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  3. Medical: Pharmaceuticals

bracketed generic validation approach

Russian translation: см.

17:49 Sep 3, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: bracketed generic validation approach
The conditions under which SV40 removal was evaluated were: 11 cm bed height, 600 cm/h linear flow rate, and approximately 250 g mAb/L QSFF resin load capacity. The QSFF column was equilibrated and the load pool was adjusted to indicated pH and conductivity set points prior to column loading. Predictability and robustness to extremes in operating parameters (e.g., flow rate, protein load, bed height) are necessary prerequisites for the applicability of the bracketed generic validation approach.
Elena Shtronda
Ukraine
Local time: 01:09
Russian translation:см.
Explanation:
универсальный/общий подход для валидации с использованием крайних вариантов
я бы перевел так на основании определения концепции этого подхода в статье Curtis et al, 2003
Selected response from:

Igor Andreev
Local time: 01:09
Grading comment
Спасибо за помощь!
4 KudoZ points were awarded for this answer



Summary of answers provided
3см.
Igor Andreev


Discussion entries: 1





  

Answers


1 day 20 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
см.


Explanation:
универсальный/общий подход для валидации с использованием крайних вариантов
я бы перевел так на основании определения концепции этого подхода в статье Curtis et al, 2003

Igor Andreev
Local time: 01:09
Native speaker of: Native in RussianRussian
PRO pts in category: 625
Grading comment
Спасибо за помощь!
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