Handheld spectrometers

Thermo Fisher Scientific in Wilmington, MA, offers several lightweight, handheld spectrometers designed to rapidly verify the identity of both raw materials and finished products. The company's TruScan and TruScan RM analyzers are based on Raman spectroscopy, and the microPHAZIR RX provides Near-Infrared (NIR) analysis. The analyzers are designed to support 21 CFR Part 11 compliance. No extensive training is required for operation, and the devices offer a simple pass/fail result by using proprietary algorithms for comparing authentic references with samples. Nondestructive testing can be done through clear packaging materials and can quickly identify substandard materials and drugs.

Pharmaceutical companies and regulatory agencies use the devices to verify raw materials and finished products, according to Duane Sword, senior director of strategic growth of Thermo Fisher Scientific's portable optical analysis business. "This method provides a more significant deterrent to counterfeiters since security measures based on packaging are often easily replicated by counterfeiters, whereas imitating the exact chemical formulation of a product is extremely difficult (and not cost-effective for counterfeiters)," he says.

Another way that a drugmaker can identify counterfeits in the supply chain is by using the services of an analytical laboratory. Manufacturers send a sample of suspected product for testing, and the medication and the packaging can be analyzed.

Using Intertek's nuclear magnetic resonance spectroscopy (NMR) services, for example, can determine whether the API is present, and if present, at what levels. These results can show whether the sample is "a genuine attempt to make a copy or simply a mock product with no intent to contain an active ingredient," says Phil Norman, vice-president of Intertek Chemicals and Pharmaceuticals Division, based in Manchester, UK. This information, says Norman, can indicate the sophistication of the counterfeit and also helps the drug manufacturer make important decisions relating to public safety. "The investigation can also reveal if the packaging is not consistent with the reference product and potentially provide a rapid option for screening out counterfeits from the marketplace," he says.

Sample investigation uses a range of analytical detection technologies, such as spectroscopy (NMR, Fourier transform infrared, NIR, and Raman); liquid chromatography–mass spectrometry; gas chromatography–mass spectrometry; and microscopy, depending on what is the best approach for the manufacturer's specific problem. This type of advanced screening is typically used in specialized cases where a high level of detailed analysis is required, Norman says. "These laboratory investigative techniques are not an alternative to portable analytical detection devices, rather they offer options for clients who require that further, more detailed step, in obtaining data to confirm that a sample is counterfeit," he says.

Examples of these situations, he says, include cases where authorities have seized product as it is imported into a country, as well as where non-governmental organizations have sourced medicines from online pharmacies as part of their own investigations, which show a high proportion of counterfeits. "It is concerning to observe that a proportion of samples arriving at Intertek laboratories for investigation have come from legitimate supply chains," he says.