灌装系统中灌装精度的影响因素分析--以柱塞泵式西林瓶灌装系统为例

Analysis of Factors Infl uencing Filling Accuracy in Filling Systems--Taking the Plunger Pump Type Penicillin Bottle Filling System as an Example

装量的精度控制是灌装机的重要指标之一,在进行灌装机PQ(性能验证)时应确认灌装机的精度,以确认该分装线的运行状态符合《药品生产质量管理规范(2010年修订)》(简称GMP)要求及生产需要,保证装量符合要求。无菌灌装不仅仅要满足严格的卫生要求,而且也要以很高的定量控制精度完成液体灌装,达到规定的灌装准确度。灌装机的精度除了与灌装机自身的规格型号、质量、性能以外,还与外界干扰因素有关。

The accuracy control of the filling volume is one of the important indicators of the filling machine.When conducting PQ(performance verification)of the filling machine,the accuracy of the filling machine should be confirmed to confirm that the operating status of the packaging line meets the requirements of the"Good Manufacturing Practice for Drugs(2010 Revision)"(GMP)and production needs,to ensure that the filling volume meets the requirements.Sterile filling not only needs to meet strict hygiene requirements,but also needs to complete liquid filling with high quantitative control accuracy to achieve the specified filling accuracy.The accuracy of a filling machine is not only related to its own specifications,quality,and performance,but also to external interference factors.