Granted Patent B2

US 7,117,901 · App. 10/084,520 · Granted Oct 10, 2006

Abstract

Claims (12)

1. Apparatus for filling containers for pharmaceutical uses, comprising a casing which envelops the set of drive and control members and has supports for containers holding the medicinal starting solutions and containers for the medicinal output solutions, the apparatus being characterized in that it comprises means for supporting and locating a unit for the suction and expulsion of the solutions, combined with a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, means for actuating the unit for the suction and expulsion of solutions, means for the programmed control of the operating cycles of the means for the closure of the flexible tubes by pinching, and means for the input of operational instructions by a keyboard, said device for actuating the plunger of the unit for the suction and expulsion of solution comprising a rotary screw and a female screw which is guided longitudinally and is coupled to the plunger.

2. Apparatus for filling containers for pharmaceutical uses according to claim 1 , characterized in that the distributor has a plurality of radial ducts which communicate at a central point and which are connected externally to flexible tubes, of which one communicates with a pump for the suction and expulsion of the solutions and the remainder communicate with sources of the solutions to be dosed and containers for the receipt or dispatch of the medicinal substances or mixtures thereof that are handled by the apparatus.

3. Apparatus for filling containers for pharmaceutical uses according to claim 1 , characterized in that the distributor is formed as a single unit of injection-moulded, thermoplastic material.

4. Apparatus for filling containers for pharmaceutical uses according to claim 1 , characterized in that the unit for the suction and expulsion of the solutions and of air is constituted by a gauged cylinder provided with means for fitting it releasably in the casing of the apparatus, and a plunger which slides inside the said cylinder and which can be advanced and retracted by said actuating device of the apparatus.

5. Apparatus for filling containers for pharmaceutical uses according to claim 1 , characterized in that it comprises means which can be programmed manually by means of a keyboard or by a programming card in order to preset the order and time of pinching of the various flexible tubes of the distributor and also the actuation of the plunger of the device for the suction and expulsion of solutions in order to define the quantity of solution drawn in and/or expelled.

6. Apparatus for filling containers for pharmaceutical uses comprising a casing which envelops the set of drive and control members and has supports for containers holding the medicinal starting solutions and containers for the medicinal output solutions, the apparatus being characterized in that it comprises means for supporting and locating a unit for the suction and expulsion of the solutions, combined with a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, means for actuating the unit for the suction and expulsion of solutions, means for the programmed control of the operating cycles of the means for the closure of the flexible tubes by pinching, and means for the input of operational instructions by a keyboard, said means for the closure of the flexible tubes of the distributor by pinching comprising individual rods actuated from inside the apparatus by axial drive elements, each of said rods being able to act on a corresponding tubular element connected to the distributor for the closure thereof by pinching of the said tube against a rigid region for guiding the tube, said drive elements being displaced axially by individual devices each comprising a drive motor, a rotary screw, and a movable female screw.

7. A method of filling containers with sterile solutions and/or mixtures thereof with an apparatus of the type comprising a casing which envelops a set of drive and control members and includes supports for containers holding a medicinal starting solution and containers for the medicinal output solutions, the apparatus further comprising means for supporting and locating a unit for the suction and expulsion of the solutions, and a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, and means for actuating the unit for the suction and expulsion of solutions, said apparatus further having means for the programmed control of the operating cycle of the means for the closure of the flexible tubes by pinching, with means for the input of operational instructions by a keyboard, said method characterized in that in the first place the dosing parameters are programmed in accordance with the substances to be used and their proportions and dose parameters, a disposable device being fitted in said housing and the containers of the starting substances being fitted on the supports of the apparatus, the containers of the starting substances being connected to the distributor and the destination container, said apparatus being operable to automatically draw in a small volume of liquid to purge the ducts of the disposable device and to eliminate towards a discharge container purging air which has remained in the unit for the suction and expulsion of solutions, drawing in the programmed volume in at least a single cycle, and discharging the liquid from the suction and expulsion unit into the destination container, said destination container being provided with a molecular filter, and the further step of drawing in air and compressing it, and discharging it into the destination container.

8. The method of claim 7 , including repeating the suction and discharge steps to complete the programmed dose.

9. Apparatus for filling containers for pharmaceutical uses comprising a casing which envelops the set of drive and control members and has supports for containers holding the medicinal starting solutions and containers for the medicinal output solutions, the apparatus being characterized in that it comprises means for supporting and locating a unit for the suction and expulsion of the solutions, combined with a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, means for actuating the unit for the suction and expulsion of solutions, means for the programmed control of the operating cycles of the means for the closure of the flexible tubes by pinching, means for the input of operational instructions by a keyboard, and a pressure sensor which is associated with the plunger of the unit for the suction and expulsion of solutions, and which can send a signal related to the minimum compressed-air pressure which a molecular filter of a container to be filled can withstand in order to test the integrity of the filter.

10. Apparatus for the filling of containers for pharmaceutical uses according to claim 9 , characterized in that the integrity test is performed by compressing air to a pressure below the bubble point of the filter for the last substance dosed and checking that the pressure does not fall during a period of a few seconds.

11. Apparatus for the filling of containers for pharmaceutical uses comprising a casing which envelops the set of drive and control members and has supports for containers holding the medicinal starting solutions and containers for the medicinal output solutions, the apparatus being characterized in that it comprises means for supporting and locating a unit for the suction and expulsion of the solutions, combined with a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, means for actuating the unit for the suction and expulsion of solutions, means for the programmed control of the operating cycles of the means for the closure of the flexible tubes by pinching, means for the input of operational instructions by a keyboard and an extension for connection to a non-sterile container, the container having a twist-off valve at one end and a male Luer lock at the other.

12. Apparatus for the filling of containers for pharmaceutical uses comprising a casing which envelops the set of drive and control members and has supports for containers holding the medicinal starting solutions and containers for the medicinal output solutions, the apparatus being characterized in that it comprises means for supporting and locating a unit for the suction and expulsion of the solutions, combined with a distributor for defining the liquid inlets and outlets, the apparatus having means for the closure of the flexible inlet and outlet tubes of the distributor by pinching, means for actuating the unit for the suction and expulsion of solutions, means for the programmed control of the operating cycles of the means for the closure of the flexible tubes by pinching, means for the input of operational instructions by a keyboard and a housing for receiving the actuating end of the plunger of the unit for the suction and expulsion of solutions and of air, which housing includes a load cell that converts the force exerted by the plunger into a signal which is processed by the control device of the apparatus and which is related to the pressure exerted by the suction and expulsion unit by means of the fixed datum of the diameter of the plunger and the force exerted, measured by the load cell, the actual pressure being adjusted to a predetermined value by control of the drive motor.

Assignments (9)