CleaningValidationPractice.ppt

13-01-2010 * NOVOZYMES PRESENTATION * Cleaning Validation Practices清洗确认实践 13-01-2010 * Module Outcomes模块成果 On completion of this module the participant should be able to prepare a draft cleaning validation protocol for an example production equipment train. 这个模型一旦完成，参与者可以准备起草一个清洁确认草约，应用于实际的生产设备。 The protocol should include the following features: 协议应包含以下内容： · Responsibilities·责任 ·Scope of the protocol( equipment train boundaries) ··方案范围（技能培训范围） Typical tests and inspections relevant to cleaning validation ·有关清洁确认的典型的测试和检测方法 Graft /example acceptance criteria with rationale ··有逻辑依据的验收准则举例 13-01-2010 * Cleaning Validation – a roadmap (1)清洁确认— 线路图（1） Create a Cleaning Validation Plan 创作一个清洁确认计划 Identify review all Equipment cleaning produces -(including ones that need to be written) an Agents 确认和检查所有的设备清洁程序（并有所记录） · Create an equipment matrix (equipment trains) 创作一个技能培训模型 Characterise the equipment (product contact surfaces, surface area measurement, hard to clean areas, swab locations) 设备的描述（产物接触面积、表面积测量值、难以清洗的区域、擦拭场所） Create a Product data spreadsheet (active materials, excipients, preservatives, solubility, toxicity, historical knowledge, batch sizes, individual dose size, maximum number of daily doses) 创作一个产品资料的电子数据表（有活性的原料、赋形剂、防腐剂、溶解性、毒性、历史特性、批量大小、单个剂量大小、每日的最大剂量） Create a Product Index Number based on the Toxicity and Solubility and then order products stating from low solubility high toxicity (higher risk) down to high solubility low toxicity (lower risk) ·以致毒性和溶解性创建一个产品的物价指数，然后将产品按低溶解性高毒性（高风险）至高溶解性低毒性排列（低风险） 13-01-2010 * Cleaning Validation – a roadmap (2)清洁确认— 线路图（2） ··Select marker product for each equipment grouping (train) ·为每个设备行列选择标记产品 Set surface limits for each marker product(chemical micro) ·为每个标记产品设表面限度（化学的和微生物的） Identify analytical test methods and ensure LOD / LOQ is consistent with the limits you have set 鉴定分析测试方法并确保LOD和LOQ没有超出预设的限度 ·Conduct swab recovery and extraction studies 进行棉签回收和提取物研究 ·Conduct surface visibly clean studies with Pro