Not many companies can claim to do business with big pharma, homeland security, Nigeria and the nutraceuticals industry at the same time. But it's all in a day's work for the Portable Optical Analysis Division of Thermo Fisher Scientific, maker of handheld instruments that identify and authenticate chemicals and raw materials without the aid of a scientist.
Originally designed to meet GMP standards for pharmaceutical companies, the technology has been adopted by the nutraceutical industry to identify amino acids, most vitamins and other raw materials used in dietary supplements. The rule is: If you can see the material with your eyes, you can scan it and know within about 30 seconds whether that material is what it says it is. It takes about six months to build a reference library of materials and to train workers to use the equipment.
"We're taking proven science that's been out there for 60 years and are packaging it in a way that's pretty analogous to the mobile-phone industry," said Duane Sword, vice president, marketing and international sales, Portable Optical Analysis Division, headquartered in Wilmington, Mass. The handheld devices, TruScan and microPHAZIR, were installed in some 300 GMP sites in the last two years – saving hundreds of scientists from boredom, said Sword.
The scanners are not meant to replace laboratories, but they do free up expensive employees from otherwise repetitive tasks. In the U.S., for example, of every 100 barrels of material that enter a facility, only 11 need to be inspected. But other countries have stricter rules, with 100 percent testing required in Taiwan, Japan, Australia and Germany to name a few, said Sword.
But Ahura Scientific's (the company's name before it was acquired by Thermo Fisher) foray into the nutraceuticals market wasn't planned. In 2006, it began business by selling post-generation chemical detectors to HAZMAT groups and pharmaceutical companies. "We had no intention at that time to build a GMP product," said Sword. "We were going after another market." That's when pharma approached the company with the handheld scanner idea – and a new business was born.
Then, two-and-a-half years ago, the company was invited to share its technology in the U.S. and European Pharmacopeia labs. While the nonprofit organizations don't buy or endorse products, they do publish best practices. This exposure helped expand the modest business, which at the time didn't have a marketing or advertising department, said Sword.
When Thermo Fisher, a $12 billion, 35,000-employee company, acquired Ahura in January 2010, it gave the company more capability and credibility to solve global customer problems. "More than I even expected, customers are looking to us as a trusted advisor," said Sword.
In fact, the Nigerian Food and Drug Administration has purchased several TruScan devices to combat chronic issues with counterfeit drugs, vaccines and poor supply-chain control in terms of quality and refrigeration. "Our product isn't only looking for blatant counterfeit products, it's also able to delineate an authentic product that's substandard or expired," said Sword. Last year, the U.S. FDA announced it was considering the technology to screen counterfeit drugs crossing U.S. borders.
Ultimately, Sword said the devices' success isn't as much about the technology as it is cost management. "We're solving a business problem. The cost of buying a handheld and maintaining it is much cheaper," than the same process with scientists in a laboratory, he said.
How the handheld scanners work
Uses Raman system for rapid raw material vertification. Raman, invented 65 years ago, shoots a laser at a chemical, solid, liquid or mixture that causes the bonds between the substances to vibrate. Each substance has a unique vibration. The software measures the energy released and delivers a PASS/FAIL decision within 30 seconds.
Uses NIR infrared system, an opposite technique from Raman, to identify pharmaceutical materials. NIR infrared shines light onto a substance to see what wavelengths the substance absorbs. This absorption is unique to every substance. The software delivers a PASS/FAIL decision within three seconds.