Nitrogen Dioxide sterilization follows log-linear microbial inactivation kinetics using Geobacillus stearothermophilus biological indicators [0.03%]
二氧化氮灭菌使用Geobacillus stearothermophilus生物指示剂遵循微生物失活的日志线性动力学
Thomas P Richards,Delaney Lisco,Tiffany Bianchi et al.
Thomas P Richards et al.
Aim: The primary purpose of this study was to determine the inactivation kinetics of Geobacillus stearothermophilus biological indicators (BIs) exposed to Nitrogen Dioxide (NO2) gas in the presence of humidity. ...
Economic Advantages of Original Container Closure Systems in Combination Product Development: Scenarios with Expert Validation and Industry-Quantified Cost-Time Savings [0.03%]
原始容器 closure 系统在组合产品开发中的经济效益：经专家验证和行业量化成本时间节省的场景分析
Mehul Desai,Daniel Waites,William Rich et al.
Mehul Desai et al.
Many on-body delivery systems (OBDSs) for subcutaneous (SC) delivery require a change in primary container closure system (CCS). This necessitates compatibility and stability testing with original packaging materials and distribution and as...
Reply to commentary on Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit [0.03%]
关于荧光颗粒生物计数与菌落单位培养计数不等同的评论答复论文
Mike Dingle,Jim Cannon,Chris Knutsen et al.
Mike Dingle et al.
Andreas Kindscher,Richard Denk,Chris Burns et al.
Andreas Kindscher et al.
This article focuses on describing control measures intended to reduce the risk of glove damages, which can be linked to contamination (particulate, microbiological). Specific risks involving gloves are analysed, assessed and minimized by m...
Viral Safety Reloaded-Insights from PDA's Virus Conference Around the Finalized ICH Q5A (R2) and NGS Workshop [0.03%]
病毒安全性再探讨-关于ICH Q5A（R2）最终定案的PDA病毒大会及NGS研讨会见闻与思考
Sebastian B Teitz,Andy Bailey,Johannes Blümel et al.
Sebastian B Teitz et al.
Mike Sadowski
Mike Sadowski
Richard Denk,Reinhold Maeck,Dirk Motzkus et al.
Richard Denk et al.
As markets for recombinant biologicals constantly grow, risks related to the biohazardous materials used are not yet always understood and assessed systematically. Thus, there is a strong need to systematically assess technical solutions in...
Settle plates with a diameter of 150 mm can be exposed to unidirectional airflow for up to 8 hours [0.03%]
直径为150mm的营养琼脂平板可在单向流中暴露长达8小时
Martin Falke
Martin Falke
Active and passive air monitoring is crucial for gaining knowledge about the microbial status of cleanroom environments for aseptic processing. Most agencies require active air monitoring of defined volumes in short time periods. However, a...
Donald C Singer,Deborah D Gross,Anthony M Cundell
Donald C Singer
The role of the microbiologist during product development of medicines ensures patient safety during clinical trials and also the continuation of microbial control through commercialization of the new product. Microbiological expertise, ins...
A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters [0.03%]
基于风险的在除菌级滤器工艺特定过滤器验证中的细菌截留试验期间进行使用前/灭菌后的完整性测试模拟的方法
Mariam Salamatian,Yvonne Gross,Magnus Stering et al.
Mariam Salamatian et al.
Pre-Use Post Sterilization Integrity Testing is implemented in sterile filtration applications by drug manufacturers using a risk-based approach with consideration of the stipulation in Eudralex volume 4, Annex 1, of the European Union Good...