First of all you should know that the endotoxin test has different
methodology, which are Gel Clot, Turbidimetric and chromogenic, it is in
your budget to evaluate which one can help you best.
The most economical (Gel Clot) would give you semi-quantitative results,
but in exchange it would have about 50 determinations per 5 mL vial
(limitations apply) and in terms of equipment you only need a heating
block, automatic pipettes, borosilicate tubes, and reagents ( Lysate,
endotoxin standard and pyrogen-free water) and an all clear oven is
calibrated and qualified, from there there are many possibilities,
depending on your substrate and the way to analyze it.
The turbidimetric and chromogenic method, although it gives you a more
accurate value, the cost is higher, but today there are highly automated
options such as the Charles River PTS, then there are more sophisticated
equipment with a relatively learning curve. short.
Finally, it all depends on your budget, in my opinion I would start with
Gel Clot, it will take longer but it gives good results, and remember that
the USP places it as one of the first options.
El jue, 16 feb 2023 a la(s) 09:54, Michael Barton ([log in to unmask])
> Hi All,
> firstly i have no experience with endotoxin testing as i am used to
> non-sterile manufacture and testing. However i have been asked to look into
> the possibility of setting up endotoxin testing. we are looking at this
> test for medical device component items initially.
> Can anyone please share what amount of effort, equipment, consumables,
> validation, running costs, specific test environment and difficulty with
> knowledge/expertise for issues and failures i would expect to deal with and
> need to overcome. Anything else you think would be good to highlight then
> please do.
> Would it only be cost effective and appropriate to maintain skills,
> calibrated equipment and consumables etc if there was a constant daily
> throughput of a specific number of batches to test.
> i will be looking to research this topic but as a starter im hoping that
> some of you could share your experience with me.
> thank you
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