Tonawanda, NY based IMA Life North America (a division of IMA S.p.A., Bologna, Italy) and Tokyo based Atonarp Inc., a scientific instrumentation and technology company that designs & manufactures molecular analysis Smart Spectrometer™ announced in December 2017 an agreement where Atonarp supplies miniaturized co-branded mass spectrometry technology to IMA Life, a world leader in the field of aseptic processing and freeze-drying solutions. The co-branded mass spectrometer will be marketed under the brand name of “Quantum”. The Quantum solution was developed in collaboration between Atonarp, IMA Life, and a major pharma company with purpose-built quantitative instrumentation for the application of freeze-drying and aseptic processing. IMA Life will exclusively use and deploy Atonarp’s mass spectrometer technology in their production freeze-drying (lyophilization) solutions as process analytical tool (PAT) to monitor potential silicon oil contamination, primary and secondary drying endpoints, and perform in-line vacuum leak detection. The Quantum complies with all FDA, electric, emissions and safety regulations, namely 21CFR part 11 compliance as well as CE and UL certifications.
“Freeze-drying today requires increased process control, acceleration of the processing time and equipment upgrades with smart use of PAT tools to remain compliant with changing regulatory landscape. Atonarp’s innovative advanced software-configurable, Ethernet connected mass spectrometry solution and augmented with IMA Life’s in-depth knowledge of the lyophilization process make this goal feasible while supporting all industry requirements and challenges. Additionally, IMA Life’s existing lyophilization customers can benefit from Atonarp’s small footprint application-specific Quantum mass spectrometer as it can be retrofitted into already installed Freeze-Dryers”, said Ernesto Renzi, President, Sales & Marketing IMA Life North America.
“We are thrilled to have recently made our first Mass Spec unit delivery to IMA Life, the market leader and innovator of production Freeze-Dryers, to enable them to empower their customers with our co-branded state-of-the-art Quantum (Atonarp-Analyzed) technology and to boost their productivity by accurately identifying the critical secondary drying endpoint, hence, reducing the lyophilization processing time and increasing the freeze-dryer use efficiency. Additionally, Atonarp’s unique silicon oil detection* and protection solution enables end-users to detect and mitigate expensive batch contamination. This application was proven by Atonarp and IMA Life in collaboration with a major pharma company.”, stated Prakash Murthy, CEO of Atonarp.
Atonarp’s solution, the industry’s smallest quantitative mass spectrometer, consumes less than half-a-cubic-foot of space (0.01m3), and delivers outstanding stability due to the use of its rugged Faraday cup detector across the entire measurement dynamic range, making it ideal for retrofitting existing equipment while reducing overall total cost of ownership. Supporting Industry 4.0, Quantum is Analytics ready, plug-and-play with only an Ethernet connection and a single 24V power supply needed to access and operate the mass spectrometer. Out-of-the-box set-up takes only minutes and built-in software, which is configurable and highly intuitive, allows users to access the mass spectrometer through a simple web browser interface anywhere in the world.
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