Innovations at INTERPHEX Guide 2022 - 21

Figure 4. ults for 5cSt silicone oil leak detection in a production lyophilizer
studies for determining the optimal port location for
contaminant leak detection.
Conclusions and Future Direction
The work presented in this paper describes not only the
benefits of having a mass spectrometer but also details
a stepwise approach in the implementation of a mass
spectrometer for contaminant detection. With over 25
installations of the Quantum mass spectrometer on
production freeze dryers, IMA Life plans to be at the
References
1.
A. Ganguly, J. Stewart, A. Rhoden, M. Volny, N. Saad, Mass spectrometry in freezedrying:
Motivations for using a bespoke PAT for laboratory and production environment,
E.J.P.Biopharm.127(2018) 298-308
2.
A. Alexeenko, A. Ganguly, S. Nail, Computational Analysis of Fluid Dynamics in
Pharmaceutical Freeze-Drying, J. Pharm Sci. 98 (2009) 3483-3494.
forefront of this research effort and collaborate with
industry leaders to develop best practices for freeze
dryer leak detection.
IMA Life
Visit our website www.ima.it/pharma for more information.
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| 21

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