Medical Device Link.

INSPECTION

The CLV620 scanner from Sick features Sick Modular Advanced Recognition Technology (SMART), an algorithm for reconstructing damaged or obscured codes.

With regulations for package serialization on the horizon, almost all pharma firms are testing or seriously looking at the use of bar codes for unique item coding and track and trace.

Bar code quality should be a critical concern for companies applying linear bar codes mandated by FDA for most pharmaceuticals and for OTCs destined for hospitals. The agency requires that codes achieve a print quality grade of at least “C,” following standards for calculating print quality defined by ISO/ANSI.

Adoption of matrix style or stacked linear codes to accommodate serial numbers and other data raises the bar on bar code quality verification, following ISO/ANSI standards. Packagers are using variable printers for coding unique bar codes on each package, creating the potential for more variations in bar code quality.

High resolution camera-based systems are generally required for reading and verifying the quality of matrix-style codes such as Data Matrix, and QR (Quick Response), a matrix code favored in countries such as Japan. Aztec is a matrix code the healthcare industry is investigating, says Tim Lydell, director of sales and marketing, Label Vision Systems (LVS; Peachtree City, GA).

“The only choice you have as companies attempt to conform with coding requirements is camera technology, because we are moving into a realm of matrix codes and human readable codes that can’t be verified to ISO print quality standards with a laser,” Lydell says.

In grading 2-D bar codes, up to 16 elements are evaluated, where nine elements are checked in linear bar code grading, Lydell says.

“The linear code is redundant,” Lydell says. “However, you can have defects in one section that change the reading or make it unreadable. In grading linear and 2-D codes, we verify every .002 inch of the code height. Both 1-D and 2-D codes can be graded to ISO print quality standards without operator intervention using the LVS Integra 9505 bar-code verification system in an offline mode.”

For unit-dose marking of blisters and small packages, pharma firms have favored the GS1 DataBar (formerly RSS) code and DataBar stacked linear formats. For accommodating yet more data, DataBar plus composite formats are used, where the composite portion is a stacked configuration of linear codes. The DataBar family are all readable and gradable using laser scanners, after printing, and for reading by the end user.

Glenn Spitz, president, Webscan (Brentwood, NY), says the choice of camera or laser scanner for bar-code quality verification will be based on the application.

“Camera solutions are best suited for 2-D codes,” Spitz says. “We also use cameras for verifying DataBar codes, where packagers are using the stacked or composite codes for adding batch and expiration data.”

“We use the camera for online applications where images have to be captured at high speed,” Spitz says. The camera provides an inline snapshot of the whole area regardless of how fast the web is moving.”

Webscan’s TruCheck product line includes offline and online laser scan systems for verifying DataBar family codes. “Laser scanning can be an advantageous solution for online scanning when you have a long linear bar code that would require a camera with a wide field of vision. That can get very expensive,” Spitz says.

Packagers have largely favored sampling of printed bar codes using lower-cost, offline stations, vendors report. Since code variation is statistically small, 100% online code inspection provides potentially little or no gain in quality control. Rewind and inspection stations are used for inspecting 100% of printed codes.

ONLINE GRADING

But rewind stations and sampling require direct human effort, without immediate detection and correction of print quality. Vendors say serialization is driving interest in on-the-printing-press inspection, where printing stops when a flawed code is discovered, and print quality is corrected online, eliminating waste.

Web camera-based systems verify and grade 1-D and 2-D codes and perform OCV/OCR on human-readable printing. Verified data can then be sent to databases supporting track and trace systems.

Spitz says most of the interest for its TruCheck InLine camera-based system has come from companies printing 2-D codes. “Digital printing processes will benefit most from our online bar code grading solution, as variable printing is a process that is more susceptible to quality variations,” he says. “We do the ISO grading process fully comprehensively, and accurately.”

The Laetus Argus Inspect wt system from Hapa & Laetus Inc. (Rockaway, NJ) provides online camera inspection for human readable text and all 1-D and 2-D bar-code symbologies on packaging components such as labels, blister packs, tubes, vials, and cartons. Line scan camera technology is used on the Laetus Polycheck System for checking the entire printing of a blister foil web or labels. The Polycheck Inspection System provides overall print verification with unlimited windows for checking OCV/OCR, lot, and expiry, and 1-D and 2-D bar codes with grading.

“We also now have solutions for marking and verifying unit-of-sale cartons inline, to complement our Laetus Tracking wt product line, which provides customers with an e-pedigree solution,” says Jeff O’Neill, director of Laetus, North America.

“We offer a conveyor system complete with a printer and a mark-and-verify inspection module that will take the carton from a cartoner, mark it with a GTIN and 2-D code, verify it, and reintroduce it to the packaging line,” O’Neill says.

Mounted on flexo, gravure, or variable data printers, Webscan’s TruCheck In-Line ANSI-grades bar codes at speeds in excess of 1500 feet per minute.

“This is an excellent option when a customer has a cartoner that cannot stabilize the carton well enough for high quality printing within the cartoner, or if there is not enough real estate to mount the printer inside the cartoner,” he adds.

“Customers are now looking for 100% inspection and verification of 2-D codes and human-readable random data, with reliable data storage, data control, and aggregation through the packaging process, to meet e-pedigree’s challenging demands,” O’Neill says.

LVS offers full web inspection of printed components online with the LVS Integra 7000. The system analyzes code to pinpoint problem areas. It also validates number sequences and inspects for print defects (blemish inspection), human readable code, and matching fields of code within a label. The integrated solution with camera, lighting, and PC processor can be mounted on a printer or on a rewind and inspection station.

“The LVS 7000 provides one inspection system that can address all of the possibilities and grade to ISO standards. Inspection of all printing is completed at the speed of the press or the rewinder in one pass of the web,” Lydell says.

“The vast majority of pharma companies are moving ahead with serialization. Some are using the DataBar family, others Data Matrix, and others human readable. Our solution is e-pedigree ready and 21 CFR Part 11 compliant in that we confirm the coding is accurate and pass a master file of the data to repositories where the serialized data is held,” Lydell says.

Sick (Minneapolis) features a level of bar code validation in its laser and camera-based bar code scanners, but without built-in ability for ISO/ANSI bar-code grading.

“We have pharma customers that are not doing ANSI grading,” says Chris Rhodes, product manager. “But you can verify that a code is acceptable, and that is where we come in. We read the codes, manipulate and route the data, and in some cases verify the quality of the bar code per the customer’s requirements.”

Sick 400 and 600 series laser scanners, used in online print-and-apply applications, verify the code data and monitor for contrast. If read rates fall below a set level, the operator is notified to take corrective action.

“This would typically result in replacing the printer heads,” Rhodes says. “Other than the bar code data itself, our camera-based ICR 8xx 2-D scanners can also output information such as error correction used, symbol contrast, code size, and code direction.”

“Inline ANSI grading is very constrained. You need shrouding to control the ambient lighting, scan the bar code at a set distance, and other conditions. Most companies are doing ANSI grading in an offline context where ANSI lighting conditions, aperture settings and read distances are controlled,” he says.

Rhodes says that although camera systems are typically required for 2-D reading, laser readers can be used providing the code is moving at some velocity under the reader.

Sick’s ICR85x laser scanner reads 2-D codes by taking and buffering 1-D slices then reconstructing them into a 2-D image.

“This can be done at very high speeds—45,000 scans per second—so you can read much faster than a traditional camera,” Rhodes says.

The first products in a new line of Sick bar scanners, the CLV620 and CLV630 launched this year, feature Sick Modular Advanced Recognition Technology (SMART). SMART is an algorithm for reconstructing damaged or obscured codes. The complete code is assembled from partial and intact portions collected as the code is read.

Lydell points out that although codes can be validated as readable, verification means verification to ISO print quality standards.