Points to Consider for Aseptic Processing Part 1 January 2015无菌工艺.pdf

蒲公英翻译小组作品，仅供内部交流 Points to Consider for Aseptic Processing Part 1 January 2015 本文件翻译由蒲公英翻译团队组织完成 Page No. 翻译人员 1-6 1 观沧海 7- 12 2 Arya 13-20 3 老妖 21-30 4-5 鲁莽 31-37 6 一沙一叶 38-43 7 上善若水 44-52 8 展成 校对 绿野仙踪 蒲公英翻译小组作品，仅供内部交流 蒲公英翻译小组作品，仅供内部交流 Topic A.1: Airflow Velocity 主题A.1：风速 Problem Statement 问题描述 Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas? 关于灌装线或其他无菌工艺区，哪些地方需要风速测定？ Recommendation 建议 Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This is typically at a distance of 15-30 cm from the filter face. 风速测定点需考虑在有意义的地方进行，并考虑其重现性。通常在距离过滤器表面15-30cm 的 地方。 Rationale for Recommendation 建议的理由 The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g., areas where products, product contact packaging components, and product contact surfaces are exposed) is to ensure adequate airflow to protect the materials from external airborne contamination and to verify continued compliance with qualified conditions. The adequacy of the environme nt can be determined, in part, from airflow velocity and airflow pattern studies, and from particulate matter monitoring (at the working position). 在单向流区域进行风速测定 （如：产品、直接接触产品的包装材料和产品接触的暴露表面等区 域）主要是确保有足够的气流来保护物料受到外部空气的污染并确认环境能持续符合要求。可 以确定环境是否适宜，从某种程度上，通过风速、气流流型研究以及悬浮粒子监测（在工作位 置）来确定。 Accurate measurements can be taken and changes over