The Ellutia 800 Series Thermal Energy Analyser (TEA) has become the industry standard for nitrosamine detection thanks to its selectivity and sensitivity for nitroso compounds
To test pharmaceutical drugs, the 800 Series TEA can be interfaced to a chemical stripping system that allows for rapid testing of apparent total nitrosamine content (ATNC). This quickly gives an accurate result for the total nitrosamine content of a sample, showing both volatile and non-volatile components.
Until recently, users were required to manually manage the handling of the hazardous chemicals used in the chemical stripping system. Now, Ellutia has produced a fully automated process for better safety, higher throughput and user friendliness.
The 800 Series TEA interfaced to the CTC PAL for automated chemical stripping can be used to quickly and accurately measure apparent total nitrosamine content.
According to the European Medicines Agency (EMA), nitrosamines are "chemical compounds classified as probable human carcinogens on the basis of animal studies."
In the EU, all marketing authorisation holders of medicines containing chemically synthesised active pharmaceutical ingredients (APIs) and, now, biological active substances, are required to conduct a risk assessment to evaluate the possibility of nitrosamines being present.
As part of the risk assessment, any sample showing any amount of nitrosamine must be reported to the national competent authorities for nationally authorised products or EMA for centrally authorised products.
Ellutia’s total nitrosamine prescreening solution offers the pharmaceutical industry a simple, accurate, and reliable test. This delivers a clear pass/fail result for ATNC in minutes, allowing samples to be immediately cleared for processing or sent for further testing.
Any positive sample can then be further analysed by GC or LC, which can be coupled to the screening system, where volatile nitrosamines such as NDMA (N-Nitrosodimethylamine) can be separated and quantified.
The Ellutia ATNC test allows pharmaceutical manufacturers to meet the requirements of the EMA risk assessment without needing to outsource testing of raw materials or of products at different stages of manufacturing.
Andrew James, Marketing Director at Ellutia, said: “The pharmaceutical industry was affected by some high-profile product recalls in which nitrosamines had been detected. This led to the introduction of guidance and regulations requiring manufacturers to check for nitrosamines in their products, which can be formed or introduced at different stages of the manufacturing process."
"Our new automated screening solution offers a fast, clear, reliable result for ATNC, without the need for special training or handling. Many pharmaceutical manufacturers are already using the previous model and are keen to get their hands on the automated system to improve their workflows. We are confident that this system will become instrumental for them in eliminating the nitrosamine concern.”
To support continued growth, Ellutia has appointed a new Financial Director, Neil Green, who has spent the last 15 years in a senior role at Price Bailey, offering accountancy consultancy and planning to SMEs, private clients and regional, national and international businesses. In his new role, Neil will have responsibility for Ellutia's financial strategic direction.