Handheld device for validating raw materials
The instrument can be pointed at raw materials to identify and authenticate the chemical composition, even if the substance is in transparent packaging.
Underpinning the technology is Raman spectroscopy, which has been accepted by regulatory bodies as a valid means of verifying raw materials.
David Bugay, president of regulatory consultancy PharmAnalysis, said: "Recognition of the versatility and reliability of Raman spectroscopy by pharmaceutical regulatory bodies validates its use as a platform for the generation and use of pharmaceutically-based spectral libraries on the TruScan instrument for pharmaceutical material (active pharmaceutical ingredients, excipients, and drug product identification and authentication).
“I am excited about the possibilities the TruScan platform brings to materials management settings, anti-counterfeit measures, and general use in pharmaceutical research and development."
The latest incarnation of TruScan has expanded the Discovery Library and added a remote recertification of calibration package.
More than 4,000 items of raw materials used in counterfeit assessments and brand security are now included in the updated Discovery Library. This provides a database of chemical compositions that TruScan searches through if the material is not consistent with the expected contents.
In addition the recertification package has been added to TruScan. This is a remotely-controlled device to ensure that TruScan is calibrated correctly. The annual certification that is required by most current good manufacturing (cGMP) compliant facilities is also received by the recertification package.
Current users of TruScan can upgrade their software to include the upgraded Discovery Library and the recertification package at no extra cost.
Ahura believes these new tools will make it easier for pharmaceutical companies to tackle the difficulties posed by a complex global supply chain and counterfeit products.
Doug Kahn, Ahura’s CEO, said: "Pharmaceutical companies are under an increasing amount of pressure by the public and by pharmacopeia, such as the US, European and Japanese, and by regulators, such as the US Food and Drug Administration, to do more to ensure the purity and quality of their materials.
"At Ahura, we endeavor to help these customers in their efforts to maintain the safety and confidence of consumers of pharmaceutical and health products throughout the world."
