57个固体制剂清洁SOP合集

一土日月 · 发表于 2020-4-23 06:15:45

下载下来学习一下

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一土日月 · 发表于 2020-4-23 08:39:56

非常感谢楼主分享

John0604 · 发表于 2020-4-23 09:18:32

小白下载看看

凡9731cacf · 发表于 2020-4-23 15:35:28

感谢分享

？。。？1 · 发表于 2020-4-23 16:00:01

学习学习，谢谢

一土日月 · 发表于 2020-4-24 06:16:16

下载学习一下，谢谢

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729506648 · 发表于 2020-4-27 10:16:03

学习

zoneh · 发表于 2020-4-27 12:32:28

一个完善的清洁程序包括以下内容：
Such content shall be included in a cleaningprocedure:
－生产结束及清洁开始间的最大保持时间 Holding time before cleaningafter production；
－清洁前连续生产的天数及批次; Continue production days and batches beforecleaning
－设备的拆卸程度 Equipment disassemble condition；
－需进行清洁的部件及位置 List of machine components needto be cleaned and location；
－详细的清洁步骤(包括每一步骤所使用的清洁器具，时间要求等); Cleaning method in detail (cleaning tool foreach step, time, volume, etc.)
－清洗水及清洗剂的选择；Water(PRW20 or PRW80) and reagent selection;
－表明设备的清洁状况和有效期限；Cleaning status identification and expirydate;
－清洁后的检查和设备清洁过期的处理；Inspection items and handling procedureafter expiry date;
－清洁后设备的储存条件；Storage condition after cleaning
－设备使用前的检查。Checking items prior to use

Cleaning Standard Operating Procedure Evaluation/清洗SOP评估

The scope of cleaning procedures includes, among others, the cleaning of vessels for compounding of bulk products, the product contact equipments during compounding (e.g. blenders and stirrers), pumps and hoses to transfer products, drums or other containers for storage of bulk, and filling equipment in packaging of bulk into finished products. All cleaning SOPs will be reviewed and updated as necessary. The review is based, among others, on the following items:
清洗规程的范围包括：批产品混合容器的清洗，合成中与产品接触的设备（如搅拌器），运送产品的泵及管道，用于存储的桶或其它容器，把批产品包装为成品的填充设备。必要时，所有的清洗SOPS都要经过审阅和更新，这些审阅基于下列几点：
1. Full cleaning instructions with detailed sequential steps/有详细步骤的完整的清洗说明
2. Cleaning tools or equipment to be used/清洗工具或所用设备
3. Cleaning agents to be used, including their preparation and final concentrations/所用的清洗剂，包括其配制和最终的浓度
4. Critical cleaning process parameters (e.g. time, pressure, temperature) to be accomplished/要完成的关键的清洁工艺参数（如：时间，压力，温度）
5. Methods and time of drying, re-assembly, tagging, and storage of cleaned equipment/清洁设备的干燥，重新装配，标识及存储的方法和时间
6. Method and criteria for cleanliness inspection after cleaning/清洗后的清洁度检查方法和标准
7. Maximum hold time allowed between cleaning and next use/清洗和再次使用的最长时间间隔
8. Documentation requirements/文件要求