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Physical Sciences Inc (PSI) has been awarded a research program from the National Institutes of Health (NIH) to develop an ultrasensitive laser-based sensor to accurately monitor ppbv to ~1000 ppmv concentrations of vapor phase hydrogen peroxide (VHP) following decontamination of parenteral drug manufacturing facilities where biologic and cellular therapeutics must be packaged under aseptic conditions.

The need to accurately monitor VHP after sterilization is critical to minimize its deleterious effects on biological drug products and potentially cause shortages of high-demand biologic pharmaceuticals. In addition, batch losses due to VHP contamination results in higher drug costs and reduced revenue. Optical sensors based on tunable laser absorption spectroscopy (TLAS) exist that can monitor VHP concentrations with limits of detection in the ppbv range. However, this approach is prone to interference from water vapor that is present at concentrations several orders of magnitude larger than the VHP concentrations during the aeration phase of decontamination. This impairs the accuracy of existing optical-based commercial instrumentation, and makes it challenging to accurately quantify VHP at ppbv levels.

PSI is demonstrating an innovative optical sensing approach to quantify VHP that suppresses interference from water and enable accurate quantification of ppbv levels of VHP even in the presence of >10,000 ppmv water. This approach will also have a broader dynamic range than existing commercial sensors can achieve, enabling monitoring of the VHP throughout the entire sterilization cycle. It will enable pharmaceutical manufacturers to minimize the loss or reduction in efficacy of biologic and cellular therapy pharmaceuticals due to oxidation from residual VHP.

For more information, contact:

Mr. William Kessler
Vice President, Applied Optics
kessler@psicorp.com
Physical Sciences Inc.
(978) 689-0003