and on points a cleaning SOP should contain. In accordance with modernGMPvocabulary examples for Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) are presented. As examples for CCPs hold
CleanHoldtimefromtheendofthecleaningprocessuntiltheequipmentisusedagain(whichmaybeproductmanufacture,autoclaving,orasteaminplace(SIP)cycle).清洁保持时间:指从清洁工艺结束至设备再次使用(也可以是产品生产、高压灭菌或在线蒸汽灭菌(CleaningAgent:Thesolutionorsolventusedinthewashingstepofacleaningprocess.Examplesof...
For this reason, a nonspecific method such as TOC or Total Protein is typically used to measure residues ofthe degraded active (as well as other organic molecules) in acleaning validation protocol.基于这个原因,在清洁验证方案中,一个非特定方法(如:TOC和总蛋白)通常被用于测量降解活性物质(其他有机分...
Cleaning Agent 清洁剂 The solution or solvent used in the washing step of a cleaning process. Examples of cleaning agents are: water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water. 用于清洁工艺中清洗步骤的溶液或溶剂。清洁剂例子如水、有机溶剂、商业...
需要金币:*** 金币(10金币=人民币1元) PDA TR49(中英文)-2010 生物制品清洁验证考虑要点.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 北京齐力佳提供 2015 Points to Consider for Biotechnology Cleaning Validation Technical Report No. 49 ISBN: 978-0-939459-30-8 © 2010 Paren...
The purpose of thatillustration is to demonstrate the low (and unmeasurable) TOC values that are achieved in suchcalculations. 由于这些测量问题,也由于降解的问题,一个更普遍的设定活性物残留限度的技术是基于工艺能力。这不是一个真正的工艺能力研究,而是基于在生物产品制造中已有的和传统的清洁操作程序来...
Examples of cleaning agents are water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water. 清洁剂:清洁工艺中用于清洗步骤的溶液或溶剂。清洁剂有水、有机溶剂、用水稀释的日用化学品和用水稀释的配方洗涤剂。 Cleaning Procedure:The documentation that assures any...
Examples of cleaning agents are water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water. 清洁剂:清洁工艺中用于清洗步骤的溶液或溶剂。清洁剂有水、有机溶剂、用水稀释的日用化学品 和用水稀释的配方洗涤剂。 Cleaning Procedure:The documentation that assures ...
Campaign 阶段性生产 The processing of multiple lots or batches of the same product serially in the same equipment 在相同的设备中的一系列工艺批次中进行的批处理 Changeover 更换品种 The steps taken for switching multi-product equipment from the manufacture of one product to the manufacture of a ...
PDA TR29(中英文)-2012清洁验证的考虑要点.pdf,Technical Report No. 29 (Revised 2012) Points to Consider for Cleaning Validation Paradigm Change in SM Manufacturing Operations Bethesda Towers 4350 East West Highway Suite 200 Bethesda, MD 20814 USA Tel: 1