Thermo Fisher Scientific has launched a new handheld X-ray fluorescence analyser called IonicX XRF Analyzer to help pharmaceutical and biopharmaceutical manufacturers to verify the identity of ionic salts in warehouses within seconds.
According to the life sciences company, the technology used by the IonicX XRF Analyzer helps save time and money that is otherwise used on conventional analysis techniques. This is achieved by directly putting laboratory-grade capabilities into the hands of raw material and quality control managers irrespective of their location in the manufacturing facility, said Thermo Fisher.
The IonicX handheld XRF analyser is said to have the capability to identify and authenticate the five most-used salts in biopharmaceutical and pharmaceutical manufacturing. Included in these are sodium chloride (NaCl), potassium chloride (KCl), magnesium chloride (MgCl2), calcium chloride (CaCl2) and sodium hydroxide (NaOH).
As per Thermo Fisher, the capability to identify the salts can bring down the time and cost of pharmaceutical materials testing and at the same time will help in keeping up with regulatory compliance and rigorous quality standards.
The IonicX XRF Analyzer is claimed to adhere to good manufacturing practices (GMP) and the 21 CFR Part 11 requirements. Specifically designed for the pharmaceutical industry, the X-ray fluorescence analyser is said to be easy-to-use, portable, fast, and needs minimal sample preparation according to Thermo Fisher.
The wi-fi enabled IonicX XRF Analyzer is designed to be lightweight and its small footprint enables easy portability.
Thermo Fisher product manager Kyle Dumke said: “Compliance and efficiency are top concerns for raw materials managers, but thoroughly analyzing all incoming materials takes time and resources.
“Pharmaceutical companies purchase these salts in large amounts and are required to test each container to meet strict regulatory requirements. That’s a tedious and costly process when using standard wet chemistry lab or near-infrared (NIR) benchtop testing. With a portable XRF analyzer, testing can be done right on the warehouse floor in seconds.”
Earlier this month, Thermo Fisher wrapped up its previously announced acquisition of an active pharmaceutical ingredient (API) manufacturing plant from GlaxoSmithKline (GSK) located in the Cork, Ireland. The acquisition will help expand its API manufacturing capabilities, said Thermo Fisher.
