Method for high vacuum sterilization of closures

• US 6,818,178 B2
• Filed: 08/01/2002
• Issued: 11/16/2004
• Est. Priority Date: 08/16/2001
• Status: Expired due to Fees

• Current Assignee: Environmental Tectonics Corp.
• Original Assignee: Environmental Tectonics Corp.
• Inventors: Kohl, Nelson E., Falkowski, Richard J.
• Primary Examiner(s): Warden, Sr., Robert J.
• Assistant Examiner(s): Chorbaji, Monzer R.
• Application Number:
  US10/208,800
• Publication Number:
  US 20030035753A1
• Time in Patent Office: 838 Days
• Field of Search: 422/3, 422/26, 422/111-112, 422/116, 422/62
• US Class Current: 422/26
• CPC Class Codes: A61L 2/07 Steam

Abstract

A heat sterilization process for small, washed, and bagged articles such as vial stoppers includes a conditioning or air removal phase prior to sterilization. During the air removal phase, a substantial majority of the liquid moisture is removed from the bagged articles by introducing brief periods of dry, warm air to the autoclave chamber. The air is introduced in short bursts at the point of greatest vacuum while pressure pulsing the chamber during the air removal phase. The air is heated and injected into the chamber through a supply valve which is rapidly opened and closed while the chamber is maintained within a preselected vacuum range between the pressure pulses. The result is a greatly reduced time for a complete sterilization and drying process.

Claims

1. A method of conditioning and sterilizing materials, comprising the steps of:

placing materials into a sealed vacuum steam autoclave chamber;

removing air from the chamber during an air removal phase by admitting steam into the chamber and initiating a series of vacuum pulses by vacuum pump means, said pulses including successive pressure-down and pressure-up segments;

injecting heated air into the chamber during said air removal phase between said pulses after each pressure-down segment and before the next pressure-up segment; and

sterilizing the materials by introducing steam into the chamber for a period of time sufficient to effect sterilization of the materials.

2. The sterilization method of claim 1 wherein the step of injecting air into the chamber during the air removal phase occurs while the chamber is maintained at below atmospheric pressure by said vacuum pump means.

3. The sterilization method of claim 2 wherein said air is injected into the chamber through an air supply valve which is rapidly opened and closed to supply short bursts of air into the chamber while the chamber is maintained within a pre-selected pressure range between said successive pressure-down and pressure-up segments.

4. The sterilization method of claim 3 including the additional step of heating and drying said air before injecting it into the chamber.

5. The sterilization process of claim 4 wherein said step of injecting air into the chamber occurs for a brief period between pressure pulses.

6. The sterilization method of claim 5 wherein said step of injecting air into the chamber occurs between pulses for approximately two minutes.

7. The sterilization method of claim 6 wherein said step of injecting air into the chamber occurs while the chamber is held in a vacuum range of between 25 and 27 inches of mercury.

8. The sterilization method of claim 1 wherein said step of sterilizing the materials is followed by the step of drying the materials with hot air in a vacuum.

9. The sterilization method of claim 1 wherein said period of time sufficient to effect sterilization is approximately 100 minutes.

10. The method of sterilizing and drying vial stoppers, comprising:

placing a plurality of vial stoppers into a semi-permeable bag while the stoppers are still wet from washing;

placing said bagged vial stoppers into a sealed vacuum steam autoclave chamber;

removing air from the chamber during an air removal phase by admitting steam into the chamber and initiating a series of vacuum pulses by vacuum pump means, said pulses including successive pressure-down and pressure-up segments;

injecting air into the chamber during said air removal phase between said pulses after each pressure-down segment and before the next pressure-up segment by admitting air through a supply valve which is rapidly opened and closed supplying short bursts of air into the chamber; and

sterilizing the materials by introducing steam into the chamber for a period of time sufficient to effect sterilization of the materials.