Molding and packaging articles substantially free from contaminants

• US 5,953,884 A
• Filed: 07/17/1997
• Issued: 09/21/1999
• Est. Priority Date: 08/22/1995
• Status: Expired due to Fees

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Gelblum, Eugene A., Robinson, Michelle, Wolstenholme, Eugene B., Wolstenholme, Ralph E., Lawecki, Mark
• Primary Examiner(s): Moon, Daniel B.
• Application Number:
  US08/895,758
• Time in Patent Office: 796 Days
• Field of Search: 264/232, 264/238, 425/73, 425/173, 425/210, 425/317, 425/404, 425/815, 454/187, 53/122, 53/127, 53/167, 53/425, 53/426, 53/428, 53/440, 141/11
• US Class Current: 53/428
• CPC Class Codes: B29C 45/0084 General arrangement or lay-out of plants B29C45/1468 takes precedence
• CPC Class Codes: B29C 45/1701 using a particular environment during moulding, e.g. moisture-free or dust-free
• CPC Class Codes: B65B 3/006 Related operations, e.g. scoring ampoules
• CPC Class Codes: Y10S 425/815 Chemically inert or reactive atmosphere

Abstract

An apparatus and method are provided for manufacturing articles, such as syringe barrels, substantially free from contaminants. The apparatus is an enclosure defining at least a class 100 and MCB-3 environment, and includes a molding isolation module and a packaging isolation module. Any contaminants that may exist within the enclosure are removed by the use of horizontal and vertical laminar airflows directed into air filter units. Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module and packaging isolation module keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers for shipment.

Claims

1. A method for manufacturing sterile syringe components, the method comprising the following steps:

providing an enclosure defining a sterile environment, the enclosure communicating with an outside environment by means of at least one air filter operable to prevent contaminants from entering the enclosure;

providing at least one mold inside the enclosure at a molding station;

providing molding material from which to mold the syringe components;

heating the molding material;

placing the heated molding material within the at least one mold;

molding a plurality of one or more syringe components from the molding material using the at least one mold, the heat generated during one or more of said heating and molding steps operable to render the molded syringe components substantially free from contaminants;

forcing air from the outside environment through the enclosure through the at least one air filter to prevent contaminants from adhering to the molded syringe components;

removing the molded syringe components from the at least one mold;

inspecting the molded syringe components in the enclosure for defects;

assembling the molded syringe components in the enclosure to form one or more syringes;

filling the one or more syringes in the enclosure with a sterile fluid; and

packaging the one or more syringes in at least one sealed package.

2. The method of claim 1 wherein said enclosure is at least a class 100 environment.

3. The method of claim 1 wherein the enclosure is at least a MCB-3 environment.

4. The method of claim 1 wherein said components are molded out of plastic.

5. The method of claim 1 and further comprising the step of introducing molding material to the mold through a gate in the enclosure.

6. The method of claim 1 further comprising the steps of:

filtering incoming air flowing into the molding station using said at least one air filter, and

within said molding station, creating a horizontal laminar airflow through the molding station to prevent settling of any contaminants.

7. The method of claim 1 further comprising the steps of:

using a robot disposed within the molding station to pick molded components from the mold;

using the robot to deposit the components on a conveyor within the enclosure; and

conveying the components to an inspection station within the enclosure.

8. The method of claim 1 further comprising the steps of:

using a mechanical arm disposed within the molding station to pick molded components from the molds;

using said mechanical arm to deposit said components on a conveyor within the enclosure; and

conveying said components to an inspection station within the enclosure.

9. The method of claim 1 further comprising the steps of:

filtering incoming air entering an inspection station within the enclosure using said at least one filter, and

creating a vertical laminar airflow in said inspection station to prevent the settling of any contaminants.

10. The method of claim 1 further comprising the steps of:

filtering incoming air entering a packaging station within the enclosure using said at least one filter; and

creating a vertical laminar airflow in said packaging station to prevent settling of any contaminants.

11. The method of claim 1 further including the steps of:

providing a sidewall of the enclosure with a transparent panel; and

inspecting the components from outside of the enclosure.

12. The method of claim 11 wherein said step of inspecting includes inserting hands and arms of an inspector into the enclosure below the transparent panel to remove scrap from the components and to reject defective ones of the components.

13. The method of claim 1 wherein said step of packaging includes:

providing a sidewall of the enclosure at a packaging station with a transparent panel; and

observing said step of packaging from outside of the enclosure.

14. The method of claim 13 wherein said step of packaging further includes:

inserting hands of a packager into the enclosure below the transparent panel to perform a packaging operation.

15. The method of claim 1 wherein said step of packaging includes:

enclosing a plurality of the syringes in a first container;

scaling the first container;

enclosing the sealed first container in a second container; and

sealing the second container.

16. The method of claim 1 further comprising the steps of:

providing a perforated work surface inside the enclosure for said step of packaging; and

directing laminar vertical airflow downwardly to pass through the perforations in the work surface.

17. A method for manufacturing sterile syringe components, the method comprising the steps of:

providing an enclosure containing a sterilizing gas;

providing at least one mold inside the enclosure at a molding station;

providing molding material from which to mold the syringe components;

heating the molding material;

placing the heated molding material within the at least one mold;

molding a plurality of one or more syringe components from the molding material using the at least one mold, the heat generated during one or more of said heating and molding steps operable to render the molded syringe components substantially free from contaminants;

removing the molded syringe components from the at least one mold;

inspecting the molded syringe components in the enclosure for defects;

assembling the molded syringe components in the enclosure to form one or more syringes;

filling the one or more syringes in the enclosure with a sterile fluid; and

packaging the one or more syringes in at least one sealed package.