49in the cleaning process. Spray devices have minimum and maximum flow rate requirements, and piping should be flushed at a speed sufficient to assure adequate flooding and turbulence. 动作被定义为清洁剂的流体动作。如浸泡,洗涤,冲击,湍流。搅动能够提高清洁剂的有效性和清洁工艺的效果。典型的手工清洗...
一些公司使用的另一个方法是排除整个设备表面少于小的百分比如1或2取样表面组成的正式回收研究在这样的情况下用于排除表面的回收值是任何其他表面种类的最低回收为此进行正式的取样回收研究或者根据公司程序要求最低可接受回收百分比 清洁验证之取样方法(PDATR49内容节选5中英文版) 清洁验证之取样方法(PDA TR 49内容节选...
清洁验证之分析方法-下(中英文版)(PDA TR 49内容节选7) 6.5 Analytical Method Validation 6.5分析方法验证 This section focuses on analytical method validation for “chemical” residues. 这部分关注化学残留的分析方法验证 Typically, endotoxin methods are compendia methods and do not require formal validation...
中文-PDA TR49 生物制品清洁验证考虑要点 下载积分: 5200 内容提示: Page 1 of 95 北京齐力佳提供 2015 Points to Consider for Biotechnology Cleaning V alidation Technical Report No. 49 ISBN: 978-0-939459-30-8 © 2010 Parenteral Drug Association, Inc. All rights reserved. 文档格式:PDF | ...
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...
PDA TR49对生物制品清洁验证的思考(中文翻译) 热度: PDA TR15切向流过滤验证在生物制品中的应用 热度: PDA TR31计算机化的实验室数据收集系统的验证和确认-中英文版 热度: 相关推荐 2010 TechnicalReportNo.49 PointstoConsiderfor BiotechnologyCleaning Validation P int t C n i r rBi t c n g C ...
清洁验证可接受限度-下(中英文版)(PDA TR 49内容节选4)4.2 limits for Cleaning agentsLimits Limits for cleaning agents will also depend on the stage of manufacturing (formulation/fill vs. bulk activemanufacture). Typical cleaning processes for biotechnology involve either a caustic wash followed by a...
清洁验证状态维护(PDA TR 49内容节选中英文版) 8.0 maintenance of Validated state 8.0验证状态维护 A key part of the validation life cycle for any system is maintenance of the validated state. This section deals with activities after the cleaning process has been designed and developed and after ...
PDA TR49 生物清洁验证 中英文翻译 文档格式: .pdf 文档大小: 1.39M 文档页数: 95页 顶/踩数: 0/0 收藏人数: 6 评论次数: 0 文档热度: 文档分类: 幼儿/小学教育--教育管理 文档标签: PDATR49生物清洁验证中英文翻译 系统标签: 中英文pdacleaning齐力佳翻译bioburden ...
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