Helmut
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Vienna, Austria,
2019-04-10 15:03

Posting: # 20140
Views: 614
 

 Sample Shipment (dry ice) ☣ [GxP / QC / QA]

Dear all,

[image]recently I saw the documentation of a sample shipment from Toronto, Canada to Graz, Austria by World Courier. This is the readout of the sensor placed between the samples:

[image]
[image]

[image]I was confused at first. –82.0 ℃ though dry ice sublimates at −78.48 ℃?
Then I remembered physical chemistry and looked at the phase diagram of CO2. −78.48 ℃ is correct but only at the standard condition for pressure (101.325 kPa). However, the cabin pressure is much lower (depending on the aircraft down to 74.5 kPa, equivalent to 2,400 m). The 767-300ER is a fairly modern aircraft and – if we trust in the logger – was pressurized to 81.4 kPa (equivalent to 1,700 m). Also the cargo deck generally is not heated. Given that, CO2 sublimates at the ambient conditions, effectively cooling the samples. Riddle solved. The scheduled flight time Toronto → Vienna is 8:35 h. Maybe bad weather or the airspace was crowded causing a delay.
No idea why the temperature went up to –64.5 ℃. Did Austrian customs officers open the box and inspect it for hours? :-D

Cheers,
Helmut Schütz
[image]

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jag009
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NJ,
2019-04-12 07:32

@ Helmut
Posting: # 20150
Views: 484
 

 Sample Shipment (dry ice) ☣

Hi Helmut,

Am I reading the graph wrong? The date below shows 12/x/2018 and the first page (the one with low and high extreme) shows 12/1x/2018?

J
Helmut
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Vienna, Austria,
2019-04-12 10:08

@ jag009
Posting: # 20151
Views: 460
 

 Sample Shipment (dry ice) ☣

Hi John,

» Am I reading the graph wrong? The date below shows 12/x/2018 and the first page (the one with low and high extreme) shows 12/1x/2018?

Oops! The first one was for the backup aliquot shipped ten days later.
This is the one matching the plot:

[image]

Cheers,
Helmut Schütz
[image]

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mittyri
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Russia,
2019-04-12 15:14

@ Helmut
Posting: # 20153
Views: 439
 

 Satisfaction?

Hi Helmut,

what were the temperature-time (exposure?) limits for that samples?
i.e. in what case would you request a satisfaction from WC?

Kind regards,
Mittyri
Helmut
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Vienna, Austria,
2019-04-12 18:59

@ mittyri
Posting: # 20155
Views: 436
 

 Satisfaction?

Hi Mittyri,

» what were the temperature-time (exposure?) limits for that samples?

Upper limit –20 ℃. That is the validated long-term stability (>1 year) of the drug. We also know that samples are stable at room temperature for 16 hours.

» i.e. in what case would you request a satisfaction from WC?

Satisfaction in the meaning of a duel (fencing, pistols, choice of weapon by the challenger)? Duno, not my thing.
Responsible for the shipment was the clinical CRO. I’m sure it has a 10+ page contract in a 6pt-font with World Courier. If WC really would have screwed up, the second aliquot would not have been shipped.

Cheers,
Helmut Schütz
[image]

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