Analysis of Issues Identified in On-Site Inspection of Tunnel Sterilization Oven Qualification and Discussion on Improvement Strategies
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.
万方数据
维普
