Cautionary Tales from the Files of 'Control'

摘要

"One particular injectable product was made and filled into a dual chamber, hourglass shaped container," recalls our GMP Agent-in-Place. "There was a stopper at the waist of the hourglass and again at the neck opening. The chambers stored different materials that would tend to interact and degrade faster if they were filled as a mixture. But they had to be mixed before usage. To mix the two chambers, the middle stopper had to be dislodged. The upper stopper was very long, so it could be pushed down enough to produce sufficient air pressure on the upper chamber to force the short middle stopper into the lower chamber. Thus, the middle stopper had to have been moveable. To make it mobile, it was heavily siliconed, which acted almost like a grease.