Vial filling system with localized clean zone

Abstract

Among other things, there is shown a system for filling vials with fluid that maintains a localized sterile zone around the filling location. In particular embodiments, the sterile zone is provided by a manifold having an internal space to which clean air is supplied. One or more filling assemblies are attached to the manifold. Vials enter the sterile zone and are filled within it. Additional structure, such as coverings for vials, are disclosed to assist in maintaining sterility.

What is claimed is: 
     
         1 . A vial-filling apparatus, comprising:
 a disposable clean-air zone including a manifold having an upper surface and a lower surface bounding an internal space, a clean-air inlet communicating with the internal space, and at least one slot in the lower surface adapted to accept at least a portion of a vial, so that such portion of the vial may enter the space through the slot,   wherein the manifold also includes at least one opening in the upper surface and over the slot, whereby fluid can be passed through the opening and into a vial at least partially in the clean-air zone.   
     
     
         2 . The apparatus of  claim 1 , further comprising a fluid transfer assembly at least partially within the opening, the fluid transfer assembly including a nozzle extending into the space in the manifold and sized and configured to enter a fill tube of a vial, a fluid port in fluid communication with the nozzle, and an air flush port in fluid communication with the nozzle. 
     
     
         3 . The apparatus of  claim 2 , wherein each fluid transfer assembly is fixed with respect to the manifold. 
     
     
         4 . The apparatus of  claim 1 , including multiple said fluid inlets above one or more said slots. 
     
     
         5 . The apparatus of  claim 1 , wherein the manifold includes a shroud around three sides of the slot, the shroud extending down from the lower surface. 
     
     
         6 . The apparatus of  claim 5 , wherein the manifold includes a guide extending down from the lower surface and curving toward the slot, whereby clean air exiting the space through the slot is guided toward the slot. 
     
     
         7 . The apparatus of  claim 6 , wherein the guide includes a lower portion spaced from the slot and lower surface sufficiently to permit a portion of a vial to pass between the lower portion of the guide and the slot and lower surface. 
     
     
         8 . The apparatus of  claim 1 , wherein the clean-air inlet is in the upper surface to one side of the manifold, and the slot is on an opposite side of the manifold. 
     
     
         9 . The apparatus of  claim 8 , wherein the clean-air inlet is in the middle of the manifold, and wherein the space of the manifold is bounded by walls extending toward the slot and outward from the clean-air inlet. 
     
     
         10 . The apparatus of  claim 1 , further comprising a plurality of vials to be filled, each such vial having a chamber for holding fluid, a fill tube, a vent tube, and a flange around the fill tube, the flange sized and configured to enter the clean-air zone. 
     
     
         11 . The apparatus of  claim 10 , further comprising at least one covering, the at least one covering attached to one or more of the flanges of the vials and covering the respective fill tubes of the flanges prior to filling, to prevent contaminants from entering the fill tube. 
     
     
         12 . The apparatus of  claim 11 , wherein the covering is attached to the flange by an adhesive. 
     
     
         13 . The apparatus of  claim 11 , wherein the covering is attached to the flange by grips attached to the flange. 
     
     
         14 . The apparatus of  claim 11 , wherein the vials include a rim extending above the flange and communicating with the fill tube, and wherein the covering engages both the rim and the flange. 
     
     
         15 . The apparatus of  claim 11 , wherein the covering is removable prior to filling so that filling need not be performed through the covering. 
     
     
         16 . The apparatus of  claim 11 , wherein the manifold is movable with respect to the vials along an axis of the fill tube. 
     
     
         17 . A system for filling vials with a biological fluid while maintaining sterility of the vials, comprising:
 a filling apparatus;   a set of one or more vials to be filled, each of the vials having a respective fill tube with an upper flange;   a conveyor for moving the vials with respect to the filling apparatus; and   a manifold for providing a clean-air zone around the flanges of the vials during filling, and for connecting to the filling apparatus, the manifold including a clean-air inlet communicating with the internal space, and at least one slot in the lower surface adapted to accept at least a portion of a vial, so that such portion of the vial may enter the clean-air zone.   
     
     
         18 . The system of  claim 17 , wherein the manifold also includes a fluid inlet in the upper surface and over the slot, whereby fluid can be passed through the fluid inlet and into a vial at least partially in the clean-air zone. 
     
     
         19 . The system of  claim 18 , wherein the fluid inlet is a part of a fluid transfer assembly fixed with respect to the manifold, the fluid transfer assembly including a nozzle extending into the space in the manifold and sized and configured to enter a fill tube of a vial and an air flush port in fluid communication with the nozzle.