隧道烘箱确认的现场检查发现问题分析及改进对策探讨

Analysis of Issues Identified in On-Site Inspection of Tunnel Sterilization Oven Qualification and Discussion on Improvement Strategies

隧道烘箱是无菌制剂生产的关键设备,承担着灭菌、除热原等功能,通常是现场检查的重点关注对象。本文汇总了2021年世界卫生组织对我国疫苗生产企业的预认证现场检查和2020~2022年我国监管部门开展生物制品检查时针对隧道烘箱确认提出的典型问题,并分析问题产生原因,探讨整改措施,旨在为进一步提升隧道烘箱确认的科学性合理性提供借鉴。

Tunnel sterilization oven is a critical equipment for the production of sterile products,responsible for sterilization,pyrogen removal,and other functions.Therefore,its qualification is typically the focus of on-site inspections.This paper collects the typical issues raised during the pre-certification on-site inspection of domestic vaccine production enterprises by the World Health Organization in 2021 and the biological product inspections conducted by domestic regulatory authorities from 2020 to 2022 regarding tunnel sterilization oven qualification.It analyzes the root causes of these issues,and discusses rectification measures,aiming to provide references for further improving the scientific and rational qualification of tunnel sterilization ovens.