Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1799.
PDA J Pharm Sci Technol. 2021 Mar-Apr;75(2):207-212. doi: 10.5731/pdajpst.2020.012419. Epub 2021 Jan 15.
The Process and Environmental Monitoring Methods Working Group, composed of members from industry and instrument manufacturers, met with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting technology, a type of rapid microbiological method. This is a summary of the meeting including submitted questions and answers, and the Process and Environmental Monitoring Methods Working Group's understanding of the FDA Emerging Technology Team's points made.
工艺和环境监测方法工作组由来自工业界和仪器制造商的成员组成,与 FDA 新兴技术团队举行了会议,讨论了生物荧光粒子计数技术,这是一种快速微生物方法。这是会议的总结,包括提交的问题和答案,以及工艺和环境监测方法工作组对 FDA 新兴技术团队提出的观点的理解。