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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:
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审核Approved by 日期Effective Date
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1. 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.
2. 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.
3. 范围Scope
3.1. 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 物理外观检测Physical test 残留物浓度限度Limits of 目测洁净无色（说明见5.5）Clean and chromaticity (see section 5.5) residue 细菌总数Total bacteria≤100CFU／mL（淋洗水washing water） 微生物限度Microbial test 细菌总数Total bacteria≤50CFU／25cm2（棉签擦拭法cotton sticker wiping） 标准范围Limits 目测洁净，干燥，无嗅Clean, dry, no scent 4. 职责Role & Responsibilities 4.1. QA manager
4.1.1. 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。
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Assign team leader, approve validation protocol and reports, issue validation certificate and decide re-validation frequency.
4.2. 验证小组组长Team leader
4.2.1. 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. 4.2.2. 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, training and technical transfer of the qualification.
4.3. QA
4.3.1. 负责验证数据及结果的审核，Review of qualification data and results. 4.3.2. 负责验证过程的监督和验证报告的审批。
Supervise the qualification and review validation report. 4.3.3. 负责验证文件管理。Manage qualification documents.
4.3.4. 负责验证管理的日常工作，制定验证计划及监督实施，验证方案管理，验证工作的协调，
验证文件的管理。
Develop validation plan and supervise the implementation of validation and manage the documents.
4.4. 实验室LAB
4.4.1. 负责制定清洁后残留物（产品残留、微生物、清洁剂等）的检测方法和残留限度。
Develop inspection methods and limits of residue (products left, microorganism, cleaning agent). 4.4.2. 负责制定取样方法和执行取样，并对清洁验证的结果进行评价。Establish sampling methods
and sample for tests, and evaluate the qualification results.
4.4.3. 负责对生产选用清洁剂种类及清洁方法进行指导。Guide the production department to
choose cleaning agent and cleaning methods.
4.5. 生产部Production
4.5.1. 负责制定清洁作业指导书，执行清洁操作以及对操作人员的培训和考核。Make the
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procedure for cleaning and conduct cleaning activities and do training for the operators. 4.5.2. 配合协调时间及人员的安排。提供必要的资源。Arrange personnel and adjust time, and
provide necessary resources.
4.6. 设备部Maintenance
4.6.1. 负责设备清洁时，对相关设备的拆卸、安装提供指导培训。Do training of de-assembly and
installation.
5.
验证内容Qualifications
5.1. 在产品生产结束后，按照作业指导书进行清洁。Follow the procedure to clean the equipments after
production.
5.2. 最难清洁部位：Position uneasy to clean 设备名称Equipment 真空乳化搅拌锅组 vacuum emulsification mix tank group 液体自动填充机 Liquid Automatic Filling Machine 5.3. 可接受的限度范围标准：Acceptance Limits 项目Project 物理外观检测Physical 目测洁净，干燥，无嗅Clean, dry, no scent test 残留物浓度限度Limits of 目测洁净无色（说明见5.5）Clean and chromaticity (see section 5.5) residue 细菌总数Total bacteria≤100CFU／mL（淋洗水washing water） 微生物限度Microbial test 细菌总数Total bacteria≤50CFU／皿 5.4. 物理外观检查：清洗后用含75%乙醇的蓝色或者与产品不同颜色的无纺布（已消毒）擦拭表面
后应无任何可见的残留物痕迹，设备及无纺布表面见本色。Physical inspection: use sterile blue or color different from that of the product cloth with 75% ethanol to wipe their surfaces, no residue is visible。
5.5. 残留物浓度限度：该组设备生产的产品所使用的活性成分均为二甲基硅油。均为无毒原料，安
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编号Number 部位Position 均质头Homo-mixer 下料管output pipe 标准范围Limits .
全性高。因此以物理外观检测洁净来代替。必要时送第三方检测一次残留物含量Residue concentration limits: active ingredients used include dimethicone, they are highly safe raw materials without toxin. So we use physical check after cleaning is accepted. And if necessary we will send once to 3rd party for checking residue.
5.6. 微生物限度检验Microorganism examination
5.6.1. 真空乳化搅拌锅组和液体自动填充机采用淋洗水冲洗方法。在清洁工序完成后，用纯化
水淋洗均质头，然后参照WI-006《微检室作业指导》，进行取样，送微生物实验室进行检测。具体检测方法参照WI-006&WI-008。
Vacuum emulsification mix tank group & Liquid Automatic Filling Machine use washing water to clean. After clean the tank and homo-mixer, we use purified water to wash the homo-mixer. Samplings refer to WI-006, and sent to micro lab. Micro test method refers to WI-006&WI-008.
5.7. 再验证周期Re-qualification frequency
QA部门根据验证结果确定设备再验证周期 QA to decide the re-qualification frequency after verifying the results. 6.
偏差处理Deviation Handling
验证出现偏差的指导原则，参考偏差处理程序。
Any deviation found will follow Deviation control procedure for handling and investigation. 7.
参考Reference
7.1. 洁净车间及设备清洁消毒规定 WI-011 7.2. 《微检室作业指导书》WI-006 7.3. 《内控标准》WI-008 7.4. 卫生标准操作规范WI-001 8.
附件Attachment
8.1. 《设备清洁验证记录》Equipments Cleaning Qualification Records
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