US3589861A - Balanced pressure process of sterilization - Google Patents
Balanced pressure process of sterilization Download PDFInfo
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- US3589861A US3589861A US730311A US3589861DA US3589861A US 3589861 A US3589861 A US 3589861A US 730311 A US730311 A US 730311A US 3589861D A US3589861D A US 3589861DA US 3589861 A US3589861 A US 3589861A
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- pressure
- gas
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- permeable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
Definitions
- a semi-permeable membrane is a membrane that is permeable to certain liquids or gases, i.e., certain liquids or gases will pass through the membrane, but others will not.
- Polyethylene is an example of a material that is permeable to certain gases, including ethylene oxide, but is essentially impermeable to other gases including air.
- gases including ethylene oxide
- membranes permeable to certain sterilizing gases yet impermeable to other gases, such as air are nylon and cellophane.
- ethylene oxide when a sealed polyethylene package is placed in an environment of a permeable sterilizing gas, such as ethylene oxide, with an arbitrarily chosen pressure of p.s.i., ethylene oxide will flow through the polyethylene until the ethylene oxide reaches an equilibrium whereby the partial pressure of the ethylene oxide on the inside of the package becomes equal to the pressure of the ethylene oxide on the outside of the package, or 15 p.s.i.
- a permeable sterilizing gas such as ethylene oxide
- the package may rupture as swelling occurs; if such a package is relatively strong, compared to a confining package such as a cardboard box, the pressure developed within the swelling packages will rupture the cardboard box. Intermediate effects could also be observed.
- a package such as polyethylene
- this gas will permeate the package in an attempt to reach uniform distribution (equilibrium) according to Grahams Law; the sum of the partial pressure of the permeated gas in the package, and the partial pressure of the residual air in ice the package, is greater than the pressure of the sterilizing gas outside the package, and hence, the package tends to swell in response to this pressure differential created by the residual air within the package that cannot escape.
- Water vapor commonly used in ethylene oxide sterilization, has its own partial pressure and contributes, along with the partial pressure of ethylene oxide, to the total pressure in the sterilizing atomsphere; since water vapor permeates polyethylene, the partial pressure of the water vapor will contribute, along with ethylene oxide and air, to the total pressure within the polyethylene package.
- the magnitude of the respective partial pressures is dependent on the concentration of each component gas present.
- This invention is a technique that was specifically designed to prevent the swelling of sealed polyethylene packages during the sterilization cycle as a result of the permeating gas.
- an external pressure is applied to the package to balance the partial pressure of the permeated sterilizing gas on the inside of the package, thus preventing the package from swelling due to this added internal pressure.
- Air is used as an impermeable gas to provide a confining over-pressure.
- This permeable confining pressure balances the pressure of the permeating sterilizing gas (including water vapor and diluent gases) so that the package cannot swell beyond its original size, despite the fact that the permeating gas reaches a concentration (pressure) equilibrium within the package; this equilibrium is manifested by an increase in pressure within the package that is counteracted by the confining im permeable pressure outside the package, and hence, no change in the size of the package will occur.
- the overpressure of the impermeable gas must, therefore, be equal to or greater than the sum of the partial pressures of all the component gases that have permeated the package at any given time.
- the absolute partial pressure of the impermeable gas in the sterilizing chamber atmosphere must be equal to or greater than the sum of the absolute partial pressures of the permeable sterillizing gases in the chamber atmosphere.
- the permeable gas is flushed from the chamber with the impermeable gas (for example, air), maintaining a balanced over-pressure, and holding this condition for a period of time to allow the permeable gas to diffuse back out of the package.
- the impermeable gas must maintain a gauge pressure equal to or greater than the absolute partial pressure of the permeale gas within the package or the package will inflate.
- the post-diffusion period may be programmed to decrease in pressure over the time period so as to minimize the possible entrance of traces of impermeable gas into the package.
- the programmed pressure decrease has been determined by experiment and coincides with the pressure decrease Within the package as the permeable gas permeates out of the package during the post-diffusion period.
- the total sterilizing reaction is a function of time and gas concentration inside the package during both of these periods.
- All phases of the cycle are carried out at greater than atmospheric pressure and no vacuum pumps are required; however, a source of pressurized air is required.
- the concentration of the sterilizing agent is limited only by the pressure capability of the vessel.
- MOISTURIZATION The nature of most industrial packages are such that a timed, in-chamber, moisture pre-conditioning period is valueless and moisture may be added immediately before, during, and/or immediately after introduction of the sterilizing gas.
- studies have revealed that a controlled moderate moisture concentration, for example, 50% to 60% relative humidity, is not required and, as a consequence, complicated electronic controls have been eliminated in the cycle disclosed. In fact, these studies also show that a high moisture concentration is most effective.
- Current sterilizing techniques now exploit this principle and the system disclosed herein senses this condition by a vapor pressure measurement with a simple pressure gauge.
- an object of the present invention to provide an improved process for sterilizing sealed packages made of semi-permeable membrane material in a permeable gas.
- Another object of the invention is to provide a sterilizing process for sterilizing goods in semi-permeable packages with a permeable microbicidal gas wherein a nonpermeable gas in the chamber around the package is used to balance the partial pressure of the permeable gas that permeates into the package, adding its partial pressure to residual air already in the package.
- Still another object of the invention is to provide an improved sterilizing cycle.
- FIG. 1 is a front isometric view of a sterilizer suitable for carrying out the process according to the invention
- FIGS. 2 and 3 are side isometric views of the sterilizer shown in FIG. 1;
- FIG. 4 is a graph of typical cycles according to the invention.
- FIG. 5 is a schematic view of a chamber that could be used in the process disclosed herein.
- FIG. 5 An apparatus in which the balanced pressure process according to the invention can be carried out is shown in FIG. 5.
- Any suitable chamber can be used that is equipped with gas supply for sterilization, air or other nonpermeable gas for over-pressure and, if desired, steam for moisturization.
- FIG. 5 diagrammatically a sterilizing chamber of double walled cylindrical type with its axis arranged horizontally. The wall is shown at 201, and the space within the wall constitutes a sterilizing chamber 8.
- One end of the sterilizing chamber is provided with a door 207 which can be locked in an airtight manner by manipulating a handle 209, so as to seal the sterilizing chamber 8 to enable any desired pressure, within the sterilizing range, to be built up therein.
- the construction of the sterilizing chamber, jacket, and door may allbe conventional.
- Within the chamber may be any suitable support for the articles to be sterilized; for example, a shelf 211 on which packages of goods 213 may be placed.
- a steam supply conduit 221 is connected to any suitable source of supply of steam at any pressure convenient to the establishment where the sterilizing apparatus is located, so long as the temperature and pressure of the steam are at least as high as the highest temperature and pressure that will be wanted in the sterilizer for moisturization of the goods, or for heating.
- the steam may be at a gage pressure of about 27 p.s.i., corresponding to a temperature of about 270 degrees F.
- the steam for use in the sterilizer for moisturization or heating passes from the supply line or conduit 221 through a manual shut-off valve 7 controlled by a handle 223 accessible near the front of the sterilizer.
- Gas may be admitted, FIG. 2, from conventional bottles through lines 271.
- the gas in the bottle may be at a pressure of approximately 800 p.s.i.g. and may be reduced in pressure by a suitable regulator to approximately 15 pounds per square inch, or the desired pressure.
- the compressed air supply conduit is indicated at 251 in FIG. 5 and is connected to any suitable source of compressed air having a pressure at least as high as the highest pressure that will be wanted within the sterilizing chamber under normal operating conditions to provide the desired over-pressure.
- the supply conduit leads to an adjustable pressure reducing valve.
- a drainage conduit 261 leads downwardly from the bottom and regulators are provided for programming postdiffusion.
- any Zuigable conventional construction mounteded at a conveniently visible and accessible position near the front of the sterilizer are the controls and timers for primary exposure and post-diffusion of any Zuigable conventional construction, indicated generally at As shown in FIGS. 2 and 3, electricity for operating the various solenoid valves and other equipment is supplied from a bus bar 300 which has the branch lines 301, 302, 303, 304, 305, 306, 307, 308, and 309 supplying the various valves, motors, and other control equipment with electricity.
- the motor 253 drives the pump 265.
- Safety valves 266 are provided to protect the inside of the chamber from excessively high pressures. Gas from lines 271 is connected to the inside of the sterilizer through line 275, FIG.
- Air for overpressure and post-diffusion is controlled by valve 252 and filter element 253.
- the air may be supplied from a compressed air source from line 254 or introduced into line 255 by pump 265 which is connected to line 255.
- the various portions of the cycle may be manually controlled from the control panel 256 which has (FIG. 3) control buttons 257 of the type familiar to those skilled in the art.
- the sterilizer chamber and controls shown in FIG. 1 are of the conventional type and are shown by way of example only.
- FIG. 4 shows a typical cycle showing an abscissa 11 and representing time in hours and an ordinate 10 representing pressure.
- the portion of the graph indicated at 21 indicates the time at which water vapor is admitted to approximately .025 p.s.i.g. to the point 12.
- the conditioned gas for sterilizing can then be admitted to bring the pressure up to say lbs. indicated at B, portion 22 of the curve, or it can be admitted to say lbs. in another example indicated at B of the curve.
- the gas pressure will then be held at a relatively constant value, for example, 10 p.s.i.g. indicated at C or 15 p.s.i.g. indicated at C.
- the pressure will then be reduced in the chamber from 15 p.s.i.g.
- the dotted line indicated at D", E", and F and the curves indicated at D, E and F indicate how the pressures in the chamber can be reduced in stages and held at some intermediate pressure for some periods of time to allow the pressure inside the package to normalize itself.
- a polyethylene bag indicated at 213, for example, containing air at zero gage and containing goods to be sterilized, is inserted in a sealed chamber 8, as shown in FIG. 5.
- the valve 270 is opened and the conditioned microbicidal gas mixture is admitted directly to the chamber to a pressure of 15 p.s.i.g. gage.
- the temperature in the chamber is to be approximately 55 degrees centigrade or 130 degrees Fahrenheit, the relative humidity 60100%. It will be noted that the atmosphere of air originally within the chamber is trapped and retained rather than removed. This air serves as the confining impermeable gas.
- the sterilizing gas is flushed from the sterilizer by the addition of impermeable gas (air) from line 251 while maintaining a pressure within the sterilizer of approximately 15 pounds per square inch gage.
- impermeable gas air
- a rapid flushing of the sterilizing gas followed by a constant bleed of air to exhaust vent 291 at a chamber pressure of 15 pounds per square inch throughout the post-diffusion period will provide the necessary ambient condition.
- the pressure outside exhaust vent 291 is atmospheric.
- a programmed decreasing pressure in which the pressure in the chamber is decreased at a predetermined rate is sometimes desirable and preferred over the constant pressure conditions.
- the atmospheric air within the chamber may be removed by the displacement or flushing with the sterilizing gas and the chamber subsequently charged to the desired pressure (concentration) with this sterilizing gas or gas mixture.
- sterilizing gases that may be used are:
- Oxfume 20 ethylene oxide, 80% carbon dioxide, known in the trade as Oxfume 20.
- an over-pressure of an impermeable gas such as nitrogen or argon may be introduced around the package at a pressure as to confine the package and prevent inflation of the package.
- an impermeable gas such as nitrogen or argon
- the sterilizing gas or gas mixture is flushed out of the chamber with the impermeable gas. This confining pressure with the impermeable gas may be maintained until the permeable sterilizing gas or gas mixture has diffused back out of the package, thus preventing inflation of the package during and after the sterilizing cycle.
- air being nearly impermeable, is used as the confining gas. Furthermore, since air is used as the impermeable gas, it is expedient to leave the atmospheric air Within the chamber and add the sterilizing gas or gas mixture to the desired pressure without flushing. If the sterilizing gas or gas mixture is added to a pressure of greater than one atmospere (14.7 p.s.i.a.), that pressure in excess of one atmosphere must be balanced by an additional equivalent amount of air pressure.
- the primary exposure period will obviously vary for the different type of loads; wrappers of different thicknesses and other properties.
- air or other impermeable gas is admitted to the chamber at a pressure equivalent to the sterilizing pressure, for example, 15 p.s.i.g., and flows through the chamber at a rate sufficient to remove all gas within one hour.
- a pressure equivalent to the sterilizing pressure for example, 15 p.s.i.g., and flows through the chamber at a rate sufficient to remove all gas within one hour.
- the cycle using 15 p.s.i.g. chamber pressure is the preferred cycle and will satisfactorily process most packages.
- An alternate cycle of 10 p.s.i.g. chamber pressure may be used for those packages that cannot be satisfactorily processed at the higher pressure.
- the chamber temperature was 115 degrees Fahrenheit, the chamber humidity 75%, and the center of load degrees Fahrenheit.
- the normal sterilizing cycle will utilize a concentration of 450 ml. of ethylene oxide per liter. This will require 15 to 17 p.s.i.g. chamber pressure. Special cycles may utilize lower or higher pressures. Sterilizing temperature will be between and degrees Fahrenheit; higher and lower temperatures may be used in special applications.
- Example I Water vapor (steam) was admitted to obtain a relative humidity as close to 100% as possible.
- Ethylene oxide gas was admitted to bring chamber pressure to 15 p.s.i.g. and at a concentration of 450 ml. per liter.
- Pressure in chamber was reduced to 4 p.s.i.g. and held for one 1) hour, continuing to bleed air out.
- Example XII Load charged as in Example I.
- Example XIII Load chamber as in Example I, with chamber containing an impermeable gas.
- Example XIV Load chamber as in Example I. (1) Admit water vapor (steam) to the chamber to obtain a relative humidity of 75 (2) Admit ethylene oxide gas to bring chamber pressure to 15 p.s.i.g. and at a concentration of 450 milligrams per liter.
- Example XV Load chamber as in Example I.
- Ethylene oxide was then admitted over the part B of the curve to bring the chamber pressure to approximately 15 p.s.i.g. in the B curve and approximately 10 p.s.i.g. in the B curve.
- the pressure in the chamber was then retained at this pressure for approximately 3 /2 hours as indicated in the curve at C and C.
- the chamber temperature was approximately 115 degrees Fahrenheit during the part C and C of the curve.
- the center of the load rose to between 80 and Fahrenheit.
- the pressure in the chamber was then reduced, as indicated at D, D and D", and held for a time E, E and E" respectively in the three cycles, as shown.
- the pressure in the chamber was then reduced as indicated and held for a time F, F and F"; respectively in the three cycles as shown.
- the pressure in the chamber was then reduced to atmospheric.
- ethylene oxide at a concentration of approximately 300 milligrams per liter was used and the center of the load rose to between 80 and 103 degrees F.
- the center of the load had a humidity of 72%, the chamber temperature was F. throughout the test.
- a Spordex test indicated 6 negative on an equilibrium and a dry test on a desiccated test, which indicated 6 positive.
- the test indicated 6 negative on an equilibrium basis and 6 positive on a desiccated basis.
- a total exposure of 3 /2 hours was used and a post-diffusion period of 3 /2 hours was likewise used.
- the sterilizer chamber was preheated to 130 Fahrenheit. Water vapor was admitted as in the first test described next above and a conventional 8/ 12 Cryoxide mixture was introduced at a concentration of approximately 300 mg./1iter and a 3 /2 hour sterilizing cycle was used and a 3 /2 hour post-diffusion cycle was used. The results were as indicated above with no appreciable swelling of the polyethylene bags.
- the tests indicated by the broken line curve indicate a moisturization during the period A, a holding period of approximately 4 hours with a 60100% relative humidity in unconfined polyethylene bags and a 4 hour post-diffusion period.
- the bags were confined in cardboard boxes.
- the cardboard boxes were intact at the end of the test and the bags were of the approximate original size.
- a process of sterilizing comprising the steps of placing the goods in a sealed package made of semipermeable material and containing a residual impermeable gas,
- permeable sterilizing gas is taken from the group consisting of ethylene oxide, propylene oxide, methyl bromid, and betapropiolactone.
- impermeable gas is taken from the group consisting of nitrogen and air.
- the permeable gas is flushed from said chamber by an impermeable gas which is the same impermeable gas as said just mentioned impermeable gas.
- the relative humidity in said chamber is between 60 and 100 percent.
- said impermeable gas is first reduced to approximately 8 p.s.i.g. then held at approximately 8 p.s.i.g. for approximately /2 hour then reduced to approximately 4 p.s.i.g. and held at this pressure for approximately /2 hour, then reduced to atmospheric pressure.
- a process of sterilizing comprising providing a sealed chamber containing air at atmospheric pressure
- a microbicidal sterilizing gas selected from the group consisting of ethylene oxide, propylene oxide, methyl bromid, and betapropiolactone to bring the pressure in said chamber to a predetermined pressure, and a temperature of approximately 130 degrees,
Abstract
Description
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US73031168A | 1968-05-20 | 1968-05-20 |
Publications (1)
Publication Number | Publication Date |
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US3589861A true US3589861A (en) | 1971-06-29 |
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ID=24934804
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US730311A Expired - Lifetime US3589861A (en) | 1968-05-20 | 1968-05-20 | Balanced pressure process of sterilization |
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US (1) | US3589861A (en) |
CA (1) | CA918374A (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0226883A2 (en) * | 1985-12-14 | 1987-07-01 | Wolff Walsrode Aktiengesellschaft | Process for fumigating the soil |
US4687635A (en) * | 1984-10-05 | 1987-08-18 | American Sterilizer Company | Porous load vapor sterilization cycle |
US4954284A (en) * | 1988-10-03 | 1990-09-04 | Allied-Signal Inc. | Azeotrope-like compositions of dichloro-trifluoroethane and ethylene oxide |
US5376333A (en) * | 1989-07-28 | 1994-12-27 | Alliedsignal, Inc. | Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics |
US6207109B1 (en) * | 1994-10-26 | 2001-03-27 | Alliedsignal Inc. | Sterilant gas mixtures of pentafluorodimethyl ether and ethylene oxide |
-
1968
- 1968-05-20 US US730311A patent/US3589861A/en not_active Expired - Lifetime
-
1969
- 1969-05-20 CA CA051903A patent/CA918374A/en not_active Expired
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4687635A (en) * | 1984-10-05 | 1987-08-18 | American Sterilizer Company | Porous load vapor sterilization cycle |
EP0226883A2 (en) * | 1985-12-14 | 1987-07-01 | Wolff Walsrode Aktiengesellschaft | Process for fumigating the soil |
EP0226883A3 (en) * | 1985-12-14 | 1988-10-19 | Wolff Walsrode Aktiengesellschaft | Process for fumigating the soil |
US4812342A (en) * | 1985-12-14 | 1989-03-14 | Wolff Walsrode Ag | Process for gassing soils |
US4954284A (en) * | 1988-10-03 | 1990-09-04 | Allied-Signal Inc. | Azeotrope-like compositions of dichloro-trifluoroethane and ethylene oxide |
US5376333A (en) * | 1989-07-28 | 1994-12-27 | Alliedsignal, Inc. | Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics |
US6207109B1 (en) * | 1994-10-26 | 2001-03-27 | Alliedsignal Inc. | Sterilant gas mixtures of pentafluorodimethyl ether and ethylene oxide |
Also Published As
Publication number | Publication date |
---|---|
CA918374A (en) | 1973-01-09 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: MORGAN GUARANTY TRUST COMPANY,NEW YORK Free format text: SECURITY INTEREST;ASSIGNOR:AMERICAN STERILIZER COMPANY, A PA CORP.;REEL/FRAME:004765/0752 Effective date: 19870827 Owner name: MORGAN GUARANTY TRUST COMPANY, 23 WALL STREET, NEW Free format text: SECURITY INTEREST;ASSIGNOR:AMERICAN STERILIZER COMPANY, A PA CORP.;REEL/FRAME:004765/0752 Effective date: 19870827 |
|
AS | Assignment |
Owner name: AMERICAN STERILIZER COMPANY, ONE MELLON BANK CENTE Free format text: RELEASED BY SECURED PARTY;ASSIGNOR:MORGAN GUARANTY TRUST COMPANY OF NEW YORK;REEL/FRAME:005581/0543 Effective date: 19910130 |