Technology

How does InfraTrac’s coded polymer layer work?

How is this technology different?

Inert ingredients are added to the polymer as it is rolled into film for shrinkwrap, neckbands, blister packs, and so on. There isn’t one “secret ingredient” that a determined evildoer could discover. Instead, there are millions of possible codes, chemical codes. The coding system (patent pending) can hold information about where the product was created, and by whom. And since it’s a wrap layer that you can’t put back on, it’s tamperproof, too.

Can the wrap be verified in the field?

Yes. There are handheld spectrometers, and a field operator (not a scientist) can use them to compare samples to the library of your real products.

What does it cost?

What is the cost of the additives InfraTrac uses to tag my wrap?

Practically nothing. These aren’t gold-coated nanospheres or tiny manufactured taggants, they are codes made from small amounts of multiple widely-available chemicals. And with dozens of FDA-friendly safe ingredients to choose from, pharmaceutical and food manufacturers have enough tagging combinations to stay ahead of counterfeiters.

How does InfraTrac’s in-dose fingerprinting work?

How is this technology different?

Various analytical techniques can tell a lab scientist whether two substances match closely enough to be considered the same. Many require time, lab equipment, training, and may even destroy the sample. InfraTrac uses near-infrared and Raman spectroscopy, a fast, non-destructive technique, makes it accessible to non-scientists, and lets you use your existing formulation as a tag. Any substance that doesn’t match your tag isn’t yours.

Do I need new FDA approval if I vary my excipients?

No. InfraTrac can detect formulation changes that fall within the SUPAC Level 1 guidelines, available on the FDA Web site. More on SUPAC-1.

Do I need new EU approval for excipient changes?

Probably not. The European Union allows a +/-10% band of variation for inactive ingredients. See the Note for Guidance: Manufacture of the Finished Dosage Forms at the European Commission Web site.

Can InfraTrac be used in the field?

Yes. There are handheld NIR spectrometers, and a field operator (not a scientist) can use them to compare samples to the library of your real products.

What does it cost?

What is the cost of the additives InfraTrac uses to tag my substances?

Nothing. Although you can use additives with InfraTrac, the beauty of this method is that you don’t have to. InfraTrac can use your existing inactive ingredients as a taggant. So if your formulation includes a percent more of lactose or a percent less of magnesium stearate, that serves as a proprietary tag. And with dozens of FDA-approved excipients to choose from, pharmaceutical manufacturers have enough tagging combinations to stay ahead of counterfeiters.

About Near-infrared (NIR)

What is NIR spectroscopy?
History of NIR
NIR spectroscopy is a well-established technique for detecting counterfeits.
NIR spectroscopy is so sensitive that it can distinguish sites of manufacture.

Cost of scanners

Near-infrared spectrometers cost about the same as RFID equipment. Lab versions cost about $50,000, and hand-helds are plummeting to a few thousand dollars. Like other computer equipment, the prices keep falling as the technology advances.

Can you offer us a package deal, equipment included?

Yes, or you can use your existing equipment with our keys and data library.

Where does this technology fit in?

Are different spectroscopy suppliers ok?

Yes, InfraTrac’s techniques work with any spectrometer. It is increasingly possible to compare across instruments using the SPC file format.

How does InfraTrac work with RFID (or other e-pedigree technologies)?

We see this technology as a complement to RFID or other e-pedigree technologies. Radio frequency tags manage the supply chain, tracking pallets and packages. We make sure that what’s inside the packages is your genuine product. You don’t need InfraTrac at every stage in your supply chain, although you may be so vulnerable to counterfeiters that you decide to check more than once.

How good is InfraTrac’s in-dose fingerprinting? Can it detect good fakes as well as crude ones?

Yes. Some other analytical techniques can detect only crude fakes, not good fakes, but InfraTrac can detect both. Furthermore, other techniques are typically slower and more cumbersome, and may destroy the sample in the process of analyzing it, by burning it or dissolving it. InfraTrac is a convenient, effective solution for detecting crude fakes, but it is even better as a solution for distinguishing good fakes. If a fake contains diluted or expired active ingredient, or is repackaged with an incorrect formulation, or is just a gray market version, InfraTrac will find it.

My product is counterfeited, but crudely. Do I need InfraTrac?

You can get away with other solutions for now, although they may be less efficient. Even visual inspection will catch some fakes. But look at the spam model: it’s an arms race. You can expect the counterfeiters to get better and better, and you don’t want to play catch-up in a dangerous market with catastrophic public relations consequences.

Can’t I just buy a spectrometer?

You can analyze contents with a spectrometer, but you can’t tag and track chemical fingerprints without InfraTrac’s patented technology. And with InfraTrac, you can detect counterfeits with an operator, not a scientist.

Intellectual Property

Will InfraTrac learn our formulations?

No, InfraTrac will not be able to figure out your formulation, nor do you need to tell us. InfraTrac technology will not allow anyone to reverse engineer your formulation. The operator version of InfraTrac contains even less information, since its goal is simply to report a match or a fake. To protect your IP further, you may choose to license our technology, and set up the libraries yourself, using our software keys.

Getting Started

How do I find out if InfraTrac will work for my products?

InfraTrac will perform a proof-of-concept test using your materials. We set up a library that determines your batch variation. If your counterfeits fall outside that band of variation, InfraTrac will find them. Contact us to set up a test, at info@infratrac.com.




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