how to validate blending process in process validation batches
it is necessary to withdrawn 10 point sampling at three different time (10 ,15 ,20 minutes at 15 RPM) when in BMR mentioned fix time (15 min at 15 RPM) of blending.
or
only withdrawn 10 point sample at mentioned time and speed in BMR (15 min at 15 RPM)
suggest me with any guideline referece
It is not necessary to withdrawn 10 point sampling at three different time intervals (10 ,15 ,20 minutes at 15 RPM) when in BMR it is specified fixed time interval (15 min at 15 RPM) of blending. This is because in the process validation we are demonstrating that the established process (and process parameters) works consistently and satisfactorily to give the end product meeting specifications / quality requirements. Hence we repeat the manufacturing process for at least three times (3 batches) to demonstrate consistency of satisfactory process.
In the process of optimization we will have to draw samples at different mixing time intervals and speed of the mixer as we have to identify the correct process parameters which give satisfactory output meeting predetermined specifications / quality requirements.
Therefore, in the process validation excercise we will have to only withdraw 10 point samples (or as per the protocol requirements) at the specified time interval and speed as per the BMR (15 min at 15 RPM) as determined in the process optimization studies.
Thank u sir for your voluble guidance
You are welcome.
