September 2020 | Sponsored | Thought Leaders

Leveraging the Benefits of New Industrial Printers for Compliance

Tags: Legislation, Public Policy, and Regulations, Technology

Peter Zalinski, Sr. Supply Chain Consultant, Barcoding, Inc., 888-412-7226

Q: What are the benefits of investing in the latest industrial printers?

A: The latest industrial printers offer a new set of features and advantages, so end users will not be upgrading just to ensure continued performance and support—they will enable new productivity and efficiency benefits. This includes higher image resolutions, improved feeds-and-speeds, and user-replaceable printheads and platen rollers, as well as new connectivity options for integration and MDM support.

While hardware upgrades can be disruptive, the short-term costs are a fraction of the long-term benefits to be gained through improved uptime, greater productivity, and more reliable labeling quality.

Q: Why should I review new industrial printers on the market like Honeywell's PX940V?

A: The strongest argument for implementing the Honeywell PX940V solution is for FDA UDI compliance labeling for medical devices. The PX940V has built-in barcode scan validation and verification. With barcode UDI labels having to comply with ISO/IEC 15415 or ISO/IEC 15416, having a quality barcode label printer that also monitors the quality of the output can save time, money, and legal hassles.

The FDA requires that 100% of UDI labels pass an ANSI/ISO grading standard; if you are not actively grading every label, the odds that every label will pass inspection is low. Random QA checks will not catch all compliance errors. In-line, real-time verification at print time will ensure that all UDI barcodes are scanned, graded, and compliant.

Q: How does the printer improve compliance labeling?

A: You can program the PX940V to assign a letter grade of A through F for ANSI or assign a numerical score of 4 through 0 for ISO for each of the barcodes that appear on any given label. The system is even designed to generate a report that you can send to your customer, providing proof of compliance labeling. All of this can be integrated with a host system to ensure traceability and archiving.

Q: Who could benefit from an upgraded industrial printer like the Honeywell PX940V?

A: As mentioned before, medical device manufacturers need in-line label validation to comply with current FDA requirements. The Drug Supply Chain Security Act (DSCSA) outlines requirements to develop and enhance drug supply chain security by 2023. This includes product tracing requirements that went into effect in 2015 for pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers (primarily pharmacies).

The requirements include unique package-level identification, with serialization extended down to the dosage level. This is satisfied using 2D barcodes and GS1 standards, so the PX940V is the perfect print quality compliance solution for pharma and biomedical companies as well.






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