Friday, September 25, 2009

Using EDXRD to Look Inside the Box for Pharmaceutical Safety

By: Alan Clock, Senior Vice President, XStream Systems

Until recently the only true way to test quality and identify fraudulent medications was through laboratory analytical methods. The inadequacies of these solutions are obvious. They are expensive and cumbersome, and usually require sending to an outsourced laboratory.

Additionally, laboratory testing requires highly trained personnel and typically destroys the product. The testing method generally requires that the tester be cognizant of a potential problem in order to properly focus the analysis.

Unfortunately, in this day and age, by the time the suspicious product gets to a laboratory environment, it has most likely already been in the supply chain for some time all the while placing consumers at risk. Furthermore, following laboratory testing, the only element of certitude is the exact product that was tested, but does not reveal any information about other similar products in the supply chain.
The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside its package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain should not require any alterations to the product or the package. The model remedy would allow packaged drugs to remain intact and be returned to the supply chain.

The perfect solution would be readily deployable with placement of the solution at strategic points within the supply chain or deployed throughout without onerous costs or extensive implementation.

This type of innovative technology would provide a level of confidence that public safety is ensured. Bottom line . . . it checks to see what is inside the box.
The One new technology which fits the definition of the ideal solution in this challenge within the supply chain is known as Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product and ultimately minimizes the need for Track and Trace technologies as the only robust solution.

EDXRD transforms the process from looking at the outside of the box with Track and Trace to looking inside the box with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or that they are taking are safe and efficacious.

EDXRD was first proposed in the 1960's as a simple and high speed way to analyze remotely the crystalline structure of material within a container. EDXRD uses high powered X-Ray beams, thus generating very high penetration power. EDXRD was first tested as a detection tool in the late 1980's, for detection of explosives hidden within luggage/packages by Philips Medical Systems. EDXRD instruments function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses high powered X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in its mission of taking EDXRD through its evolution to a robust Molecular Screening tool. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System. This machine made a historically complex technology easy to operate for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

EDXRD’s first intended use is in the pharmaceutical industry where the XT250 material identification system detects fraudulent, adulterated or counterfeit drugs. The system also enhances quality in the manufacturing processes and provides consumer protection to the end user. With its superior X-Ray penetrating power, fast results and scalability, EDXRD can verify and detect materials in both small and large packages. Also, due to the vast flexibility of the technology, EDXRD will be well suited for many other markets.

In subsequent versions, now in development, EDXRD technology will incorporate high speed and larger capacity. These improved systems will increase the scale and capabilities of the technology and allow for high levels of integration within all stages of supply chains from manufacturing all the way through, including dispensing.

In summary, EDXRD provides a near perfect what you see is what you get (WYSIWYG) environment for the pharmaceutical industry. While Track and Trace technologies like RFID, Serialization, Taggants and Pedigree’s are important elements in supply chain security, EDXRD is the ultimate “completer” for patient safety and supply chain integrity. With an aggressive Molecular Screening Program which is offered by XStream Systems, each member of the pharmaceutical supply chain can minimize risk to the consumer, severely undermine liability risks of all members of the pharmaceutical supply chain, and thwart nefarious criminal enterprises that prey on the healthcare of others.

To learn more about XStream’s EDXRD technology, visit us at:

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