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c/coldchain·posted 2 years ago by u/phase_two_pete

the stability question that gets asked weekly, answered properly

Failure

The title is the argument: the stability question that gets asked weekly, answered properly. Here is the rest of it.

You cannot infer potency from a temperature record. The record tells you what happened to the box; only a test tells you what happened to the material.

Regional stock changes the question rather than answering it: shorter lanes mean less exposure and fewer variables, which is why the warehouse question is worth asking before ordering in summer.

A transit temperature logger records a distribution, and time above a threshold matters as much as peak temperature. That is the argument for logging rather than guessing.

Ask me anything specific. Anything general I will probably get wrong.

2,355 up / 2,449 down50% upvoted16 commentsid tg96q319 May 2024

16 comments

16 in this archive, depth 5

best — the order this archive was captured in

u/curious_panel_only11 points·2 years ago

Lyophilisation removes the water that drives most degradation pathways. That is why the dry cake is comparatively robust and the reconstituted solution is not.

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[removed]8 points·2 years ago

[removed by moderator]

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u/careful_gradient_again3 points·2 years ago

What was the packaging — rigid outer, gel packs, anything insulating?

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u/phase_two_peteOP2 points·2 years ago

Small fix — refrigerated, not frozen, once it is in solution.

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u/ines_lindqvist1 point·2 years ago

Cosigning the regional stock point. Ordering from a warehouse in Poland took the whole question off my table.

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u/india_generic_g2 points·2 years ago

regional stock removes most of this problem entirely

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u/solene_abubakar3 points·2 years ago

the door shelf is the worst place in the fridge

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u/elodie_kuipers9 points·2 years ago

a warm gel pack tells you the pack failed, not that the material did

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u/bence_ibarra2 points·2 years ago·edited

Yes — reconstitution date on the vial. It is the number you will want and cannot reconstruct.

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u/prior_auth_painappeals1 point·2 years ago·edited

Correction: that stability figure covers the lyophilised powder, not the reconstituted solution. Different claim entirely.

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u/jarno_adeyemi1 point·2 years ago

How many days in transit, and which month?

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u/phase_two_peteOP2 points·2 years ago

That is the ambient temperature at the destination, not the temperature inside the box. The logger measures the second one.

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u/cesar_teixeira1 point·2 years ago

Gel packs are designed for a duty cycle. A liquid pack at the end of a longer-than-expected transit is a pack behaving as specified, not evidence of an excursion in the vial.

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u/phase_two_peteOP7 points·2 years ago

Correcting myself above: the transit was 3 days, not the figure I posted. Same conclusion, wrong number.

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u/anjali_tamm11 points·2 years ago

a logger costs less than a vial and answers the question permanently

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u/osman_eriksen8 points·2 years ago

Kept a vial at room temperature for eleven days by accident. Tested it out of guilt. It was fine.

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About c/coldchain

Temperature and stability in the real world: what an excursion actually costs you, why lyophilised powder is far more forgiving than reconstituted solution, how to read a logger CSV, and how to photograph a failed shipment so the conversation with the vendor is short.

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