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Bar Code System Increases Throughput, Satisfies Validation Requirements

Originally Published MPMN November 2001

PROFILE

Bar Code System Increases Throughput, Satisfies Validation Requirements

Features include real-time error messages

Scanning the bar code attached to the mold produces a product-specific bar code label that also serves as the seal for each individually bagged part.

Injection molding plastic parts for the medical industry typically requires more-stringent manufacturing processes than are customary in other markets. Parts produced for the healthcare industry must submit to a rigorous validation process to ensure that they meet FDA regulations. Custom injection molder and contract manufacturer Nypro Inc. (Clinton, MA) is no stranger to these exacting standards; it has been producing blood diagnostic units, intravenous check valves, and contact molds for years. But in 1999, the company realized it had a problem. The validation system it was using was slowing production rates and was not Y2K compliant.

Company officials soon recognized that money could resolve the system's noncompliance, but nothing could be done to increase its speed. "Machine operators were waiting up to 5 minutes to generate a label," says Nypro project engineer Jim Rogers. "And if somebody scanned the same serial number twice or scanned the wrong thing, it would take them forever to get the error message." The company needed a system that could handle these complex transactions in real time with zero fault tolerance. After looking at several vendors, Nypro turned to Intermec Technologies Corp. (Everett, WA).

An operator scans bagged parts to cross-reference lot and cavity information.

Intermec proposed a bar code scanning workstation consisting of the company's Model 6540 computer terminal, a Model 7421 bar code label printer, and a Model 1800 CCD scanning device. As medical parts come off the production line, an operator bags them individually and scans a bar code attached to the mold. This scanning prompts the printer to generate a label based on that particular mold. This label is then scanned itself and used as a seal to close the bag. Scanning the bag's bar code prompts the system to verify mold cavity information and cross-reference previous scans to validate lot and cavity numbers. If the operator forgets to scan or scans the same label twice, the system produces an audible error signal.

Nypro installed these workstations on each of its 65 injection molding machines and has been pleased with the results. Not only did the company achieve regulatory compliance, but the system is roughly eight times faster than its predecessor. "Generating a label now takes only seconds," explains Rogers, "and operators are getting error messages in real time." Because each validation system also operates independently, a malfunction in one unit does not affect the rest. Nypro is so pleased with the workstations that it plans to install an Intermec wireless data-capture system in its warehouse in the near future. "None of our competitors has anything like it," concludes Rogers. "We are capable of doing things for bar coding right now that no one else can."

Zachary Turke

Copyright ©2001 Medical Producut Manufacturing News

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