No drug or pharmaceutical intermediate manufacturer today, anywhere in the world, is safe from the threat of counterfeiting. As recent events have shown, the threat affects not only finished pharmaceuticals but active ingredients and even pharmaceutical excipients.
In 2006, the documented cases of counterfeiting reported through the Pharmaceutical Security Institute (PSI) increased by 22%, according to Henk de Jong of Servier, who presented data at an April meeting of the International Pharmaceutical Excipients Council (IPEC). “If we lose trust in our pharmaceutical manufacturing and distribution chain, from the source of raw materials to the patients, then our whole system runs the risk of being undermined,” said de Jong.
However, he noted that prosecution efforts have intensified, with arrests for making counterfeits increasing 63% in 2006, and arrests for transporting fake drugs up 89%. As more drug companies develop anticounterfeiting strategies, they are also building portfolios based on a mix of imaging, coding, overt and covert security technologies. Here’s a very partial sampling of some of the latest anticounterfeiting technologies, of all types, that are now available.
The RxSpec 700Z is a tool that fits the FDA’s call for applying new technologies to distinguish legitimate drugs from counterfeits.
ASD, Inc., Boulder, Colo., www.asdi.com
Portable NIR Addresses Need for Speed
The 4-lb. Phazir RX offers a portable NIR solution allowing use of batteries that offer over 10 hours of operating life between charges. The devices allow analysis to be completed in 1-2 seconds and offer both qualitative and quantitative material analysis, including both identification and concentration level measurements. Polychromix, Inc., Wilmington, Mass., www.polychromix.com
TruScan is a handheld instrument which enables fieldbased identification of counterfeit pharmaceuticals. Already used worldwide for inspection of raw materials, this technology can instantly confirm or deny the identity of a given compound, even through blister packs or sealed bottles. Using Raman spectroscopy, TruScan can analyze and provide a highly accurate assessment of the validity of a pharmaceutical agent, even distinguishing between different polymorphs or generic versions of a drug. Ahura Scientific, Wilmington, Mass., www.ahurascientific.com
Simplified Sampling for Portable NIR
This manufacturer has worked with China’s SFDA to provide instrumentation for checking counterfeits. Offering a range of NIR, Raman, and NMR analyzers, the company recently introduced Mobile IR, a portable FT-IR spectrometer that can be used for both organic and inorganic materials.
Bruker Optics, Billerica, Mass., www.brukeroptics.com
SWIFT, short for Scanning With Incredibly Fast Times, enables per pixel measurement times as fast as 7ms. A 50,000 spectrum image can be obtained in six minutes. Horiba Jobin Yvon, Edison, N.J., www.jobinyvon.com
NIR, from Spectroscopy to Imaging
Chemical imaging combines traditional infrared spectroscopy with microscopic and macroscopic imaging capabilities, providing spatial and spectral information in a single measurement.
Malvern Instruments, Worcestershire, www.malvern.com
Covering All Bases
Guardmark was designed to provide the essential three levels of security: A covert recognizable image that can be magnified, encrypted data, and covert security measures. It is said to offer ultra high resolution images and optically varying effects, but it can also offer a multicolor digital signature and can be verified visually or by machine vision systems.
DataLase, Norcross, Ga., www.datalase.com
ROI within a year
Anchored by NanoInk’s NanoEncryption technology, NanoGuardian enables manufacturers to track, trace and authenticate the integrity of their products across the supply chain. Designed to work on the unit-dose level, nanoencryption is a layered pharmaceutical brand protection solution based on proprietary nanolithographic encryption technology. It incorporates semi-overt, covert and nanoscale forensic features. Authentication testing takes within 24-48 hours and is nondestructive. The encryption technology on each tablet is linked, directly, to batch-specific data, including serial number, manufacturing date, location and supply chain ship-to locations.
NanoInk, Chicago, Ill., www.nanoink.net
Bullish on RFID
Working with TAP Pharmaceuticals and Mayo Clinic, this manufacturer has expanded its pharmaceutical collaboration for track and trace systems based on RFID. Its platform uses an encrypted digital signature combined with a unique identifier at the manufacturing site to establish product authenticity, and that combination is decrypted and read at the dispensing site to validate authenticity.
3M Track and Trace, St. Paul, Minn., http://solutions.3m.com
The Enxue enterprise brand security system comprises labels each containing its own unique magnetic “fingerprint.” The material consists of randomly distributed miniature magnets. The magnets’ distribution provides a “fingerprint” that can be read using an inexpensive scanner. When the label needs to be verified, a handheld scanner is used to authenticate.
Singular ID, Singapore, www.singular-id.com
ePedigree or Traditional
The TRACELESS System uses forensically undetectable markers that can be placed into printed materials or product packaging and are detectable by secure, handheld readers. Med-Health Pharma LLC, a prescription drug re-packager, is using the system to protect its product packages (each holding between 10 and 30 doses) from counterfeiting. It can also work as part of an ePedigree system, as markers can be added to a barcode via thermal transfer and other basic printing techniques.
Kodak, Rochester, N.Y., http://graphics.kodak.com
As part of the single-source printing solutions for pharmaceutical manufacturers, this manufacturer provides brand protection with materials such as integrated micro-printing, holography, color-shifting inks, varnishes, taggants, threads, frangible papers, and digital watermarks.
Cortegra, Parsippany, N.J., www.cortegra.com
Security Foil Ofers Printing Flexibility
Recently developed for pharmaceutical primary packaging, the CPI Security Foil allows fine-line graphics, text, logos and micro-features to be applied directly to the surface of the aluminum during the rolling process. Because the images are embedded in the foil, they cannot be removed and because the high precision laser technology that created CPI Security Foil is not readily known or available on the market, it cannot be imitated or copied by counterfeiters.
Constantia-Hueck Foils Inc., Wall, N.J., www.hueckfoils.com
This vendor offers an integrated graphic studio that allows users enhance the brand image and that incorporate optical security elements, visible or hidden, that are difficult to imitate. Hologram Industries, Bussy-Saint-Georges, France, www. hologram-industries.com Encryption and Easy Authentication This manufacturer’s platform is based on security codes that can easily be authenticated, using a portable scanner, camera phone or the Internet.
Yottamark, Inc., Redwood City, Calif., www.yottamark.com