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suchit_bhavsar ★ India, 2012-10-25 16:03 (4983 d 00:38 ago) Posting: # 9458 Views: 5,739 |
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Hello to all of you One confusion in the temperature during the segregation, as per approved protocol "after separation of the blood sample, polypropylene tubes containing plasma will be stored at -70 plus or minus 10 degree celsius " If temperature has been observed up to 90 degree celsius during the shipment/ segregation, is it acceptable, kindly give your suggestion Regards, Suchit Bhavsar |
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ElMaestro ★★★ Denmark, 2012-10-25 17:43 (4982 d 22:58 ago) @ suchit_bhavsar Posting: # 9459 Views: 4,744 |
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Hi s_b, ❝ (...) "after separation of the blood sample, polypropylene tubes containing plasma will be stored at -70 plus or minus 10 degree celsius " ❝ ❝ If temperature has been observed up to 90 degree celsius during the shipment/ segregation, is it acceptable, kindly give your suggestion 1. It would be exceptional if the cooler temperature adversely affected the stability -but- 2. Strictly the temprature is out of your specified range and a regulator may crack down on it. Since you ask I assume that you did not receive two aliquots sent separately and where the other shipment was ok. I think you could try to quickly revalidate (accuracy and ... ?) after freeze/thaw to -90, but I acknowledge timing is a potential issue here. Apart from that you could consider a kind of capa here. Ask 5x why starting e.g. with: Why was the protocol specification 70 degs C +- 10 degs C? Why was the shipment out of this range? Although the FDA may ask companies to increase their vendor oversight activities I have yet to see any company asking World Courier for permission to audit  — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2012-10-25 21:29 (4982 d 19:12 ago) @ suchit_bhavsar Posting: # 9460 Views: 4,717 |
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Dear Suchit, ❝ If temperature has been observed up to 90 degree celsius during the shipment/ segregation, is it acceptable, kindly give your suggestion I suppose you mean - 90°C. Otherwise I think the answer to your question is a clear no I'm a bit surprised that you measured a temperature of -90°C during shipment and segregation. Dry ice normally sublimates at -78.5°C at atmospheric pressure. I would first check the recommended usage range of the temperature probe used to measure that temperature, its qualification/certification and the uncertainty of measurement at such temperatures. Regarding the effect of such a deviation, if confirmed, on your samples: I would not be worried unless you are working on a biological product (protein or peptide). Regards Ohlbe — Regards Ohlbe |
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suds4u ☆ India, 2012-10-26 13:22 (4982 d 03:18 ago) @ Ohlbe Posting: # 9461 Views: 4,645 |
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Hi, To comment dry ice temperature can go upto -82°C in a closed environment. In this case the probe was in dry ice for a long time and has gone up to -90°C. We practice recording of protocol deviation if the storage temperature goes below -80C° [range allowed -70 ± 10°C]. We have conducted audit of the world courier and have got resolved many of the issues that were observed during the shipment [both received and sent].  Suds |
Ing. Helmut Schütz