@@pharmaengineering Sir, As this may not be applicable for all cases. In case of API molecule, here 0.5mm/year loss may not be accepted due to increase in metal content in the HPLC(Purity).
@@Mike-ic2bn Dear Mike, In case of pharmaceutical manufacturing the API's will be tested for elemental impurities periodically and hence if the compatibility to be tested using coupon method the limit shall be considered as less than 0.02 mm/year
Sir, on what standards you have given the range ??
What is the source for this ?
These are the common standards that we follow in industry while mapping an equipment
@@pharmaengineering
Sir, As this may not be applicable for all cases.
In case of API molecule, here 0.5mm/year loss may not be accepted due to increase in metal content in the HPLC(Purity).
@@Mike-ic2bn Dear Mike, In case of pharmaceutical manufacturing the API's will be tested for elemental impurities periodically and hence if the compatibility to be tested using coupon method the limit shall be considered as less than 0.02 mm/year
@@pharmaengineering Sir, Thank you Noted.
I was thinking about the guidelines or any Standard approved range.
Sir is that possible Do scale up for Buchi to RCVD
Can be done, but ensure that the speed of Buchi corresponds to critical speed of RCVD
Buchi is 220 rpm,and RCVD is 10 RPM