiang Medicine plant's new MES-aided labeling and identification solution is scheduled to include its powder-injection, active-feed, oral-solid tablet, soft-gel and chewable lines by the end of 2015.
"We chose to work with Rockwell Automation on this project because its MES technology is more advanced and because our local vendors are not as familiar with the FDA's 21 CFR Part 11 regulations" as Rockwell Automation says Teo. "Rockwell Automation also gives us a better support team in China."