口罩机验证方案.pdf

. .. 全自动 C 型口罩机验证方案 目 录 1.验证概述 ································································································· 2· 2.验证目的 ································································································· 2· 3.验证范围 ································································································· 2· 4.验证小组成员及职责 ·················································································· 2· 5.验证时间安排 ··························································································· 3· 6.验证依据 ································································································· 3· 7.验证 ······································································································· 3· 8.偏差及变更控制 ························································································ 4· 9.结果评价及建议 ························································································ 4· 10. 再验证周期 ···························································································· 5· 11.附表 ······································································································ 5· z. . . .. 1.验证概述 1.1 设备描述 全自动 C 型口罩机主要用于本公司生产各种规格的口罩，该设备从原材料入料到成品的 完成均为一条线作业，性能稳定，操作简单，包装成品美观，质量良好，符合医用口罩 的制作质量要求。 1.2 设备主要技术参数 电源：220V 50~60Hz 功率： 4500W 工作类型：超声波熔接 操作频率： 15KHz 最高生产速度： 30 个/Min 机器外型尺寸：长 5000mm X 宽 2000mm X 高 1800mm 机器重量： 600Kg 2.验证目的 为