Process and apparatus for compounding hyperalimentation solutions

• US 4,372,100 A
• Filed: 12/17/1981
• Issued: 02/08/1983
• Est. Priority Date: 11/01/1979
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Miller, Robert A., Larson, Kenneth W., Schopen, Joseph L.
• Primary Examiner(s): Culver, Horace M.
• Application Number:
  US06/331,495
• Time in Patent Office: 418 Days
• Field of Search: 53/428, 53/434, 53/469, 53/474, 53/512, 53/111 R, 128/214 R, 128/214 C, 128/214 D, 128/214.2, 366/160, 366/162, 366/173, 366/174, 366/182, 366/337, 127/14, 127/21, 127/55, 222/129, 222/145, 137/602, 137/604, 137/605, 137/606, 137/808, 137/809, 137/4, 137/92, 137/205, 141/105, 141/286, 141/9, 141/10, 141/114, 141/313
• US Class Current: 53/428
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: B01F 23/40 Mixing liquids with liquids; Emulsifying
• CPC Class Codes: B01F 35/833 Flow control by valves, e.g. opening intermittently

Abstract

A process and apparatus for mixing at least two parenteral solutions, sterilizing the resulting mixture, and transferring the sterilized mixture into an extensible, plastic receiving bag. The apparatus includes a mixing chamber into which the solutions can be delivered, a bacterial organism retentive filter for sterilizing the mixture of the solutions received from the chamber, such a receiving bag, tubing for transferring each of the solutions to be chamber, and second tubing for transferring the sterilized mixture from the filter to the bag. All are combined and then sterilized as a unit. In one embodiment of the invention, the bag is placed in a vacuum chamber to facilitate transfer of the mixture through the apparatus and the mixing chamber has a baffle or system of baffles for creating turbulence in the solutions while they are being mixed. The diameter and length of each tubing leading into the chamber from a solution holding container is preselected with respect to the viscosity of the solution in that holding container, so that both solutions reach the chamber at the same time or in a selected order and are mixed in an equal or preselected proportion therein.

Claims

1. An apparatus useful for the sterile compounding of at least two solutions comprising:

a container for receiving the compounded solutions;

a mixing chamber in fluid-flow communication with the receiving container and with the source of each solution;

a filter interposed in the fluid-flow communication between the mixing chamber and receiving container for sterilizing the mixture after it is mixed in the chamber;

tubing connected between the filter and the receiving container for delivery of the sterilized mixture to the receiving container;

wherein the solutions may be delivered to the mixing chamber, mixed therein, delivered to the filter, and then delivered to the receiving container and wherein at least the sterilizing portion of the filter, the tubing, and the receiving container are a sterile unit; and

at least three uniform size tubes communicating with the mixing chamber for automatically controlling the quantity of each solution in the compounded mixture, each of said uniform size tubes being adapted for connection to a different solution source and through which the solution of the particular source can be delivered to the chamber, wherein the number of solution sources provided for a particular solution determines the quantity of that solution in the mixture.

4. The apparatus of claims 1, 2 or 3 wherein the mixing chamber further comprises at least one baffle for increasing the turbulence of and enhancing the mixture of the solutions being compounded.

2. An apparatus useful for the sterile compounding of at least two solutions comprising:

a container for receiving the compounded solutions;

a mixing chamber in fluid-flow communication with the receiving container and with the source of each solution;

a filter interposed in the fluid-flow communication between the mixing chamber and receiving container for sterilizing the mixture after it is mixed in the chamber;

tubing connected between the filter and the receiving container for delivery of the sterilized mixture to the receiving container;

wherein the solutions may be delivered to the mixing chamber, mixed therein, delivered to the filter, and then delivered to the receiving container and wherein at least the sterilizing portion of the filter, the tubing, and the receiving container are a sterile unit; and

first and second tubes for automatically controlling the quantity of each solution in the compounded mixture, each tube communicating with said mixing chamber, being of a preselected size, and being adapted for transferring to said mixing chamber a solution from a particular solution source, wherein the size of the first and second tubes determines the amount of solution delivered through the tube and, consequently, the amount of that solution in the mixture.

3. An apparatus useful for the sterile compounding of at least two solutions comprising:

a container for receiving the compounded solutions;

a mixing chamber in fluid-flow communication with the receiving container and with the source of each solution;

a filter interposed in the fluid-flow communication between the mixing chamber and receiving container for sterilizing the mixture after it is mixed in the chamber;

tubing connected between the filter and the receiving container for delivery of the sterilized mixture to the receiving container;

wherein the solutions may be delivered to the mixing chamber, mixed therein, delivered to the filter, and then delivered to the receiving container and wherein at least the sterilizing portion of the filter, the tubing, and the receiving container are a sterile unit; and

two inlets of different dimensions in said mixing chamber through each of which a solution from a solution source is delivered into said mixing chamber, for automatically controlling the quantity of each solution in the compounded mixture, wherein the dimension of each inlet determines the amount of solution delivered therethrough into said chamber and, consequently, the amount of that solution in the mixture.

5. A process for the sterile compounding of at least two solutions comprising the steps of:

delivering each solution from a solution source to a mixing chamber;

automatically controlling the quantity of each solution delivered to the chamber by providing at least three uniform size tubes communicating with the chamber, each of which is adapted for connection to a different solution source and through which the solution of the particular source can be delivered to the chamber, wherein the number of solution sources providing for a particular solution determines the quantity of that solution in the mixture;

mixing the solutions in the chamber;

sterilizing the mixture after it is mixed in the chamber by delivering the mixture to a filter in fluid-flow communication with an outlet of the chamber;

delivering the compounded mixture to a receiving container through tubing connected between an outlet of the filter and the receiving container, at least the sterilizing portion of the filter, the filter outlet, the tubing, and the receiving container being a sterile unit; and

hermetically sealing the receiving container after the mixture has been received therein.

8. The process of claims 5, 6 or 7 further comprising the step of providing at least one baffle in the chamber for increasing the turbulence of and enhancing the mixture of the solutions being compounded.

6. A process for the sterile compounding of at least two solutions comprising the steps of:

delivering each solution from a solution source to a mixing chamber;

automatically controlling the quantity of each solution delivered to the chamber by providing first and second tubes communicating with the chamber, being of a preselected size and being adapted for transferring to the chamber a solution from a particular solution source, wherein the size determines the amount of solution delivered through the tube and, consequently, the amount of that solution in the mixture;

mixing the solutions in the chamber;

sterilizing the mixture after it is mixed in the chamber by delivering the mixture to a filter in fluid-flow communication with an outlet of the chamber;

delivering the compounded mixture to a receiving container through tubing connected between an outlet of the filter and the receiving container, at least the sterilizing portion of the filter, the filter outlet, the tubing, and the receiving container being a sterile unit; and

hermetically sealing the receiving container after the mixture has been received therein.

7. A process for the sterile compounding of at least two solutions comprising the steps of:

delivering each solution from a solution source to a mixing chamber;

automatically controlling the quantity of each solution delivered to the chamber by providing two inlets of different dimensions in the chamber through each of which a solution from one of the solution sources is delivered into the chamber, wherein the dimension of each inlet determines the amount of solution delivered therethrough into the chamber;

mixing the solutions in the chamber;

sterilizing the mixture after it is mixed in the chamber by delivering the mixture to a filter in fluid-flow communication with an outlet of the chamber;

delivering the compounded mixture to a receiving container through tubing connected between an outlet of the filter and the receiving container, at least the sterilizing portion of the filter, the filter outlet, the tubing, and the receiving container being a sterile unit; and

hermetically sealing the receiving container after the mixture has been received therein.