[b][COLOR=“black”]Why you have to increase the blending time?
Is there a insolubility or partial solubility of the product in the solution-Solubility issues?
Is the process is not stable?
Did you find a precipitation in your packed product after packing or long time before expiration in your IV pouches-- PARTICLE OR POST PRECIPITATION ISSUES?
Or any supernatent formation if you filter in sparkler filter–that is a residue over filter media?
Is it due to stability or clarity?–HAZINESS Formation[/color][/b]
You must find the why this deviation was implemented at first place-- and write a Process deviation form.
If we are reffering in blending and manufacturing operation in an IV fluid, such a variation time have to be examined and validated properly. The reason is that the previous 30 minits that was a validated parameter deviated because of a cause.What is your RCA (Root cause analysis) outcome?
To maintain the stability of changed process without any further deviation this Blending process must be examined and the batches must be kept for accelerated stability.
Keeping accelerated stability for this particular cause is always good and better. This gives a clear view if you have a regulatory inspection with short intimation time.