is mean kinetic temperature is applicable for incubators also
Hi Ratnaraju,
if you are concerned about microbiological or BOD incubators often found in labs the answer is NO or not required to calculate MKT (mean kinetic temperature). But if you are concerned about bigger chambers including walk-in Chambers, YES we can do. Arithmetic mean or MKT (which is higher than arithmetic mean) was earlier proposed for stability chamber however this is now also used in evaluation of temperature excursions in the dynamic arena of Good Distribution Practices. Principally the MKT is to be used or meaningful where the fluctuation (sinusoidal) or periodic spikes of temperature is seen and this often happen in larger chambers or area (including storage areas). for a longer duration temperature monitoring, temperature often varies and it does not same for all EDLM (Electronic Data Logger Monitoring), so to enable analyst to determine a mean temperature use of MKT is often useful. Despite the usefulness of mean figures, it is essential not to disregard the actual temperature data; these figures reveal the occurrence of temperatures that are outside the specified storage temperature range.
Hope I answer your query.
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For product Quinine Dihydrochloride we already prepared BPCR, flow chart, testing protocol, spec all related documents.
But we want to prepare it from different route (from different intermediate - one step additional) then, is it possible that Quinine Dihydrochloride have two different route process BPCR ??? (2 different process route for the same product)??
Plz sir reply me with satisfactory explanation. I’m awaiting for your favourable reply…thanks sir…