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suchit_bhavsar ★ India, 2011-06-23 07:55 (5072 d 10:24 ago) Posting: # 7161 Views: 6,792 |
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Hii to All My question is, After blood sample collection at defined time point we are seprating plasma and storing it in deep freezer at -70 degree. So samples will be stored time point wise. Now after compeltion of clinical phase we are doing segregation to segregate plasma samples according to subject wise and sending it to analytical laboratory. Segregation we are doing on dry ice. So is it necessary to maintain temperature during segregation ? and temepreture data for that ? Regards, Suchit Bhavsar Edit: Please see (and follow) this post! [Helmut] |
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swapnil.kuche ★ 2011-06-23 10:35 (5072 d 07:44 ago) @ suchit_bhavsar Posting: # 7162 Views: 5,902 |
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Dear Suchit, ❝ Segregation we are doing on dry ice. So is it necessary to maintain temperature during segregation ? As you are doing segregation in dry ice so it is always advisable to monitor temperature (not required to be maintain ) and please confirm that the temperaure at which you are doing segration should be well covered for specific period during method validation e.g. long term/short term stability at specific temperature). Apart from that you also have to check if any thawing of samples was happenening. In such case again you have to confirm the all freeze thaw cycles till completion of bioanalysis as per method validation e.g number of freeze thaw cycle validated. ❝ is it necessary to maintain temepreture data for that ? If you are monitoring the temperature it is better to maintain temepreture data for that provided this data should be reviewed throughly and justified properly as per validated method if required. Care should be taken if any deviation happened then same shold be justified by repeating respective validation parameter agin. Hope it will satisfy your concern. Regards, Swapnil Kuche Edit: Standard quotes restored. [Helmut] |
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suchit_bhavsar ★ India, 2011-06-23 12:03 (5072 d 06:16 ago) @ swapnil.kuche Posting: # 7163 Views: 5,743 |
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Dear Swapnil Thanks for the reply Can you explain me that if i want to validate dry ice then what should be the procedure ? Regards, Suchit Bhavsar |
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swapnil.kuche ★ 2011-06-23 12:48 (5072 d 05:31 ago) @ suchit_bhavsar Posting: # 7164 Views: 5,803 |
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Dear Suchit, ❝ if i want to validate dry ice then what should be the procedure ? Dry ice is never be validated.  In validation we are performing different stability studies by considering probable scenario in actual conduct of clinical or bioanalytical phase. For example 1) During clinical & bioanalytical phase there may be chances that plasma samples may be freez and thaw repeatdly that's why we are performing freeze thaw stability. 2) As we are keeping storing plasma samples in deep freezers for long period of time so we have to perform long term stability for particular period at required temperature. I will suggest you to disscuss these stability approach in validation with one of your bioanalytical personnel. Do your home work. I will confidant that you will completely extract proper meaning of my last post after that. Regards, Swapnil D. Kuche Edit: Standard quoting character (‘»’) restored – please leave them in place in the future! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2011-06-23 20:51 (5071 d 21:28 ago) @ swapnil.kuche Posting: # 7167 Views: 5,840 |
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Dear Swapnil, don’t feed the troll! Have a look at this rather strange thread opened by Suchit two weeks ago… — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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swapnil.kuche ★ 2011-06-24 11:23 (5071 d 06:56 ago) @ Helmut Posting: # 7168 Views: 5,689 |
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Dear HS, I will take care in future. Sorry......................... Regards, Swapnil |
Ing. Helmut Schütz