摘要
为考察PVDF过滤器除菌过滤工艺在预定工艺条件下的可靠性及其对轮状病毒疫苗生产用水解乳蛋白-MEM培养液产品质量的影响。本研究通过对PVDF 0.2μm滤芯在细菌截留、润湿完整性、化学兼容性、可提取物/浸出物、吸附性等项目进行验证,并考察除菌过滤对水解乳蛋白-MEM培养液p H和渗透压的影响。结果表明,除菌级测试用过滤器在测试条件下能有效截留挑战水平≥10~7 cfu/cm^(2)的B.diminuta(ATCC 19146)的挑战菌悬液;最小允许泡点值为0.328 MPa;最大允许扩散值为9.4 mL/min;除菌滤器与培养液具有良好的化学兼容性;可提取物均来自滤芯组成成分;过滤前后水解乳蛋白-MEM培养液的总氮含量无显著性差异(P>0.05)。在实际应用中除菌过滤后水解乳蛋白-MEM培养液p H值显著高于除菌过滤前pH值(P<0.05),除菌过滤前后水解乳蛋白-MEM培养液渗透压值无显著性差异(P>0.05)。综上,PVDF滤芯适用于轮状病毒培养液的生产。
In order to investigate the reliability of PVDF filtration process and its effect on the quality of hydrolyzed milk protein-MEM culture solution for rotavirus vaccine production under predetermined conditions.In this study,the bacterial retention,wetting integrity,chemical compatibility,extractable/extractives,and adsorbability of PVDF 0.2μm filter was verified,and the effects of bactericidal filtration on pH and osmotic pressure of hydrolyzed milk protein-MEM culture solution were investigated.The results showed that under the test conditions,the filter can effectively trap the challenging bacteria suspension of B.diminuta(ATCC 19146)with the challenge level≥107 cfu/cm^(2),and the minimum allowable bubble point is 0.328 MPa.The maximum allowable diffusion value was 9.4 mL/min.The bactericidal filtration had good chemical compatibility with the culture medium,and the extracts were all from the filter components.There was no significant difference in the total nitrogen content of hydrolyzed milk protein-MEM culture medium before and after filtration(P>0.05).In practical application,the pH value of hydrolyzed milk protein-MEM culture medium after filtration was significantly higher than that before filtration(P<0.05),but the osmotic pressure value of hydrolyzed milk protein-MEM culture medium before and after filtration had no significant difference(P>0.05).In conclusion,PVDF filter is suitable for the production of rotavirus culture medium.
作者
韩丹
赵帅
徐海蓉
张攀高
白彩虹
谢澎
赵阳
Han Dan;Zhao Shuai;Xu Hairong;Zhang Pangao;Bai Caihong;Xie Peng;Zhao Yang(Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730000,China)
出处
《广东化工》
2025年第14期118-121,共4页
Guangdong Chemical Industry
关键词
PVDF滤芯
除菌过滤
工艺验证
PVDF filter element
bactericidal filtration
process verification
作者简介
韩丹(1987-),女,山西忻州人,医学生物工程师,大学本科,主要研究方向为疫苗生产。
