LABEL PRODUCTION UNDER THE MICROSCOPE:Can Vision Systems Safeguard Label Integrity?A Whitepaper from PRISYM ID

LABEL PRODUCTION UNDER THE MICROSCOPE • PAGE 2 OF 6 LABEL PRODUCTION UNDER THE MICROSCOPE • PAGE 3 OF 6

WHY DO YOU NEED A VISION SYSTEM?The FDA’s label quality requirements for medical products state:

“When issued for use, labeling must be carefully examined to make certain the contents of the labeling comply with the labeling specifications in the device master record for the specific device being produced. This examination must include any control numbers or expiration dates used on the labels. A record of this issuance check, including the date and name of the person performing the examination, must be made in the device history record.”

In a recent vision systems survey* the results showed that 67% of respondents said that the most frequent cause of errors during the label printing process was due to human error – something that can’t be ignored. So Vision Systems should and are becoming an important piece of the inspection puzzle due to their speed, consistency and accuracy.

The survey also highlighted that over 45% of respondents’ organizations either sometimes or frequently had quality control issues with their labels during the production process, yet only 20% either had a vision system or were planning to install one.

Vision Systems help detect and alert the production staff of errors such as:

• Incorrect barcodes and label elements unreadable to the human eye

Mechanical failures:

• Under-burn – occurring when not enough heat is used to thermally transfer print onto a label. If the print is too light it may start to cause a problem when barcodes are scanned. Text may also become illegible over time

• Over-burn – occurring where too much heat is applied. This causes bars or characters to be printed too thickly and make barcodes and text become unreadable

• Lines or streaks – where the ribbon is creased, warped or folded leaving a missing line in the direction of the print

• Spots or voids – where over time, elements on the

printhead will burn out or the printhead becomes dirty leaving an unprinted spot or small area on the label

• Poor defined characters – when printing too fast or using incorrect/poor quality label paper and ribbon combination Offset or misplaced print – when labels are loaded incorrectly, critical information can be printed on the wrong area of the label requiring them to be rejected

All of these are real and significant risks. Once a vision system has been set up and validated, it will continuously inspect labels for all of the above to a consistent quality – impossible for a human to match.

SETTING THE RIGHT REQUIREMENTSAs with most things, there needs to be a “happy medium” when it comes to setting the requirements for a new Vision System. You want it to catch important errors, but not halt production for things that really have no impact on the functionality of the label. As part of your inspection strategy, a decision needs to be made of ‘what is it that you actually want to inspect?’.

The intricacy of setting up a vision system grows when you think of what is actually of critical importance on a printed label. Of course the expiry date is critical, barcodes need to be scanned and also the marketing information might be imperative to the company brand. However if there are aspects like demarcation lines, then these could be seen as less critical in the inspection process.

These decisions are important and worth taking the time over; as for the sake of this upfront effort the speed of inspection can be radically changed. If you’re inspecting the whole contents of a large label to great precision, then it could easily take over a second. However if time is a critical consideration, then reducing the number of areas or fields being inspected and only inspecting them to the relevant level you, will minimalize disruption to the overall print time.

There are also many other setting options when it comes to Vision Systems, depending on what you’re trying to measure:

• Is the current print the same as the last?• Is the current print the same as the first?• Is the current print the same as the first (that was

also checked and verified by a person)?• Is the current print the same as the stored and

approved version?• Is the current print the same as the stored and

approved version, with the relevant pieces of data?

SURELY A LABEL’S JUST A LABEL?At its most basic form, the dictionary definition of a label is ‘a piece of paper, card, or other material attached to an object to identify it or give instructions or details concerning its ownership, use, nature, destination, etc.’, however what does this really mean when labeling something of significance such as a product used in the healthcare market?

Incorrect or faulty labels could affect any one of us in our everyday lives with little or no effect, however to an organization in the healthcare market, information given by a pharmaceutical or medical device company on a label could at best cause discomfort and at worst cause serious harm or even death.

Medical device and pharmaceutical organizations know labeling errors must be avoided at all costs, but they are still a major reason for FDA product recalls. The reality of faulty labels can have crippling effects on an organization - that don’t only hit the production floor.

• On-going compliance problems with the FDA & other regulatory bodies

• Risk to patient safety and litigation proceedings• Issues with the supply chain and recall logistics• Damage to brand reputation

Although there are many aspects of a label that can be controlled in advance, there will inevitably be errors that don’t arise until the printing process begins. Steps can be taken to avoid potential problems, such as increasing the number of times the product/label is inspected, but this means a vast increase in time, cost and a reliance on human intervention.

SO WHAT IS A VISION SYSTEM?A Vision System is a digital camera that takes an image of the printed label as well as software that compares that image against a control or sample. It can be located directly after the printer head, soon after, or at an entirely unrelated place to the printing process.

Inspection systems have been around for quite a while, but have only recently come into general usage. Wider availability and choice have made them a realistic option for manufacturers and the technology has also come a long way. Early systems were limited by resolution and read speeds, but now the speed is comparable to printing speed, and the resolutions have significantly increased (up to 400dpi).

The evolution of vision systems has developed further to integrate with label lifecycle management software, allowing manufacturers to manage and document their labels from design, approval, print and inspection through audit logs.

LABEL PRODUCTION UNDER THE MICROSCOPE: CAN VISION SYSTEMS SAFEGUARD LABEL INTEGRITY?

LABEL PRODUCTION UNDER THE MICROSCOPE • PAGE 4 OF 6 LABEL PRODUCTION UNDER THE MICROSCOPE • PAGE 5 OF 6

PRISYM ID World Class Label Management Software PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors. PRISYM ID is the market leader in providing validatable world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients.

LABEL PRODUCTION UNDER THE MICROSCOPE • PAGE 5 OF 6

MANAGING FAILURESSo what’s a failure and how do you manage it? It is important to determine what you will do when your Vision System detects a faulty label and how many errors or failures can be tolerated. Is it acceptable to tolerate some failures, but only a certain level? What about three consecutive failures? Or six from a complete batch? Or is just one error, one too many? The answer probably lies in the severity of the error and the impact it would have on the product and/or consumer.

Dependent on the type of label and the severity an error can cause, Vision Systems need to be programmed to work to a level that makes sense for your process. For example, if there’s one pixel missing through a horizontal line of text, then the person reading it might not even notice it and will still be able to understand every letter, word and meaning of that line. Or if the Vision System detects that the print is 0.1mm away from the center, it might be so slight that you wouldn’t need to take action. These two examples would be classed as false failures. Although false failures (where a label is rejected when it’s not actually faulty) are far better than false positives (a label that should be rejected is allowed to pass through), having too many false fails will slow the whole printing process down, and potentially impede an otherwise efficient process.

Once your Vision System has detected a faulty label, you need to decide what the process will be for removing it. Do you want to stop the process and remove the label for further inspection followed by controlled disposal? Is the printer capable of retracting the label and over-printing a large “X” to ensure the label would never be used on a product? Or would you need to track the label or product until it can be defaced or removed automatically?

With new developments in the technology surrounding vision, solutions are now available to manage the full process from label design, format ready-for-print labels, mask for inspection, inspect during/post print and finally audit log. This can be done on a global scale.

All label failures need to be recorded and auditable to comply with various country specific regulations. This can be done with paper records or with label lifecycle management software. By implementing vision as part of your label management process you may not even need to retain the faulty label since you’ll have a picture of the label showing the exact reason for the failure and the ability to zoom in or review remotely.

SUMMARYPreviously, label integrity involved a two-stage process, with the design and print process often being managed separately from the inspection process, either on an ad-hoc basis and/or off-site from the core print production. This two-stage process can be prone to human error and can cause unnecessary delays in the print process as errors that are identified need to be manually checked and corrected. Vision Systems integrated as part of a label lifecycle process offers significant power, compliance support and value when it comes to eliminating labeling errors.

But they must be implemented as part of a considered plan. Make sure you understand your requirements, market regulations and corporate brand guidelines and build the process to meet both the industry’s and your organization’s needs. It’s vital to ensure you’re equipped with all of the expertise required to implement a solution efficiently, so that it will achieve the right outcome. Remember; vision systems will only be part of the process, the ability to produce evidence if required upon an audit is the key to compliance.

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

www.prisymid.com | info@prisymid.com