设备清洁验证案.docVIP

PROCEDURES/INSTRUCTIONS 设备清洁验证方案 Equipments Cleaning Qualification Protocol 文件编号Doc. No.: 文件版本Revision: 修订日期Revision Date: 拟案单位Issued by: 编辑Author 审核Approved by 校对Reviewed by 日期Effective Date 概述Description Dermasil OTC 产品生产设备组由真空乳化搅拌锅组和液体自动填充机组成。主材采用不锈钢，易清洗，耐消毒。造型美观大方，各系统转动灵活、平稳，温度调节灵敏、易控制。该组设备主要生产活性成分相同的护肤产品。微生物控制尤为重要。 Manufacturing equipment for Dermasil OTC skincare product includes vacuum emulsification mix tank group Liquid Automatic Filling Machine. These equipments adopt stainless steel materials, and facilitate cleaning and resist disinfection. They are easy to control and have good design, flexible and stable system, sensitive temperature adjusting. These equipments are used to produce skin care products with same active ingredients. Control the microorganism is significant. 目的Purpose 检查并确认OTC生产设备清洁规程制定是否具有可操作性和科学性，保证清洗后的设备能够满足工艺要求。 This is to check and verify if these equipments for OTC products are scientific and designed to facilitate operation. 范围Scope 本验证方案主要适用于以下Dermasil OTC护肤产品生产设备的清洁验证。 This protocol is applied for cleaning qualification of these equipments for Demersil OTC Skincare products; 项目Project 标准范围Limits 物理外观检测Physical test 目测洁净，干燥，无嗅Clean, dry, no scent 残留物浓度限度Limits of residue 目测洁净无色（说明见5.5）Clean and chromaticity (see section 5.5) 微生物限度Microbial test 细菌总数Total bacteria≤100CFU／mL（淋洗水washing water） 细菌总数Total bacteria≤50CFU／25cm2（棉签擦拭法cotton sticker wiping） 职责Role Responsibilities QA manager 负责指派验证小组组长，负责验证方案及报告批准，发放验证证书，确认再验证周期。Assign team leader, approve validation protocol and reports, issue validation certificate and decide re-validation frequency. 验证小组组长Team leader 即具体验证项目的主导人，主导和协调验证工作，负责方案的起草，记录数据的收集以及报告整理。 Team leader is the leader of specific qualification projects, lead to and coordinate qualification assignment, draft the protocol and collect the data and records and sort out reports. 负责首次清洁验证方案的起草，完成报告。并指导验证实施、培训及技术移转。 Draft first cleaning validation protocol and complete the reports, and guide the implementation