A、B厂家除菌过滤器在人血白蛋白除菌工艺中的适用性研究

Study on the Applicability of A,B Manufacturer's Filter in the Process of Human Albumin

为考察A、B厂家除菌过滤器在人血白蛋白除菌工艺中的适用性,本文对比A、B厂家除菌过滤器与人血白蛋白之间兼容性、可提取物及细菌截留的结果,并对A、B厂家除菌过滤器在人血白蛋白实际生产过程中及产品质量数据进行分析。结果显示,A、B厂家除菌过滤器与人血白蛋白具有良好的兼容性,可提取物均来自滤膜及其支撑骨架,有效细菌截留挑战水平均≥107 cfu/cm2,使用不同厂家除菌过滤器后产品质量数据均符合要求,在实际生产过程中B厂家过滤压力小于A厂家。通过对除菌过滤器验证结果及实际生产数据的比对分析,发现A、B厂家除菌过滤器能够达到除菌过滤要求,均适用于人血白蛋白生产过程中的除菌过滤,B厂家更适用于人血白蛋白除菌过滤。

In order to investigate the applicability of A and B sterilization filters in the sterilization process of human albumin,this paper compares the results of compatibility,extractables and bacterial retention between A and B sterilization filters and human albumin,and analyzes the data of A and B sterilization filters in the actual production of human albumin and the quality of the products.The results showed that the compatibility between the decontamination filters of A and B manufacturers and human albumin was good,the extractables came from the membrane and its supporting skeleton,the effective bacterial retention challenge level was≥107 cfu/cm2,and the product quality data of the decontamination filters of the different manufacturers met the requirements,and the filtration pressure of the B manufacturer was smaller than that of the A manufacturer in the actual production process.Through the comparison and analysis of the validation results of the sterilization filters and the actual production data,it is found that the sterilization filters of manufacturers A and B can meet the requirements of sterilization filtration,and are suitable for sterilization filtration in the production of human albumin,and manufacturer B is more suitable for sterilization filtration of human albumin.