Container closure integrity testing and process validation of closed system transfer devices for aseptic reconstitution of drug vials connected to fluid bags.
Roland Benjamin van den BergKübra AkgölEleonora L SwartBastiaan NuijenMirjam CrulPublished in: European journal of hospital pharmacy : science and practice (2023)
Both CSTDs connected to the drug vials met the terms of closure integrity by using the dye ingress test. The aseptic procedure of CSTD B was validated with the media fill test when reconstituted in a GMP grade A environment, but failed for CSTD A. Both CSTDs failed the media fill test when reconstituted under non-classified environmental conditions.