Originally Published PMPN May 2005
Software
Packaging Software Adds Capabilities While Cutting Costs
Software offerings allow professionals to speed up packaging lines, catch errors, and control quality, all adding up to cost reduction.
by Christina Elston
Contributing Editor
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In the pharmaceutical and medical packaging industry, software fills many needs. It can search for defects, monitor inventory, track suppliers and materials, and help companies maintain compliance with FDA regulations and other standards. But as companies implement new software systems for a variety of reasons, they are also discovering an additional benefit—cost savings.
“We’ve seen a much-increased focus on cost throughout the medical supply chain,” says Chris Heim, president of HighJump Software, a 3M company (Eden Prairie, MN).
ELECTRONIC LABELING
FDA’s Structured Product Labeling (SPL) mandate, which will go into effect this October and requires labeling content to be submitted in XML format, has spurred the implementation of one type of cost-saving technology.
XML improves efficiency by allowing information on the label to be “harvested” for other uses, explains Joe Jenkins, marketing director of Arbortext (Ann Arbor, MI). The firm developed its Product Information Application to help companies achieve and maintain compliance with the SPL mandate. Copy created and approved for a label can be reused in a package insert or brochure without the time and cost of retyping and additional proofing. The system also can import information from existing databases into an XML document, allowing for automated creation of product Web sites, promotional materials, and other outputs of approved labeling. “You get greater control of your content,” says Jenkins. “You can reuse it instead of having to recreate it.”
The technology has existed for some time, but only gained attention in the medical industry during the past two to three years, says Jenkins. He adds that one medical device customer has even begun creating packaging artwork from XML documents and automating the entire artwork publishing process.
BAR CODING SOFTWARE
Another new software tool seeks to help companies with bar coding. The AccuMaster Online, created by Product Identification & Processing Systems Inc. (PIPS; New York City), is a Web-based digital bar code tool for companies that want a single validated package for bar code artwork. The product produces digital Universal Product Codes (UPC), Reduced Space Symbology (RSS) and its composite components, and 2-D Datamatrix digital bar code masters for packaging art. “It’s really a new paradigm in digital bar code software,” says vice president George Wright IV.
AccuMaster synthesizes the digital bar code master software into a server-based package with a Web interface, available to anyone, anywhere. It takes less than 1 minute to send a digital bar code master to anywhere in the world. The tool contains all bar code requirements for various countries, which PIPS keeps updated. “Everyone gets bar codes from the same proven kernel,” Wright says. At press time, the firm was scheduled to release Phase 1 for RSS and composite symbology in April, according to Wright.
AUTOMATED
PROOFREADING
Also gaining increased interest in pharmaceutical and medical packaging is automated label proofreading. Though such systems have been around for at least a decade, the past two years have brought tremendous improvements, according to Mike Negin, founder and president of Mnemonics Inc. (Mt. Laurel, NJ). While previous proofing software simply broke a label document down into small areas and directed the operator to visually compare those to the master image, Mnemonics software shows the operator only those areas of the document that will potentially require corrective action, speeding the process up to four times.
The operator then decides what action needs to be taken. “The idea was, we’re going to replace the human visual systems, but let the human make the final decision,” says Negin.
One customer found a broken type in the beginning of a run and was able to stop the press, correct the problem, and prevent a potential $12,000 loss during the first 15 minutes of press time, he explains. The software also allows proofing reports to be shared electronically, eliminating the need for proofs to be shipped back and forth. It could reduce turnaround time at press checks from a week to half a day.
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| Global Vision’s Docu-Proof C3 software compares text in unlike formats. It also features an advanced medical dictionary. |
Global Vision Inc. (Montreal) is releasing an updated version of its Docu-Proof C3, which general manager David Perlis calls a copy and content comparator. The software can compare text in unlike formats, such as Word to Illustrator or to Quark or to PDF. The stand-alone product’s new release will feature an advanced medical dictionary. A sister product, Digital-Page, overlays two images and shows any differences.
Complete Inspection Systems (CIS; Indialantic, FL) continues to install automatic proofreading systems at companies like Bayer Healthcare and others. They are being used for text and image comparisons.
LABEL INSPECTION
Another new technology that could tremendously improve efficiency in labeling allows for grading of bar code quality in-line, according to Robert Rack, president of RDG/ BarCodeAmerica.com (Madison, NJ). Along with machine vision system maker Cognex (Natick, MA), the company has created a new system, called WebSpect, that allows 100% inspection of label webs at high speeds. This system inspects human readable copy and grades bar code quality.
WebSpect uses line-scan technology that captures one detailed line of pixels at a time and builds an image line by line, allowing for complete inspection of a wide area of any length. “Label length is not an issue. Very-high-speed inspections at 350 to 700 feet per minute for up to 7 to 14-in. wide webs are possible,” says Rack.
The system detects flaws at a much finer level of detail than many others, according to Rack. It is one of the only existing systems that inspect 100% of the label area. WebSpect can pass results directly into the attached PLC (programmable logic controller) system and stop the label web if needed. Similar technology can be adapted to blister packaging machines with the company’s BlistSpect vision system, says Rack.
PIPS is planning to introduce another in-line tool to verify bar code print quality “in real time, at blister line speeds,” says Wright. Historically, bar code quality verification has been a static, off-line process. “Today the real challenge is to bring that capability into high-speed pharmaceutical packaging where the printing is done in-line,” Wright says. PIPS expects its new product to enter the market around the second quarter of this year.
LINE PRODUCTIVITY
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| Pilgrim Software’s system helps pharmaceutical companies track supplier quality and audit processes and controls. |
While some software is helping packagers do more in-line, other systems help them ensure that their lines are operating at optimum efficiency. Parsec Automation Corp. (Brea, CA) created its TrakSys software to help companies improve packaging line productivity using OEE (overall equipment effectiveness) as a key performance indicator, according to vice president Scott Klages. The system ties right into the PLCs on automated lines and records machine status. For instance, if machines in a line were stopping, it would indicate where, for how long, and why, allowing companies to solve problems, boost line capacity, and improve their product output.
The pharmaceutical industry hasn’t traditionally focused on line efficiency in this way, but interest is growing, says Klages. Parsec has cosponsored OEE benchmarking sessions for the pharmaceutical industry with companies such as Merck, Hospira, and Cardinal Health serving on an advisory board to set the agendas for the meetings. “This is a really, really hot issue right now,” Klages says. “The pharmaceutical companies are really under a lot of pressure now to reduce costs, and they have a lot of potential to do so,” Klages says.
Nikki Willett, director of products at Pilgrim Software (Tampa, FL), has also noticed companies responding to this pressure. Pharmaceutical companies, she notes, are forced to invest in research and development, which ensures the future of the brand. But they still must cut costs where they can. “From a bottom-line perspective, you’ve got to cut down on the cost of manufacturing,” she says.
Reducing scrap and rework have become key cost-cutting targets, according to Willett. Systems like Pilgrim’s that track supplier quality, help audit suppliers and internal processes and controls, manage deviations and nonconformances, handle complaints, and ensure that equipment is calibrated for the best use are useful. While the majority of customers used to come to Pilgrim because they were facing regulatory action, during the past two years, “more than 50% of our customers are coming to us for continuous process improvement,” Willett says.
At Sparta Systems (Holmdel, NJ), manager of operations Steve Cagle has also noted more customers focusing on cost-cutting along with compliance. Cagle says that many companies implementing Sparta’s quality management software realize a high return on investment. “During a customer presentation at our last user conference, it was pointed out that implementing TrackWise had saved the customer $5.6 million and $300,000 per year in recurring costs,” Cagle says. “This was accomplished by consolidating inefficient and redundant systems into a single centralized system and by streamlining business processes using the software.” TrackWise is an off-the-shelf suite of software products that can be used to monitor process or product deviations, audits, complaints, and change controls.
Benefits of improved quality include cycle-time reduction, as Sparta found in a customer survey conducted last year. “Results showed that 40% of clients have experienced 25% or more cycle time reduction, and 85% of clients have seen over 10% reduction,” he says.
DESIGN COSTS
Package designers in the medical and pharmaceutical industry are also increasingly focused on cost, according to Heidi Larsen, vice president of Cape Products at Cape Systems (Dallas). “They have to evaluate cost-versus-benefit situations every time a new package is considered,” she says. “The packaging department is becoming less isolated from marketing, distribution, R&D, and other areas within a company, so not only are they thinking beyond the package, but are also encouraging other departments to look to packaging.”
Software has evolved to help designers determine the most efficient way of patterning and nesting patterns together, and can calculate the materials waste associated with various patterns, according to Sean Arney, president of RulesSoftware (Austin, TX).
The company also offers new ways to deploy and support the software on-line, which can save customers time and consulting fees, Arney says.
Cape Pack software will also evaluate variable products, alternative pack arrangements, quantities, case sizes, and pallet patterns. “We have features that will evaluate alternative product sizes, so that more-efficient packaging can be considered and implemented.” “When these features are used in combination, the results can mean great savings for the company,” says Larsen.
Software can also be used to monitor tooling and film performance during blister forming. Montesino Associates LLC (Wilmington, DE) now offers Amcor Flexibles Healthcare Inc.’s (Mundelein, IL) Black Box blister simulation technology.
The tool simulates barrier film formation so that engineers can determine any areas in the blister cavity where barrier may thin out. Montesino also offers 3-D Smart, which predicts how blister-tooling designs will perform, even before they are made.
KEEPING TRACK
Keeping track of where products and materials are located is an increasingly important quality and safety issue in the industry, but it can be a cost issue as well. Warehouse management software from HighJump Software can drastically cut the time needed to perform a recall, according to senior manager of public relations Mike Devine. “The mock recalls used to take a day. Now they take 20 minutes,” one customer recently reported.
An additional benefit is that the software maintains product genealogy without implementation of an additional system. “I think we’re seeing a huge growth in demand for maintaining genealogy of products, from raw materials all the way to the consumer,” says president Chris Heim. “It’s nice to have it happen automatically, as opposed to building that audit trail with a lot of additional cost.”
The PAS-X process automation system from Werum (Towaco, NJ) also helps compile product genealogy. The system supports the handling of bills of materials and other documentation needed to ensure the quality of the finished product, according to Dietmar Mueller, vice president of American operations. “We do the tracking from the incoming raw materials to the finished package,” he says.
Mueller believes such systems eventually will be able to be extended to provide track-and-trace capability for the entire supply chain, including product delivered to the patient. To that end, Werum has a product in development now, but Mueller says RFID technology will need to improve for the system to be practical. For example, he says, RFID readers will need to keep up with the speed of packaging lines and still provide accurate information. “If you look at high-speed packaging lines, that’s quite a challenge,” says Mueller.
Gary Parish of Complete Inspection Systems agrees that there may be problems yet with RFID as a track-and-trace tool. “A lot of hoopla surrounds RFID devices on pharmaceutical packaging and pedigrees—documentation used to pinpoint who handles the drug as it moves through the supply chain,” he says. “Although these are steps in the right direction in preventing counterfeit products, they still fall short of guaranteeing that consumers receive authentic drugs.”
CIS is introducing a new product called AutoProof Pro Stealth that allows users to store images of their authentic products, which have been marked in some way—either through bar codes or other markers—and compare those images to products in the field.
Additional new tools will no doubt be developed as technology—and the needs of the packaging industry—continue to evolve. But it is clear that no matter how far into the future software systems look, if they truly want to meet the needs of pharmaceutical and medical packagers they will need to continue to keep one eye on the bottom line.
Copyright ©2005 Pharmaceutical & Medical Packaging News
