IMA Life and Atonarp enter supply agreement of co-branded mass spectrometer for pharmaceutical lyophilisation applications
Tonawanda, New York based IMA Life North America and Atonarp, a scientific instrumentation and technology company that designs and manufactures molecular analysis Smart Spectrometer; announced in December 2017 an agreement where Atonarp supplies miniaturised co-branded mass spectrometry technology to IMA Life, a global specialist 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 (lyophilisation) 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 lyophilisation process make this goal feasible while supporting all industry requirements and challenges.
"Additionally, IMA Life’s existing lyophilisation 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- Analysed) technology and to boost their productivity by accurately identifying the critical secondary drying endpoint, hence, reducing the lyophilisation 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.