Micro-isolator steam sterilization cycle and apparatus

• US 5,429,800 A
• Filed: 12/01/1993
• Issued: 07/04/1995
• Est. Priority Date: 12/01/1993
• Status: Expired due to Fees

• Current Assignee: American Sterilizer Company (Steris Corporation)
• Original Assignee: American Sterilizer Company (Steris Corporation)
• Inventors: Barron, William R., Miraldi, Peter T., Ruffo, Anthony B.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Dawson, E. Leigh
• Application Number:
  US08/160,500
• Time in Patent Office: 580 Days
• Field of Search: 119/15, 119/17, 119/18, 435/287, 422/26, 422/33, 422/292, 422/298, 422/299, 422/108, 422/109, 422/110, 422/112, 422/113, 53/431
• US Class Current: 422/26
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation

Abstract

A particularly useful method is disclosed for sterilizing micro-isolators in which a sipper bottle is contained. In the present invention, sterilization is effected by using a microprocessor control to regulate the pressure within a sterilization chamber in response to temperature conditions. Pressure within the chamber is regulated so that as temperature is raised and lowered, the boiling point of water in the sipper bottle is never exceeded. Prior to sterilization, the chamber is evacuated of air to permit effective distribution of steam. Subsequent to sterilization, the chamber is again evacuated in order to evaporate condensed steam that covers the micro-isolator and its contents. During each of these evacuations, the microprocessor control regulates the rate of vacuum draw down so that the boiling point of water in the sipper bottle is again not exceeded. This method permits micro-isolators to be sterilized with sipper bottles full of water, without losing a significant volume of water. The method of the present invention thus provides micro-isolators that are ready to use, including the drying of the micro-isolator, complete with bedding and food.

Claims

1. A method of sterilizing a container including an article containing water comprising the steps of:

providing a sterilization chamber for receiving a container including an article containing water to be sterilized;

introducing steam into said chamber for raising chamber temperature to a predetermined sterilization temperature wherein the steam is introduced at a predetermined pressure sufficient to avoid boiling the water in the article;

maintaining the temperature and pressure levels for a sufficient interval so that sterilization of said container and article containing water is effected;

exhausting the sterilization chamber of steam while maintaining that temperature and pressure levels within the chamber below the boiling point of water by introducing compressed gas into the chamber in order to exhaust the steam and lower the temperature so as to cool the container and article, said compressed air is introduced at a predetermined pressure sufficient to avoid substantially boiling the water at the maintained temperature;

evacuating said chamber to a subatmospheric pressure, said subatmospheric pressure being controlled sufficiently to evaporate steam condensate that adheres to said chamber and articles, but sufficient to avoid boiling the water in the article; and

restoring chamber pressure to atmospheric level.

2. The method of claim 1 further comprising the step of:

prior to said steam introducing step, providing a preliminary evacuation of said chamber to lower chamber pressure to an initial subatmospheric level at such a rate that the boiling point of water is not exceeded for the temperature of the chamber.

3. The method according to claim 2 wherein the initial subatmospheric level is 1.0-7.4 psia.

4. The method according to claim 2 wherein said preliminary evacuations are followed by a predetermined number of vacuum pulses, wherein for each pulse, the chamber pressure is lowered to the initial subatmospheric level and then raised again to atmospheric level.

5. The method according to claim 1 wherein said container is a micro-isolator including accommodations for laboratory animals.

6. The method according to claim 5 wherein the accommodations include a sipper bottle which contains water and is exposed to the pressure of the chamber for the entire sterilization cycle.

7. The method according to claim 1 wherein the subatmospheric level is 2.0-7.4 psia.

8. The method according to claim 1 wherein said steam introducing step raises chamber temperature to at least 118°

C. and chamber pressure to at least 28 psia.

9. The method according to claim 8 wherein the predetermined sterilization interval is about 5 minutes or 15 F_o values.

10. The method according to claim 8 wherein the compressed air during the exhausting of the sterilization chamber is at a level sufficient to raise and maintain chamber pressure to at least 34 psia.

11. The method according to claim 1 wherein the chamber pressure is maintained at the subatmospheric level for a predetermined dwell time, sufficient to effect the evaporation of steam condensate.

12. The method according to claim 11 wherein the dwell time is 1-90 minutes.

13. The method according to claim 1 wherein said evacuation further comprises the application of a predetermined number of vacuum pulses, wherein for each pulse, the chamber pressure is lowered to the subatmospheric level and then raised again to atmospheric level.

14. A method of providing a sterilization cycle for a plurality of articles, comprising the steps of:

providing a transfer box into which are inserted a plurality of articles;

providing a sterilization chamber for receiving the transfer box including said plurality of articles to be sterilized;

introducing a steam charge into said chamber for raising chamber pressure and chamber temperature to predetermined levels wherein temperature and pressure are maintained for a sufficient interval so that sterilization of the transfer box including said plurality of articles is effected;

exhausting the sterilization chamber of steam while introducing a flow of compressed air such that temperature and pressure levels within the chamber do not exceed the boiling point of water;

providing a drying evacuation of said chamber in order to lower chamber pressure to a subsequent subatmospheric level, while controlling temperature so that the boiling point of water is not exceeded, said subsequent subatmospheric level being sufficient to evaporate steam condensate that adheres to said chamber and articles; and

providing an air break to restore chamber pressure to atmospheric level;

removing said transfer box from the sterilizer into a non-sterile environment, whereby said plurality of articles remain sterile while inside the unopened transfer box.

15. The method of claim 14 comprising the step of:

prior to the introduction of the steam charge, providing a preliminary evacuation of said chamber to lower chamber pressure to a initial subatmospheric level at such a rate that the boiling point of water is not exceeded for the temperature of the chamber.

16. The method according to claim 14 wherein said container is a micro-isolator and said plurality articles includes accommodations for laboratory animals, further including food, bedding and a sipper bottle, wherein the sipper bottle includes water which is exposed to the pressure of the chamber for the entire sterilization cycle.

17. A method of sterilizing a container including an article containing water, comprising the steps of:

providing a sterilization chamber for receiving a container including an article containing water to be sterilized;

monitoring a temperature of the article containing water so as to produce a monitored temperature;

introducing steam into said chamber for raising chamber temperature to a predetermined temperature sufficient to insure sterilization of the container and articles wherein the steam is introduced into said chamber at a predetermined pressure sufficient to avoid boiling the water in the article in response to the monitored temperature;

maintaining the temperature and pressure levels for a sufficient interval so that sterilization of the container and article containing water is effected;

exhausting the sterilization chamber of steam and cooling the chamber while maintaining the pressure within the chamber at a sufficient level to avoid boiling the water in response to the monitored temperature;

evacuating said chamber to a subatmospheric pressure in response to the monitored temperature, said subatmospheric pressure is controlled sufficiently to evaporate steam condensate that adheres to said chamber and articles but sufficient to avoid boiling the water in the article; and

restoring chamber pressure to atmospheric level.

18. A method of sterilizing a container including an article containing water comprising the steps of:

providing a sterilization chamber for receiving a container including an article containing water to be sterilized;

evacuating said chamber to an initial subatmospheric pressure sufficient to avoid boiling the water in the article;

introducing steam into said chamber for raising chamber temperature to a predetermined sterilization temperature wherein the steam is introduced at a predetermined pressure sufficient to avoid boiling the water;

maintaining the temperature and pressure levels for a sufficient interval so that sterilization of said container and article containing water is effected;

exhausting the sterilization chamber of steam by introducing compressed air into the chamber in order to lower the temperature so as to cool the container and articles, said compressed air is introduced at a predetermined pressure sufficient to avoid boiling the water;

evacuating said chamber to a subatmospheric pressure, said subatmospheric pressure is controlled sufficiently to evaporate steam condensate that adheres to said chamber and article but sufficient to avoid boiling the water in the article; and

restoring chamber pressure to atmospheric level.