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c/coldchain·posted 1 year ago by u/andres_restrepo

[Discussion] lyophilised is doing more work than we give it credit for

Discussion Cold Box ×9 Sourced ×2

lyophilised is doing more work than we give it credit for. Not a hot take, just something I have not seen said plainly here.

Put a logger in three consecutive orders. Two never went above the range at all and the third spent four hours warm on a Friday. Cost me almost nothing to stop wondering.

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.

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.

Research-use-only material is not approved for human use and nothing here should be read as a recommendation to use it.

2,611 up / 332 down89% upvoted51 commentsid q34jp81 Sep 2024

51 comments

30 in this archive, depth 5

best — the order this archive was captured in

u/ines_lindqvist347 points·1 year ago

A stability statement is only meaningful with its conditions attached: temperature, duration, light exposure, and whether it covers powder or solution. Ask which.

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u/sten_palacios92 points·1 year ago

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.

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u/tidy_vialdrawer_watch28-32 points·1 year ago

Moved everything off the fridge door after reading a thread here and my temperature log immediately got boring.

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u/coldchain_karencold chain229 points·1 year ago·edited

I would not freeze it in solution. That is a different failure mode and a worse one.

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u/andres_restrepoOP165 points·1 year ago·edited

ask which lines are held in regional stock before you order in July

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u/nayeli_iyer211 points·1 year ago

write the reconstitution date on the vial

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u/milan_mensah165 points·1 year ago

write the reconstitution date on the vial

Agreed, and a logger costs less than the vial you are worrying about.

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u/britt_okwuosa115 points·1 year ago

Wrote the reconstitution date on the vial for the first time last year. Have never once since wondered how old a solution is.

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[removed]158 points·1 year ago

[removed by moderator]

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u/analog_alphabet176 points·1 year ago

insulation buys hours, not days

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u/vito_chowdhury137 points·1 year ago

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

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u/niels_norgaard114 points·1 year ago

Asked QST which lines they hold regionally and got a straight list back. That answered my summer ordering question completely.

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u/cesar_teixeira32 points·1 year ago

Once in solution, the relevant risks are hydrolysis, aggregation and, for some sequences, oxidation. Refrigeration slows all three; freezing a solution introduces a separate risk at the ice interface.

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u/ireland_drugs_pay9 points·1 year 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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u/search_before_post72 points·1 year ago

Yes — a logger in the box turns a fortnight of speculation into a chart.

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u/jarno_adeyemi84 points·1 year ago

ask what storage condition the stability statement was written against

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u/nikhil_asante24 points·1 year 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/kian_ekstrom45 points·1 year ago

fridge, not freezer, once it is in solution

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u/anya_rautio46 points·1 year ago

powder at room temperature for a few days is usually a non-event

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u/vito_chowdhury29 points·1 year ago

Which lane, and had it been quoted at that transit time?

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u/ice_pack_auditcold chain18 points·1 year ago

Do you know what storage condition the stability statement covers?

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u/marit_laurent5 points·1 year ago

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

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u/nikhil_asante52 points·1 year ago

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

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u/usb_logger_ursulaMOD85 points·1 year ago

Merged into the seasonal thread for that lane so the reports sit together.

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u/maren_sorensen58 points·1 year 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/lina_almeida67 points·1 year ago

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

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u/nils_ferreira40 points·1 year ago

How many days in transit, and which month?

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u/andres_restrepoOP16 points·1 year ago

Powder or already in solution?

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u/source_or_silence9 points·1 year ago

Powder or already in solution?

Adding the practical version: ask which lines are held regionally before you order in July.

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u/milan_mensah2 points·1 year ago

a summer lane and a winter lane are different lanes

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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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