口服固体制剂生产过程中滤袋使用和管理的GMP要求

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<p>口服固体制剂生产过程中滤袋使用和管理的GMP要求</p><p>流化床双室过滤袋WSGPRO200</p><p>口服固体制剂生产过程中可能与产品直接接触的滤袋通常包括：流化床干燥/制粒机上的集尘过滤袋，流化床包衣机的微丸拦截过滤袋，湿法制粒机锅盖上的呼吸器，压片或胶囊填充设备附属的抽尘滤袋等生产设备使用的滤袋。因为多数滤袋均使用在流化床设备上，以流化床上的滤袋为例进行讨论滤袋使用和管理的GMP要求。</p><p>流化床滤袋按种类又可分为：单室过滤袋，双室过滤袋，多室过滤袋和金属过滤器等；因其直接接触产品，完整性，洁净状态和使用的符合性对产品收率，含量，均匀度，粒度等质量特性有直接影响；同时，因流化床设备的特殊性，要求其过滤袋应有消除静电等安全要求，因此，口服固体制剂生产过程中滤袋的使用和管理尤其需要关注。金属过滤器通常被看作流化床与物料直接接触的部件之一，其选型要求，使用管理，清洁方法，相关验证的策略以及必要的共线生产评估应和设备结合一并考虑。</p><p>滤袋的选择：滤袋的制作单位应具备相应的加工资质或技术能力，滤袋原材料的提供单位应提供滤袋的材质说明，证明其符合GMP用途，还应提供具体的技术参数。滤袋的尺寸规格，材质应符合国家或行业标准。根据物料的情况选用适当的材质，原则上除考虑透气性外，还应考虑漏粉率，防止物料消耗过大，如涤纶长纤维材质的滤袋，分厚薄两种，应正确使用；而流化床干燥制粒机必须使用含有导电性质的过滤袋，导电性过滤袋的电阻应符合安全规定。流化床包衣机的拦截过滤袋还需要考虑孔径大小，保证过滤掉细小的粉尘，截留住微丸。</p><p>滤袋的管理：使用部门应做好滤袋的领取，发放，清洗，消毒，使用管理。使用部门应建立滤袋检查记录，对滤袋进行编号，必要时实行专人管理。滤袋实行定置存放，并按不同的品种，规格分类，建议做编号或标识；使用部门应建立滤袋检查记录，并制订相应的检查流程，对滤袋的安装，使用，清洁，状态进行检查记录，特别是清洁和使用次数或时限需要重点记录，作为评估滤袋寿命的关键参数。</p><p>滤袋的存储：滤袋接收后应确认规格尺寸，材质等符合工艺要求，按品种，数量进行编号，并标识，定置存放，存放环境与制粒环境保持一致</p><p>滤袋的使用：使用部门应制定滤袋的使用管理程序。使用前按品种，规格领用，确认滤袋完好并记录；安装，操作结束确认滤袋的完整性，并建立检查记录，如发现滤袋有破损，按偏差处理。</p><p>滤袋的清洁：使用部门应制定详细的滤袋清洁方法，消毒规程及清洁周期。滤袋初次使用应进行清洁，消毒。流化床的过滤袋建议每个活性物料使用一套专用过滤袋，并对滤袋的清洁效果进行相关的清洁验证，并按验证结果，确定清洁方法，存储期限，选用合适的清洁剂；清洁时按规定流程，严格分品种独立清洗。滤袋清洗，晾干后按品种，规格分别整理，标识洁净存储期限，定置存放。</p><p>滤袋的附件：对于悬挂滤袋的连接件，不锈钢金属环，不锈钢卡宾扣等，应视同滤袋的使用和管理要求类似；材质符合GMP要求，坚固结实，不容易脱落，损坏，能够耐酸碱洗涤；卡宾扣需有防脱装置。</p><p><br/></p><script 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口服固体制剂生产过程中滤袋使用和管理的GMP要求_常州力马干燥科技有限公司