Device (100) for reconstituting an active ingredient in sterile powder, comprising a vial (4) containing the active ingredient; a flexible bag (1) containing a sterile liquid; a connecting component (5) secured to the vial (4) and to the flexible bag (1); an elastomeric sealing ring (10) arranged between the connecting component (5) and the vial (4), an axially perforated spike (7), constrained to the connecting component (5), wherein a sterile chamber (70) is provided, delimited by the vial (4), by the connecting component (5) and by the sealing ring (10, 110), whereby the active ingredient is reconstituted in sterile conditions.

Apparatus and method are disclosed for opening a frangible internal cannula located in flexible fluid flow path. The frangible cannula has first and second portions joined by a frangible junction and the apparatus and method cause bending of one portion of the cannula relative to the other portion that results in breaking of the frangible junction and opening of the flow path to fluid flow therethrough.