制药设备随着科学技术的进步,设备已向机电一体精密化方向发展,如触摸屏、PLC、伺服电机、PID控制阀等自动化部件,设备维护人员要有相应的技术素养,才能解决设备稳定运行的各类因素。确保设备的稳定,主要是设备的基因(前期管理:选型、采购、安装)的品质以及组合精度严重左右着生产中的产品质量;然后是操作,工人不熟悉设备性能而造成的误操作、延误维护检修等问题对产品质量构成不良影响也屡见不鲜。
为了降低设备发生故障的几率,让生产设备处于高效稳定运转状态,为设备可以持续生产出高质量的产品提供保证。需要强化全员参与设备管理(TPM),选择合适的生产线硬件、增强维修工技术水平,提高设备综合效率、节能减排,使设备性能达到最优状态。
•培训是增强维修技术水平的有效途径,掌握科学技术的普及培训,在生产过程中显得尤其重要。
•前期设备选择、安装、调试是稳定的基因(案例3),选择不当引起投资浪费、技术指标又达不到工艺参数标准、后继维修费用高。
生产过程中的提高设备综合效率,主要有以下的特点:
A:立足于本岗位的设备、设施提问题、查隐患、抓整改,“敢于暴露问题,力求解决问题”“整改、评价”良性循环,改善现有的设备性能;
B:科学技术是第一生产力,掌握科学技术的劳动者是生产力中最根本的力量。无论生产工具(设备)多么先进,都要由人来制造和使用,它只是生产力发展水平的一个标志。不断提高认识和技能,成为多面手员工,灵活运用设备功能;
C:操作工人、检修工必须掌握“四懂”、“三会”的要求,运用必要的改进或预防措施(CAPA)、5W、持续改进提高(PDCA)工具,解决影响产品生产、质量及降低生产成本的因素;如一些小的部位可以由操作人员自主保养,而不是一出现故障就找维修人员。当然,如果发生大的故障,应该马上找维修人员,此时操作人员可以在旁边协助,以加快维修的进程,同时也可以学到一些维修的知识。
D:维护、检修、改善提升活动的情况进入管理系统,有历史档案记录、电子化数理统计分析,为完善提供基础数据。实行“计划检修”、避免待设备发生故障,进行检修,产品质量、产量就会受到不良的影响。
E: 对全员参与设备维护、检修工作中取得效果进行总结、评奖,提高员工参与TPM活力。
结语:如何降低设备故障率,避免API及制剂生产过程中的,莫名的跑料、质量异常的现象而引起的经济损失?因为在生产前,设备通过维护、清洗、消毒后的各部件状态不一定还原到验证初始状态,就容易出现跑料、质量异常等问题。从而特别要关注生产前,进行“保持持续的验证状态”的确认,纠正措施和预防措施(CAPA)落实到位,降低不必要经营的经济损失。
问题来了我们按计划进行了设备确认, 在实际生产时工艺参数还不能够在许可的范围内波动,数据完整性符合性达不到要求。强化了全员参与设备管理(TPM),增强维修工技术水平, 但设备故障率还不少。
主要原因设备的设计,“质量源于设计”,如联动线逐道烘箱、干热灭菌器的升降温速度、温度均匀度指标达不到工艺需求的参数。设计不到位典型案例,如1000+温度加热管上热量,没有让气流充分给交换出来,引起升温慢、加热管过热容易烧坏的诱因。后期生产过程中,你如何折腾技术参数都难以符合要求。设备设计、选择、安装、调试是生产稳定的基因。FAT时对关键技术参数进行确认,是否符合工艺参数许可范围内波动,数据完整性符合要求。设备设计、选择、安装、调试是生产稳定的基因。FAT时对关键技术参数进行确认,是否符合工艺参数许可范围内波动,数据完整性符合要求,不然你PQ时设备的技术参数达不到DQ要求的机率比较高。
设备DQ(质量源于设计)是否合适,主要考察、确认该设备的设计在实际生产过程中的参数符合工艺需求情况。如基因筛选(选型、采购、安装)严重左右着生产中的产品质量。在确认过程中设备难免会出现不同的问题,关键在于对 偏差调查、评估,采取相应的纠正措施和预防措施(CAPA),设备技术指标得到提升,符合产品和工艺需求的参数要求,降低风险(异常跑料、环境污染等)在我们总结的以下5个案例链接中都有所体现。
制订计划进行验证并不难,关键是改善设备不合理的结构,让工艺参数能够在许可的范围内波动,数据完整性符合要求。
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