Folding cartons, labels, inserts, outserts, enclosures—Keller Crescent Co. (Evansville, IN) prints just about anything pharmaceutical and healthcare product companies need to package and promote products for consumer use.
FDA requirements for pharmaceutical label inspection have become increasingly stringent in the past few years, so Keller Crescent decided to implement automatic label inspection. "The pharmaceutical industry has been looking for an automated label inspection solution for a long time," says Bob Jocham, Keller Crescent's vice president, technical services. "Human inspection using strobe systems is slow with declining accuracy over time. A missing decimal point in dosage information may seem to be a small error, but we consider it a critical one."
To produce perfect labels, Keller Crescent presented specific needs and standards early in 1999 to Focus Automation Systems Inc. (Waterloo, ON, Canada), a provider of high-speed automated inspection systems. In the time since, Focus developed and refined its PharmaVision system to meet the rigorous quality demands of top pharmaceutical manufacturers like Keller Crescent's customer, Eli Lilly & Co., which also provided input to the printer and Focus throughout PharmaVision's development.
In the making for about five years, PharmaVision is a combination of inspection hardware and software that uses patented algorithms that allow normal print variation but identify critical defects. Every inch of every label is inspected, unlike other sampling inspection systems that view only a portion of each label. Also, frame-based systems need to freeze the web to inspect the label, losing time and accuracy. In contrast, PharmaVision's line-scan camera and pipeline vision process every label on a moving web at full production speeds.
"We're proud to be part of an initiative that pushes quality assurance in pharmaceutical label printing to this level. It's likely that other printers will adopt this technology sooner or later to remain competitive in the industry," says Ned Lewis, associate engineering consultant of global printing, packaging, and labeling for Eli Lilly.
The system allows users to set multiple inspection levels for any label. This feature provides increased inspection of critical copy areas while enabling less-critical areas to be set at standard inspection levels. The system can also detect spots and defects within the stock surface.
A patented dual-comparison approach makes all this possible. A golden template detects defects that develop over time, like a color shift or streak, while a patented algorithm detects small instantaneous defects like missing text.
Keller Crescent implemented the CGMP-validated automated optical inspection system in October 1999. "We're very proud to be first to deliver this caliber of automated inspection system to the pharmaceutical industry," says Ron Strauss, Focus president and CEO. "We feel strongly that printers who are serious about getting and keeping important pharmaceutical customers will soon want to adopt this technology."
Keller Crescent and Focus had CGMP validation of the system in mind from the beginning. "We were very impressed with how the system met the IQ, OQ, and PQ components of our validation process," says engineering consultant Christopher Clarke of Clarke Engineering, which was contracted by Keller Crescent to validate the new system. PharmaVision successfully passed all validation protocols, which were developed under CGMP validation guidelines.
"The addition of PharmaVision technology has provided us with a major step closer to our goal of 100% defect-free labels," says Don Minton, Keller Crescent's executive vice president. "The Focus team understood the label printing and finishing business and used that knowledge to deliver a robust, complete solution that meshed easily with our existing staff and processes. The bottom line is that PharmaVision gives us a strong competitive advantage."
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