Study on Quality Attributes, Stability, and Compatibility of Bacille Calmette-Guérin for Therapeutic Use(Vial-packaged)

OBJECTIVE To evaluate the quality attributes, stability, and compatibility of Bacille Calmette-Guérin for therapeutic use(BCGt) following the replacement of ampoules with vial-packaged consisting of medium-borosilicate glass injection vials and chlorobutyl rubber stoppers.

METHODS The vial-packaged BCGt was tested according to the methods specified in the Chinese Pharmacopoeia(2025 edition), with additional tests including container-closure integrity testing and tumor inhibition test(Ehrlich's ascites carcinoma). The critical quality attributes were compared between the vial-packaged and ampoule-packaged BCGt. In addition, migration studies, examination of inner surface corrosion, accelerated simulated delamination testing, and acute toxicity testing of the rubber stoppers were conducted on the vial packaging system.

RESULTS No significant differences were observed between the vial-packaged and ampoule-packaged BCGt in terms of the various quality attributes and viable count under accelerated stability. Although a significant difference(P<0.05) was observed in moisture content under real-time stability between the two presentations, this difference did not affect the viable count or concentration. Under different storage temperatures and orientations, the inner surfaces of the vials remained smooth and intact, with no evidence of corrosion, delamination, or migration of harmful substances. The acute toxicity test of the rubber stoppers met the specified requirements.

CONCLUSION The combination of vials and rubber stoppers can serve as an alternative packaging to ampoules.