Device for reconstituting and administering drugs

A device for reconstituting an active ingredient in the form of sterile powder, comprising:

• a vial containing said active ingredient as sterile powder having a mouth, a neck and a pierceable closing member which closes the mouth;
• an annular step being present between the mouth and the neck;
• a flexible bag containing a sterile liquid;
• a connecting component fixed to the vial and to the flexible bag;
• an axially perforated spike, constrained to the connecting component and adapted to pierce the closing member, said axially perforated spike comprising a tip, facing towards the closing member, and a head opposite to the tip, said axially perforated spike being inserted in a hole of the connecting component,
• a pierceable membrane sealing the hole of the connecting component;
• a sealing member sealing the closing member at the mouth and being anchored to said annular step, said sealing member having an open central portion and being arranged so as to leave a central portion of the closing member uncovered;
• an elastomeric sealing ring arranged between the connecting component and the closing member of the vial and in contact with the sealing member, with at least a portion of the sealing ring being received in an annular groove provided on the connecting component,
• wherein there is provided a hermetically sealed, empty sterile chamber, delimited by the closing member, by the connecting component and by the elastomeric sealing ring, the hermetically sealed sterile chamber delimited at a top thereof by the pierceable sealing membrane and by the connecting component, laterally by the elastomeric sealing ring, and at a bottom thereof by a part of an upper side of the sealing member and by the uncovered central portion of the closing member;
• wherein the connecting component is provided with a plurality of coupling teeth which fix the connecting component to the vial, the coupling teeth being in abutment against the portion of the sealing member that covers said annular step of the vial so that the elastomeric sealing ring is subjected to compression, so as to ensure hermetic sealing of the sterile chamber;
• wherein the axially perforated spike is adapted to slide from a rest position inside the flexible bag to a working position, piercing the pierceable sealing membrane before crossing the hermetically sealed sterile chamber and piercing the closing member when a pressure is exerted on the head with at least one finger of a hand, allowing the passage of the sterile liquid from the flexible bag to the vial, and of the reconstituted active ingredient from the vial to the flexible bag,
• whereby the active ingredient is reconstituted in sterile conditions.