Low-Temperature Plasma Decontamination of Pharmaceutical Fill/Finish Operations

药品灌装/涂饰操作的低温等离子体净化

• 批准号: 9138375
• 负责人: Kristin L Galbally-Kinney
• 金额: $ 22.99万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9138375
• 关键词: Address; Anti-Bacterial Agents; Atmospheric Pressure; Biological Testing; Biotechnology; Characteristics; Charge; Chemicals; Collaborations; Communities; Decontamination; Detection; Development; Devices; Diagnostic; Doctor of Philosophy; Dose; Drug Industry; Effectiveness; Environment; Equipment; Evaluation; Event; Excision; Flushing; Gases; Generations; Geometry; Goals; Government; Hour; Hydrogen Peroxide; Industry; Manufacturer Name; Measurement; Measures; Monitor; Nitric Oxide; Nitrogen; Optics; Output; Oxygen; Ozone; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Phase; Plasma; Process; Production; Property; Protein Structure Initiative; Reactive Oxygen Species; Research; Residual state; Risk; Sampling; Scientist; Singlet Oxygen; Small Business Innovation Research Grant; Sterilization; System; Technology; Temperature; Testing; United States Food and Drug Administration; Vaccines; Viral; cold temperature; design; efficacy testing; improved; industry partner; innovation; killings; manufacturing facility; microwave electromagnetic radiation; novel; operation; performance tests; physical science; prescription drug costs; programs; prototype; public health relevance; research and development; vapor

 DESCRIPTION (provided by applicant): The goal of the proposed SBIR program is to develop an innovative, atmospheric pressure microwave microplasma technology for the generation of charge-neutral reactive oxygen and nitrogen species to replace vapor Phase hydrogen peroxide (VPHP) in parenteral drug manufacturing facilities, including barrier isolator sterilization system and lyophilizers. The proposed replacement of VPHP will eliminate the significant shortcomings associated with residual VPHP following sterilization including its deleterious effects on biotechnology drug therapies and the challenge associated with reliably monitoring part per billion (ppb) levels of VPHP in a manufacturing environment without the need for a PhD level scientist to operate the chemical detection system. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, the industry Quality by Design (QbD) initiative, and Executive Order 13329 to modernize pharmaceutical manufacturing. The proposed R&D supports increasing the availability of critical drug products like vaccines and biotechnology drugs, the fastest growing segment of the industry. Improved manufacturing technologies will ultimately reduce the costs of prescription drug products.

 描述（由申请方提供）：拟定SBIR项目的目标是开发一种创新的大气压微波微等离子体技术，用于生成电荷中性的活性氧和氮物质，以替代胃肠外药物生产设施（包括屏障隔离器灭菌系统和冻干机）中的气相过氧化氢（VPHP）。VPHP的拟议替代品将消除与灭菌后残留VPHP相关的重大缺点，包括其对生物技术药物治疗的有害影响，以及与在生产环境中可靠监测十亿分之一（ppb）水平的VPHP相关的挑战，而无需博士级科学家操作化学检测系统。该开发针对USFDA过程分析技术（PAT）倡议，用于将质量纳入药品，行业质量设计（QbD）倡议和行政命令13329，以实现药品制造现代化。拟议的研发支持增加疫苗和生物技术药物等关键药品的供应，这是该行业增长最快的部分。改进的制造技术将最终降低处方药产品的成本。