Coding Ink and Substrate Materials are Crucial to Pharmaceutical Serialization

Home / Coding Ink and Substrate Materials are Crucial to Pharmaceutical Serialization - August 6, 2017 , by admin

There are laws that regulate pharmaceutical inkjet coding. One of the new rules is in serialization, which is part of ensuring that the printing is being done correctly and is legible from the production line to the customer and throughout the drug supply chain. If anything happens to interfere with the process, there is the potential of a bottleneck, back up in the process, issue.

There are three main challenges that are rarely known when it comes to serialization:

1) Decoding & Verifying
2) Substrate Materials
3) Product Handling

The DQSA (the Drug Quality and Security Act, has burdened the industrial ink coding world with more challenges that most people are unaware of in regard to laser, thermal inkjet, or thermal-transfer ribbon printing.

They are now burdened with the challenge of putting down more data and embedding gradable and readable 2D Datamatrx barcodes. Most commonly, their purposes, these relates to printing on labels, vials, bottles, syringes, or folded boxes.

What’s the difference between reading and grading?

When you read a barcode at your grocery store or pharmacy, or scan it with your smartphone, you’re essentially verifying the presence of said barcode that you can see and that a scanner can easily read. If it can be read, that should be good enough, right? However, it is not.

The DSCSA (the Drug Supply Chain Security Act) and the FDA (the Food and Drug Administration) have deemed that the “Verification of the product identifier may occur by using human-readable or machine-readable methods”.

The EU (European Union) says a grade of C is imperative to their Falsified Medicines Directive.

The three biggest Pharmaceutical wholesalers want “B” grade quality printing.

While all that relates mostly to reading, that is no longer enough. High-grade verifying is crucial in today’s digital tech society. Scanners will likely be replaced by cameras that operate at high speeds that can read and verify pharmaceutical codes rapidly.

There are six categories in grading standards.

1) Contrast
2) Modulation
3) Grid Non-Uniformity
4) Axial Non-Uniformity
5) Fixed Pattern Damage
6) Unused EC

These standards are used to determine the grade for the barcode. Each of these categories are given a numeric grade from A to F, then the lowest grade of the six determines the overall barcode grade. That grade needs to be at least a B or close to that.

While any printer can handle that, there are still some hidden challenges that remain in decoding and verifying barcodes.

What are some hidden challenges?

• Thermal Inkjet Printer – A perfect black serialized code can be printed via this process on a dark blue label, but the vision system will give it a low grade each time because it lacks contrast, one of the grading parameters.

• Laser–A laser coder can perfectly code white characters on a red background that would pass without a problem, but the cameras read in the grayscale format, so that printing couldn’t even be graded because the camera won’t see it at all.

• Substrates – Substrates are inherently not created equal. For example, a carton or a label that doesn’t have a good mineral layer will cause the codes to bleed (lowering the grade), problems with bonding, or light fastness where the colors fade, lighten, or otherwise change over time. Such matters require testing across materials to ensure a higher grade.

• Changes in substrates – Even a slight change or an inconsistent substrate (defects in a substrate, etc.) can result in the false assumption that your printing system is failing. That isn’t always the problem. Sometimes it’s the substrate, which leads to the conclusion that you should test and check with your vendors in case they have changed their materials before printing.

These are only four of the grading challenges facing printing companies that provide coding services for pharmaceutical companies today. It’s important to be aware of these instances and ensure that your printing gets the required grade for your printed materials and customers.

Speed and graphics are crucial to the grading process of industrial inks for coding (BTW: Get your Ink from Needham Ink). It’s not about getting new printing equipment. It’s about knowledge and understanding of how the printing technology works on various substrates, the vision systems, and the host material. Getting those all under control creates the ideal grade “B” for pharmaceutical coding.

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