SBIR/STTR Award attributes
Project Summary/AbstractPhysical Sciences Inc. (PSI) is developing a sensor that can accurately measure ppbv to ~1000 ppmv concentrations of vapor phase hydrogen peroxide (VPHP). This sensor will be used for inline monitoring of VPHP concentrations of barrier isolators used for fill/finish operations of parenteral drugs. The capability to accurately and sensitively monitor VPHP is critical, as residual concentrations as low as 30 ppbv have been shown to oxidize biologics and reduce their efficacy. The need to accurately monitor VPHP 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 VPHP contamination results in higher drug costs and reduced revenue. Optical sensors based on tunable laser absorption spectroscopy (TLAS) exist that can monitor VPHP concentrations with limits of detection in the ppbv range, however the TLAS approach is prone to interference from water vapor which is present at concentrations several orders of magnitude larger than the VPHP concentrations during the aeration phase of decontamination. This impairs the accuracy of existing optical-based commercial instrumentation, and makes it challenging to accurately quantify VPHP at ppbv levels. In addition, the sensors are not robust for manufacturing scale operations, requiring highly trained users and frequent recalibration. In the Phase I program, PSI demonstrated an innovative sensing approach that was capable of quantifying 38 ppbv of VPHP in the presence of 20,000 ppmv water. This approach has broad dynamic range from ppbv to 1000 ppmv – far greater than current commercial sensors, enabling monitoring of VPHP concentrations throughout the entire sterilization cycle with a single instrument. During the Phase II program, a portable prototype sensor based on the benchtop experiment will be fabricated and tested in the laboratory and in field testing on a barrier isolator and a vacuum freeze dryer. Field testing will occur at a company that builds barrier isolators for the pharmaceutical industry. Laboratory studies will demonstrate a detection of ≤ 10 ppbv in 60 seconds of averaging, and the capability to measure up to ~1000 ppmv of VPHP. Software will be developed to automate control of the sensor, enabling unattended operation – a critical element in the path towards commercialization of the technology. Unattended operation of the sensor will be demonstrated in field testing by the end of the program.
