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生物荧光粒子计数器讨论:与 FDA 新兴技术团队举行的过程和环境监测方法工作组会议摘要。

A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team.

机构信息

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.

出版信息

PDA J Pharm Sci Technol. 2021 Mar-Apr;75(2):207-212. doi: 10.5731/pdajpst.2020.012419. Epub 2021 Jan 15.

DOI:10.5731/pdajpst.2020.012419
PMID:33452049
Abstract

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.

摘要

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。

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