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What gauge minimises coring through a rubber stopper?

Asked 3 Apr 2024Modified 2.0 years agoViewed 22k times
38

My setup is a refrigerator with a logger and a small work area I wipe down, nothing more.

These are treated as interchangeable and I do not think they are.

If both are acceptable I would like to know that, so I can stop thinking about it.

Is there a defensible reason to prefer one, or is this a coin flip?

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PS
askedplunger_stop18k283 Apr 2024

5 Answers

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18

The relevant detail is that rounding to the nearest whole syringe unit is usually the right error to make, but understanding which direction it is and why matters.

Dead space quantified: a fixed-needle insulin syringe holds roughly 3 to 5 µL in the hub and needle after the plunger bottoms out. A luer-lock syringe with a detachable needle holds 35 to 100 µL depending on the hub design. At 5 mg/mL that is 15 to 25 µg lost per draw on the insulin syringe and 175 to 500 µg on the luer-lock — which over ten draws is the difference between losing a rounding error and losing half a milligram.

The concentration you actually work with is label claim times content fraction divided by actual diluent volume, which is usually not the same as the nominal concentration because content is usually not 100 per cent and you rarely measure the diluent volume to 0.1 mL precision.

Worth noting: the concentration after reconstitution is not the same as the label claim, and most people do not account for the difference.

If in doubt, use more diluent and accept the shorter usable window.

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SC
answeredstopper_core50k1381 May 2024
6This is the first explanation of that which has actually made sense to me. – ines_brandt 2 months ago
7Note that the label instructions differ between agents on precisely this point. – pierce_count 3 months ago
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11

Work in the order concentration, then volume, then units, and the arithmetic stops being confusing. Concentration is milligrams per millilitre and comes from the vial contents and the diluent volume. Volume per dose is dose divided by concentration. Units on a U-100 syringe are volume in millilitres multiplied by one hundred.

Air bubbles at these volumes are a measurement problem rather than a safety one. A 2 mm bubble in a 0.3 mL syringe is roughly 4 µL, which at 10 units drawn is a four per cent error.

The part that matters: on filtration: a 0.22 µm syringe filter will remove particulates and organisms, and it will also adsorb a fraction of your peptide onto the membrane — with a low-binding PVDF or PES membrane the loss is typically a few per cent.

The limitation is that technique reduces risk, it does not remove it, and nothing you can do outside a controlled environment makes a non-sterile preparation sterile.

Write the arithmetic on the vial label. It costs nothing and removes the step where you reconstruct it from memory.

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JF
answeredjuliette_farnese12k2812 May 2024
2Minor: the trial name is hyphenated in the original publication. – e_dziedzic 6 months ago
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9

Write the units at every step, because units errors are the failure mode that catches everyone eventually.

Number of stopper piercings matters less than the gauge doing the piercing. A 30G or 31G needle through a butyl stopper leaves a track that reseals; a 21G or 18G drawing needle punches a core and can drop it into the solution.

It helps to be literal here: do not use the same needle to pierce the stopper and to administer. The tip is blunted by the stopper, and the hub now contains a dose you are about to lose to dead space anyway.

One qualification: if your arithmetic and someone else's disagree by a factor of ten, one of you has made a unit error, and writing out the units at every step is the diagnostic.

Do the arithmetic twice, ideally with someone else doing it independently.

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HP
answeredhana_petrikova19k2816 Jul 2024
6I tested this on two lots and got the same answer, so at least it reproduces. – h_pergande 9 months ago
7The timing signature is the useful part. Everything else is confounded. – tyndall_haze 31 days ago
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7

Concretely, this is one of those calculations where checking your work takes two minutes and prevents a very consequential error.

The rounding error accumulates if you round too many times — rounding concentration to 5.0, rounding the dose volume to 0.1 mL, rounding the unit reading to 10 — and the safest approach is to work the full precision and round only the final answer.

Published data on syringe dead space quantifies low-dead-space designs as retaining under 2 µL against 35 µL or more for conventional detachable-needle syringes.

If in doubt, use more diluent and accept the shorter usable window.

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EV
answeredesther_vandeVelde49k389 Apr 2024
5

The part that matters: the single most useful thing to do is write the arithmetic on the vial label, because you will reconstruct it from memory at an inconvenient moment if you do not.

Room temperature before drawing is worth the ten minutes. Cold solution is more viscous, draws slower, and condensation on a cold barrel makes it harder to read the meniscus.

The content assay results from major testing services show that nominal vial claim and measured content differ by one to ten per cent, making content a driver of dose error.

Write the arithmetic on the vial label. It costs nothing and removes the step where you reconstruct it from memory.

edited 19 May 2024 by ines_brandt — clarified the distinction between purity and content

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IB
answeredines_brandt93k24820 Apr 2024

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