Italian pharmaceutical manufacturer Abiogen Pharma has chosen Thermo Fisher Scientific's Antaris FT-NIR analytical system to perform raw materials characterisation in its manufacturing facilities.
With the complete Antaris FT-NIR platform fully installed, analysis of one container of raw material now takes Abiogen only two minutes at the point of raw materials receipt compared with traditional, time-consuming laboratory-based methods that take up to an hour to complete.
Deployment of Antaris FT-NIR has greatly reduced the company's instrument and chemical costs and increased productivity, leading to significant savings in labour and equipment. It has also enabled Abiogen to comply with regulatory guidelines requiring each individual raw material in a recipient to be characterised.
Previously Abiogen used separate methods for each raw material container including UV-Vis spectroscopy, IR spectroscopy and gas chromatography (GC). This resulted in high variable costs, including the cost of instruments, reagents and chemicals. Carrying out separate analyses for different raw materials also required a substantial amount of time in the analytical laboratory, taking scientists away from higher-level tasks and increasing their workload.
Since the implementation of Antaris FT-NIR, Abiogen has significantly increased productivity by eliminating the need to sample each raw material container separately, allowing laboratory workers to spend more time on r&d. The company has also achieved compliance with the European Pharmacopoeia 5th edition (2002), which specifies NIR spectroscopy as the best universal method for raw material testing.
The Antaris analyser allows analysis in the original packaging, eliminating the need to open the main container, and does not need to be operated within a designated sampling area. Furthermore, it is a non-contact and non-destructive technique, is highly reproducible and does not require any sample preparation.