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Thank you for the explanation. It was very clear which helped me to finally understand the method development and validation.

for DI, table 2 and 3 discuss sample requirements, however, as stated, it can be placed in the media whole or cut up. Is there any restriction on the testing being performed in separate jars or a composite sample (ie, if you are testing 4 units, can all 4 be placed in the media together with passing B/F, or does USP require them to be placed in 4 jars separately?)

Brilliant overview, thanks Cynthia

Hi we use DI but using syringes to transfer from product container to media - would you still class this as higher risk than filtration even though its closed system? Also I've spoken with tech advisor from a major sterility test consumable supplier and they advised no issues with large volumes over filters but need validate. I've never heard of an upper limit of volume that you can filter? Thanks

It's informative

Thank you for the presentation

Thank you so much.very helpful.

This was an excellent presentation. Thank you.

how we evaluated simple physical stability test that everyone can do by times for oil product (color, smell, and separation) or give the citation

Very much informative. Thanks

Thank you for the presentation 😊

Is the product validation done by arl or onsite?

Sir, what is description as per USP monographs, it nomenclature and definition or it's something else

Hello, thank you for the video! I have a couple of questions according to the ATP Bioluminescence test. According to different sources, oxygen is required for the reaction to occur and luminescence to be produced (Luciferin needs oxydation to be converted into its light-producing form). How can anaerobic organisms be detected with this assay if oxygen is not present in the media for them? (for example FTM) Thank you in advance.

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Thanks for sharing all these information. A lot of congratulations to Thomas Kupiec for an excellent explanation.

Question. I'm attempting to put together a method for suitability using membrane filtration method (millipore pump). Should all challenge organism be pumped into canister be exposed to both TSB and FTM? Leaving you with 6 TSB samples and 6 FTM samples for incubate? Or should it only be 3 and 3 representing 3 TSB challenge organisms and 3 FTM organisms?

Great work there, totally clear explanation.Thanks.

Thank you for this lecture