BAG handles aseptic filling/closing for both products in vials and ampoules. BAG can process aqueous as well as alcoholic solutions with batch sizes range from clinical quantities up to 200L for commercial purposes.
The on-site facilities can process vials from 2R format up to 50H as well as 1- to 5-ml ampoules. Special formats are available upon request.
Formulation of bulk products are performed in a grade C environment and the solution is then transferred to a grade A clean room for sterile filtration and aseptic filling. Pre-production activities (washing, depyrogenation of vials/ampoules, preparation of material…) and post-production (cleaning…) are carried out in a grade C and D environment.
All product contact components are either disposable or dedicated, enabling BAG to process a wide range of different compounds. All classified facilities and production equipment are periodically requalified according to GMP.