相关实验视频
Updated: Sep 13, 2025

Determining Viral Disinfection Efficacy of Hot Water Laundering
Published on: June 21, 2022
工业VH2O2杀菌应用的设备和工艺验证:海报在2025年PDA周发布
1Life Sciences Equipment and Service - STERIS Corporation, Stoneville, NC, USA mary_vangaasbeck@steris.com.
蒸发过氧化 (VH2O2) 低温灭菌对于敏感的医疗器械,如预填注射器,是有效的. 这种方法正在获得监管支持,加强其在制药制造和设备灭菌中的使用.
科学领域:
- 消毒技术 消毒技术 消毒技术
- 医疗器械制造业 医疗器械制造业
- 制药科学 制药科学 制药科学
背景情况:
- 蒸发过氧化 (VH2O2) 已经在生物污染中使用了30多年,在医疗器械的终端灭菌中使用了20年.
- 越来越多的监管接受,包括ISO 22441和FDA的认可,加强了VH2O2杀菌的地位.
- 即将到来的标准 (EN 17180,ISO 11138-6) 和修订的指南 (AAMI TIR 17) 将进一步支持VH2O2的实施.
研究的目的:
- 为VH2O2杀菌器的设备和工艺验证提供指导.
- 为实施VH2O2灭菌工艺提供建议.
- 要突出对符合性,材料和VH2O2杀菌的文档的关键要求.
主要方法:
- 对VH2O2杀菌现有和即将推出的标准和监管指南的审查.
- 对设备和工艺验证的关键元素的分析.
- 专注于产品应用的材料兼容性和文档要求.
主要成果:
- VH2O2杀菌是一种经过验证和越来越受欢迎的方法,用于敏感的医疗设备.
- 全面的指导是可用的,并为流程验证和设备资格开发.
- 材料兼容性和文档对于成功实施VH2O2杀菌至关重要.
结论:
- 低温VH2O2杀菌是一种强大的,可靠的技术,用于敏感的药物输送设备.
- 遵守不断变化的标准和指导方针可确保有效且符合标准的灭菌过程.
- 这种方法促进了组合产品和医疗器械的安全和有效杀菌.
更多相关视频
07:00Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
14:17The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military
Published on: June 29, 2014
相关概念视频
Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...
Methods of Sterilization I: Physical Methods
Steam sterilization uses non-toxic, low-cost moist heat in the form of saturated steam under pressure, which is fast, microbicidal, and sporicidal, and quickly warms and penetrates fabrics. Autoclaves, or steam sterilizers, expose each item to direct steam contact for a predetermined time at the necessary...
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Physical Methods for Controlling Microbial Growth: Radiation and Filtration