Porous load vapor sterilization cycle

• US 4,687,635 A
• Filed: 10/05/1984
• Issued: 08/18/1987
• Est. Priority Date: 10/05/1984
• Status: Expired due to Fees

• Current Assignee: American Sterilizer Company (Steris Corporation)
• Original Assignee: American Sterilizer Company (Steris Corporation)
• Inventors: Kaehler, Kristine M., Krahe, Ronald P., Miraldi, Peter T., McBride, Richard A.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Johnson, William R.
• Application Number:
  US06/658,396
• Time in Patent Office: 1,047 Days
• Field of Search: 422/26, 422/27, 422/108-111, 422/3, 422/34, 422/33
• US Class Current: 422/26
• CPC Class Codes: A61L 2/06 Hot gas
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation

Abstract

A steam sterilization cycle having a conditioning stage, a sterilizing stage, a drying stage and an air admission stage which provides maximum removal of entrapped air from full or partial porous loads. The conditioning stage includes a plurality of pressure/vacuum pulses. The final vacuum pulses are deeper than the initial pulses. The sterilizing stage includes a diffusion dwell come-up which gradually increases the temperature and pressure of the chamber to the predetermined sterilization temperature by a sequence of pressure rises followed by pressure plateaus which permit substantially complete steam penetration of the load and substantial equalization of the actual load temperature and the temperature sensed by the sterilizer controls and substantially eliminates superheating the chamber. The cycle may also include a step for detecting and reacting to unacceptable levels of noncondensable gas present in the chamber during the sterilization stage.

Claims

1. A method of increasing the temperature and pressure within a sealable chamber wherein a porous load is disposed for processing and from both of which noncondensable gases have been substantially removed comprising:

after sealing said chamber, subjecting said chamber to a plurality of pressurization steps wherein a condensable vapor having transferable latent heat is so injected into said chamber that (a) said plurality of pressurization steps are sufficient to so gradually elevate the temperature and pressure within said chamber to a predetermined temperature and pressure effective for processing said porous load that the opportunity for substantially surpassing said predetermined temperature is substantially eliminated, and (b) said plurality of pressurization steps are sufficient to permit such penetration of said porous load by said vapor that said porous load reaches a general temperature equilibrium with said vapor in said chamber at about the same time as said chamber reaches said predetermined temperature to avoid superheating said chamber relative to said porous load;

each said pressurization step including a pressure rise during which said vapor is injected into said chamber followed by a pressure plateau, greater than the previous pressure plateau, during which said chamber is isolated and said vapor is not injected into said chamber to permit said vapor injected during said pressure rise to penetrate said porous load to displace noncondensable gases and to permit said chamber and said porous load temperatures to stabilize.

2. A method as recited in claim 1 further comprising a conditioning stage for substantially removing noncondensable gases from said chamber and said porous load, said conditioning stage comprising:

subjecting said chamber and said load to a plurality of cyclic pressure pulses below an upper pressure level related to said predetermined temperature by injecting said vapor into said chamber and evacuating said chamber, each cyclic pressure pulse including a vapor injecting phase during which the pressure is increasing and an evacuating phase during which the pressure in said chamber is decreasing;

said evacuating phases of said plurality of pressure pulses including at least one initial evacuating phase during which the pressure in said chamber is decreased to a first lower pressure level and at least one final evacuating phase during which the pressure in said chamber is decreased to a second lower pressure level which is lower than said first lower pressure level.

3. A method as recited in claim 1 wherein said predetermined temperature is a temperature effective for sterilizing said porous load.

4. A method as recited in claim 3 wherein said condensable vapor is steam.

5. A method as recited in claim 4 wherein said predetermined temperature is between about 134°

C. and 138°

C. and said plurality of pressurization steps are completed in about two minutes.

6. In a method for sterilizing porous loads in a sterilizer having a sealable pressure chamber and associated piping wherein a condensable vapor having transferable latent heat is employed as a sterilizing agent, said method having at least a conditioning step during which noncondensable gases are removed from said chamber and said load, followed by a sterilization step an improvement in said sterilization stem comprising:

subjecting said chamber to a plurality of pressurization steps wherein said vapor is so injected into said chamber that (a) said plurality of pressurization steps are sufficient to so gradually elevate the temperature and pressure effective for sterilizing said porous load that the opportunity for substantially surpassing said predetermined temperature is substantially eliminated and (b) said plurality of pressurization steps are sufficient to permit such penetration of said porous load by said vapor that said porous load reaches a general temperature equilibrium with said chamber at about the same time as said chamber reaches said predetermined temperature to avoid superheating said chamber relative to said porous load, each said pressurization step including a pressure rise during which said vapor is injected into said chamber followed by a pressure plateau, greater than the previous pressure plateau, during which said chamber is isolated and said vapor is not injected into said chamber to permit said vapor injected during said pressure rise to penetrate said porous load to displace noncondensable gases and to permit said chamber and said porous load temperature to stabilize; and

holding said chamber at said predetermined temperature for a predetermined period of time sufficient to sterilize said porous load.

7. A method as recited in claim 6 further comprising a drying stage following said sterilization stage during which a vacuum is maintained for a period effective for drying said load, and an air admission stage following said drying stage during which sterile air is admitted to said chamber to bring said chamber to atmospheric pressure.

8. A method as recited in claim 6 wherein said vapor is steam.

9. A method as recited in claim 6 further comprising an improvement in said conditioning stage, said improvement comprising:

subjecting said chamber and said load to a plurality of cyclic pressure pulses below an upper pressure level related to said predetermined tempeature by injecting said vapor into said chamber and evacuating said chamber, each cyclic pressure pulse including a vapor injecting phase during which the pressure is increasing and an evacuating phase during which the pressure in said chamber is decreasing;

said evacuation phases of said plurality of pressure pulses including at least one initial evacuating phase during which the pressure in said chamber is decreased to a first lower pressure level and at least one final evacuation phase during which the pressure in said chamber is decreased to a second lower pressure level which is lower than said first lower pressure level.

10. A method as recited in claim 9 wherein said associated piping includes a remote section and said method further comprises steps for detecting and responding to unacceptable levels of noncondensable gas in a fluid in said chamber during said sterilization stage, said fluid including at least said vapor, said noncondensable gas detecting step comprising:

communicating said fluid within said chamber to said remote section during said sterilization stage;

condensing said vapor from said fluid and discharging said condensate from said remote section as said fluid is communicated to said remote section so that any noncondensable gas within said fluid accumulates in said remote section;

measuring the temperature of said accumulating noncondensable gas within said remote section; and

employing the measured noncondensable gas temperature to automatically fail said sterilization cycle when the measured noncondensable gas temperature equals a preselected temperature effective for indicating the presence of a predetermined unacceptable level of noncondensable gas in said chamber.

11. A method as recited in claim 10 wherein said predetermined unacceptable level of noncondensable gas is produced by a leak greater than 1 mm Hg/min at 50 mm Hg.

12. A method as recited in claim 10 wherein said vapor is condensed by surrounding said remote section with atmospheric air sufficiently cool to condense said vapor.