A lack of sterility assurance results in the most recalls of pharmaceutical products, causing increased costs and critical shortages of important drugs (such as the influenza vaccine). This proposed Phase I research program will demonstrate the use of a tunable diode laser absorption spectroscopy (TDLAS) based vapor phase hydrogen peroxide (VPHP) sensor for barrier isolator cycle development. This sensor will enable more rapid and reliable development of sterilization cycles, equipment qualification and continuous monitoring, which will significantly improve sterility assurance and drug quality. During the proposed program Physical Sciences Inc. will demonstrate ultra-sensitive VPHP and water vapor detection and correlate sterilization cycle parameters and isolator material loading patterns to biological indicator kill rates. This Small Business Innovation Research Phase I project addresses an immediate need for a real-time means for measuring trace amounts of vapor phase hydrogen peroxide (VPHP) in pharmaceutical filling and packaging systems. The specific innovation is the use of a high-resolution spectroscopy-based sensor that can provide ultra-sensitive detection of critical sterilization parameters throughout the cycle and allow investigation of real-world fill/finish parameters (such as packaging material uptake of VPHP). VPHP is a commonly used sterilant which must be carefully monitored to ensure sterility assurance and it must be completely removed prior to pharmaceutical filling operations due to it deleterious effects on pharmaceutical products. Currently there is no commercially available sensor that can provide continuous VPHP measurements throughout the entire sterilization and purge cycles. The proposed sensor will provide this capability, allowing real-time process monitoring and control. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, increasing the availability of critical drug products (such as vaccines) and reducing the costs of prescription drug products. The research will provide a new tool for validating sterilization processes and for improving and qualifying barrier isolators and vapor hydrogen peroxide generators. The sensor will improve the isolator monitoring and allow fewer opportunities for microbial contamination during processing formulations, improved drug quality, efficacy, availability and lower manufacturing cost due to reduced waste. If proven effective, we estimate that the market potential for the VPHP sensor over the next ten years could exceed 500 units and $25M. The sensor has the potential to save the pharmaceutical industry $M by enabling more rapid development of sterilization cycles and by enabling more rapid FDA approval for drug fill/finish operations. ? ? ?
