Where Inspection Is Essential

Some areas on your packaging line demand a careful look--from an inspection system, that is.

By Christina Elston
 

In a world that increasingly measures success in terms of “sigma,” the pharmaceutical industry performs an impressive feat, according to Christoph Lehmann, senior manager of the Visiotec division of Uhlmann Packaging (Towaco, NJ). “Some say the pharmaceutical industry creates a two sigma product, but puts a Six Sigma product on the market,” Lehmann says.

What makes the difference? Inspection systems.

AUTOMATED PROOFREADING

Because something as seemingly minor as a misplaced decimal point on a pharmaceutical label or an insert could have major consequences for a patient, accurate proofreading is essential. The AutoProof Pro Imaging Suite from Complete Inspection Systems (CIS; Indiatlantic, FL) automates the process of comparing inserts, labels, and cartons for both text and graphics.

CIS systems employ scanners and digital and CCD-based cameras. “There is a tremendous range of new products becoming available in the industrial digital camera world, allowing us to capture images of 2048 × 1536 pixels,” says CIS president Gary Parish. “In the scanner world, systems are available to scan up to a 54 × 54-in. document in a single pass.”

The system proofs documents in minutes versus days. It provides 90,000 inspection points per inch, dramatically reducing the number of errors, the company claims. For comparing documents in multiple languages, CIS technology uses a Unicode system for accurate comparison of keystrokes.

VisioRead from Uhlmann features (1) a measuring tool to check syringe scale, (2) a measuring tool to check label position, (3) an OCR/OCV tool to verify with four cameras vial codes, and (4) an OCR/OCV tool for other codes.

PRINT-QUALITY VERIFICATION

Verifying print quality is another essential element in making medications safe for patients. Label Vision Systems Inc. (LVS; Peachtree City, GA) supplies both in-line and off-line vision inspection systems for this purpose. The off-line system, the Integra 9500, introduced in 2004, verifies linear bar codes and 2-D Data Matrix codes and advises operators on whether they meet ISO standards. If a code does not pass, the system directs the operator to the precise problematic area of the code.

The LVS 7000, which hit the market last year, verifies bar codes and Data Matrix codes in-line. It also checks for blemishes and sequential numbering and performs optical character verification (OCV) of printed images. “This provides for 100% inspection of the print quality,” says president Tim Lydell, claiming that the LVS systems are the only machines on the market with these specific capabilities. “LVS also makes its equipment extremely easy to use and intuitive for the operator,” Lydell adds.

BAR CODE READERS

Inspection systems can also play a vital role in guarding product authenticity and patient safety. Microscan Systems Inc. (Renton, WA) is focused exclusively on fixed-mount bar code readers, which can support track-and-trace technology. Applications include verifying the correct assembly of product, package, and package insert.

“A recent trend is the migration from 1-D bar codes to 2-D symbols, such as Data Matrix and PDF417, which are preferred for product traceability because of their large data capacity, scalability, and errorcorrection feature,” says marketing specialist Shelae Howden.

And the technology is continuing to develop. “Advanced scanners will incorporate vision technologies to be able to both decode data and perform detailed visual inspections, the results of which will be saved and cataloged for future review and compilation of product histories,” Howden says. For instance, one recent use included scanning bar coded reagent chemical packaging to verify the accuracy of encoded instructions. “Scanner decode speeds will continue to increase, allowing greater production line speeds and increased factory output,” Howden explains.

In-Sight Explorer software from Cognex guides robots to inspect packages on the line.

MACHINE VISION

As the pharmaceutical industry feels increasing cost pressure, companies are working to build flexibility into their production lines—including running multiple products on one line, reports Kris Bierbaum, packaging industry manager at Cognex Corp. (Natick, MA). Machine vision helps make this possible. “It offers them the ability to speed up lines and to manufacture products more accurately,” Bierbaum says.

Other drivers toward machine vision inspection include new drug-delivery systems that create new applications for inspection technology, and FDA mandates regarding unit-dose marking and track-and-trace. “Our technology seems to be filling a growing niche,” Bierbaum says.

A vision system pioneer, Cognex offers four different technology platforms. These include the PC Platform for high-end applications such as “virtual product inspection,” cost-effective vision sensors for less-demanding applications, “smart sensors” that handle presence-absence inspection but also can track orientation, and hand-held and fixed-mount ID readers.

Also an industry pioneer, Systech International (Cranbury, NJ) first introduced its machine vision system—TIPS Sentri—as part of its packaging performance management solution in the early 1990s. Within the pharmaceutical industry at that time, only piecemeal solutions requiring custom integration were available. “We recognized an opportunity to anticipate the needs of our pharmaceutical customers who were looking to streamline their packaging operations,” says Mike Soborski, director of inspection solutions. “We decided that we could build a standard inspection solution that did not require the level of customization otherwise necessary.”

The company created one of the first machine vision systems deployed in pharmaceutical packaging to run on an Intel/Microsoft platform, making use of off-the-shelf acquisition hardware. Systech also developed application-specific tools for the most commonly needed pharmaceutical packaging inspection operations.

Systech is interested in further extending the ease-of-use concept to fully automate the deployment of machine vision. “Creating tools that are self-diagnostic, self-training, and self-tuning will transform machine vision from being a mandated and sometimes grudgingly accepted technology to a sought-after tool that improves packaging line productivity and efficiency,” Soborski says.

Uhlmann Packaging tailors its Visiotec machine vision systems to inspecting a form of packaging that is becoming increasingly popular in the United States—blister packaging. Blisters are in wide use in other parts of the world, and hospital unit-dose packaging will make blisters more popular in the United States, observes Uhlmann’s Lehmann. “There is only one hurdle in the United States—child resistance,” he says. In the marketplace, among companies packaging in blisters, “99.9% are using an inspection machine or camera,” he says. “In bottle packaging, there is almost no optical inspection.”

Visiotec has taken blister inspection beyond the usual—which covers only one side of the product. “The side from below is usually not inspected,” says Lehmann, “but it is the one visible for the patient. “We can also do an inspection from the bottom side with one of our systems.” The company’s philosophy, according to Lehmann, is to do everything possible to optimize pharmaceutical manufacturing and packaging processes. “Our objective is to give our customers tools and systems to improve quality, get more efficient, and get rid of headaches and concerns about issues in packaging and processing,” he says.

MIDDLE GROUND

“Smaller, faster, cheaper” are the watchwords in vision inspection, says Steve Wong, industry manager of pharmaceutical and medical products at Banner Engineering (Plymouth, MN). For this reason, Banner offers vision sensors—also known as “smart” cameras. “The smart sensor really fills the gap between the single-point photoelectric sensor and complex machine vision systems,” says Wong.

Customers using this sensor can handle changes in the inspection configuration without outside help. “They can really take ownership in the configuration and maintenance of the system,” Wong says. “Maintaining a system with our vision sensors can be very cost-effective,” he adds.

The system is designed to be intuitive for users familiar with Windows, taking a point-and-click approach. “It walks you through, basically from the setup to actually running the program,” says Wong. Future development in the area will focus on ease of deployment and use. “The trend is going to be to make it easy for our customers to install and configure the system,” Wong says. “Ease of use and value really go hand-in-hand.”

MIX AND MATCH

To handle combinations of bar code reading and vision inspection, Hapa & Laetus (Pompton Plains, NJ) offers the Argus WT. It allows mixing of both bar code inspection devices and B-Cam vision devices that can perform OCV and OCR, and verify product ID number, lot number, and expiration date. The intelligent cameras feature three inspection windows and the capability to verify five lines of text with up to 40 characters, reports Jeff O’Neil.

The company, purchased in April by Coesia (Bologna, Italy), also offers the Polycheck WT for full blister-web or label-web print-quality inspection. “It can check every letter of print on the entire web, down to a couple of pixels,” says O’Neil. The device will check bar codes, lot numbers, and expiration dates, plus grade bar codes.

The WT (Web Technology) concept offers another layer of flexibility. The system establishes an Ethernet network on the packaging line, giving each vision or bar code device its own server. This means that additions or changes to devices can be handled without revalidating the entire system.

GETTING TO THE CAUSE

It isn’t enough for an inspection device to simply detect a problem. Eventually, someone needs to figure out what caused the problem. “There’s always a question as to how that defective product came to be,” says Jim Dechman, president and CEO of Monitoring Technology Corp. (Fairfax, VA). The company’s 20/20 Hindsight and 20/20 Hindsight gigE do high-speed camera recording for just this purpose.

Because production lines are often running too fast for the human eye to follow the action, the cameras allow rewinding and slowing down. “Basically, it’s industrial TiVo,” Dechman says. The cameras take from 60 to 3000 pictures per second, depending on the speed of the line. The upper speed range was achieved about two years ago with the launch of Hindsight gigE, which makes use of gigabyte Ethernet cameras and keeps up to five hours in memory.

The system, says Dechman, is one of the few that are designed specifically for packaging. “The folks that developed Hindsight came from packaging lines,” he says. “The software has a different feel that’s just a lot easier to use.” Other systems have been designed for the automotive industry, for research applications. “It only adds value if it’s actually used, and it only gets utilized if it’s easy to use,” Dechman says.

With ease-of-use and economic issues on the minds of those creating and developing inspection technology, there’s little doubt that the pharmaceutical industry will continue to push the “sigma” envelope, helping to keep quality high and patients safe.

 

 

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