Method for mixing and dispensing

• US 10,729,795 B2
• Filed: 01/12/2004
• Issued: 08/04/2020
• Est. Priority Date: 01/12/2004
• Status: Active Grant

• Current Assignee: Veltek Associates Incorporated
• Original Assignee: Veltek Associates Incorporated
• Inventors: Vellutato, Sr., Arthur L.
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US10/754,629
• Publication Number:
  US 20050163651A1
• Time in Patent Office: 6,049 Days
• Field of Search: 422 22
• CPC Class Codes: A61L 2/022 Filtration
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: B65B 55/16 by irradiation

Abstract

A method for sterilizing a concentrated composition and a diluent. The diluent is contained in a large container, and the concentrated composition is contained in a small container that is positioned within the large container. The combined containers are placed in at least one sealing layer that is hermetically sealed, and is also preferably placed in a second sealing layer that is also hermetically sealed. The bagged container is then placed in a carton, which preferably has a liner, and the carton is closed. The carton is then irradiation sterilized. The carton is delivered to the clean room. At a first staging area, the carton is opened and the bagged container is removed and brought to a second staging area. At the second staging area, the second sealing layer is removed and the container can be stored in the first sealing layer. The container is brought into the clean environment, where the first sealing layer is removed. At that point, the small container is opened and the chemical composition is released into the large container, so that the chemical composition mixes with the diluent. The container can then be shaken until the chemical composition is thoroughly mixed with the diluent.

Claims

1. A method of sterilizing a chemical composition comprising the steps of:

providing a first container with a first chemical composition and a second container with a second chemical composition, wherein the first container is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition, and wherein the first and second containers are configured to be used in a clean environment without contaminating the clean environment;

sealing the first and second containers in a first sealing layer to form a first sealed container enclosure;

enclosing said first sealed container enclosure in a shipping container to form a closed shipping package; and

externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said first and second containers, said first sealed container enclosure, and said closed shipping package.

2. The method of claim 1, wherein the second container is positioned inside the first container.

3. The method of claim 1, wherein the second container is integral to the first container.

4. The method of claim 1, wherein said second chemical composition comprises a disinfectant liquid.

5. The method of claim 1, wherein said first chemical composition comprises a diluent.

6. The method of claim 1, wherein said second chemical composition comprises phenol.

7. The method of claim 1, wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys.

8. The method of claim 7, wherein the irradiating step comprises applying the gamma radiation to the closed shipping package in a plurality of directions.

9. The method of claim 1, wherein the first chemical composition can be released into the second container in a clean environment so as to combine the first and second chemical compositions in the clean environment.

10. The method of claim 1, further comprising opening the first container in a clean environment to release the first chemical composition into the second container so as to combine the first and second chemical compositions in the clean environment.

11. The method of claim 1, wherein the first container has a neck forming a chamber, and wherein the second container is positioned inside the neck.

12. The method of claim 1, wherein the second container is positioned inside the first container, and the first chemical composition can be combined with the second chemical composition without removing the second container from the inside of the first container.

13. The method of claim 1, wherein the clean environment is a space designed, maintained, and controlled to prevent particle and microbiological contamination of products inside the space.

14. The method of claim 1, wherein the clean environment is a clean room.

15. The method of claim 1, wherein the clean environment is a controlled environment.

16. The method of claim 1, wherein the clean environment clean room controlled environment that is designed, maintained, and controlled to prevent particle and microbiological contamination of products inside the clean room controlled environment.

17. The method of claim 1, wherein the first and second containers can be used in a clean environment without contaminating the clean environment.

18. The method of claim 1, wherein the first and second containers are designed to be used in a clean room environment without contaminating the clean environment.

19. The method of claim 1, wherein the first and second containers are not frangible.

20. The method of claim 1, wherein the first and second containers are structurally configured to be used in a clean environment without contaminating the clean environment.

21. The method of claim 1, wherein the second container has a nozzle that remains fixed to the second container as it is moved between a closed position that retains the second chemical composition and an opened position that releases the second chemical composition into the first container.

22. The method of claim 1, wherein the second container has a nozzle that is pulled to move between a closed position that retains the second chemical composition and an opened position that releases the second chemical composition into the first container.

23. A method of storing a first and second chemical composition for use in a sterile environment, said first and second chemical compositions being respectively contained in a first and second container, wherein the first and second containers are configured to be used in a clean environment without contaminating the clean environment, said first and second containers being hermetically sealed in successive first and second hermetically sealed container enclosures, and a shipping enclosure to form a closed shipping package adapted to be transported, comprising the steps of:

removing the first and second containers and the first and second hermetically sealed container enclosures from the shipping enclosure of the closed shipping package;

transporting the first and second containers and the first and second hermetically sealed container enclosures to the storage area;

storing the first and second containers enclosed in the first and second hermetically sealed container enclosures in the storage area for a period of time;

after the period of time, removing the second hermetically sealed container enclosure and transporting the first and second containers contained in the first hermetically sealed container enclosure to the sterile environment for use;

removing the first hermetically sealed container enclosure in the sterile environment for use of the first and second chemical compositions in the sterile environment; and

,

releasing the first chemical composition from the first container into the second container to mix with the second chemical compositions in the sterile environment.

24. The method of claim 23, wherein the storage area is a sterile storage area.

25. The method of claim 23, wherein said first chemical composition is a diluent and the second chemical composition is a disinfectant, and the first and second chemical compositions are sterilized in said first and second containers by gamma radiation.

26. The method of claim 25, wherein the gamma radiation is in the range of about 20 to 50 kilograys.

27. The method of claim 23, wherein said first container is located within the second container.

28. The method of claim 23, wherein each of said first and second sealing layers is formed of a single layer of closed cell polyethylene.

29. The method of claim 23, wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys.

30. A method of sterilizing a chemical composition comprising the steps of:

providing a container having a first compartment for retaining a first chemical composition and a second compartment for retaining a second chemical composition, wherein the first compartment is positioned with respect to the second compartment so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition, and wherein the container is configured to be used in a clean on t without contaminating the clean environment;

sealing the container in a first sealing layer to form a first sealed container enclosure;

enclosing said first sealed container enclosure in a shipping container to form a closed shipping package; and

externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said container, and said first sealed container enclosure.

31. The method of claim 30, wherein said second chemical composition comprises a disinfectant liquid.

32. The method of claim 30, wherein said first chemical composition comprises a diluent.

33. The method of claim 30, wherein said second chemical composition comprises phenol.

34. The method of claim 30, wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys.

35. The method of claim 34, wherein the irradiating step comprises applying the gamma radiation to the closed shipping package in a plurality of directions.

36. The method of claim 30, wherein the clean environments a space designed, maintained, and controlled to prevent particle and microbiological contamination of products inside the space.

37. The method of claim 30, wherein the clean environment comprises a clean room.

38. The method of claim 30, wherein the clean environment is a controlled environment.

39. The method of claim 30, wherein the first chemical composition can be combined with the second chemical composition without removing the second container from the inside of the first container.

40. The method of claim 30, wherein the clean environment is a clean room controlled environment that is designed, maintained, and controlled to prevent particle and microbiological contamination of products inside the clean room controlled environment.

41. The method of claim 30, wherein the container can be used in a clean environment without contaminating the clean environment.

42. The method of claim 30, wherein the container is designed to be used in a clean room environment without contaminating the clean environment.

43. The method of claim 30, wherein the container is not frangible.

44. The method of claim 30, wherein the first and second containers are structurally configured to be used in a clean environment without contaminating the clean environment.

45. A method of sterilizing a chemical composition comprising the steps of:

providing a first container with a first chemical composition and a second container with a second chemical composition, wherein the first container is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition, and wherein the first and second containers are structurally configured to be used in a clean environment without contaminating the clean environment, wherein the first container has a nozzle that remains fixed to the second container as it is moved between a closed position that retains the first chemical composition and an opened position that releases the first chemical composition into the second container;

sealing the first and second containers in a first sealing layer to form a first sealed container enclosure;

enclosing said first sealed container enclosure in a shipping container to form a closed shipping package; and

externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said first and second containers, said first sealed container enclosure, and said closed shipping package.

46. A method of mixing a first and second composition in a sterile environment comprising:

placing said first and second chemical compositions in a respective first and second compartment, wherein the first and second containers are configured to be used in a clean environment without contaminating the clean environment;

hermetically sealing said first and second compartments in a sealing layer to form a hermetically sealed container enclosure;

irradiating the hermetically sealed container enclosure to simultaneously sterilize said first and second chemical compositions, said first and second compartments, and said hermetically sealed container enclosure to form a sterilized hermetically sealed container enclosure;

introducing the sterilized hermetically sealed container enclosure into the sterile environment;

releasing the first chemical composition from the first compartment into the second compartment, so that the first chemical composition mixes with the second chemical composition.