During the routine media run, if the 100% filled ampoules turned to “turbid” not because of viable contamination but b/c of un assignable cause which was concluded after extensive investigation of all possibilities, (1) do we need to go for multiple media fill runs as per the guidelines or three media fill trial as per EU to establish the confidence for the aseptic filling operation? (2) Did anybody come across of such situation?
Regards
Alam
Since you have found out the cuasing agent making the media in the ampoules turbid after Root cause investigation, close that RCA, Rectify the defect and perform the media fill once again and have extra precuation on that particular place or event or process where last time it ruined your batch fill.
The reason for this is MEDIA TURBIDITY. This is a serious issue.
You must prove that the media filled in ampoules are sterile by means of all science based Microbial conclusions.
Till then this particular remains unsolved or unproved event in the eyes of auditor.
Media turbidity is caused by interference. But one of the conclusions as per microbial data is that this can be or might be caused by microbial escursions.
This is a serious issue so one must perform again with all necessary controls in place to prove that SAL in filling zone is good and compliant.
I see there is no short cuts in this particular event.Because it is directly comming into risk evaluation at highest point and it seriously interferes with patient safety.