CN1164214A - Method of packaging medical article - Google Patents
Method of packaging medical article Download PDFInfo
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- CN1164214A CN1164214A CN 95196315 CN95196315A CN1164214A CN 1164214 A CN1164214 A CN 1164214A CN 95196315 CN95196315 CN 95196315 CN 95196315 A CN95196315 A CN 95196315A CN 1164214 A CN1164214 A CN 1164214A
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Abstract
A method for sterilizing an article supported in a housing is provided. The method includes placing an article in a housing, introducing pressurized steam and a sterilizing gas into the housing and closing the housing. The sterilizing gas may be mixture of ethylene oxide/carbon dioxide or ethylene oxide/nitrogen. The percent by volume of ethylene oxide in the housing at the conclusion of the sterilizing gas introducing step may range from at least about 2 % to about 25 % by volume. The present invention is particularly well suited for use with a form-fill-seal process.
Description
Invention field
The present invention relates to utilize a kind of sterilization method of sterilizing gas.More specifically, the sterilization gas sterilization method that the present invention relates to is a surgical article of utilizing sterilization property gas to sterilize and made by nonwoven fabrics, as operation dress or drop cloth.
Background of invention
As is generally known, many disposable and recycling surgical article, the particularly surgical article of being made by fabric more specifically are meant surgical garments, need to carry out disinfection before using in operation.These surgical garments comprise as surgery clothes such as surgical drape and operation dress.Sterilization method can have many kinds, comprises radiation, steam, plasma discharge and carries out disinfection with sterilizing gas.About sterilizing with sterilizing gas, a kind of sterilizing gas more commonly used is an epoxyethane.Two kinds of well-known sterilization methods that utilize epoxyethane comprise the sterilization of (i) chamber and (ii) Anderson Si Terui-Ztel (Anderson Steri-Jet
TM) method.
The chamber sterilization generally includes four-stage: (i) pretreatment, (ii) sterilization, the (iii) degassing, (iv) quarantine.At pretreatment stage, the medical article that is sterilized is at first become buttress by sign indicating number, is placed into pretreatment chamber then.The temperature and humidity of pretreatment chamber generally transfers to 100-140 and 40%-80% relative humidity.Whole pretreatment stage is kept this condition, finishes with about 12 to about 72 hours usually.
The purpose of pretreatment stage is to improve temperature and the relative humidity that is become the article of buttress by sign indicating number.Under this higher temperature, ethylene oxide molecule is considered to have higher activity; Thereby it is more effective as disinfectant.In addition, under higher relative humidity condition, epoxyethane is considered to easier passing and is used to make packaging compositions and the material that is sterilized article.
Sterilisation stage generally includes and will become the article of buttress to be transferred to disinfection room from pretreatment chamber through pretreated sign indicating number.The size of disinfection room can be several cub ft to 3500 cub fts or bigger.Temperature in the fully enclosed disinfection room can be 100-140 °F.In addition, can extract a part of gas in the fully enclosed disinfection room out, making its internal pressure is about 300 to about 900 millibars.By fabrication portion vacuum in the fully enclosed disinfection room, thereby the concentration that has reduced epoxyethane has reduced the danger that epoxyethane catches fire.
After reaching partial vacuum, generally be lower than the low pressure water vapor of 15psi, make the relative humidity in the disinfection room keep 30%-80% by injection.After injecting steam,, need to be commonly referred to as " length of the halt " through after a while for guaranteeing the wetting of all sterilization indoor articles.
After the length of the halt, sterilizing gas is fed disinfection room.After feeding epoxyethane and the such sterilizing gas of the compound of nitrogen as shown in the Examples, the pressure in the disinfection room can be the 500-2300 millibar.The concentration of epoxyethane is 400mg/l usually at least in the disinfection room, and can be up to 1500mg/l or higher.With the ethylene oxide treatment time can be 2-12 hour or longer, used time length determines by some factors, comprises temperature, pressure, humidity, used Slerilant mixture characteristic and is sterilized the character of article.
When handling the article long enough after the time, vacuumize and, sterilizing gas is extracted out in disinfection room with air or nitrogen rinsing by a series of with sterilizing gas.When using epoxyethane, inflammable in oxygen or air because of it, disinfection room is used the unreactable gas rinsing usually, as nitrogen.
It behind the sterilisation stage deaeration stage.The degassing generally includes article sterile, that sign indicating number becomes buttress is moved into the degassing or air-exchanging chamber from disinfection room.Degassing indoor temperature remains on 90-140 °F usually.
In the end the stage, promptly quarantine the stage, the article that take out from degas chamber are stored in a quarantine district.Take out sample and detect aseptic.Waiting for that aseptic between assay period, can further outgas to article.Quarantine and aseptic are identified can use 3-14 days.Like this, do not include quarantine, most of medical articles adopt traditional chamber sterilization method to use 48-72 hour.
Anderson Si Terui-Ztel's method (claiming the Anderson method later on) is except the article that will pack are separately sterilized with Si Terui-Ztel's device sterilization rather than with disinfection room, and it is similar to the chamber sterilization method.The Anderson method comprises four-stage, i.e. pretreatment, sterilization, the degassing and quarantine.
Pretreatment stage comprises puts into special-purpose ready made sack with surgical article.The time and the conditional likelihood of the pretreatment time of these surgery article and condition and chamber recited above sterilization pretreatment stage.
After pretreatment was finished, article were placed in Si Terui-Ztel's device in sack and the bag.Si Terui-Ztel's device is a kind of bar-shaped parcel hot enclosuring device that has scalable aliform thing.Seal up close the sack that closes before, the aliform thing is inserted in the sack between upper and lower sealer bar.This scalable aliform thing inserts from bag mouth.Then, sealer bar is sealed bag mouth around the aliform thing.By the passage in the scalable aliform thing,, make that usually the pressure in the sealing sack is about 500 to about 700 millibars with the part air extraction in the osed top sack.After vacuumizing, the passage by the aliform thing injects bag with 100% epoxyethane.After having annotated epoxyethane, extract the aliform thing out and seal sack.Usually after injection epoxyethane finished, the concentration of epoxyethane was 400 to about 1000mg/l approximately in each sack.
These osed top sacks are placed in degas zone then.Like this, the sterilization and the degassing are carried out in degas chamber simultaneously.After the degassing, sack is moved to the quarantine district and carries out the aseptic evaluation.Do not include the quarantine stage, the Anderson method may be with 36-48 hour.
Although above-described method is all effective for the sterilization of surgical article, the both has some shortcomings.A shortcoming is the length of two kinds of method required times, and another shortcoming is the concentration at the used epoxyethane of sterilisation stage.Under such ethylene oxide concentration, normally about 400 to about 1500mg/l, all worrying from security standpoint consideration toxicity and comb..
Therefore, the epoxyethane sterilization that needs a kind of surgical article of sterilizing within a short period of time.Also need simultaneously a kind of epoxyethane sterilization that reduces toxicity and flammability hazard.Like this, this patent provides a kind of improved epoxyethane sterilization, and detailed description and claim below further reading will more be known this improved epoxyethane sterilization.
Summary of the invention
At the problems referred to above that art technology ran into, the invention provides a kind of sterilization method that the article period of service is lacked than traditional sterilization method.And embodiments more of the present invention further provide a kind of sterilization method that can reduce the sterilizing gas fire hazard.
Sterilization method of the present invention utilizes a kind of sterilizing gas, for example the epoxyethane among the embodiment.The method comprises puts into a kind of case with being sterilized article.In one embodiment, a kind of suitable casing can be made by two sheets one on the other that are applicable to the integral sealing process.The material that also requires to make sheet has enough permeabilitys and simultaneously pollutants is had enough isolations sterilizing gas.Like this, the concentration of the sterilizing gas in the needed case can be kept the sufficiently long time and effectively article be carried out disinfection, and can allow the sterilizing gas of q.s to remove simultaneously in the time of appropriateness or diffuses to the casing outside by sheet material.
In the integral sealing method, be sterilized article and be placed in a kind of case, this case can be fit to support flap and a sheet that covers article and bottom of being sterilized article and determine by a size that is shaped in advance of bottom.A nozzle with holes is used for gas turnover casing between top flat and egative film.Have that gas is that steam is passed in the case by this nozzle with holes extracting out by this nozzle with holes in the part case when vacuumizing at least.In one embodiment, steam pressure is at least about 15 to about 80psi in the nozzle, in particular for about 45 to about 60psi.Steam is passed in the case, is about 40 to about 100 millibars of mercury column up to the case internal pressure.
After casing is added to enough pressure by steam, sterilizing gas is fed in the case by nozzle with holes.In one embodiment, the sterilizing gas of a certain amount of substantially pure is passed in the case, is about 300 to about 700 millibars of mercury column up to the case internal pressure.When using epoxyethane as sterilizing gas, the percent by volume of epoxyethane is about 2% to about 50% in the case when feeding sterilizing gas one EOS, particularly being about 3% to about 25%, more specifically is about 5% to about 10%, further is about 6% to about 8%.
In another embodiment, sterilizing gas can be the compound of epoxyethane and a kind of or several carrier gas.In one embodiment, carrier gas can be a nitrogen.In the another embodiment, carrier gas can be a carbon dioxide.Epoxyethane and carrier gas are passed in the case and are about 300 to about 700 millibars of mercury column up to the case internal pressure.After reaching enough pressure in the case, remove this nozzle with holes, adopt any common encapsulating method then,, the contacted part of upper and lower flap is enclosed in together, thereby has sealed casing as heat-sealing.When the sterilizing gas in feeding case is the compound of epoxyethane and a kind of carrier gas, the percent by volume of the interior epoxyethane of case is about 2% to about 25% when feeding sterilizing gas one EOS, more specifically being about 5% to about 10%, further particularly is about 6% to about 8%.
The osed top casing is transferred to degas zone then.Interior the about 70-160 of temperature of this zone.The osed top casing is kept the enough time in this regional domestic demand, usually at least about 4 hours, so that the casing degassing.
After the degassing, casing is transferred to the quarantine district and carries out the aseptic evaluation.Remove one step of quarantine, all finish this integral sealing and generally be less than 18 hours with the degassing, this obviously lacked than common sterilization method in required 36-72 hour.
The accompanying drawing summary
Fig. 1 is a kind of schematic top plan view of the gas chlorination equipment of sterilizing.
Fig. 2 is an intermittently mixed system scheme drawing of a kind of epoxyethane/nitrogen.
Fig. 3 is the continuous mixed system scheme drawing of a kind of epoxyethane/nitrogen.
Fig. 4 A-4F is a kind of section-drawing that seals the station, each stage of signal seal process.
Detailed Description Of The Invention
Forward now accompanying drawing to also at first with reference to figure 1, this is the concise and to the point figure of sterilization gas chlorination equipment 10 Show. Device 10 comprises an induction system 12, is used for the article (not showing) of sterilization not Be transported to a pair of integral sealing (claiming later on FFS) machinery 14. As following described in detail, disappear Poison gas is directly supplied with FFS machinery. The casing that consists of in FFS machinery encases and will be sterilized Behind the article, just in casing, pass into steam and sterilizing gas. When the steam that passes into q.s and sterilization After the gas, closed box.
Steam and sterilizing gas pass into and the sealing of casing can be in the zone 16 of a sealing Carry out. In the zone 16 of sealing, each casing is packaged and be deposited in vanning district 18. Code becomes The casing of buttress is transported to degas zone 20 by induction system 19, again by automatic storage and output system (after Claim ASRS) 22 processing. ASRS22 comprises transporter 23 and storage shelf 24. In the closed area 16 In, particularly in degas zone 20, temperature can be maintained at about 70 to about 160 °F, concrete and Speech is at about 90 to about 150 °F, more specifically at about 120 to about 140 °F. If be sterilized thing The material of product and formation casing can bear the temperature of raising, and the temperature in this closed area can Remain on 160 °F. The casing of stacking in degas zone 20, to stop the sufficiently long time so that Effectively degassed. Usually be at least during this period of time about 4 hours, particularly be at least about 4 hours extremely About 18 hours.
After the sufficiently long time of process, the casing of stacking is shifted out by transportation system 26 and is sealed the zone 16. In case 16 shift out from the closed area, the casing of stacking is stored in the quarantine district and (does not express Come), until that evidence is sterilized article is aseptic, and if residual gas is arranged, measure residual Stay the amount of sterilizing gas. After reaching satisfactorily these tests and identifying requirement, the article of packing can Used with distribution.
Be suitable for not sterilizing objects of the present invention and comprise such article; They can be wrapped in In the casing, more specifically they can be wrapped in the casing that the FFS machine consists of, and Compatible with sterilizing gas. More specifically, these article comprise disposable and recycling outside Section's article. Further particularly, these article comprise the surgery thing of being made by macromolecular material Product. Further particularly, surgical article refer to as shown in the Examples by high-molecular fabric system The surgical garments and the drop cloth that become.
At Ben Chu, term " macromolecular material " refers to synthesized polymer material or natural polymer material Material is although more likely use in the present invention the former. At Ben Chu, term " high-molecular fabric " Refer to the made fabric of macromolecular material that to make fabric by any.
The example of natural macromolecular material comprises: cotton, rubber, silk, hair and cellulose, and this A little only is some examples that provide. Synthesized polymer material can be thermosets or thermoplastic successively Property material, more usually thermoplastic. Thermosetting polymer only illustrates and comprises: alkyd Resin, such as phthalic anhydride-glycerol resin, maleic acid-glycerol resin, adipic acid-glycerine Resin and phthalic anhydride-pentaerythritol resin; Allyl resin, in these resins, as Phthalic acid di-allyl ester, DAIP, diallyl maleate and the acid of chlorine mattress The monomers such as diallyl are as the non-volatile crosslinking agent of petchem; Amino resins is such as aniline-formaldehyde resin, ethylene urea-formaldehyde resin, dicyandiamide-formaldehyde resin, melamine-formaldehyde tree Fat, sulfamide-formaldehyde resin and Lauxite; Epoxy resin, as crosslinked epoxychloropropane-Bisphenol a resin; Phenolic resins such as phenol-formaldehyde resin, comprises linear phenol-aldehyde resin and solvable Property phenolic resins; Reach thermosetting polyester, silicone resin, polyurethane.
Thermoplastic polymer only illustrates and comprises: the polyacetals of end-blocking, and such as poly-(oxidation methylene) Or polyformaldehyde, poly-(trichloroacetaldehyde), poly-(valeraldehyde), poly-(acetaldehyde), poly-(propionic aldehyde) etc.; Acrylic acid is poly-Compound, as polyacrylamide, poly-(acrylic acid), poly-(methacrylic acid), poly-(ethyl acrylate), Poly-(methyl methacrylate) etc.; Fluorocarbon polymer, as poly-(tetrafluoroethene), perfluor substituted ethylene-Propylene copolymer, ethylene-tetrafluoroethylene copolymer, poly-(CTFE), ethene-trifluoro chloroethene Alkene copolymer, poly-(vinylidene fluoride), polyvinyl fluoride etc.; Polyamide, (6-is amino own as gathering Sour) or gather (epsilon-caprolactams), polyhexamethylene adipamide, polyhexamethylene sebacamide, poly-(11-amino hendecanoic acid) etc.; Nomex is such as poly-(imino group-1,3-phenylene imido isophthalic two Acyl) or claim poly-(-phenylene isophthaloyl amine) etc.; Parylene, as poly--right-Inferior dimethylbenzene, poly-(chloro-right-Ya dimethylbenzene) etc.; Polyaryl ether, (oxygen-2,6-two as gathering Methyl isophthalic acid, the 4-phenylene) or poly-(to phenylene oxygen) etc.; Polyarylsufone, as poly-(oxygen-Isosorbide-5-Nitrae-Phenylene sulfonyl-Isosorbide-5-Nitrae-phenylene oxygen-Isosorbide-5-Nitrae-phenylene-isopropylidene-Isosorbide-5-Nitrae-Ya benzene Base), gather (sulfonyl-Isosorbide-5-Nitrae-phenylene oxygen-Isosorbide-5-Nitrae-Ya benzenesulfonyl-4,4 '-two phenylenes) Deng; Merlon is such as poly bisphenol or the poly-(carbonyldioxy-Isosorbide-5-Nitrae-phenylene isopropylidene-Isosorbide-5-Nitrae of title-phenylene) etc.; Polyester, such as poly-(ethylene glycol terephthalate), poly-(terephthalic acid (TPA) butanediol Ester), poly terephthalic acid (cyclohexylidene-Isosorbide-5-Nitrae-dimethyl ester) or claim poly-(Oxymethylene-Isosorbide-5-Nitrae-The inferior methoxyl group terephthalate of cyclohexylidene) etc.; Polyarylene sulfide is such as poly-(to diphenyl sulfide) or the poly-(sulphur of title Generation-Isosorbide-5-Nitrae-phenylene) etc.; Polyimides is such as poly-(benzene tetramethyl acylimino-Isosorbide-5-Nitrae-phenylene) Deng; Polyolefin, such as polyethylene, polypropylene, poly-(1-butylene), poly-(2-butylene), poly-(1-Amylene), poly-(2-amylene), poly-(3-Methyl-1-pentene), poly-(4-methyl-1-pentene), 1,2-gathers-1,3-butadiene, Isosorbide-5-Nitrae-poly--1,3-butadiene, polyisoprene, polychlorostyrene fourth Diene, polyacrylonitrile, poly-(vinyl acetate), poly-(vinylidene chloride), polystyrene etc.; Aforementioned list The copolymer of body, such as acrylonitrile-butadiene-styrene copolymer (ABS) etc., etc. At some In the embodiment, high-molecular fabric is to be made by polyolefin. In other embodiments, polyolefin Refer to polypropylene.
Term " fabric " " be used to refer to sheet or Web materials that any fiber is made here widely.In other words, this fabric to small part is that fiber by random length constitutes.Like this, fabric may be weaving or nonwoven sheet material or net material, and these fabrics all are to make at an easy rate with the known method of the people who has common technical ability in this area.For example, nonwoven fabrics is to use as melt jet, and coforming is spunbond, combing, and the such method of air lay and wet-laying is made.In addition, these fabrics may be made up of one or more layers.And a kind of multiply cloth may comprise film, scrim and other non-textile material.
Have been found that the nonwoven fabrics of being made by polyolefin-based fiber is particularly suitable for the present invention.The example of this nonwoven fabrics is the polypropylene non-woven fabric of being produced by enrollment proxy person's Kimberley-Clarke (Kimberly-Clark) company.A kind of multi-layer nonwoven fabrics is a kind of spunbond, melt jet, spunbond (SMS) nonwoven fabrics, is to be produced by Kimberly-Clark Corporation.
This spunbond, melt jet, nonwoven fabric can be obtained by three layers of independent stratum, and their are by laminated together each other.A kind of 4,041,203 descriptions of U.S. Patent No. that prepare the method for laminated fabric by the people such as Brock of common transfer like this, this patent intactly is used for herein as a reference.In addition, this is spunbond, melt jet, nonwoven fabric can by at first make a kind of spunbond-the melt jet layer prepares.This spunbond-melt jet layer forms by one deck melt jet is placed on one deck spunbond layer.It is laminated that second layer spunbond layer is placed in the melt jet of spunbond-melt jet layer of before having made subsequently.Usually, two skins provide the intensity of nonwoven fabrics, and internal layer provides barrier property.Comprise SMS nonwoven fabrics described above, other nonwoven fabrics reaches, and comprises other material of fabric, film, foam/film laminated product and their composite, can be used for constituting being applicable to fabric of the present invention.
Suitable sterilizing gas is such some gases, they at least can with non-sterile article and compatible as operating parameters such as temperature and pressures, and when q.s exists, these article of can sterilizing effectively through after a while.In one embodiment, sterilizing gas is the compound of a kind of carrier gas and a kind of gas of sterilizing.Carrier gas is such some gases, they at least can with sterilization gas or the gas mixture and to be sterilized article compatible of sterilizing.The example of sterilization gas comprises epoxyethane, ozone, and hydrogen peroxide steam and plasma, but not only be confined to these.The example of carrier gas comprises nitrogen, carbon dioxide and dichlorodifluromethane, but be not limited to these.When the sterilization gas bag is drawn together the compound of epoxyethane and one of nitrogen or carbon dioxide, the percent by volume of the epoxyethane that exists can be at least about 2% usually, more specifically, be about 3% to about 25%, further particularly, be about 5% to about 10%, particularly about 6% to about 8%.
The suitable gas mixing system that is used for hybrid epoxidized ethane and one of nitrogen or carbon dioxide as shown in Figures 2 and 3.These systems not only comprise the intermittent feeding method but also comprise the continuous feed method.A kind of be used for hybrid epoxidized ethane and nitrogen intermittence mixed system 208 example as shown in Figure 2.Intermittently mixed system 208 comprises nitrogen feed device 210, and it inserts in a pair of liquid epoxy ethane source 212.This gas feed device 210 helps keep pressure in the epoxyethane source 212 by the band pressure nitrogen that feeds usually about 70psi in epoxyethane source 212.In addition, the nitrogen above the liquid epoxy ethane helps to reduce the possibility that epoxyethane catches fire in epoxyethane source 212.
Liquid epoxy ethane source 212 below links together piping manifold and a pair of mixing channel of describing in detail 214 by a kind of.Liquid epoxy ethane 212 is transported to carburetter or H Exch 218 by pipeline 216 from the source.H Exch 218 is transformed into gaseous ethylene oxide with liquid epoxy ethane.Gaseous ethylene oxide is transported to mixing channel 214 by pipeline 220 from H Exch 218.Nitrogen is from source nitrogen 222, such as a kind of nitrogen film system, is transported to mixing channel 214 by pipeline 224.The concentration of epoxyethane is by a kind of autonomous cruise speed system (not shown) monitoring and control, and this autonomous cruise speed system comprises valve, computer hardware and software, and all these is known by those skilled in the art.From the gas analyzer 226 that is connected mixing channel 214, as infrared spectrum analyser, the signal of output is input to autonomous cruise speed system.The gas mixture that comes out from mixing channel 214 is transported in the FFS machinery by pipeline 228.
A kind of example of continuous gas mixed system 308 as shown in Figure 3, it comprises the source nitrogen 314 that liquid state or gaseous nitrogen atmosphere can be provided and is inserted into the nitrogen feed device 310 in a pair of liquid epoxy ethane source 312.Nitrogen is from source nitrogen 314, and a kind of cryogenic nitrogen source of the gas as shown in the Examples (a kind of liquid nitrogen source of the gas) or a kind of nitrogen filtering film source (a kind of gaseous nitrogen source of the gas) enter H Exch 318 by pipeline 316.The nitrogen that comes out from H Exch 318 enters heat control treatment trough 320.Liquid epoxy ethane enters treatment trough 320 through over-heat-exchanger 324 with liquid form from epoxyethane source 312 by pipeline 322.At treatment trough 320, the gaseous nitrogen atmosphere bubbling feeds liquid epoxy ethane.The temperature and pressure of the steam (compound of epoxyethane and nitrogen) by control slit 320 tops can be controlled by treatment trough 320 and discharge and by the epoxyethane in the steam of pipeline 326 and the percentum of nitrogen.This gas mixture passes through another H Exch 328 by pipeline 326 conveyings, and the slow middle groove 330 of last arrival.Gas one,, is analyzed as infrared spectrum analyser just by gas analyzer 332 to dashpot 330.Can be input to a kind of autonomous cruise speed system (not shown) from the data of gas analyzer 332 outputs, this autonomous cruise speed system is similar to and described above the mixing in the step at gas is used for the autonomous cruise speed system that control gaseous is mixed.The gas mixture that comes out from dashpot 330 is transported to FFS machinery by pipeline 334.
Another example that is applicable to sterilization gas mixture of the present invention is epoxyethane/carbon dioxide mixture.Epoxyethane/carbon dioxide mixture can be by premixed, and this pre-mixed gas is delivered directly to FFS machinery, is injected in the FFS case.When premixed, carbon dioxide is about 91.5% carbon dioxide and about 8.5% epoxyethane to the percent by volume of epoxyethane.Under this concentration, epoxyethane/carbon-dioxide premix is commonly referred to be nonflammable.Like this, this premixed epoxyethane/carbon dioxide mixture provides a kind of nonflammable, the continuous air-flow inequality with other epoxyethane mixed method, and a kind of method in back requires to store and handle dense epoxyethane.
(do not have example) in one embodiment, premixed epoxyethane/carbon dioxide can be liquefied.Such liquified mixt steel cylinder links together by a kind of manifold.The compound of this liquefaction is through a volatilizer, and the gas mixture of generation is stored in the holding tank.This gaseous mixture is transported to FFS machinery from holding tank then.Usually, the pressure of the gaseous mixture in FFS machinery should be at least about 20psi, and particularly about 40 to about 45psi.In some instances, because carbon-dioxide Joule-Thomson coefficient need provide heat to gas pipe line when gas leaves holding tank.
Device 10 may further include epoxyethane scrubber system (not signal).Such system is that those skilled in the art is well-known.Epoxyethane scrubber system is used for controlling or eliminates epoxyethane entering into air.Such system is transformed into carbon dioxide and water vapour with the catalytic oxidation technology with epoxyethane usually.A kind of such epoxyethane purifier system, the i.e. special (ETO-Abator of system of Ai Tuo-Abbe
TM) can (the Donaldson Company, Inc.of Minneapolis MN) obtains from the Donaldson Company, Inc of Minnesota State Minneapolis.
Referring now to Fig. 4 a-4F,, they have illustrated a kind of sealed chamber or containment station 410.Containment station 410 is one of many stations on the FFS operating line of this patent.The example of other station and system on the FFS operating line (not signal) comprises egative film and top flat station, and article distribute station, delivery system, and vanning and/or piling station.
The egative film station softens egative film 412 and fully moulds its shape, makes it to be used for accepting article 414 (Fig. 4 A).Top flat station (not signal) is determined the direction of top flat 416 (Fig. 4 A) according to egative film 412.The top flat station is printing or stickup information or guiding written material on top flat 416 also.The orientation of top flat 416 and egative film 412 is in order to form casing 417 (Fig. 4 A) in sealed chamber.
Top flat and egative film, promptly 416 and 412, may make by various materials.The examples of material that is suitable for making top flat comprises the laminated product of paper and paper and polyolefin film, plastics, and polyolefin film, polyethylene foil, density polyethylene film with high and laminated product thereof, nylon 66 and polyolefin nonwoven fabrics, but not only be confined to this.The examples of material that is suitable for making egative film comprises the coextrusion ethylene-vinyl acetate copolymer, ethylene-vinyl acetate copolymer, the ethylene-vinyl acetate laminated product, ethylene-vinyl acetate/ionomer resin/ethylene-vinyl acetate laminated product and polyethylene foil particularly, but not only be confined to this.The trade mark of ionomer resin is SURLYN
The material require of making top flat and egative film is suitable for for example a kind of hot pin of a kind of thermal source or other bonding or fusion source commonly used, and is partly bonding or fuse together.And the structure that also requires to make the material of top flat 416 and/or egative film 412 will allow the sterilization gas of q.s or sterilization gas mixture to enter casing 417, and can therefrom deviate from (during the degassing).Cross sample, after finishing disinfectant program, being sterilized article can take out from case 417, and does not have residual quantity sterilization gas or the sterilization accident that gas mixture brought or dangerous.Also require behind fully sheathed case 417, for example bonding or fused portion top flat and egative film are respectively 416 and 412, and top flat 416 and egative film 412 be all to as bacterium, virus, and dust, pollutantss such as fluid have enough isolated property.
Article distribute station 410 that article 414 to be sterilized suitably are placed in the egative film 412 of shaping.Delivery system is suitably placed these sheets and for its numbering along this integral sealing operating line.The vanning station is packed the closed box of being sent by containment station 410 of predetermined number in the packing.The piling station is placed on the packing of predetermined number on the pallet.
In containment station 410, carry out several work in succession.These work comprise evacuation, and gas is introduced program and sealing schedule.Such described in detail as follows, Fig. 4 A-4C has illustrated evacuation, Fig. 4 D to illustrate gas to introduce program, and Fig. 4 E has illustrated sealing schedule.
Referring now to Fig. 4 A,, containment station 410 comprises a lid 418 that has pore 420, and the sidewall 421 that extends downwards.The foot of sidewall 421 is continuous limits 422, and it engages with the upper surface of top flat 416.
Vertical adjustable Sealing formboard 424 comprises upwardly extending sidewall 425, is fixed with a continuous seal part 426 at the topmost of sidewall 425.This Sealing formboard also comprises a pore 428 and a platform with holes 430.The determining of lid 418 and Sealing formboard 424 sizes makes that the part of the part on limit 422 and T type rubber 426 is overlapping.
Be fixed on that to cover on the 418 interior platforms 432 with holes be a pair of cylinder 434, each cylinder comprises a piston 435 (Fig. 4 E) that is fit to do perpendicular movement.The top of each cylinder 434 is fixed on the platform 432.The hot enclosuring device 436 of a sidewall 440 that has horizontal plane 438 and extend downwards is fixed on two pistons 435 along horizontal plane 438.The lowermost part of sidewall 440 has a limit 442.The determining of the limit 442 of hot enclosuring device 436 and the size of Sealing formboard 424 makes that the part of the part on limit 442 and T type rubber 426 is overlapping.
Vacuum starts from sealed chamber 410 placing a kind of egative film that makes 412 and top flat 416 that is used for holding articles 414, shown in Fig. 4 A.Herein, top flat and egative film promptly are respectively 416 and 412, loosely contact each other.Nozzle 446 is inserted in top flat and egative film promptly is respectively between 416 and 412.
Vacuum next step, shown in Fig. 4 B, Sealing formboard 424 is raised, and makes itself and top flat and egative film promptly be respectively 416 and 412 and contacts and both part is pressed against each other.The raising of Sealing formboard 424 also the top of valve 446 is enclosed within top flat and egative film promptly is respectively between 416 and 412.Sealing formboard 424 and lid 418 promptly 412 and 416 are exerted pressure to egative film and top flat respectively, make top flat and egative film promptly produce sealing function between 416 and 412.In this sealed chamber profile, casing has partly been sealed.Egative film and top flat i.e. 412 and 416 closed contacts but unfixing or fuse together each other, and hole 448 provides a kind of gas-selectively ground to advance or go out the method for casing 417.
In this program, the raising of Sealing formboard 424 also produces the chamber of three separation in containment station 410 except that partially enclosed casing 417.Alphabetical A is used in these three chambers in Fig. 4 B, B, C signal.Chamber A is determined by the space between the upper surface of lid 418 inner face and top flat 416.Pore 420 provides a kind of method that gas advances or go out chamber A of optionally transmitting.Chamber B is determined by the inside of casing 417.Hole 448 provides a kind of gas-selectively ground to advance or go out the method for chamber B by nozzle 446.Chamber C is then determined by the space between the lower surface of the inner face of Sealing formboard 424 and spacer screen 412.Hole 428 provides a kind of gas-selectively ground to advance or go out the method for chamber C.
Fig. 4 C has illustrated the final step of vacuum.Arrow has been illustrated the motion of gas in chamber A, B and C.In this step,, in chamber A, B and C, cause partial vacuum by suitable valve and pump structure (not signal).Usually, the pressure in three chamber A, B and C can be reduced to about 30 to about 100 millibars of mercury column.Like this, the portion of air in chamber B and the article 414 can shift out by hole 448.
Fig. 4 D has illustrated gas to feed program.Chamber A and C eliminate vacuum.Chamber A and C feed gas by pore 420 and 428 respectively.During chamber A and C feeding gas, or after a while, gas is fed chamber B by hole 448.
In one embodiment, one of gas that is passed into chamber B is steam.Steam pressure at nozzle 446 can be about 15 to about 80psi and more specifically be about 45 to about 60psi.The another kind of gas that feeds chamber B is sterilizing gas described above.Steam and sterilizing gas can successively or feed chamber B simultaneously.When steam and sterilizing gas are when successively feeding, can at first feed steam, feed sterilizing gas then.In this case, feeding the force value of steam in the B of chamber to chamber B is about 40 to about 100 millibars.After removing vapour source, feeding the force value of sterilizing gas in the B of chamber to chamber B is about 300 to about 700 millibars of mercury column.When at first feeding sterilizing gas when feeding steam then, it is about 290 to about 630 millibars of mercury column up to the force value of chamber B that sterilizing gas can be passed into chamber B.Can feed the pressure of steam in the B of chamber to chamber B then and be at least about 300 to about 700 millibars of mercury column.When steam and sterilizing gas were fed chamber B simultaneously, it was about 300 to about 700 millibars of mercury column that these gases are passed into chamber B the pressure up to the there.
When the sterilizing gas that is passed into chamber B was about 100% epoxyethane, the percent by volume that is present in the epoxyethane of chamber B and other gas can be in following scope: epoxyethane-Yue 2%～about 50%; Steam-Yue 2%～about 20%; Air-Yue 0%～about 78%.
When the sterilizing gas that feeds chamber B was the compound of epoxyethane and a kind of carrier gas, the percent by volume that is present in this mixture gas of chamber B and other gas can be in following scope: epoxyethane-Yue 2%～about 25%; Carrier gas-Yue 25%～about 96%; Steam-Yue 2%～about 20%; Air-Yue 0%～about 30%.When carrier gas is nitrogen, its percent by volume at chamber B can be about 25%～about 96%, particularly be about 60%～about 90%, more specifically be about 65%～about 85%, be 70%～about 80% especially approximately.When carrier gas is carbon dioxide, its percent by volume at chamber B can be about 25%～about 96%, particularly be about 60%～about 90%, more specifically be about 75%～about 85%, particularly about 70%～about 80%.
Fig. 4 E has illustrated sealing schedule.In this program, the source of the gas that leads to nozzle 446 is removed, and the gas that had before led to chamber A is retained within it.By the stretching, extension of piston 435, hot enclosuring device 436 is put down, and the limit 442 of sealed mold 436 is contacted with the upper surface of top flat 416.When providing enough pressure and temperature and through behind the time enough, top flat and egative film promptly are respectively 416 and 412 and are fixed together to top flat 416 by sealed mold 436, by as bonding or fusion, so just sealed case 417 close.Feed gas to chamber A and C continuously by hole 420 and 428 respectively during this period, when making fully enclosed containment station 410 in seal casing 417, the sterilizing gas of remnants can be shifted out from chamber A and C.
Referring now to Fig. 4 F,, by shrinking piston 435 (not signal), hot enclosuring device 436 has been raised, makes limit 442 leave top flat 416 1 segment distances.Sealing formboard is withdrawn, makes T type rubber 426 leave egative film 412 1 segment distances, and illustrates that clearly valve is removed.Fully enclosed case 417 is transferred system now downwards and delivers to vanning/piling station and outgas.Usually, when fully enclosed case 417 carried out downwards, another case that supports article entered containment station 410, and this containment station program repeats.
The present invention further is described by the following examples.Yet, no matter from inwardly or on the scope, these embodiment do not constitute any restriction to the present invention.
Embodiment 1
Program: a kind of article to be sterilized are put in unlimited, the ready-made egative film.These article are the disposable operation dress that fold.The fabric of operation dress is three layers of nonwoven fabrics polypropylene material of a kind of SMS of being known as.SMS is the prefix abbreviation of spunbond (Spunbond), melt jet (Meltblown), spunbond (Spunbond), and it is laminated together then to make trilaminate material with the method.For example see people's such as Brock U.S. Patent No. 4,041,203.
Si Bodesi spore vitta is that (AMSCO AmericanSterilizer Co.Erie, product PA) are placed in the diverse location in casing and the folded articles in AMSCO America sterilizer Co.,Ltd.Si Bodesi spore bar is to be used for monitoring biological indicator xeothermic or the oxirane disinfection process.For the test figures that is reported among Table I-V, the spore bar is three positions that are placed in the case.A spore bar is placed on above the folding clothes, and second spore bar is placed in the folding clothes, between the 3rd spore bar is placed at the bottom of clothes and the case.
For the test figures that is reported among Table VI-VIII, the spore bar is placed on five places in the case.A spore bar is placed on above the folding clothes, between second spore bar is placed at the bottom of folding clothes and the case, the 3rd spore bar is placed on and is positioned at the first and second spore bar position intermediate in the clothes, the 4th spore bar is placed on and is positioned at the first and the 3rd spore bar position intermediate in the clothes, and the 5th spore bar is placed on the second and the 3rd spore bar position intermediate.
Positive sign, "+" is used for representing biologically active or disinfection not on the spore bar.Negative sign, "-" is used for the biological nonactive or disinfection of expression.For being considered to already sterilised article, the analysis of all spore bars all should show biological nonactive in the case.
The casing that comprises content is put in the machinery of a kind of Multivac AGW chamber, and this machinery is Sepp Haggenmuller KG, 8941 Wolferschwenden, a kind of product of Germany.The open end of casing is placed between the interior heat seal bars of chamber sterilization machine.The lid of chamber sterilization machine shut and to small part disinfection room and the case gas be drawn out of.
The steam of 45～65psi at first is passed in this fully enclosed chamber sterilization machine.Feeding pressure then in this fully enclosed chamber sterilization machine is the sterilizing gas of 35～60psi, and this sterilizing gas is the compound of epoxyethane/carbon dioxide or epoxyethane/nitrogen.Through the sufficiently long time so that the gas that feeds is dispersed in fully enclosed chamber sterilization machine and the casing that opens wide in after, casing is heat-sealed the device sealing.
Use chamber wash sterilization machine in the air then.In case reach bar pressure in the sterilization machine of chamber, the lid of chamber sterilization machine is opened and the leak free casing is moved out of.Then this leak free casing be placed into a kind of ventilation temperature maintenance in 130～140 stove, outgased 4～24 hours.
For Table I, II, IV-IX, deaeration stage is analyzed the spore bar later immediately.For Table III, deaeration stage was analyzed the spore bar in about 3 days later.
The result
The test parameters and the sterilization result of Table I-V report epoxyethane/carbon dioxide mix sterilizing gas.About Table I and II, if pressure is at least 500 millibars of mercury column when feeding this EOS of epoxyethane, and when in case, feeding this EOS of epoxyethane, its percentum is about 7.3%～about 7.4%, or about 58mg/l epoxyethane, sterilization is finished in the shortest time usually, promptly finishes after 6 hours about the degassing greatly.If pressure is at least 500 millibars of mercury column when feeding this EOS of epoxyethane, and the degassing time is about 16 hours, sterilization also can be finished at (about 6.9% epoxyethane when feeding the epoxyethane end in case, or about 55mg/l epoxyethane) under the lower ethylene oxide concentration.
About Table III, sterilization was finished after the degassing at least on the 7th day.At bag 1-3 and 5-9, in case, feed epoxyethane when finishing the percentum of its existence be about 6.8%～about 7.8%, or about 60mg/l～about 81mg/l epoxyethane.Through after during this period of time, the not disinfection of bag 4 is because sealing fully of parcel when heat-sealing mostly.
Referring now to Table IV and V,, sterilization was finished by about 9.5 hours in the degassing in about 7.5 hours, during the degassing in the case degree of vacuum be at least 60 millibars of mercury column, and its percentum is about 6.9%～about 7.3% or about 71mg/l～about 81mg/l when feeding the epoxyethane end in case.
Table I packing degree of vacuum vapor tension gas mixture air pressure degassing time test results
1 30mb～65mb 6.00% air 500mb 6 hours 25 minutes is aseptic
7.00% steam amounts to
7.40％ETO 58.8mg/l
79.61％CO
2 ETO
2 30mb～55mb 5.00% air 600mb 6 hours 5 minutes are aseptic
4.17% steam amounts to
7.72％ETO 73.7mg/l
83.11%CO
2ETO note: mb=mercury vacuum millibar number/pressure
CO
2=carbon dioxide
The ETO=ethylene oxide gas
Packing composition=Starflex-C, 6.25mil/Phoenix EPPFF-B, paper-polymer laminate
Tympanites compound=8.5%ETO/91.5%CO
2
Table II packing degree of vacuum vapor tension gas mixture air pressure degassing time test results l 30mb～68mb 6.00% to gas 500mb 5 hour 45 minutes is aseptic
7.60% steam amounts to
7.34％ETO 58.4mg/l
79.06%CO
2ETO 2 30mb～5 hours 40 minutes 2+/1-of 67mb 5.00% air 600mb
6.17% steam amounts to
7.55％ETO 72.0mg/l
81.28%CO
2ETO 3 30mb～5 hours 30 minutes 1+/2-of 50mb 4.29% air 700mb
2.86% steam amounts to
7.89％ETO 87.9mg/l
84.96%CO
2ETO 4 30mb～84mb 4.00% air 750mb 5 hours 25 minutes are aseptic
7.20% steam amounts to
7.55％ETO 90.0mg/l
81.25%CO
2ETO 5 30mb～5 hours 17 minutes 2+/1-of 88mb 6.00% air 500mb
11.60% steam amounts to
7.00％ETO 55.7mg/l
75.40%CO
2ETO 6 30mb～5 hours 11 minutes 2+/1-of 88mb 5.00% air 600mb
9.67% steam amounts to
7.25％ETO 69.2mg/l
78.08％CO
2 ETO
Table II (continuous table) packing degree of vacuum vapor tension gas mixture air pressure degassing time test results 7 30mb～5 hours 5 minutes 2+/1-of 98mb 4.29% air 700mb
9.71% steam amounts to
7.31％ETO 81.4mg/l
78.69%CO
2ETO 8 30mb～5 hours 5 minutes 3+ of 92mb 4.00% air 750mb
8.27% steam amounts to
7.46％ETO 88.9mg/l
80.28%CO
2ETO 9 30mb～81mb 6.00% air 500mb 16 hours 20 minutes are aseptic
10.20% steam amounts to
7.12％ETO 56.6mg/l
76.68%CO
2ETO 10 30mb～86mb 5.00% air 600mb 16 hours 15 minutes are aseptic
9.33% steam amounts to
7.28％ETO 69.5mg/l
78.39%CO
2ETO 11 30mb～90mb 4.29% air 700mb 16 hours 14 minutes are aseptic
8.57% steam amounts to
7.41％ETO 82.5mg/l
79.74%CO
2ETO 12 30mb～89mb 4.00% air 750mb 16 hours 11 minutes are aseptic
7.87% steam amounts to
7.49％ETO 89.3mg/l
80.64％CO
2 ETO
Table II (continuous table) packing degree of vacuum vapor tension gas mixture air pressure degassing time test results
13 40mb～95mb 8.00% air 500mb 16 hours 00 minute are aseptic
11.00% steam amounts to
6.89％ETO 54.7mg/l
74.12％CO
2 ETO
14 44mb～95mb 7.33% air 600mb 15 hours 53 minutes are aseptic
8.50% steam amounts to
7.15％ETO 68.3mg/l
77.01％CO
2 ETO
15 41mb～92mb 5.86% air 700mb 15 hours 50 minutes are aseptic
7.29% steam amounts to
7.38％ETO 82.2mg/l
79.47％CO
2 ETO
16 41mb～92mb 5.47% air 750mb 15 hours 45 minutes are aseptic
6.80 steam amounts to
7.46％ETO 88.9mg/l
80.28％CO
2 ETO
16 hours 5 minutes 3+ of 17 30mb～80mb 90.00 air 500mb (+Control) 10.00% steam amounts to
0％ETO 0mg/l
0%CO
2ETO note: mb=mercury vacuum millibar number/pressure
CO
2=carbon dioxide
The ETO=ethylene oxide gas
Packing composition=Starflex-C, 6.25mil/Phoenix EPPFF-B, paper-polymer laminate
Tympanites compound=8.5%ETO/91.5%CO
2
Table III
The packing degree of vacuum air % vapour pressure steam % mixture E TO% CO of gas (mb) ETO after 7 days
2％ ( mg/l ) ,1 90mb 16.07～110mb 3.57 560 6.83 73.53 60.83 4.5 3 (-) /0 ( + ) 2 90mb 13.85～125mb 5.38 650 6.87 73.90 70.97 5.5 3 (-) /0 ( + ) 3 90mb 12.16～140mb 6.76 740 6.89 74.19 81.10 6.5 3 (-) /0 ( + ) 4 60mb 9.92～80mb 3.31 605 7.38 79.40 70.97 6.5 0 (-) /3 ( + ) 5 60mb 8.63～95mb 5.04 695 7.34 78.99 81.10 4.5 3 (-) /0 ( + ) 6 60mb 10.71～110mb 8.93 560 6.63 73.53 60.83 5.5 3 (-) /0 ( + ) 7 30mb 4.62～50mb 3.08 650 7.85 84.46 81.10 5.5 3 (-) /0 ( + ) 8 30mb 5.83～65mb 6.80 515 7.43 79.95 60.83 6.5 3 (-) /0 ( + ) 9 30mb 4.96～80mb 8.26 605 7.38 79.40 70.97 4.5 3 (-) /0 ( + ) 10 30mb 4.05～80mb 6.76 740 0.00 89.19 0 5.4 0 (-) /3 ( + )*6.76 740 0.00 89.19 0 5.4 hours 0 (-)/3 (+) of 11 30mb, 4.05～80mb
* *Has only CO
2, do not have ETO
Table TV
Gas (mb) ETO packing degree of vacuum air % vapor tension steam % mixture E TO% CO
2％ ( mg/l ) 1 90mb 16.07～110mb 3.57 560 6.83 73.53 60.83 7.5 0 (-) /3 ( + ) 2 90mb 13.85～125mb 5.38 650 6.87 73.90 70.97 8.5 2 (-) /1 ( + ) 3 90mb 12.16～140mb 6.76 740 6.89 74.19 81.10 9.5 3 (-) /0 ( + ) 4 60mb 9.92～80mb 3.31 605 7.38 79.40 70.97 9.5 3 (-) /0 ( + ) 5 60mb 8.63～95mb 5.04 695 7.34 78.99 81.10 7.5 3 (-) /0 ( + ) 6 60mb 10.71～110mb 8.93 560 6.83 73.53 60.83 8.5 2 (-) /1 ( + ) 7 30mb 4.62～50mb 3.08 650 7.85 84.46 81.10 8.5 3 (-) /0 ( + ) 8 30mb 5.83～65mb 6.80 515 7.43 79.95 60.83 9.5 2 (-) /1 ( + ) 9 30mb 4.96～80mb 8.26 605 7.38 79.40 70.97 7.5 0 (-) /3 ( + )
Table V
Gas (mb) ETO packing degree of vacuum air % vapor tension steam % mixture E TO% CO
2％ ( mg/l ) 1 90mb 16.07～110mb 3.57 560 6.83 73.53 60.83 4.5 1 (-) /2 ( + ) 2 90mb 13.85～125mb 5.38 650 6.87 73.90 70.97 5.5 1 (-) /2 ( + ) 3 90mb 12.16～140mb 6.76 740 6.89 74.19 81.10 6.5 1 (-) /2 ( + ) 4 60mb 9.92～80mb 3.31 605 7.38 79.40 70.97 6.5 0 (-) /3 ( + ) 5 60mb 8.63～95mb 5.04 695 7.34 78.99 81.10 4.5 1 (-) /2 ( + ) 6 60mb 10.71～110mb 8.93 560 6.83 73.53 60.83 5.5 0 (-) /3 ( + ) 7 30mb 4.62～50mb 3.08 650 7.85 84.46 81.10 5.5 0 (-) /3 ( + ) 8 30mb 5.83～65mb 6.80 515 7.43 79.95 60.83 6.5 0 (-) /3 ( + ) 9 30mb 4.96～80mb 8.26 605 7.38 79.40 70.97 4.5 1 (-) /2 ( + )
The test parameters and the sterilization result of Table VI-IX report epoxyethane/nitrogen mixing sterilizing gas.About Table VI-VIII, sterilization is finished after about 5 hours from feeding the epoxyethane degassing usually, and at this moment its concentration in case is about 13.7% when feeding the epoxyethane end.Feed epoxyethane when finishing its concentration in case be under about 11.4% the situation, sterilization is finished after about 12 hours feeding the case degassing from epoxyethane.Referring now to Table I X,, especially referring to packing numbers 11 and 12, the concentration of epoxyethane is about 3.9%, and sterilization is finished after case was outgasing about 22 hours feeding from epoxyethane usually.
Table VI packing degree of vacuum vapor tension gas mixture air pressure degassing time test results 1 30mb～80mb 11.43%ETO 320mb 24 hours is aseptic
77.14％N
2 ETO/N
2
7.14% steam 300mb 5-spore vitta
4.29% air N
22 30mb～80mb 11.43%ETO 320mb 12 hours are aseptic
77.14％N
2 ETO/N
2
7.14% steam 300mb 5-spore vitta
4.29% air N
23 30mb～50mb 11.43%ETO 320mb not sterilization in 6 hours
81.43％N
2 ETO/N
2
2.86% steam 330mb 4+/1-spore vitta
4.29% air N
24 30mb～50mb 11.43%ETO 320mb 12 hours are aseptic
81.43％N
2 ETO/N
2
2.86% steam 330mb 5-spore vitta
4.29% air N
25 30mb～50mb 11.43%ETO 320MB 24 hours are aseptic
81.43％N
2 ETO/N
2
2.86% steam 330mb 5-spore vitta
4.29% air N
2Note: mb=mercury vacuum millibar number/pressure
N
2=nitrogen
The ETO=ethylene oxide gas
Packing composition=Starflex-C, 6.25mil/Phoenix EPPFF-B, paper-polymer laminate
Tympanites compound=25.0%ETO/75.0%N
2
Packing #1-2,88471-60; #3-5,88726-60
Table VII packing degree of vacuum vapor tension gas mixture air pressure degassing time test results 1 30mb～80mb 13.87%ETO 600mb 8 hours is aseptic
72.80％N
2
8.33% steam
5.00% air, 2 30mb～80mb 13.75%ETO 600mb not sterilization in 9 hours
72.91％N
2
8.33% steam 1+/4-spore vitta
5.00% air, 3 30mb～80mb 13.75%ETO 600mb 10 hours are aseptic
72.91％N
2
8.33% steam
5.00% air, 4 30mb～80mb 13.75%ETO 600mb 11 hours are aseptic
72.91％N
2
8.33% steam
5.00% air, 5 30mb～80mb 13.75%ETO 600mb 12 hours are aseptic
72.91％N
2
8.33% steam
5.00% air note: mb=mercury vacuum millibar number/pressure
N
2=nitrogen
The ETO=ethylene oxide gas
Packing composition=Starflex-C, 6.25mil/Phoenix EPPFF-B, paper-polymer laminate
Tympanites compound=15.87%ETO/84.13%N
2
Table VIII packing degree of vacuum vapor tension gas mixture air pressure degassing time test results 1-3 30mb～80mb 13.87%ETO 600mb not sterilization in 4 hours
72.80％N
2
8.33% steam 2+/3-spore vitta
5.00% air 4-6 30mb～80mb 13.75%ETO 600mb 5 hours is aseptic
72.91％N
2
8.33% steam
5.00% air 7-9 30mb～80mb 13.75%ETO 600mb 6 hours is aseptic
72.91％N
2
8.33% steam
5.00% air 10-11 30mb～80mb 13.75%ETO 600mb 7 hours is aseptic
72.91％N
2
8.33% steam
5.00% air 12-15 30mb～80mb 13.75%ETO 600mb 8 hours is aseptic
72.91％N
2
8.33% steam
5.00% air note: mb=mercury vacuum millibar number/pressure
N
2=nitrogen
The ETO=ethylene oxide gas
Packing composition=Starflex-C, 6.25mil/Phoenix EPPFF-B, paper-polymer laminate
Tympanites compound=packing 1-3,16%ETO/84%N
2, all other packing number, 15.87%ETO/84.13%N
2
Table I X
Gas (mb) ETO packing degree of vacuum air % vapor tension steam % mixture E TO% N
2％ ( mg/l ) 1 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 2.00 2 (-) /1 ( + ) 2 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 2.20 1 (-) /2 ( + ) 3 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 7.40 3 (-) /0 ( + ) 4 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 7.45 3 (-) /0 ( + ) 5 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 22.03 3 (-) /0 ( + ) 6 30mb 4.29～50mb 7.14 620 14.35 74.22 159.73 22.24 3 (-) /0 ( + ) 7 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 2.00 0 (-) /3 ( + ) 8 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 4.00 0 (-) /3 ( + ) 9 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 7.21 0 (-) /3 ( + ) 10 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 7.20 0 (-) /3 ( + ) 11 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 22.00 3 (-) /0 ( + ) 12 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 21.50 3 (-) /0 ( + ) 13 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 2.50 0 (-) /3 ( + ) 14 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 3.22 0 (-) /3 ( + ) 15 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 5.22 0 (-) /3 ( + )
Table I X (continuous table)
Gas (mb) ETO packing degree of vacuum air % vapor tension steam % mixture E TO% N
2％ ( mg/l ) 16 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 19.20 2 (-) /1 ( + ) 17 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 19.35 2 (-) /1 ( + ) 18 30mb 4.29～50mb 7.14 620 3.90 84.67 43.38 19.44 2 (-) /1 ( + ) 19 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 2.07 0 (-) /3 ( + ) 20 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 4.43 1 (-) /2 ( + ) 21 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 4.45 0 (-) /3 ( + ) 22 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.38 3 (-) /0 ( + ) 23 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.39 3 (-) /0 ( + ) 24 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.51 3 (-) /0 ( + ) 25 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 2.00 0 (-) /3 ( + ) 26 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 4.02 0 (-) /3 ( + ) 27 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.03 3 (-) /0 ( + ) 28 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.04 3 (-) /0 ( + ) 29 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.10 3 (-) /0 ( + ) 30 30mb 10.00～50mb 16.67 220 11.00 62.33 52.48 18.11 3 (-) /0 ( + )
Although the present invention has described some special embodiment about it in detail, be to be understood that, understood noted earlier after, those skilled in the art can easily find out with these embodiments difference and cooresponding alternate embodiment.Therefore, scope of the present invention should be come assessment as additional claim and any cooresponding with it requirement.
Claims (20)
1. the method for a connection with wrapping of piece comprises:
Put this object in a kind of case;
Extract in the case portion gas at least out
In case, feed steam and sterilizing gas after vacuumizing this step; With
Seal this case.
2. the method for claim 1 also is included in feeding gas one and goes on foot this step of partially enclosed casing before.
3. the process of claim 1 wherein that sterilizing gas is the compound of epoxyethane and a kind of carrier gas.
4. the process of claim 1 wherein that the percent by volume of epoxyethane in case is at least about 2% when feeding this EOS of gas.
5. the process of claim 1 wherein that steam and sterilizing gas are fed in the case simultaneously.
6. the process of claim 1 wherein that the pressure of steam when feeding arrives about 80psi for about 15psi in case.
7. the method for claim 1, further comprise this leak free casing of heating to about 120 °F～about 140 °F at least about 4 hours.
8. the method for a connection with wrapping of piece comprises:
Put these article in a kind of case;
Partially enclosed this casing;
Provide a kind of gas circuit to be used for communicating with gas in the case;
Extract in case portion gas at least out by this gas circuit;
In case, feed steam and a kind of sterilizing gas by this gas circuit;
Remove this gas circuit from casing; With
Seal this casing.
9. the method for claim 8, wherein these article are a kind of nonwoven fabrics article.
10. the method for claim 8, wherein the case internal pressure is about 30～about 100 millibars of mercury column when vacuumizing this EOS.
11. the method for claim 8, wherein steam and sterilizing gas are fed in the case simultaneously.
12. the method for claim 8, wherein sterilizing gas is the gaseous mixture of epoxyethane and at least a carrier gas.
13. the method for claim 12, the percent by volume that epoxyethane exists in case when wherein feeding this EOS of gas is at least about 2%.
14. the method for a sterilizing objects comprises:
Put these article in a kind of egative film of shaping;
Constitute a kind of casing by on the egative film of this shaping, covering a kind of top flat;
Part seals this casing;
In this case, place a kind of valve;
Extract in case portion gas at least out by this valve;
In case, feed steam and a kind of sterilizing gas by this valve;
Remove this valve and seal this casing; With
Heat this leak free casing to about 120 °F～140 °F at least about 4 hours.
15. the method for claim 14, wherein steam and epoxyethane are fed simultaneously.
16. the method for claim 14, wherein sterilizing gas is the compound of epoxyethane and a kind of carrier gas, and carrier gas therein is to be selected from carbon dioxide and nitrogen.
17. the method for claim 16, wherein the percent by volume of the epoxyethane that exists in the case when this EOS of ventilation is at least about 2%.
18. the method for claim 16, wherein the percent by volume of the epoxyethane that exists in the case when this EOS of ventilation is about 4%～about 10%.
19. the product that the method for claim 1 is produced.
20. the product that the method for claim 14 is produced.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 95196315 CN1164214A (en) | 1994-09-23 | 1995-09-13 | Method of packaging medical article |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/311,669 | 1994-09-23 | ||
| CN 95196315 CN1164214A (en) | 1994-09-23 | 1995-09-13 | Method of packaging medical article |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1164214A true CN1164214A (en) | 1997-11-05 |
Family
ID=5083192
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 95196315 Pending CN1164214A (en) | 1994-09-23 | 1995-09-13 | Method of packaging medical article |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1164214A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103492270A (en) * | 2011-01-27 | 2014-01-01 | Cfs德国股份有限公司 | Packaging machine and method for producing evacuated and/or gassed packagings |
| CN112122242A (en) * | 2020-08-12 | 2020-12-25 | 王倩倩 | Medical instrument disinfection method |
| CN113022975A (en) * | 2021-03-03 | 2021-06-25 | 江西诺捷科技股份有限公司 | Disposable sterile trachea disinfection equipment for packing of medical instrument |
-
1995
- 1995-09-13 CN CN 95196315 patent/CN1164214A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103492270A (en) * | 2011-01-27 | 2014-01-01 | Cfs德国股份有限公司 | Packaging machine and method for producing evacuated and/or gassed packagings |
| CN103492270B (en) * | 2011-01-27 | 2015-07-15 | Cfs德国股份有限公司 | Packaging machine and method for producing evacuated and/or gassed packagings |
| CN112122242A (en) * | 2020-08-12 | 2020-12-25 | 王倩倩 | Medical instrument disinfection method |
| CN113022975A (en) * | 2021-03-03 | 2021-06-25 | 江西诺捷科技股份有限公司 | Disposable sterile trachea disinfection equipment for packing of medical instrument |
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