可删除复制_PSC_CV Add 1 清洁验证补充.pptxVIP

Coupon If the size of the equipment with a specific contact surface is too small for appropriate testing, the study may be performed on coupons of the material of suitable size.如果设备接触表面的大小太小, 不适合测试, 试验可用大小合适的coupon来做。CouponTasly should use coupons of similar surface finish to perform validation of the cleaning methods for 316L steel, EPDM gasket and other product contact surfaces.天士力应使用类似表面涂料的coupon来进行清洁验证316L不锈钢、EPDM垫片和其它产品接触表面。Acceptance Criteria-SWAB接收标准-擦拭法Chemical residual化学残留A. 1/1000 of the normal therapeutic dose 1/1000标准治疗剂量B.10ppm (parts per million)百万分之一C.LD502.Detergent清洁剂3.Microb