WO1997029789A1 - System and method for real-time monitoring and control of load sterilization and parametric release - Google Patents
System and method for real-time monitoring and control of load sterilization and parametric release Download PDFInfo
- Publication number
- WO1997029789A1 WO1997029789A1 PCT/US1997/003271 US9703271W WO9729789A1 WO 1997029789 A1 WO1997029789 A1 WO 1997029789A1 US 9703271 W US9703271 W US 9703271W WO 9729789 A1 WO9729789 A1 WO 9729789A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sterilization
- sterilant
- load
- parameter value
- cycle
- Prior art date
Links
Classifications
-
- 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
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- 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
- A61L2/24—Apparatus using programmed or automatic operation
Definitions
- the monitored information is transmitted to an external stand - alone control and display unit adding to the expense of a sterilization system.
- Neither approach provides the capability of real-time monitoring of critical load parameters with direct and simultaneous conveyance of the information to the sterilizer control system allowing real-time control of critical sterilization parameter levels within the load.
- prior load-simulation devices monitor only such parameters as temperature, pressure, time, moisture or the presence of a sterilant . They do not provide the capability of also directly monitoring the concentration of a chemical sterilant, such as ethylene oxide gas or hydrogen peroxide liquid or vapor, in a load, or of directly conveying the results to the sterilization control for real-time control of the sterilant concentration in the load.
- a chemical sterilant such as ethylene oxide gas or hydrogen peroxide liquid or vapor
- Chemical integrators provide a visual indication (e.g., a color change) that predetermined sterilization parameters were presumably achieved; for example, in the case of steam or ethylene oxide sterilization, a chemical integrator might indicate that a given temperature with the presence of moisture was achieved for a given time.
- Chemical integrators are not sophisticated enough to monitor critical cycle parameters (e.g., temperature, pressure, sterilant concentration) to a confidence level that would assure that sterilization has occurred and to allow release of the load for use based on the indicator results alone. Therefore, biological indicators are additionally employed.
- the biological agent in the indicator will be killed, and thereby indicate cycle efficacy.
- the requirement fora sometimes lengthy incubation of the biological indicator to assure confirmation of sterility can result in an undesirable time delay after cycle completion before the sterilization efficacy is known This delay can significantly affect productivity and, therefore, the cost of processing goods through the sterilization system, in addition to the inconvenience of delayed turnaround of critical medical oriental instruments.
- Parametric release is based on the physical monitoring in the chamber of the parameters of pressure, temperature and rate of change of temperature and pressure during the moist heat sterilization cycle.
- the chamber control is set for a predetermined cycle, to achieve and maintain predetermined critical parameter levels for a given period of time.
- the chamber parameters are monitored throughout the cycle. If the monitoring indicates a difference between a set and measured parameter value that exceeds specified limits, a warning is given to the cycle operator. If the monitoring indicates that the critical levels in the chamber are achieved and maintained for the time required to achieve a given sterility assurance level, the cycle is considered efficacious and the load is released for use.
- parametric release systems are designed to provide monitoring and notification only of achieved parameters in the chamber. They do not suggest providing real-time sensing data to the sterilizer control system to enable the sterilizer control to react to changes in the critical parameters and adjust them in order to avoid unsuccessful cycles. Rather, current International Organization For Standardization (ISO) and European Committee for Standardization (CEN) standards require that the monitoring system for parametric release be separate from the sterilizer control system. Further, the process is described only for control of parameters in the chamber and does not address the monitoring and control of the critical parameter levels in the load itself.
- ISO International Organization For Standardization
- CEN European Committee for Standardization
- a device that provides real-time monitoring of critical sterilization parameters in the load and is also integrated with the sterilizer control system to enable the control to react to monitored changes in the critical parameter levels and adjust them in real-time in order to avoid unsuccessful cycles.
- a device that reproducibly simulates a standard challenge load undergoing sterilization and that contains critical parameter sensors that are directly integrated into the sterilizer control system.
- a sterilization system that provides for the release of a load when the critical values of sterilization parameters in the load are shown to have been met .
- a challenge load-simulating device is provided.
- a housing defines a sterilant or disinfectant receiving opening.
- a baffle which is resistant to penetration of a sterilant or disinfectant is disposed adjacent the sterilant or disinfectant receiving opening.
- a receiving area receives the sterilant or disinfectant that penetrates past the baffle.
- a sensor probe is positioned at the receiving area for real-time sensing during a sterilization or disinfection cycle of the received sterilant or disinfectant to determine a sterilization or disinfection parameter value therefrom.
- a transmitting means electronically transmits the sterilization or disinfection parameter value from the device for use by a control system which provides real-time control of the - 5 - sterilization or disinfection cycle in accordance with the transmitted parameter value.
- a method of monitoring and controlling a sterilization or disinfection process in a sterilization or disinfection chamber is provided.
- a challenge load-simulating device that has a baffle that is resistant to penetration by a sterilant or disinfectant and a receiving area for receiving sterilant and disinfectant that penetrates the baffle is placed in the chamber.
- a sterilization or disinfection cycle is conducted in the chamber.
- a physical property at the receiving area is sensed and a corresponding electronic parameter value is generated.
- the sensed parameter value is transmitted to a control system.
- the sterilization or disinfection cycle is controlled in real-time in response to the transmitted, sensed parameter value.
- One advantage of the present invention is that it enables a sterilization or disinfection cycle to be monitored and controlled in real-time.
- Another advantage of the present invention is that it enables a determination to be made while a sterilization cycle is in progress whether the necessary conditions for sterilization or disinfection have been achieved. Still further advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
- FIGURE IA is a schematic illustration of the present invention, including a load-simulating device connected to a sterilization chamber and sensor probes integrated into the sterilizer control system and a parametric release monitoring system.
- FIGURE IB is a schematic illustration of a load simulating device positioned within a sterilizer drain line.
- FIGURE 2 illustrates an embodiment of a sensor fitting in accordance with the invention.
- FIGURES 3A, 3B and 3C are schematic illustrations of the load-simulating device of the invention.
- FIGURES 4A and 4B illustrate an embodiment of a load simulating device of the invention in a closed configuration and an exploded view, respectively.
- FIGURES 5A, 5B and 5C schematically illustrate another embodiment of a load-simulating device of the invention.
- FIGURE 6 illustrates an example of the pre-exposure phase of a steam sterilization cycle which may be employed in the invention.
- FIGURE 7 illustrates an example of the exposure phase of a steam sterilization cycle which may be employed in the invention.
- FIGURE 8 illustrates an example of a timing cycle which may be employed in the invention.
- the present invention is concerned with the real-time control of sterilization cycle parameters within a load simulation device that simulates the same conditions as those within an acceptable standard challenge load to be sterilized. Integration of such a load-simulating device into a sterilization chamber parameter sensing system allows real- time monitoring and transmission of cycle parameter values from the load-simulating device to the sterilizer control system. If the parameter values fall outside the range of acceptable values, the sterilizer control system directs the operation of control means, such as heaters, valves, pumps, timers, etc. in real time to bring the parameter values into an acceptable range within the load-simulating device.
- control means such as heaters, valves, pumps, timers, etc.
- the invention may be used with any sterilization process in which a successful outcome depends on achieving and maintaining controllable sterilization parameters for a given time.
- sterilization processes include, but are not limited to, sterilization with steam, ethylene oxide gas, liquid and vaporized hydrogen peroxide, liquid and vaporized formaldehyde, liquid and vaporized peroxy compounds, ozone, ionized gases, plasmas, and combinations thereof.
- the load-simulating device is integrated into the sterilizer parameter sensing and control system and employs one or more resistance barriers to penetration of the sterilant, in the form of a tortuous path, similar to the barrier encountered by a sterilant penetrating a load of wrapped goods or goods in a sealed pouch.
- the acceptable standard challenge load simulated by the load simulating device reflects a "worst-case" load to be sterilized. Therefore, each type of resistance barrier in the load-simulating device is specifically designed for the particular sterilant to be employed in order to accurately simulate load conditions, or worst-case conditions, using the specified sterilant.
- a sufficient resistance barrier may comprise a tortuous path for entrance of the sterilant into the device.
- the resistance barrier may additionally or alternatively comprise another tortuous path within the interior of the device, such as a packed material or a baffle or series of baffles.
- the resistance barrier may be purely a physical barrier and/or may also comprise a physical or chemical material which is slightly absorptive of the sterilant.
- Suitable resistance barrier materials may include, but are not limited to, cellulosic materials for steam and/or ethylene oxide sterilants, teflon, silicon, polypropylene and polycarbonate materials for ethylene oxide and/or hydrogen peroxide sterilants, and combinations thereof.
- Effective resistance barrier materials for other sterilants, such as formaldehyde, ozone, or ionized gases and plasmas, are known to persons skilled in the art of sterilization.
- the system includes a sterilization chamber 1 having a sterilant inlet 2 and sterilant inlet valve 3 and a chamber drain line or exhaust outlet 4 and chamber outlet valve 5.
- a load-simulating device 6 is located within the chamber 1 and is removably connected to a chamber wall 7 or chamber drain wall 8 as described herein below. If connected to a chamber wall 7, the load-simulating device 6 is preferably located in a recessed portion 9 of the chamber wall 7, such that the load-simulating device 6 does not interfere with loading and unloading of goods in the chamber 1.
- the device 6 When the device 6 is employed in a steam sterilization chamber, it is more preferable to locate the device 6 close to or within the drain line 4 in order to detect more readily the presence of unwanted air that will tend to settle there, as known in the art, and allow for correction of the problem, as described herein below.
- the load simulating device 6 comprises a housing 10 for a resistance barrier 11 to penetration of a sterilant and a receiving area 12 for sterilant that successfully penetrates the resistance barrier 11.
- At least one sensor probe 13 is positioned in the receiving area 12 of the load simulating device 6 for real-time sensing and monitoring of at least one sterilization parameter value during a sterilization cycle.
- a connection flange or a weld fillet 15 (more clearly shown in FIGURE 2) connects the device 6 to the sterilization chamber wall 7 or drain line wall 8 at or near the location of the sensor probe 13.
- An optional use indicator 50 is preferably positioned on a surface of the load-simulating device 6 in contact with the chamber environment .
- the use indicator 50 serves only to indicate, preferably by a visible color change, that the load-simulating device 6 has been exposed to a sterilant.
- the use indicator 50 is not intended to serve as a chemical integrator.
- the housing 10 of the device 6 is constructed with a small opening 14 at one end, to allow a liquid, gas or vapor sterilant to enter into the interior of the device 6 .
- the illustrated opening in the housing is used in conjunction with the interior resistance barrier 11 that provides a tortuous path for the sterilant.
- the sterilant may alternatively enter the device by another route, preferably one that provides a tortuous path/resistance barrier, such as through a seam in the housing, or penetration by wetting through material comprising the housing wall.
- the additional resistance barrier 11 in the interior of the device may also be included or be optional. Therefore, the device is intended to provide one or more resistance barriers/tortuous paths, depending on the characteristics of the sterilant employed.
- the load-simulating device 6 itself is preferably shaped to simulate a dead-ended lumen, known to be difficult to sterilize because of the known difficulty of sterilant penetration into lumens in general. Therefore, in a preferred embodiment, the device 6 itself, by virtue of simulating a dead-ended lumen, comprises a resistance barrier to penetration of the sterilant.
- the liquid, gas or vapor sterilant in the sterilization chamber 1 enters the load-simulating device 6 and is constrained to follow a prescribed path.
- the sterilant passes through the optional resistance barrier 11 and sterilant that penetrates the barrier 11 reaches the receiving area 12 where it come into contact with the sensor probe 13. Therefore, there is a fluid connection between the sterilization chamber 1 and the sensor probe 13.
- the sensor probe 13 may be present as a single probe or a plurality of probes or sensing elements.
- Parameters which may be sensed by the sensor probe or probes 13 include, but are not limited to, temperature, pressure, concentration of sterilant, relative humidity and multiples and combinations of these.
- a set of sensor probes may contain two or more pressure sensors (Pl, P2) and two or more temperature sensors (Tl, T2) and two or more chemical sterilant concentration sensors (Cl, C2) ; and each parameter may be sensed by two or more separate sensing probes or by a single probe housing two or more sensing elements.
- multiple probes preferably dual probes, for sensing a particular parameter are employed to comply with ISO and/or CEN standards requiring a separate set of sensing probes for parameter control and for parametric release of the load.
- Multiple probes for example, an array of concentration-sensing elements, may be necessary in order to determine the concentration of certain chemical sterilants, such as multi-component sterilants.
- a transmitting means 16 is connected to each sensor probe or sensing element 13 for transmitting a sensed parameter value from the sensor probe 13 to a receiving means 19, such as the sterilizer control system 17 or a parametric release monitoring system 18.
- the transmitting means 16 may comprise any means that is capable of transmitting the sensor data to the receiving means 19 including, but not limited to, electrical connection of the sensor probe 13 to the receiving means 19 and electronic or radio frequency transmission of the sensor data to the receiving means 19.
- the sterilizer control system 17 may be any system including, but not limited to, a microprocessor or a logic circuit that is programmed to receive the sensed parameter value and also to control the value of the parameter in real ⁇ time during the sterilization cycle by governing a plurality of parameter control means 100 which operate valves, pumps, timers, heaters, etc.
- the sterilizer control system 17 is also programmed to store a predetermined reference sterilization parameter range and to compare the received sensed parameter value to the reference parameter range. If the sensed parameter value falls within the reference parameter range, acceptable sterilization conditions are indicated, and the cycle continues. If the sensed parameter value falls outside of the reference parameter range, the sterilizer control system 17 is programmed to signal the parameter control means 100 to operate until the value of the sensed parameter falls within the reference parameter range.
- the sterilizer control system 17 signals the parameter control means 100 to operate a chamber heating means until the temperature reading of the temperature-sensing probe 13 in the load-simulating device falls within the range that is acceptable for sterilization. If a sensed sterilant concentration in the load-simulating device 6 is below The acceptable limit, the sterilizer control system 17 signals the parameter control means 100 to control the operation of a sterilant injector to increase the concentration of sterilant injected into the chamber 1, until the concentration of sterilant sensed by the concentration-sensing probe 13 is at an acceptable value, or within a range of acceptable values .
- the sterilizer control system 17 also signals a timer to be reset to compensate for the time during which the sterilization cycle experienced unacceptable conditions.
- critical parameters are interdependent .
- the concentration of the vapor that is allowable, i.e., does not exceed the dew point concentration, in the load at any given time is dependent on the temperature, pressure, and/or relative humidity in the load at that time. Therefore, in systems such as these, the sterilizer control system is programmed to monitor more than one parameter and analyze the data to determine whether or not the Environmental conditions are within the acceptable range of values.
- a redundant set or sets of temperature, pressure or other sensors 13, such as relative humidity or chemical sterilant concentration sensors may be incorporated.
- one set of sensor probes (T2, P2, C2) is used only as a parametric release monitoring system 18, for monitoring sterilization parameters to determine if acceptable sterilization conditions in the load-simulating device 6 have been achieved and the load may be released as sterilized.
- Another set of sensors probes (Tl, Pl, Cl) in the load-simulating device 6 transmits readings of temperature, pressure or other parameter levels to the sterilizer control system 17 for controlling the process parameters by the parameter control means 100.
- the release monitoring sensors (T2, P2 , C2) are preferably connected to a user interface (display and/or printout) circuit which is separate from the circuit that connects the sterilizer control system 17 and the sensors (Tl, Pl, Cl) that provide data for process control.
- a user interface display and/or printout
- the independent release monitoring sensors act as a back-up and redundant system to the sensors integrated into the sterilizer control system.
- FIGURE 2 illustrates an embodiment of one possible sensor fitting 20 for use in the present invention, for containing at least one 22, and preferably a plurality of sensor probes 22, 23, 24, and for attaching the sensor probe or probes to the load-simulating device 6, and to the chamber wall 7 or drain wall 8. It is envisioned that any sensor fitting which is capable of accommodating the sensor probes and load-simulating device and accomplishing the objectives of the invention, may be alternatively used in the practice of the invention.
- a temperature sensor probe 22, a pressure sensor probe 23 and a chemical sterilant concentration sensor probe 24 are used in the practice of the invention.
- these probes are meant to be representative only, and are interchangeable with probes measuring other parameters, such as relative humidity. They may also represent a plurality of one or more types of probes, such as a plurality of concentration-sensing probes for different components of a multi-component chemical sterilant, or a plurality of temperature or pressure sensing probes.
- this embodiment of the sensor fitting 20 comprises a housing 25 having an outer wall and an interior wall which defines a hollow interior having a first end 27 and a second end 29 and side walls 31.
- the first end 27 of the sensor fitting 20 is shaped to protrude into the interior of the chamber 1 through a complementary opening in the chamber wall 7 or chamber drain wall 8.
- the outer wall of the housing 25 is secured to the chamber wall 7 or drain wall 8 by means of a connection flange or a weld fillet 15 that provides a seal between the sensor fitting 20 and the chamber wall 7 or drain wall 8.
- the second end 29 of the sensor fitting 20 extends exteriorly from the chamber wall 7 or drain wall 8.
- the first end 27 and second end 29 and the sidewalls 31 of the sensor fitting 20 comprise openings 30 for receiving a sensor probe or plurality of sensor probes (see below) .
- a temperature sensor probe 22 extends through the hollow interior of the length of the sensor fitting 20 and comprises a tip portion 21 which protrudes beyond the open first end 27 of the sensor fitting 20, a middle portion 26 contained within the hollow interior of the sensor fitting 20, and a base portion 28 which extends beyond the open second end of the sensor fitting 20.
- the position of the temperature probe 22 within the hollow sensor fitting 20 may be optionally stabilized by means of a support flange 32, connected to an interior wall of the housing 25, containing a plurality of openings 34 sufficient to ensure that a fluid environment is maintained throughout the hollow interior of the sensor fitting 20.
- the housing 25 of the sensor fitting 20 comprises an opening or a plurality of other openings 30 for receiving other sensor probes.
- the probes illustrated in FIGURE 2 include, but are not limited to, a pressure sensing probe 23 and/or a chemical sterilant concentration sensing probe 24.
- Each of the sensor probes 23, 24 is in fluid connection with the hollow interior of the sensor fitting 20 and is engaged, preferably threadably engaged, to the housing 25 to form a seal between the sensor probe 23, 24 and the sensor fitting 20.
- Each of the sensor probes 22, 23, 24 terminates in a separate transmission means 16, extending from each probe and external to the sensor fitting 20 for transmitting sensed data to the receiving means 19.
- the base portion 28 of the temperature probe 22, including the transmitting means 16, further extends through a compression fitting 35 comprising a housing 36 defining an anterior opening 37 containing a flexible ring member 38, preferably a ferrule, that encircles the base portion 28 of the probe 22 and a space 39 surrounding the ring member 38, and a posterior opening 40 for affording the passage of the base portion 28 of the temperature probe 22 therethrough, the transmission means 16 extending exteriorly from a posterior opening 40.
- the compression fitting 35 is removably engagable to the second end 29 of the sensor fitting 20.
- a pressure-tight seal between the compression fitting 35 and the sensor fitting 20 is achieved when the second end 29 of the sensor fitting 20 threadably engages the anterior opening 37 of the compression fitting 35, occupies the space 39 between the housing 36 and the ring member 38 and thereby, sealably compresses the ring member 38 around the temperature probe 22.
- the first end 27 of the sensor fitting 20 is shaped to protrude into the interior of the chamber 1 through a complementary opening in the chamber wall 7 or chamber drain wall 8.
- the first end 27 of the sensor fitting 20 is also removably and sealably connectable, preferably threadably connectable, to the load simulating device 6 within the chamber 1.
- the tip portion 21 of the temperature probe 22 extends beyond the first end 27 of the sensor fitting 20.
- the top portion 21 of the temperature probe 22 extends into the receiving area 12 of the load-simulating device 6 but does not contact or extend into the resistance barrier 11.
- the load-simulating device 6 is removably connected to the premounted sensor fitting 20 inside the chamber wall 7 or drain wall 8 at the location of the probes 13 in the manner illustrated in the embodiment of FIGURE 2.
- the load-simulating device may be, and preferably is, disposable. Alternatively the device may be reusable if, for example, it is recharged or dried out (in the case of a sterilization cycle involving moisture) .
- the sensor probes may be permanently or temporarily mounted to the chamber, as desired.
- sensor probes 48 are removably connectable to the load-simulating device as illustrated in FIGURE 2 and described herein above.
- a sensor connector 41 which may extend into the interior of the chamber, has a electrical connector portion 42 connected to the chamber wall 7 or drain line 8, and a signal transmission means portion 44 connectable to a signal receiver (not shown) .
- the sensor probes 48 terminate in one or more complementary electrical interfaces 46.
- the sensor probes 48 are preconnected to a load-simulating device and then interfaced to the sterilizer control via an electrical connection inside the chamber.
- the sensor probes are also reusable and/or disposable.
- FIGURES 4A, 4B, 5A, 5B, and 5C illustrate embodiments of a load simulating device which may be employed in the present invention.
- the precise nature of the load-simulating device to be used for a given sterilization cycle depends on the nature of the sterilant and the sterilization parameters to be monitored.
- a load-simulating device for a steam sterilization cycle, a hydrogen peroxide vapor sterilization cycle and an ethylene oxide sterilization cycle, etc. may be different from each other, because of different critical sterilization parameters and sterilant properties.
- the resistance barrier in the load-simulating device preferably comprises a barrier material, such as a cellulosic, that absorbs heat, and the sensors within the device preferably monitor and provide for control of both temperature and pressure within the device.
- a tortuous path for penetration of the sterilant into and through the device preferably comprises a physical barrier to the flow of the gas.
- the materials selected for the barrier are determined by the solubility and diffusion rate of the ethylene oxide in the material and the thickness of the barrier. For example, ethylene oxide has a higher diffusion rate through silicon than through polyethylene, so polyethylene is preferable to silicon as a barrier material.
- the sensor probes employed for an ethylene oxide cycle preferably monitor and provide for control of temperature, pressure, relative humidity and concentration of the sterilant within the load-simulating device.
- a preferable load simulating device for hydrogen peroxide liquid or vapor sterilization includes a dead-ended device and a resistance barrier comprising a physical restriction of the flow of the sterilant (e.g., through a restricted orifice or orifices) and/or requiring changes in direction of flow (e.g. , around baffles) .
- the preferred materials of construction of the resistance barrier comprise those which inhibit gas penetration and do not substantially absorb the sterilant.
- polyethylene, polypropylene, teflon, silicon, and polycarbonate are preferred materials.
- the sensor probes employed for a vapor hydrogen peroxide cycle preferably monitor and provide for control of temperature, pressure, relative humidity and concentration of the sterilant within the load-simulating device.
- the preferred load-simulating devices generally include a housing defining one or more resistance barriers to the passage of a sterilant and a receiving area where sterilant which has penetrated the resistance barrier(s) come into contact with one or more sensor probes .
- one of the resistance barriers may be a dead ended lumen defined by the housing.
- the load-simulating device shown in FIGURE 4A in a closed configuration and in FIGURE 4B in an exploded view is illustrative of a housing comprising a tortuous path for entry of a sterilant into the interior of the device .
- a typical exterior housing for use in a steam or ethylene oxide sterilization cycle is disclosed in commonly owned U.S. Patents 4,839,291 and 4,914,034.
- the housing 54 of a canister 52 comprises a central tubular portion 56, a first tubular end portion 58 and a second tubular end portion 60.
- the central tubular portion 56 has two open ends.
- Each of the tubular end portions 58, 60 includes an outer member 62 having a closed end, and an inner member 64 having an open end.
- the outer member 62 of tubular end portion 58 further has a hole or opening 68 in its closed end that is covered with an adhesive backed tab 70.
- the tab 70 permits the optional opening or closure of hole 68.
- the inner members 64 of each of the end portions 58, 60 telescope into the central tubular portion 56 of the housing 54 allowing each of the outer members 62 to abut the central tubular portion 56 and form a seam or gap 72 between the central tubular portion and the outer members 62 of the tubular end portions 58, 60.
- the seam or gap 72 forms a tortuous path for entry of the sterilant into the interior of the canister 52.
- the seam or gap 72 may optionally be covered by a sterilant-permeable layer (not shown) , such as medical grade paper, to form a further tortuous path for entry of the sterilant into the interior.
- a sterilant-permeable layer such as medical grade paper
- Another tortuous path for entry of the sterilant is defined by the close tolerance between the telescoping surfaces of the central tubular portion 56 and inner members 64 of the end portions 58, 60 of the housing 54.
- the device may optionally contain a further resistance barrier
- sterilant passage such as a packed material or a baffle or series of baffles
- sterilant passage such as a packed material or a baffle or series of baffles
- an internal resistance barrier is employed when the sterilant enters the canister through opening 68 when tab 70 is removed.
- the central tubular portion 56 of the canister 52 illustrated in FIGURES 4A and 4B includes a connection fitting 74 that is removably connectable to a sensor fitting, as illustrated in FIGURE 2.
- the device optionally has a use indicator 50 positioned on an exterior surface.
- FIGURES 5A, 5B, and 5C illustrate another embodiment of a load-simulating device which incorporates a tortuous path in the interior of the device .
- a typical device may include a tortuous path as described for a steam sterilization cycle disclosed in commonly owned U.S. Patent 4,594,223.
- the tortuous path may be different from the disclosed device
- the device 80 comprises a resistance barrier 82 within a canister housing 84 and a use indicator 50 on the exterior of the canister.
- One end of the housing 84 is in fluid communication with the chamber environment and has an opening 86 for the passage of a sterilant into and through the length of the device.
- the receiving area 88 for sterilant fluidly penetrating the resistance barrier 82 has a connection fitting 90 at the opposite end for removable attachment to a sensor fitting as shown in FIGURE 2.
- the receiving area 88 is constricted to prevent resistance barrier material from entering the receiving area.
- the constriction also serves as a collection area for any unwanted air mixed with the steam, the air being in fluid contact with the sensors, to allow control of the cycle for correction of the problem or aborting of the cycle.
- the materials from which the housing of the load simulating device and/or any internal resistance barrier are manufactured may be different from each other and are selected to be compatible with the sterilant employed.
- the housing material may be slightly absorptive of the sterilant, but may not be so absorptive as to affect the concentration level of sterilant in the chamber in the area surrounding the device or to result in high levels of residual sterilant which may be difficult to remove at the completion of the sterilization cycle.
- Suitable, and preferred, housing and/or resistance barrier materials may include, but are not limited to, cellulosic materials for steam and/or ethylene oxide sterilants; teflon, silicon, polypropylene and polycarbonate materials for ethylene oxide and hydrogen peroxide sterilants; and combinations thereof.
- FIGURES 6, 7, and 8 illustrate the method of the invention in a typical steam sterilization cycle employing the real-time monitoring and control of cycle parameters within the load-simulating device and parametric release of the load for use when the parameters are met .
- a steam sterilization cycle is illustrated, the method of the invention can be modified by one skilled in the art to accommodate any sterilant such as ethylene oxide, hydrogen peroxide, formaldehyde, ozone, peroxy compounds, and the like.
- the parameters of temperature, pressure and time are preferably monitored.
- the parameters of temperature, pressure, relative humidity, time, and the concentration of ethylene oxide are preferably monitored.
- the parameters of temperature, pressure, relative humidity, time, and the concentration of the sterilant are preferably monitored.
- a s illustrated in FIGURE 6, the method of the invention begins with a pre-exposure phase pulse (number "i") 101 which, for a pre-vacuum type sterilizer is typically a vacuum pull and steam charge, and for a gravity type sterilizer is typically a steam flush with an open drain line.
- a pre-exposure phase pulse number "i”
- test device the pressure probe. If, for example due to air in the device, the sensed pressure (P test + .
- P test P set 102
- a pass situation is indicated, and the temperature is sensed by the temperature probe. If the sensed temperature (T Cest ⁇ Y°C) does not fall within an acceptable predetermined set point temperature (T set + Y°C) range, for example due to the presence of air in the device, the sterilizer control system signals the parameter control means
- the same principles of pass/fail apply to the sensed pressure and temperature in the load-simulating device during this exposure phase.
- the exposure timer is stopped 120 for the time required to bring the parameters into the acceptable range, as illustrated in FIGURE 8. If the elapsed time (FT elapse ) 121 exceeds a certain set point (900 seconds, in the example) 122, the cycle is aborted 123, in order to avoid an infinite cycle.
- the monitoring sensors in the load-simulating device transmit data to a receiving means comprising a parametric release sensing system.
- the parametric release system When the data indicate that the critical parameters of the cycle have been achieved in the load-simulating device, the parametric release system presumes the load has been sterilized. The parametric release monitoring system thus allows release of the load for use when the monitored sterilization parameter levels indicate sterilization cycle efficacy within the load-simulating device.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69721499T DE69721499T2 (en) | 1996-02-16 | 1997-02-11 | SYSTEM AND METHOD FOR REAL-TIME MONITORING AND CONTROL OF TREATMENT STERLIZATION AND PARAMETRIC RELEASE |
AU21943/97A AU709496B2 (en) | 1996-02-16 | 1997-02-11 | System and method for real-time monitoring and control of load sterilization and parametric release |
CA 2244992 CA2244992A1 (en) | 1996-02-16 | 1997-02-11 | System and method for real-time monitoring and control of load sterilization and parametric release |
EP97914835A EP0881917B1 (en) | 1996-02-16 | 1997-02-11 | System and method for real-time monitoring and control of load sterilization and parametric release |
AT97914835T ATE238815T1 (en) | 1996-02-16 | 1997-02-11 | SYSTEM AND METHOD FOR REAL-TIME MONITORING AND CONTROL OF TREATMENT STERILIZATION AND PARAMETRIC RELEASE |
JP52961597A JP4015699B2 (en) | 1996-02-16 | 1997-02-11 | System and method for monitoring and controlling sterilization and parametric release in real time |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/602,515 | 1996-02-16 | ||
US08/602,515 US5788925A (en) | 1996-02-16 | 1996-02-16 | Method for real time monitoring and control of load sterilization and parametric release |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1997029789A1 true WO1997029789A1 (en) | 1997-08-21 |
WO1997029789B1 WO1997029789B1 (en) | 1997-10-23 |
Family
ID=24411666
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/003271 WO1997029789A1 (en) | 1996-02-16 | 1997-02-11 | System and method for real-time monitoring and control of load sterilization and parametric release |
Country Status (10)
Country | Link |
---|---|
US (1) | US5788925A (en) |
EP (1) | EP0881917B1 (en) |
JP (1) | JP4015699B2 (en) |
KR (1) | KR100486678B1 (en) |
CN (1) | CN1130228C (en) |
AT (1) | ATE238815T1 (en) |
AU (1) | AU709496B2 (en) |
DE (1) | DE69721499T2 (en) |
ES (1) | ES2194191T3 (en) |
WO (1) | WO1997029789A1 (en) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000006211A1 (en) * | 1998-07-27 | 2000-02-10 | Steris Corporation | Real-time monitoring and control of anti-microbial processing |
NL1017308C2 (en) * | 2001-02-07 | 2002-08-08 | Ask B V I O | Method and device for determining the process conditions for sterilization. |
WO2008022741A1 (en) * | 2006-08-23 | 2008-02-28 | Meiko Maschinenbau Gmbh & Co. Kg | Method for assessing and guaranteeing the thermal hygiene effect in a multi-tank dishwasher |
US7581457B2 (en) * | 2005-10-12 | 2009-09-01 | Agence Spatiale Europeenne | Method and apparatus for testing materials |
WO2012037431A1 (en) * | 2010-09-17 | 2012-03-22 | 3M Innovative Properties Company | Device and method for determining sterilization conditions |
WO2014075768A1 (en) * | 2012-11-13 | 2014-05-22 | Olympus Winter & Ibe Gmbh | Control system for a cleaning device, and cleaning device |
WO2016174143A1 (en) * | 2015-04-29 | 2016-11-03 | W & H Dentalwerk Bürmoos GmbH | Method and device for evaluating the effectiveness of the processing of medical, in particular dental, hollow-body instruments |
US10130728B2 (en) | 2013-12-16 | 2018-11-20 | 3M Innovative Properties Company | Systems and methods for controlling humidity |
US10161895B2 (en) | 2014-12-23 | 2018-12-25 | 3M Innovative Properties Company | Electronic moisture sensor |
US11079340B2 (en) | 2014-12-23 | 2021-08-03 | 3M Innovative Properties Company | Methods of monitoring wetness utilizing a resonant circuit |
Families Citing this family (83)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6153102A (en) * | 1995-02-13 | 2000-11-28 | Aksys, Ltd. | Disinfection of dead-ended lines in medical instruments |
US6325972B1 (en) * | 1998-12-30 | 2001-12-04 | Ethicon, Inc. | Apparatus and process for concentrating a liquid sterilant and sterilizing articles therewith |
US6394111B1 (en) | 1997-06-11 | 2002-05-28 | Ethicon, Inc. | Detection of cleanliness of a medical device during a washing process |
US7246627B2 (en) * | 1997-06-11 | 2007-07-24 | Ethicon, Inc. | Monitoring of cleaning process |
AU753047B2 (en) * | 1997-11-14 | 2002-10-03 | Ethicon Inc. | Method for measuring the concentration of hydrogen peroxide vapor |
US6368867B1 (en) * | 1998-01-29 | 2002-04-09 | International Business Machines Corporation | Monitor for verification of ozone reaction |
AU1827600A (en) | 1998-11-23 | 2000-06-13 | Ecolab Inc. | Non-corrosive sterilant composition |
US6852279B2 (en) * | 2002-06-28 | 2005-02-08 | Ethicon, Inc. | Sterilization with temperature-controlled diffusion path |
US6333002B1 (en) | 1998-12-30 | 2001-12-25 | Ethicon, Inc. | Sterilization process using small amount of sterilant to determine the load |
US7670550B2 (en) * | 1998-12-30 | 2010-03-02 | Ethicon, Inc. | Rapid sterilization system |
US7569180B2 (en) | 2004-10-12 | 2009-08-04 | Ethicon, Inc. | Sterilization system and method and orifice inlet control apparatus therefor |
US7252800B2 (en) * | 1998-12-30 | 2007-08-07 | Ethicon, Inc. | Sterilization system and method and inlet control apparatus therefor |
US6318151B1 (en) * | 1999-07-26 | 2001-11-20 | Abbott Laboratories | Self-contained sterilant monitoring assembly and method of using same |
US20020081228A1 (en) * | 1999-12-21 | 2002-06-27 | Hui Henry K. | Monitoring sterilant concentration in diffusion-restricted regions as a basis for parametric release |
US6528016B1 (en) * | 2000-06-27 | 2003-03-04 | Ethicon, Inc. | Method for rapidly determining the acceptability of loads to be sterilized |
DE20019360U1 (en) * | 2000-11-15 | 2001-06-21 | Bosch Albert | Measuring device for recording temperature-dependent measured values |
AU2635102A (en) * | 2000-12-15 | 2002-06-24 | Anton Aulbers | Device for monitoring a wash process |
US7186374B2 (en) | 2001-02-16 | 2007-03-06 | Steris Inc. | Vapor phase decontamination of containers |
US6936434B2 (en) | 2001-04-17 | 2005-08-30 | Steris Inc. | Vapor phase decontamination process biological indicator evaluator resistomer (BIER) vessel |
US6794649B2 (en) | 2001-07-09 | 2004-09-21 | Pharmaceutical Systems, Inc. | Spectrophotometric determination of gas phase compositions |
US7129080B2 (en) * | 2001-10-05 | 2006-10-31 | Steris Inc. | Vitro model of priocidal activity |
US7803315B2 (en) | 2001-10-05 | 2010-09-28 | American Sterilizer Company | Decontamination of surfaces contaminated with prion-infected material with gaseous oxidizing agents |
ATE415981T1 (en) * | 2002-01-16 | 2008-12-15 | Steris Inc | FLEXIBLE ARRANGEMENT FOR SPACE DEFINITION |
US7186372B2 (en) * | 2002-03-29 | 2007-03-06 | Ethicon, Inc. | Method for determining lumen penetration of a vapor phase sterilant |
US7807100B2 (en) * | 2002-06-28 | 2010-10-05 | Ethicon, Inc. | Sterilization system and method with temperature-controlled condensing surface |
US7578969B2 (en) * | 2002-08-07 | 2009-08-25 | American Sterilizer Company | Decontamination system for mail and other articles |
CN1747750A (en) * | 2003-01-31 | 2006-03-15 | 斯特里斯公司 | Building decontamination with vaporous hydrogen peroxide |
US7071152B2 (en) * | 2003-05-30 | 2006-07-04 | Steris Inc. | Cleaning and decontamination formula for surfaces contaminated with prion-infected material |
US7186373B2 (en) * | 2003-07-22 | 2007-03-06 | Steris Inc. | Visual detector for vaporized hydrogen peroxide |
US20050129571A1 (en) * | 2003-12-10 | 2005-06-16 | Steris Inc. | Ozone enhanced vaporized hydrogen peroxide decontamination method and system |
US7452504B2 (en) * | 2004-05-28 | 2008-11-18 | Ethicon, Inc. | Sterilization/disinfection cycle control |
KR20070085841A (en) | 2004-11-08 | 2007-08-27 | 프레쉬포인트 홀딩스 에스아 | Time-temperature indicating device |
US7429353B2 (en) * | 2005-07-21 | 2008-09-30 | American Sterilizer Company | Method and apparatus for injecting a metered quantity of a liquid into a chamber |
US20070098591A1 (en) * | 2005-10-31 | 2007-05-03 | Georg Frinke | Method and apparatus for low energy vaporization of liquid oxidizing agents or solutions |
US11185604B2 (en) | 2006-03-31 | 2021-11-30 | Deep Science Llc | Methods and systems for monitoring sterilization status |
US20070231192A1 (en) * | 2006-03-31 | 2007-10-04 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Sterilization methods and systems |
US8932535B2 (en) | 2006-03-31 | 2015-01-13 | The Invention Science Fund I, Llc | Surveying sterilizer methods and systems |
US8758679B2 (en) | 2006-03-31 | 2014-06-24 | The Invention Science Fund I, Llc | Surveying sterilizer methods and systems |
US8114342B2 (en) * | 2006-03-31 | 2012-02-14 | The Invention Science Fund I, Llc | Methods and systems for monitoring sterilization status |
US8277724B2 (en) | 2006-03-31 | 2012-10-02 | The Invention Science Fund I, Llc | Sterilization methods and systems |
US7638090B2 (en) * | 2006-03-31 | 2009-12-29 | Searete Llc | Surveying sterilizer methods and systems |
US20070254015A1 (en) * | 2006-04-28 | 2007-11-01 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Sanitizing surfaces |
US7700056B2 (en) * | 2006-08-10 | 2010-04-20 | American Sterilizer Company | Modular decontamination system |
JP4742058B2 (en) * | 2007-02-22 | 2011-08-10 | 株式会社エアレックス | Decontamination method |
US7919059B2 (en) * | 2007-04-27 | 2011-04-05 | American Sterilizer Company | Vaporized hydrogen peroxide decontamination system with concentration adjustment mode |
US7850925B2 (en) * | 2007-06-15 | 2010-12-14 | American Sterilizer Company | Apparatus for removal of vaporized hydrogen peroxide from a region |
US8007717B2 (en) * | 2007-08-14 | 2011-08-30 | American Sterilizer Company | Method and apparatus for decontaminating a region without dehumidification |
KR100873412B1 (en) * | 2008-04-23 | 2008-12-11 | 최은경 | Cold plasma sterilizing device for medical materials and equipment and control method thereof |
KR101655144B1 (en) | 2008-06-04 | 2016-09-07 | 지 파텔 | A monitoring system based on etching of metals |
EP2288879B1 (en) | 2008-06-04 | 2018-01-24 | G Patel | A monitoring system based on etching of metals |
EP2350307B1 (en) * | 2008-11-06 | 2016-07-27 | 3M Innovative Properties Company | Process challenge device and methods |
JP2010115451A (en) * | 2008-11-15 | 2010-05-27 | Earekkusu:Kk | Decontamination apparatus, method of determining decontamination condition in the same, and method of managing decontamination condition in the same |
US8381494B2 (en) * | 2010-01-25 | 2013-02-26 | Stork Food & Dairy Systems B.V. | Method for controlling the operation of an aseptic filling machine |
CN102160897A (en) * | 2010-02-20 | 2011-08-24 | 中国石油化工集团公司 | Method for monitoring online sterilization terminals of processing equipment and piping system during sterile manufacturing process |
JP2011218094A (en) * | 2010-04-14 | 2011-11-04 | Tamura Teco:Kk | Ozone sterilization testing equipment |
JP5737601B2 (en) * | 2010-08-11 | 2015-06-17 | 三浦工業株式会社 | Gas sterilizer |
JP5630171B2 (en) * | 2010-09-14 | 2014-11-26 | 三浦工業株式会社 | Operation control method of gas sterilizer |
US8975067B2 (en) | 2010-12-22 | 2015-03-10 | 3M Innovative Properties Company | Self-contained sterilization indicators including a neutralizer for residual oxidizing sterilant |
US8641985B2 (en) * | 2011-08-25 | 2014-02-04 | Tuttnauer Ltd. | Control system for ozone sterilization in multiple compact chambers |
SI24136A (en) * | 2012-07-18 | 2014-01-31 | Peter Kozin | Method for controlling sterility of a sterilized medical device and sterilization module for carrying out said method |
KR101453627B1 (en) * | 2012-12-31 | 2014-10-21 | 송혁 | Electronic sterilization validation system |
CN116712589A (en) * | 2013-03-13 | 2023-09-08 | 史赛克公司 | Sterilization container capable of providing an indication of whether or not a sterilized surgical instrument in the container is properly sterilized |
CN103272249B (en) * | 2013-06-14 | 2015-06-17 | 山东新华医疗器械股份有限公司 | Sterilization cabinet provided with multicore temperature probe |
CN103656704A (en) * | 2013-12-17 | 2014-03-26 | 杨亮月 | Ethylene oxide sterilization device |
CN103800926A (en) * | 2013-12-17 | 2014-05-21 | 杨亮月 | Ethylene oxide sterilizing and exhaust gas zero-emission treatment system |
CN103656703A (en) * | 2013-12-17 | 2014-03-26 | 杨亮月 | Ethylene oxide sterilization method based on weight coefficient distribution |
CN106102783B (en) * | 2014-01-20 | 2019-12-17 | 韦勒工程公司 | Sterilization system for a blow/fill/seal machine |
US10451595B2 (en) | 2014-01-27 | 2019-10-22 | Jp Laboratories, Inc | Indicating devices based on lateral diffusion of a mobile phase through a non-porous stationary phase |
WO2016040170A1 (en) | 2014-09-09 | 2016-03-17 | Safe Foods Corporation | Anti-microbial application equipment with controls |
CN104771774B (en) * | 2015-03-20 | 2017-09-26 | 江苏神农灭菌设备股份有限公司 | Dynamic rotary sterilizing cabinet |
CA2998327A1 (en) | 2015-09-11 | 2017-03-16 | Stryker Corporation | Sterilization enclosure for surgical instruments |
WO2017091385A1 (en) * | 2015-11-24 | 2017-06-01 | Medivators Inc. | Method and apparatus for monitoring fluid properties relating to medical device's cleanliness |
WO2017188931A1 (en) * | 2016-04-26 | 2017-11-02 | Safe Foods Corporation | Auger dip apparatus for applying antimicrobial solution |
US10441672B2 (en) | 2016-04-26 | 2019-10-15 | Asp Global Manufacturing Gmbh | Apparatus and method for detecting moisture in a vacuum chamber |
US9931427B2 (en) | 2016-05-11 | 2018-04-03 | Ethicon, Inc. | Apparatus and method for detecting moisture in a vacuum chamber |
CN105999333B (en) * | 2016-07-14 | 2019-07-26 | 楚天科技股份有限公司 | A kind of hydrogen peroxide sterilization method |
CN106075516A (en) * | 2016-07-26 | 2016-11-09 | 张剑 | A kind of pressuresteam sterilization process verification device and sterilizing effect monitoring method thereof |
US10458705B2 (en) | 2017-02-02 | 2019-10-29 | Asp Global Manufacturing Gmbh | Apparatus and method for detecting moisture in a vacuum chamber |
CN107233586A (en) * | 2017-08-03 | 2017-10-10 | 深圳出入境检验检疫局动植物检验检疫技术中心 | A kind of vacuum steaming processing unit and its method |
CN109125767A (en) * | 2018-09-17 | 2019-01-04 | 中国电子系统工程第二建设有限公司 | A kind of laboratory automatic fumigation system |
EP3431108A3 (en) * | 2018-09-28 | 2019-05-08 | Ellab A/S | Challenge device for use with a measuring unit for testing steam sterilization efficiency and a method of manufacture of a challenge device |
US11690504B2 (en) | 2019-04-22 | 2023-07-04 | Medivators Inc. | Automated endoscope reprocessing unit with in-line peracetic acid sensor |
CN110327479A (en) * | 2019-08-14 | 2019-10-15 | 蚌埠学院 | A kind of ethylene oxide sterilizing monitoring method and device |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2427834A1 (en) * | 1973-06-08 | 1975-01-09 | Sybron Corp | METHOD FOR DETERMINING THE TOTAL NUMBER OF MICROORGANISMS KILLED DURING A STERILIZATION AND DEVICE FOR CARRYING OUT THIS PROCEDURE |
WO1993021964A1 (en) * | 1992-05-05 | 1993-11-11 | Colvin Richard R | Sterilizer test method and apparatus |
EP0604387A1 (en) * | 1992-12-15 | 1994-06-29 | SBM SCHOELLER-BLECKMANN Medizintechnik Gesellschaft m.b.H. | Measuring arrangement |
DE9319369U1 (en) * | 1993-12-16 | 1995-04-20 | Intermedical S A | Measuring device for monitoring sterilization conditions |
WO1995032742A1 (en) * | 1994-05-27 | 1995-12-07 | Minnesota Mining And Manufacturing Company | Electronic test pack using parametric measurements for sterilizers |
Family Cites Families (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3982893A (en) * | 1975-09-08 | 1976-09-28 | Sybron Corporation | Sterilizer control method and apparatus |
US4067691A (en) * | 1976-04-16 | 1978-01-10 | Mercy Hospital And Medical Center | Sterilizing system and automatic control therefor |
US4164538A (en) * | 1977-11-11 | 1979-08-14 | American Sterilizer Company | Load conditioning control method for steam sterilization |
US4203947A (en) * | 1977-11-11 | 1980-05-20 | American Sterilizer Company | Load conditioning control apparatus for steam sterilization |
US4261950A (en) * | 1979-02-06 | 1981-04-14 | American Sterilizer Company | Sterilizing apparatus and integrated sterilizer control |
US4309381A (en) * | 1979-11-06 | 1982-01-05 | American Sterilizer Company | Establishing and ascertaining desired air removal in steam sterilization |
US4687635A (en) * | 1984-10-05 | 1987-08-18 | American Sterilizer Company | Porous load vapor sterilization cycle |
US4594223A (en) * | 1984-12-20 | 1986-06-10 | American Sterilizer Company | Device for detecting the presence of noncondensable gas in steam sterilizers |
US4839291A (en) * | 1987-05-15 | 1989-06-13 | American Sterilizer Company | Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles |
US4914034A (en) * | 1987-05-15 | 1990-04-03 | American Sterilizer Company | Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles |
US5039495A (en) * | 1988-04-21 | 1991-08-13 | Flexiclave, Inc. | Apparatus for sterilizing articles such as dental handpieces |
JPH0386251A (en) * | 1989-08-28 | 1991-04-11 | Todoroki Sangyo Kk | Chemical reaction controller |
US5271893A (en) * | 1989-11-24 | 1993-12-21 | Duncan Newman | Apparatus for steam sterilization of articles |
US5368821A (en) * | 1990-03-28 | 1994-11-29 | Mdt Corporation | Sealable sterilizer cassette |
US5258921A (en) * | 1991-01-31 | 1993-11-02 | Mdt Corporation | Automated purge control of sterilizers |
US5390322A (en) * | 1991-02-01 | 1995-02-14 | O'brien; Michael J. | Apparatus and method for retaining cycle memory in electronic sterilizer controls |
US5270948A (en) * | 1991-02-01 | 1993-12-14 | Mdt Corporation | Control means including a diagnostic operating mode for a sterilizer |
US5164161A (en) * | 1991-02-01 | 1992-11-17 | Mdt Corporation | Proportional temperature control of a sterilizer |
US5478749A (en) * | 1993-02-01 | 1995-12-26 | Dyke; Denis G. | Method and article for providing an indication of the presence of air in steam |
US5340537A (en) * | 1993-04-16 | 1994-08-23 | Big Three Industries, Inc. | Temperature indicating compositions |
-
1996
- 1996-02-16 US US08/602,515 patent/US5788925A/en not_active Expired - Lifetime
-
1997
- 1997-02-11 CN CN97193796A patent/CN1130228C/en not_active Expired - Fee Related
- 1997-02-11 AT AT97914835T patent/ATE238815T1/en not_active IP Right Cessation
- 1997-02-11 WO PCT/US1997/003271 patent/WO1997029789A1/en active IP Right Grant
- 1997-02-11 ES ES97914835T patent/ES2194191T3/en not_active Expired - Lifetime
- 1997-02-11 AU AU21943/97A patent/AU709496B2/en not_active Expired
- 1997-02-11 EP EP97914835A patent/EP0881917B1/en not_active Expired - Lifetime
- 1997-02-11 JP JP52961597A patent/JP4015699B2/en not_active Expired - Fee Related
- 1997-02-11 DE DE69721499T patent/DE69721499T2/en not_active Expired - Lifetime
- 1997-02-11 KR KR10-1998-0706317A patent/KR100486678B1/en not_active IP Right Cessation
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2427834A1 (en) * | 1973-06-08 | 1975-01-09 | Sybron Corp | METHOD FOR DETERMINING THE TOTAL NUMBER OF MICROORGANISMS KILLED DURING A STERILIZATION AND DEVICE FOR CARRYING OUT THIS PROCEDURE |
WO1993021964A1 (en) * | 1992-05-05 | 1993-11-11 | Colvin Richard R | Sterilizer test method and apparatus |
EP0604387A1 (en) * | 1992-12-15 | 1994-06-29 | SBM SCHOELLER-BLECKMANN Medizintechnik Gesellschaft m.b.H. | Measuring arrangement |
DE9319369U1 (en) * | 1993-12-16 | 1995-04-20 | Intermedical S A | Measuring device for monitoring sterilization conditions |
WO1995032742A1 (en) * | 1994-05-27 | 1995-12-07 | Minnesota Mining And Manufacturing Company | Electronic test pack using parametric measurements for sterilizers |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6156267A (en) * | 1996-02-16 | 2000-12-05 | Steris Corporation | Apparatus and method for real-time monitoring and control of anti-microbial processing |
WO2000006211A1 (en) * | 1998-07-27 | 2000-02-10 | Steris Corporation | Real-time monitoring and control of anti-microbial processing |
NL1017308C2 (en) * | 2001-02-07 | 2002-08-08 | Ask B V I O | Method and device for determining the process conditions for sterilization. |
EP1230936A1 (en) * | 2001-02-07 | 2002-08-14 | Answers, Solutions and Know-how B.V. i.o. | Method and device for determining the process conditions in sterilization |
US7581457B2 (en) * | 2005-10-12 | 2009-09-01 | Agence Spatiale Europeenne | Method and apparatus for testing materials |
WO2008022741A1 (en) * | 2006-08-23 | 2008-02-28 | Meiko Maschinenbau Gmbh & Co. Kg | Method for assessing and guaranteeing the thermal hygiene effect in a multi-tank dishwasher |
WO2012037431A1 (en) * | 2010-09-17 | 2012-03-22 | 3M Innovative Properties Company | Device and method for determining sterilization conditions |
US9523614B2 (en) | 2010-09-17 | 2016-12-20 | Robbert-Jan Hermsen | Device and method for determining sterilization conditions |
WO2014075768A1 (en) * | 2012-11-13 | 2014-05-22 | Olympus Winter & Ibe Gmbh | Control system for a cleaning device, and cleaning device |
US10130728B2 (en) | 2013-12-16 | 2018-11-20 | 3M Innovative Properties Company | Systems and methods for controlling humidity |
US10967087B2 (en) | 2013-12-16 | 2021-04-06 | 3M Innovative Properties Company | Sterilizer with a humidity control system |
US10161895B2 (en) | 2014-12-23 | 2018-12-25 | 3M Innovative Properties Company | Electronic moisture sensor |
US11079340B2 (en) | 2014-12-23 | 2021-08-03 | 3M Innovative Properties Company | Methods of monitoring wetness utilizing a resonant circuit |
WO2016174143A1 (en) * | 2015-04-29 | 2016-11-03 | W & H Dentalwerk Bürmoos GmbH | Method and device for evaluating the effectiveness of the processing of medical, in particular dental, hollow-body instruments |
Also Published As
Publication number | Publication date |
---|---|
DE69721499D1 (en) | 2003-06-05 |
KR100486678B1 (en) | 2005-06-16 |
AU709496B2 (en) | 1999-08-26 |
MX9806612A (en) | 1998-12-31 |
DE69721499T2 (en) | 2004-04-08 |
US5788925A (en) | 1998-08-04 |
ATE238815T1 (en) | 2003-05-15 |
CN1215997A (en) | 1999-05-05 |
JP4015699B2 (en) | 2007-11-28 |
KR19990082579A (en) | 1999-11-25 |
ES2194191T3 (en) | 2003-11-16 |
JP2000506029A (en) | 2000-05-23 |
CN1130228C (en) | 2003-12-10 |
EP0881917A1 (en) | 1998-12-09 |
AU2194397A (en) | 1997-09-02 |
EP0881917B1 (en) | 2003-05-02 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP0881917B1 (en) | System and method for real-time monitoring and control of load sterilization and parametric release | |
US6156267A (en) | Apparatus and method for real-time monitoring and control of anti-microbial processing | |
CA3122224C (en) | Sterilization container capable of providing an indication regarding whether or not surgical instruments sterilized in the container were properly sterilized | |
ES2281562T3 (en) | ELECTRONIC READER FOR STERILIZATION MONITORS. | |
EP1025863B1 (en) | Electronic test pack using parametric measurements for sterilizers | |
US6412334B1 (en) | Leak detector for endoscopes | |
WO1997029789B1 (en) | System and method for real-time monitoring and control of load sterilization and parametric release | |
EP1198259B1 (en) | Self-contained sterilant monitoring assembly | |
JP5952283B2 (en) | Apparatus and method for determining sterilization conditions | |
US20140241942A1 (en) | Intracavity Ultrasound Probe Disinfectant System | |
US8486691B2 (en) | Apparatus for assessing the effectiveness of a sterilization process | |
US8137311B2 (en) | Test method and apparatus for verification of medical device functionality | |
CA2244992A1 (en) | System and method for real-time monitoring and control of load sterilization and parametric release | |
MXPA98006612A (en) | System and method for real-time supervision and parameter load and release sterilization control | |
EP0696922A1 (en) | A system and method of sterilization of objects | |
JP7183404B2 (en) | Sterile container sterility damage and control system | |
JPH03159650A (en) | Device for receiving sterilization indicator and device for testing efficacy of sterilizer | |
WO2020225834A1 (en) | Detector device for detecting medical items, and related detection method | |
JPH09313577A (en) | Steam sterilizer |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
WWE | Wipo information: entry into national phase |
Ref document number: 97193796.6 Country of ref document: CN |
|
AK | Designated states |
Kind code of ref document: A1 Designated state(s): AU BR CA CN JP KR MX SG |
|
AL | Designated countries for regional patents |
Kind code of ref document: A1 Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE |
|
DFPE | Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101) | ||
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
ENP | Entry into the national phase |
Ref document number: 2244992 Country of ref document: CA Ref document number: 2244992 Country of ref document: CA Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: 1997914835 Country of ref document: EP |
|
WWE | Wipo information: entry into national phase |
Ref document number: PA/a/1998/006612 Country of ref document: MX Ref document number: 1019980706317 Country of ref document: KR |
|
WWP | Wipo information: published in national office |
Ref document number: 1997914835 Country of ref document: EP |
|
WWP | Wipo information: published in national office |
Ref document number: 1019980706317 Country of ref document: KR |
|
WWG | Wipo information: grant in national office |
Ref document number: 1997914835 Country of ref document: EP |
|
WWG | Wipo information: grant in national office |
Ref document number: 1019980706317 Country of ref document: KR |