关于提升除菌过滤工艺药液灌装率的探讨

The exploration in the promotion of liquid filling rate by the sterile filtration process

目的基于本公司除菌过滤工艺,建立1套提升药液灌装率的优化方案。方法通过阐释国内外法规对除菌过滤的定义和要求,并结合公司现行除菌过滤程序,制定了1套硬件和操作程序的优化方案,并对该方案进行药液回收率评估和潜在失效模式与后果分析风险评估(FMEA)。结果对现行除菌过滤工艺优化后进行估算,每吨血浆可增加人凝血酶原复合物灌装量88瓶;人血白蛋白(10 g,20%)灌装量12瓶;静注人免疫球蛋白(2.5 g,5%)灌装量12瓶;每吨血浆增收3.72万元。该优化方案的FMEA风险评估结果为低风险。结论通过药液回收评估结果和FMEA风险评估结果能够证明该优化方案具有现实可行性,值得借鉴和推广。

Objective To construct an optimum design with the purpose of promoting the liquid filling rate by the sterile filtration procedure. Methods By way of elucidating definition and requirements of sterilizing filtration by regulations at home and abroad along with company procedure,an optimized protocol of hardware and operation procedure was designed and established. Also,a corresponding assessment was conducted by the liquid recovery method evaluation and Failure Mode and Effects Analysis（ FMEA）. Results An estimation was undertaken after refining the sterile filtration procedure. Each ton of plasma could sum up to 88 bottle units of human prothrombin complex,12 bottle units of human albumin（ 10 g,20%）,and12 bottle units of human immunoglobulin for intravenous injection（ 2. 5 g,5%）. The output value increased by 37 200 RMB per ton of plasma accordingly. Results from FMEA risk assessment demonstrated that the optimization program had low risk.Conclusion The results from the assessment by the liquid recovery and FMEA risk assessment prove that the optimization program had realistic feasibility and was worth learning and promoting.