can we run three or more filling cubicles at a time if our system is validated answer the question by keeping a view on number of operators in controlled area ( risk of high bioburden )
Dear faraz,
Risk of bio burden in what? means in filling cubicles :), All the filling cubicles are seperate from each other and there air pattern are not interfering, filling area are positive air pressure so question of risk of particle generation is out of course, so you can easily operate your filling lines, if you have conducted media fill trial at simultaneously three cubicle operation.
I am talking about the risk of contamination during our daily process if we run three cubicles simultaneously on the other hand running a single cubicle , the fact about MEDIA FILL is that mostly the practice of all Pharma companies is to take extra precuation in media fill and become more vigilant during the said process as compared to daily routine filling process so the risk of increasing bioburden in running three cubicles is very high as compared to runing a single cubicle because the main and major source of contamination in controlled area is the personnel.( Is any guidline available which clearly shows the best practise of Aseptic filling regarding the above said saubject) Please expedite with reference