Ely, Cambridgeshire, 21st June, 2022: 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. For testing of 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. The new automated system will be on show at stand A2.330A at this year’s
Analytica. There will be an opportunity for event attendees to learn more about the
new system and its applications within the pharmaceutical industry in Ellutia’s
presentation being held on June 22, 2022 at 4.00 pm – 4.30 pm Hall B1 Stand No.
141
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 pre-screening 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.
To learn more, watch our video and visit www.ellutia.com.