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除菌过滤器(0.2μm+0.1μm)","bipura-dsr-chu-jun-guo-lv-qi-0-2-m-0-1-m",{"id":166,"title":167,"slug":168},158,"Bipura®DER 除菌过滤器(0.45μm+0.1μm)","bipura-der-chu-jun-guo-lv-qi-0-45-m-0-1-m-0",[170,174],{"id":171,"title":172,"slug":173},165,"PRET™ SP14","pret-sp14",{"id":175,"title":176,"slug":177},164,"PRET™ SP 气体除菌过滤器(0.2μm)","pret-sp-qi-ti-chu-jun-guo-lv-qi-0-2-m",[179],{"id":180,"title":181,"slug":182},168,"PREF™ TP 系列过滤器","pref-tp-xi-lie-guo-lv-qi",[184,188],{"id":185,"title":186,"slug":187},171,"BiviroX® Pre 除病毒预过滤器","bivirox-pre-chu-bing-du-yu-guo-lv-qi",{"id":189,"title":190,"slug":191},170,"BiviroX® 除病毒过滤器","bivirox-chu-bing-du-guo-lv-qi",[193],{"id":194,"title":195,"slug":196},175,"BiFluxa®Ⅱ代平板式切向流过滤膜包","bifluxa-dai-ping-ban-shi-qie-xiang-liu-guo-lv-mo-bao",[198,202,206],{"id":199,"title":200,"slug":201},76,"验证服务","yan-zheng-fu-wu",{"id":203,"title":204,"slug":205},112,"工艺开发","gong-yi-kai-fa",{"id":207,"title":208,"slug":209},111,"仪器服务","yi-qi-fu-wu",{"breadCrumbs":211,"content":212,"cover":213,"createTime":214,"description":215,"id":216,"nextDetail":217,"preDetail":218,"relatedNews":222,"relatedNewsDetailList":225,"slug":242,"sort":23,"status":43,"title":243,"type":28,"updateTime":244},null,"\u003Cp>为了规范和指导无菌药品生产中除菌过滤技术的应用，确保药品的安全性、有效性和质量稳定性，国家药品监督管理局组织制定了《除菌过滤技术及应用指南》（以下简称《指南》，自\u003Cspan>2018\u003C/span>年\u003Cspan>10\u003C/span>月\u003Cspan>1\u003C/span>日起施行）。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan style=\"font-size: 10.5pt;\">《指南》基于当前的认知与科技水平起草，旨在提供一个全面的框架，帮助药品生产企业、工程设计、设备制造以及药品监管单位的人员在无菌药品生产中选择、设计、验证和使用除菌过滤系统。本文将详细解读《指南》的内容，并根据其要求分析除菌过滤器的选择原则。\u003C/span>\u003C/p>\u003Cp style=\"text-align: center;\">\u003Cstrong>《指南》解读\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>1. \u003C/strong>\u003C/span>\u003Cstrong>除菌过滤技术概述\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">除菌过滤技术是指采用物理截留的方法去除液体或气体中的微生物，以达到无菌药品相关质量要求的过程。这一过程主要依赖于除菌级过滤器的使用，其孔径通常在\u003Cspan>0.22\u003C/span>微米或更小，以截留包括细菌和支原体在内的微生物。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>2. \u003C/strong>\u003C/span>\u003Cstrong>过滤工艺及系统设计\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">在设计过滤工艺时，需要根据待过滤介质的属性和工艺目的选择合适的过滤器，并确定过程参数。例如，用于支原体去除的过滤器孔径通常为\u003Cspan>0.1\u003C/span>微米，而除菌过滤则使用\u003Cspan>0.22\u003C/span>微米的过滤器。此外，过滤系统的设计还需考虑以下因素：\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>过滤器的选择\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：选择过滤器时，应充分考察其与待过滤介质的兼容性，避免对产品质量产生不利影响。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>过滤膜面积\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：合理的过滤膜面积需经过科学评估，过大可能导致产品收率下降、成本上升，过小则可能延长过滤时间、导致堵塞甚至产品报废。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>系统结构\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：应注意避免卫生死角，确保过滤系统结构的合理性。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>工艺参数\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：根据实际工艺要求确定过滤温度范围、最长过滤时间、过滤流速、灭菌条件等参数。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>3. \u003C/strong>\u003C/span>\u003Cstrong>除菌过滤验证\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">除菌过滤验证包括除菌过滤器本身的性能确认和过滤工艺验证两部分。性能确认主要关注过滤器的微生物截留能力，而工艺验证则结合具体的待过滤介质和工艺条件进行，包括细菌截留试验、化学兼容性试验等。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>4. \u003C/strong>\u003C/span>\u003Cstrong>完整性测试\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">除菌过滤器使用后，必须立即对其完整性进行测试并记录。使用前，应通过风险评估的方式确定是否进行完整性测试，以及测试哪一级过滤器或者两级过滤器都要进行检测，并确定在过滤器灭菌前还是灭菌后进行\u003C/p>\u003Cp style=\"text-align: center;\">\u003Cstrong>除菌过滤器的选择\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\"> 根据《指南》的要求，选择除菌过滤器时需考虑多个因素，以确保过滤器的有效性和安全性。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>1. \u003C/strong>\u003C/span>\u003Cstrong>过滤材料与相容性\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">选择过滤器时，应确保过滤材料与被过滤成分之间具有良好的相容性。过滤材料不得因与产品发生反应、释放物质或吸附作用而对产品质量产生不利影响。常见的过滤材料包括聚醚砜（\u003Cspan>PES\u003C/span>）、醋酸纤维素（\u003Cspan>CA\u003C/span>）和聚偏氟乙烯（\u003Cspan>PVDF\u003C/span>）等。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>聚醚砜（\u003C/strong>\u003Cspan>\u003Cstrong>PES\u003C/strong>\u003C/span>\u003Cstrong>）\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：蛋白吸附率低，流速快，适合支原体保护和无菌过滤。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>醋酸纤维素（\u003C/strong>\u003Cspan>\u003Cstrong>CA\u003C/strong>\u003C/span>\u003Cstrong>）\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：适用于各种溶液的过滤，具有良好的通量和流速。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cstrong>聚偏氟乙烯（\u003C/strong>\u003Cspan>\u003Cstrong>PVDF\u003C/strong>\u003C/span>\u003Cstrong>）\u003C/strong>\u003Cspan style=\"font-size: 10.5pt;\">：适合高通量过滤，化学稳定性强。\u003C/span>\u003C/p>\u003Cp style=\"text-align: justify;\">在选择时，应根据待过滤介质的特性和工艺要求，选择最合适的过滤材料。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>2. \u003C/strong>\u003C/span>\u003Cstrong>完整性检测\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">除菌过滤器的完整性检测是确保其有效性的关键步骤。常用的完整性检测方法包括气泡点试验和单向流试验。通过这些试验，可以检测过滤器的完整性，确保其在使用过程中不会发生泄漏。\u003C/p>\u003Cp style=\"text-align: justify;\">在选择过滤器时，应优先选择能够进行准确完整性检测的过滤器，并定期进行完整性测试，以确保其持续有效。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>3. \u003C/strong>\u003C/span>\u003Cstrong>灭菌与微生物截留能力\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">除菌过滤器必须能够经受\u003Cspan>121℃\u003C/span>的蒸汽灭菌，并且微生物截留试验合格。灭菌后的过滤器应确保无菌，以避免对下游系统造成污染。\u003C/p>\u003Cp style=\"text-align: justify;\">在验证过滤器的微生物截留能力时，通常采用缺陷型假单胞菌作为标准挑战微生物，因为其直径和长度适中，能够代表产品及生产过程中发现的最小微生物。如果缺陷型假单胞菌不能代表最差条件，则应选择其他足够细小的细菌进行挑战试验。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>4. \u003C/strong>\u003C/span>\u003Cstrong>过滤器类型与孔径\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">根据待过滤介质的特性和工艺要求，选择合适的过滤器类型和孔径。例如，\u003Cspan>0.1\u003C/span>微米的过滤器通常用于支原体去除，而\u003Cspan>0.22\u003C/span>微米的过滤器则用于除菌过滤。\u003C/p>\u003Cp style=\"text-align: justify;\">在选择过滤器时，还应考虑其使用场景和便捷性。一次性使用的过滤器通常提供预灭菌包装，使用方便快捷，适合无菌药品生产中的使用。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>5. \u003C/strong>\u003C/span>\u003Cstrong>认证与检测报告\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">选择除菌过滤器时，应查看其认证和检测报告，确保设备符合相关生物安全性标准。例如，\u003Cspan>USP\u003C/span>（美国药典）和\u003Cspan>EP\u003C/span>（欧洲药典）等标准对过滤器的性能和安全性有明确要求。\u003C/p>\u003Cp style=\"text-align: justify;\">此外，还应关注过滤器的接口兼容性，确保其与现有设备和工艺系统的兼容性。例如，\u003Cspan>GL45\u003C/span>接口适用于实验室常规接收容器，能够确保使用时的便利性和安全性。\u003C/p>\u003Cp style=\"text-align: justify;\">\u003Cspan>\u003Cstrong>6. \u003C/strong>\u003C/span>\u003Cstrong>过滤器供应商管理\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">药品生产企业在选择除菌过滤器供应商时，应进行严格的审核和管理。这包括审核供应商提供的验证文件和质量证书，确保其提供的过滤器是除菌级过滤器。同时，还应与供应商签订质量协议和产品变更控制协议，以确保过滤器的质量和稳定性。\u003C/p>\u003Cp style=\"text-align: justify;\">在生产过程中，如果采用不同生产商提供的过滤器，或同一生产商的不同材质或成膜工艺的过滤器，应分别进行验证和测试，以确保其符合工艺要求。\u003C/p>\u003Cp style=\"text-align: center;\">\u003Cstrong>碧途生物 让过滤更专业\u003C/strong>\u003C/p>\u003Cp style=\"text-align: justify;\">碧途生物是一家专注于过滤材料研发与生产的创新企业\u003Cspan>, \u003C/span>由材料科学家和生物制药行业工艺专家共同创办。我们不仅供应高质量产品，还提供全方位的技术支持和服务，协助客户解决生产难题并优化工艺流程。\u003C/p>\u003Cp class=\"image-paragraph align-center\" data-align=\"center\">\u003Cimg src=\"https://www.bitootech.com/uploads/20241114/22114852e1314dfd023433401345906d.jpg\" height=\"\" width=\"471.328px\" data-align=\"center\" style=\"width: 471.328px; max-width: 100%; height: auto;\">\u003C/p>\u003Cp style=\"text-align: center;\">\u003Cspan style=\"font-size: 10px;\">Fig.1 碧途生物自主研发生产除菌滤膜\u003C/span>\u003C/p>\u003Cp style=\"text-align: left;\">\u003C/p>\u003Cp class=\"image-paragraph align-center\" data-align=\"center\">\u003Cimg src=\"https://www.bitootech.com/uploads/20241114/bfb4a265125d54313257b9b7ee0f088c.png\" height=\"\" width=\"471.328px\" data-align=\"center\" style=\"width: 471.328px; max-width: 100%; height: auto;\">\u003C/p>\u003Cp style=\"text-align: center;\">\u003Cspan style=\"font-size: 10px;\">Fig.2 除菌滤膜电镜图\u003C/span>\u003C/p>\u003Cp style=\"text-align: center;\">\u003C/p>\u003Cp class=\"image-paragraph align-center\" data-align=\"center\">\u003Cimg src=\"https://www.bitootech.com/uploads/20241114/f1a46981bd988d61bf5124b34fe34f82.png\" height=\"\" width=\"842px\" data-align=\"center\" style=\"width: 842px; max-width: 100%; height: auto;\">\u003C/p>\u003Cp>\u003Cspan style=\"font-size: 10px;\">\u003Cbr>\u003C/span>\u003C/p>\u003Cp style=\"text-align: center;\">Fig.3 除菌滤膜电镜图\u003C/p>\u003Cp style=\"text-align: left;\">\u003Cspan style=\"font-size: 14px;\">    \u003C/span>\u003Cspan style=\"font-size: 10.5pt;\">Bipura ™系列预过滤及除菌级过滤器采用非对称PES膜材制备而成。该系列滤芯因其独特的非对称膜材孔道设计，在保证过滤效果的前提下，具有高流速、高载量、低蛋白吸附等特点。应用于培养基预过滤、除菌过滤，缓冲液除菌过滤，产品除菌过滤、生物负荷控制等工艺过程，致力于为客户带来良好的过滤解决方案。\u003C/span>\u003C/p>\u003Cp style=\"text-align: left;\">\u003Cspan style=\"font-size: 10.5pt;\">\u003Cbr>\u003C/span>\u003C/p>\u003Cp class=\"image-paragraph align-center\" data-align=\"center\">\u003Cimg src=\"https://www.bitootech.com/uploads/20241114/f39ee5e5ee2ec0def92a886e57c9b113.png\" height=\"\" width=\"1064.66px\" data-align=\"center\" style=\"width: 1064.66px; max-width: 100%; height: auto;\">\u003C/p>\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cbr>\u003C/span>\u003C/p>","https://cdn.biocaftea.com/dnweb/1e373e5f00dd4669652c037bb7710137.png",1767773495,"《除菌过滤技术及应用指南》解读与除菌过滤器选择分析",114,{},{"id":219,"slug":220,"title":221},113,"bi-tu-sheng-wu-yuan-man-wan-cheng-a-lun-rong-zi","碧途生物圆满完成A轮融资",[223,224],110,82,[226,235],{"cover":227,"createTime":228,"description":229,"id":224,"relatedNews":230,"slug":232,"sort":23,"status":43,"title":233,"type":25,"updateTime":234},"https://cdn.biocaftea.com/dnweb/e5b7b85a55e0a1ae4b9711e2fb918482.png",1765976946,"勇往职前，共创未来 | 碧途生物BD团队招聘进行中",[224,231],109,"yong-wang-zhi-qian-gong-chuang-wei-lai","勇往职前，共创未来",1767943453,{"cover":236,"createTime":237,"description":238,"id":223,"relatedNews":239,"slug":240,"sort":23,"status":43,"title":238,"type":28,"updateTime":241},"https://cdn.biocaftea.com/dnweb/a3ba9d98dea760d3603cd46efab9ff73.png",1767497236,"膜科学与技术发展简史",[231,224],"mo-ke-xue-yu-ji-shu-fa-zhan-jian-shi",1767943470,"jie-du-yu-chu-jun-guo-lv-qi-xuan-ze-fen-xi","解读与除菌过滤器选择分析",1767943316,1789897342708]