Wide Dynamic Range Hydrogen Peroxide Sensor for Sterilization Cycle Development

描述（由申请人提供）：缺乏无菌保证导致大多数药品召回，导致成本增加和重要药物（如流感疫苗）严重短缺。这个拟议的第一阶段研究计划将展示基于可调谐二极管激光吸收光谱（TDLAS）的气相过氧化氢（VPHP）传感器在屏障隔离器循环开发中的使用。该传感器将使灭菌周期、设备鉴定和连续监测的开发更加快速和可靠，这将显著提高无菌保证和药品质量。在拟议的项目中，物理科学公司将演示超灵敏VPHP和水蒸气检测，并将灭菌周期参数和隔离器材料加载模式与生物指示剂杀灭率相关联。这个小企业创新研究第一阶段项目解决了对实时测量制药灌装和包装系统中微量过氧化氢（VPHP）的方法的迫切需求。具体的创新是使用基于高分辨率光谱的传感器，可以在整个循环中提供关键灭菌参数的超灵敏检测，并允许调查实际填充/完成参数（例如包装材料VPHP的摄取）。VPHP是一种常用的灭菌剂，必须仔细监测以确保无菌保证，并且在药品灌装操作之前必须完全去除，因为它对药品有有害影响。目前，市面上还没有一种传感器可以在整个灭菌和吹扫周期内提供连续的VPHP测量。拟议的传感器将提供这种能力，允许实时过程监控和控制。这一发展的目标是USFDA过程分析技术（PAT）倡议，以建立药品质量，增加关键药品（如疫苗）的可用性，并降低处方药产品的成本。该研究将为验证灭菌过程以及改进和鉴定屏障隔离器和蒸汽过氧化氢发生器提供新的工具。该传感器将改善隔离器监测，减少制剂加工过程中微生物污染的机会，提高药品质量、疗效、可用性，减少浪费，降低制造成本。如果被证明是有效的，我们估计VPHP传感器在未来十年的市场潜力可能超过500个单位和2500万美元。该传感器有可能通过更快地开发灭菌周期和更快地批准药物填充/完成操作，为制药行业节省100万美元。

DESCRIPTION (provided by applicant): 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.