Pharma industry packaging lines are long combinations of different machines to count pills, fill containers, apply labels, covers and caps, and wrap in secondary packaging—all, of course, in a regulated environment of cGMP practices. There are quality and validation checks at various points to ensure that improperly assembled packages are excluded from the line for rework. The trend has been to use more vision systems to check these quality measures, but as the level of automation goes up, so does the need for collecting, compiling and storing data.
These were some of the factors at hand when Schering-Plough recently installed a packaging line in Ireland. The product container includes the ShellPak wallet from MeadWestvaco, which incorporates child- resistant features into its closure, and a blister card. To inspect all these components in a cost-effective manner, Schering-Plough chose the Sentri vision system of Systech International (Cranbury, NJ).
According to Schering-Plough’s project group leader, David Read, the company sought an integrated, automated inspection system that would check product type and security features, verify cartons for country destination and ensure correct label printing (which can vary by destination). Blisters also would need to be inspected to verify product orientation, lot numbers and expiration dates. Another key driver at the time was the need to integrate vignette detection.
Since the line was specified, set up and operations initiated, very positive results have been obtained. Additional headcount for manual inspection has been avoided, and rework has declined significantly. Most importantly, Read says, the company has the confidence it can reliably track each package from the original batch, through to verified packaging and labeling steps, and onto to shipment to specific countries. Further, the solution is scalable for future packaging needs, such as new country-specific labeling requirements.
The company is so pleased with its results that it has ordered Sentri systems for two other packaging lines.
Validate and record
Len Valeo, product marketing director for Systech, notes that the Sentri system includes a variety of capabilities: optical character recognition and verification, barcode verification and print-quality verification. “You not only want to verify that, say, the letter “B” is not the number “8” on a label identifier—something that can be challenging with variations images from some coding technology—but you want to ensure that the lot information on the label agrees with what’s actually in the package, all at high speeds and with auditable data records.”
Sentri is designed to interface smoothly with higher-level software products of Systech: the Systech Advisor, a line management offering for controlling multiple inspection and inspection related processes on a line and collecting packaging line data and Systech Guardian, which enables plant-wide visibility and management of packaging processes.
“Some leading pharma companies are making preparations for what they feel are inevitable future product-tracking requirements,” he says. “We think a step-by-step approach leveraging configurable, scalable, and repeatable technology such as Systech’s is a good way to address this.” PC