Products
TruScanRM & microPHAZIR Rx for rapid authentication of suspected counterfeit or substandard pharmaceuticals in the fieldTruScanGP testing pillsTruScan Classic for for rapid authentication of suspected counterfeit or substandard pharmaceuticals in the fieldmicroPHAZIR Rx for rapid authentication of suspected counterfeit or substandard pharmaceuticals in the fieldTruScanRM for rapid authentication of suspected counterfeit or substandard pharmaceuticals in the field

TruScan, microPHAZIR & the Pharmaceutical Fake Drug Problem (Handheld Raman and NIR)

 

Fake drugs (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 fake drugs 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/fake drugs from the market is authenticating the dosage form of the medication itself to confirm its chemical composition.

Click to view PDFClick to download a copy of the Thermo PAI Fake Drug Testing Technical Note

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':

 

Watch the You Tube Video of famous US News Journalist, Dan Rather on: Fake Drugs in Africa

To view further articles and video's on Combating the Fake Drug issue click here

Raman Spectroscopy - TruScan, TruScanRM, TruScanGP for Pharmaceutical Fake Drug 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.

The new Thermo Scientific TruScan RM is our lightest, fastest and most portable handheld instrument for rapid authentication of suspected counterfeit or substandard pharmaceuticals in the field. TruScan RM allows users with less than a day of training to perform highly-reliable analysis wherever pharmaceuticals are distributed.

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.

TruScan offers an unparalleled solution for rapid, accurate raw material inspection:

  • Easy to operate by non technical users
  • Field deployment possible in days
  • Portable handheld and weighs less than 2 lb (0.9kg)
  • Rugged - design based on military specifications for field use
  • Delivers clear Pass/Fail result in seconds
  • Fast method development in as little as 1 hour
  • Non-contact, non-destructive scan through plastic, glass, blister packs, clear gel-caps
  • Rechargeable battery permits field use for up to four hours
  • Performs reliable analysis on powders, tablets, and liquids
  • No on-going cost for consumables or service
  • Battery operated instrument (4 hours on a single charge)
  • Supported 24/7/365 live customer support; extended service, support and warranty programs available


Click to view PDFClick to download a copy of the TruScanRM Brochure (PDF); Learn more by visiting the TruScanRM page

Click to view PDFClick to download a copy of the TruScanGP Brochure (PDF) Learn more by visiting the TruScanGP page

Click to view PDFClick to download a copy of the Thermo PAI Fake Drug Testing Technical Note


Compliance Overview:

Click to view PDFClick for an overview of relevant global regulatory and commercial requirements, including UL intrinsic safety certification
 

Click to view PDFClick to download a copy of Thermo Scientifics Portable Optical Analysis Product Line Overview: 'Material Identification Solutions for Good Manufacturing Practice (GMP) Environments'


TruScan & TruScanRM are designed to support 21 CFR part 11 compliance.

NIR Spectroscopy - microPHAZIR Rx for Pharmaceutical Fake Drug Analysis


microPHAZIR RX is a handheld NIR analyser that enables on-the-spot verification of pharmaceuticals at the point-of-need. Weighing 2.75 lb (1.25 kg), the analyser is battery powered and completely self-contained for portable analysis.

  • The microPHAZIR RX analyser offers provides rapid, accurate counterfeit detection:
  • Rugged portable handheld solution
  • Lightweight 2.75 lb (1.25 kg) device
  • Intuitive Color LCD screen
  • Rechargeable Li-Ion batteries
  • Long battery operation
  • Simple operation, no experience required
  • Minimal training required
  • Instantaneous (1-2 seconds) results
  • Non-destructive measurement
  • Results are logged in a on-board database
  • Fully programmable via PC software
  • Ready-to-use library with 100s of ingredients
  • Integrated barcode scanner
  • 21 CFR Part 11 compliant
  • IQ/OQ/PQ qualification package
  • USP 1119 & EP 2.2.40 compliant
  • EMEA & PIC/S Compliant
  • Traceable standards available
  • Validation services available


microPHAZIR Rx is designed to support 21 CFR part 11 compliance.

Click to view PDFClick to download a copy of the microPHAZIR Rx Brochure (PDF)


To view further articles and video's on Combating the Fake Drug issue click here

 

 

 

 

 

 

 

 

 

 

 

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