Pharmaceutical Manufacturing Instrumentation
Recent roll-out of the USFDA Quality-by-Design (QbD) guidelines, the Process Analytical Technology (PAT) initiative, and guidelines from the International Committee on Harmonization (ICH) all rely upon a science-based understanding of pharmaceutical manufacturing processes to improve product quality and manufacturing efficiency. This understanding requires new analytical measurement techniques and instrumentation. PSI is on the forefront in developing and applying these new tools.
We focus on aseptic fill/finish manufacturing applications including manufacturing operations that utilize barrier isolators and lyophilization, often used to process the fastest growing segment of the pharmaceutical industry, biopharmaceuticals. Our product portfolio consists of:
- LyoFlux: TDLAS-based Water Vapor Mass Flow Rate Monitor
- Lyo3D: Optical Coherence Tomography Freeze Drying Microscopy (OCT-FDM)
- Mini-Lyo: 7-vial freeze dryer for emulating process scale-up operations
- Head Space Analyzer (HSA): TDLAS-based vial headspace pressure analyzer
- VPHP Monitor: TDLAS-based Vapor Phase Hydrogen Peroxide Sensor
For more information, contact Bill Kessler , (978-738-8253).