TruScan & the Pharmaceutical Counterfeiting Problem
Check out the *NEW* TruScan RM - Lighter, Faster, Portable Anti-Counterfeiting
Counterfeit pharmaceuticals represent a violation of intellectual property rights and a serious public health risk. The World Heath Organization (WHO) estimates that roughly 10 percent of the world’s pharmaceuticals may be counterfeit or substandard, with some regions of the developing world with far higher rates.
Even in Europe and the United States, counterfeit drugs are increasingly entering the supply chain, particularly via internet sales. These drugs at best will not deliver the therapy they promise and at worst can endanger patients’ lives. Thousands of people, many of them young children, have lost their lives because they failed to receive needed treatment when they unknowingly took counterfeit drugs.
Efforts to combat counterfeit pharmaceuticals to date have largely focused on making the product packaging difficult to copy. However, in many places, drugs are not sold in their original packaging, and counterfeiters have become very adept at imitating even the most sophisticated packaging. One of the most promising approaches to removing counterfeit drugs from the market is authenticating the dosage form of the medication itself to confirm its chemical composition.
This Video has been developed by NAFDAC (Nigerian Agency for Food and Drug Administration and Control) and describes the use of TruScan in Nigeria for pharmaceutical anti-counterfeiting. To watch this short video click 'play':
Raman Spectroscopy for Pharmaceutical Anti-Counterfeiting Analysis
TruScan allows users without extensive chemistry training to perform highly reliable analyses to authenticate medication directly in the field, wherever pharmaceuticals are found in the market.
Using Raman spectroscopy, TruScan examines the chemical composition of all components of a pharmaceutical dosage — APIs, excipients, fillers, dyes, coatings — to create a unique spectrum or chemical “fingerprint” representing the specific authentic material. Any slight deviation from the original formulation will lead to a detectable change in the measured spectrum, making TruScan an ideal tool for rapid detection of counterfeit pharmaceuticals in the field.
Designed for Field Use
TruScan is rugged and lightweight, making it ideal for use in even the most harsh field conditions. Instruments can be administered via the internet, allowing field staff to easily upload new authentic references or to download reports to a secure central server as needed.
Accurate
TruScan compares the spectrum of a sample in question with an authentic reference and provides reliable “Pass” or “Fail” results within seconds. The majority of all drugs can readily be analyzed with TruScan with extremely high accuracy.
Cost-Effective
TruScan replaces costly tests typically conducted in the laboratory by trained chemists with a tool easy enough for anyone to use with minimal training. It enables a far greater number of tests to be conducted at a fraction of the cost as there are no consumables.
Click to download a copy of the TruScan Brochure (PDF)Click to download a copy of the TruScan Anti-Counterfeit Brochure (PDF)
TruScan offers an unparalleled solution for rapid, accurate raw material inspection:
- Easy to Use —Extremely simple operation with minimal training. No advanced education necessary.
- Fast implementation—Method creation with authentic sample is quick and easy (<1 hour per method)
- Accurate—Independent trials indicate that majority of pharmaceutical products can readily be tested with an extremely high degree of accuracy
- Rapid—Takes less than one minute to analyze an unknown
- Non-Contact— Scan through plastic, glass, blister packs, clear gel-caps without consuming any sample
- Versatile—Can analyze powders, tablets, and liquids
- Proven—Currently in use by pharmaceutical companies and government agencies across the world
- Convenient—With a 5-hour battery life and rugged construction, it is ideally suited for field monitoring of pharmaceutical supply
- Cost-effective—No on-going consumables cost
- Customisable— can be customised (device and/or software) to accommodate individual user needs
- Durable —Rugged and lightweight (<1.8 kg/4 lbs); design based on military specifications for ruggedness and field use
- Powerful —On-board computer with proprietary algorithms contains library of 3,000 reference spectra; users can easily and quickly add many more
- Scaleable —Network capable and designed for web-based administration of multiple units
- Always Up to Date —Software upgrades can be managed via internet or CF cards
Compliance Overview:Click for an overview of relevant global regulatory and commercial requirements, including UL intrinsic safety certification;
Click to download a copy of Thermo Scientifics Portable Optical Analysis Product Line Overview: 'Material Identification Solutions for Good Manufacturing Practice (GMP) Environments'
TruScan was designed to support 21 CFR part 11 compliance.
