CN102688512B - Sterilization process challenge test tube - Google Patents
Sterilization process challenge test tube Download PDFInfo
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- CN102688512B CN102688512B CN201110455410.1A CN201110455410A CN102688512B CN 102688512 B CN102688512 B CN 102688512B CN 201110455410 A CN201110455410 A CN 201110455410A CN 102688512 B CN102688512 B CN 102688512B
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Abstract
The invention provides a sterilization process challenge test tube. The sterilization process challenge test tube comprises a tube body, a steam damping structure, an optional porous material and a sterilization indicator, wherein one end of the tube body is provided with an opening and the tube body is composed of a transparent chamber for placing the sterilization indicator, a chamber for placing the optional porous material and a chamber for placing the steam damping structure; and in the sterilization process, steam sequentially passes through the opening and the steam damping structure and finally arrives at the sterilization indicator, wherein the optional porous material can be placed between the steam damping structure and the opening or the steam damping structure and the sterilization indicator.
Description
Technical field
The present invention relates to a kind ofly for verifying the device of sterilizing effect, and more specifically, relate to a kind of challenge test set that can be used for pressuresteam sterilization process.
Background technology
Many medical devices needed to carry out sterilization treatment before using.Due to advantages such as efficient, cheap and safety and environmental protections, steam is widely used in the sterilization process of Hospital medical equipment.Particularly, the medical device that needs sterilizing is positioned in steam sterilizer cavity, by evacuation and steam injection, gets rid of the air in steam sterilizer cavity, then inject high-pressure saturated steam, thereby realize the effective sterilizing of medical device.
Some needs the medical device of sterilizing to have the feature of similar porous material, for example include the dressing type parcel of operating coat, this class needs the medical device of sterilizing to be generally packaged in porous type packaging material, to carry out sterilizing, these porous type packaging material allow steam to enter, and can prevent entering of microorganism, yet the packing of this form can affect the infiltration efficiency of steam, thereby may weaken the sterilization effect of steam.In addition, other need the medical device of sterilizing to have the feature of similar tube chamber type apparatus, endoscope for example, and it has long and narrow inner chamber, and steam must could be realized sterilizing by its long and narrow inner chamber.Except above-mentioned restriction, in bactericidal unit, useful load and the load mode of medical apparatus and instruments subject to sterilization all can affect the effect that penetrates of steam, thereby affect the effectiveness of sterilizing.Therefore, must make the steam of effective dose contact the sufficiently long time with medical device subject to sterilization in bactericidal unit, just can guarantee the sterilization effect of whole bactericidal unit.
Sterilization effect in order to ensure whole bactericidal unit, conventionally sterilization process being challenged to test set is placed in sterilization packaging the position of difficult sterilizing carries out sterilizing together with article subject to sterilization, if this sterilization process challenge test set shows that sterilizing is qualified, all sterilizing is qualified to think medical device in whole bactericidal unit.These sterilization process challenge test sets contain biological indicator and/or chemical indicator.Chemical indicator reflects the effectiveness of sterilizing by change color, and biological indicator is by the effectiveness of the killing effect reflection sterilizing of spore.The example of these sterilization process challenge test sets is shown in United States Patent (USP) 5830683 and 5418167.
United States Patent (USP) 4839291 discloses a kind of process challenge test set, and it comprises outer tube and inner tube, thereby these outer tubes and inner tube fit together to produce winding raod footpath, stops effectively penetrating of the sterilizing factor.But this device volume is large and cost is higher, in addition, only by use slightly different materials in constructing apparatus, can not be easily and regulate exactly its sensitivity to specific sterilization process challenge.
WO 0113964 discloses a kind of process challenge test set, by simulating specific products for the resistance of specified microorganisms deactivation, sterilization or sterilization process, is provided for verifying the device of sterilization process effect.Use the method for this device to comprise: to make the device that contains biological indicator carry out deactivation or sterilization process, cultivate the microorganism of surviving in any biological indicator, evaluate the effectiveness of deactivation or sterilization process.This device mainly comprises the base material of built-in sealing, and this base material consists of barrier film materials.For specific sterilization process, need to select specific biological indicator and base material, to guarantee the effectiveness of sterilization process challenge.
From above-mentioned prior art, current sterilization process challenge test set comprises two types, and a kind of is dressing type process challenge test set, another kind of tube chamber type process challenge test set.Wherein, in dressing type process challenge test set, be provided with porous material, for example absorbent paper card, loads for dressing types such as simulation such as operating coats; Tube chamber type process challenge test set comprises elongated pipe, for simulating the tube chamber type that has a long and narrow inner chamber such as endoscope etc., loads.
Summary of the invention
One object of the present invention is to provide a kind of sterilization process challenge testing tube, and it can be tested for the process challenge of simulative tube chamber type Sterilization load, and this is loaded to whether sterilizing thoroughly judges.
Another object of the present invention is to provide a kind of sterilization process challenge testing tube, and it is tested for simulating the process challenge of tube chamber type Sterilization load and dressing type Sterilization load, and this is loaded to whether sterilizing thoroughly judges.
In one aspect, the invention provides a kind of sterilization process challenge testing tube, described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
Steam damping structure, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator and the cavity of placement steam damping structure, and
In sterilization process, steam is sequentially by opening and steam damping structure, and finally arrives sterilisation indicator.
In yet another aspect, the invention provides a kind of sterilization process challenge testing tube, described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
Steam damping structure,
Porous material, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator, the cavity of placing porous material and place the cavity of steam damping structure, and
In sterilization process, steam sequentially passes through opening, porous material and steam damping structure, and finally arrives sterilisation indicator.
In yet another aspect, the invention provides a kind of sterilization process challenge testing tube, described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
Steam damping structure,
Porous material, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator, the cavity of placing porous material and place the cavity of steam damping structure, and
In sterilization process, steam sequentially passes through opening, steam damping structure and porous material, and finally arrives sterilisation indicator.
Sterilization process challenge testing tube of the present invention can be tested for the process challenge of analog space chamber type Sterilization load, and this is loaded to whether sterilizing thoroughly can be let pass and judge.
Sterilization process challenge testing tube of the present invention can also be tested for simulating the process challenge of cavity type Sterilization load and dressing type Sterilization load, and this is loaded to whether sterilizing thoroughly judges.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of sterilization process challenge testing tube according to an embodiment of the invention;
Fig. 2 is the schematic diagram of sterilization process challenge testing tube according to another embodiment of the invention;
Fig. 3 is the schematic diagram of the sterilization process challenge testing tube of another embodiment according to the present invention;
Fig. 4 is the schematic diagram of steam damping structure (staggered laminar) according to an embodiment of the invention;
Fig. 5 is the cross-sectional schematic that is placed with the body of the steam damping structure in Fig. 4;
Fig. 6 is the schematic diagram of steam damping structure (helical structure form) according to another embodiment of the invention;
Fig. 7 is the cross-sectional schematic that is placed with the body of the steam damping structure in Fig. 6;
Fig. 8 is the schematic diagram of a lamination of employing in steam damping structure (staggered laminar) according to an embodiment of the invention; With
Fig. 9 is the schematic diagram of a flight of employing in steam damping structure (helical structure form) according to an embodiment of the invention.
The specific embodiment
The invention provides a kind of sterilization process challenge testing tube, described sterilization process challenge testing tube comprises: body, described body has opening in its one end, steam damping structure, and sterilisation indicator, wherein said body comprises: place the transparent cavity of sterilisation indicator and the cavity of placement steam damping structure, in sterilization process, steam is sequentially by opening and steam damping structure, and finally arrives sterilisation indicator.Optional porous material can be placed and make: in sterilization process, steam is sequentially by opening, porous material and steam damping structure, and finally arrive sterilisation indicator, or steam is sequentially by opening, steam damping structure and porous material, and finally arrives sterilisation indicator.Specifically describe the included parts of sterilization process challenge testing tube of the present invention below.
Fig. 1 is the schematic diagram of sterilization process challenge testing tube according to an embodiment of the invention.This sterilization process challenge testing tube comprises body (1), steam damping structure (2) and sterilisation indicator (4).
Fig. 2 is the schematic diagram of sterilization process challenge testing tube according to another embodiment of the invention.This sterilization process challenge testing tube comprises body (1), steam damping structure (2), porous material (3) and sterilisation indicator (4).
Fig. 3 is the schematic diagram of the sterilization process challenge testing tube of another embodiment according to the present invention.This sterilization process challenge testing tube comprises body (1), porous material (2), steam damping structure (3) and sterilisation indicator (4).
Body
Body comprises the transparent cavity of placing sterilisation indicator and the cavity of placing steam damping structure, and optionally comprises the cavity of placing porous material.
Described body can be all transparent or partially transparent, and the part cavity of the placement sterilisation indicator that at least described body is included should be transparent, with guarantee can be from body visual observation to sterilisation indicator state.
The transparent cavity of placing sterilisation indicator can be flat cavity, and can have a groove 5, is convenient to this flat cavity to break into two with one's hands and take out the sterilisation indicator including.The body end of placing helical structure has an opening, and steam can enter from this opening.At actual sterilization process, first steam enter in body by the opening of body end, after the steam damping structure in body, arrives the cavity of placing sterilisation indicator, thereby and react the effect that demonstration steam penetrates with sterilisation indicator.
Alternatively, at actual sterilization process, first steam enter in body by the opening of body end, after the steam damping structure in body, penetrate the loose structure in body, finally arrive to place the cavity of sterilisation indicator, thereby and react the effect that demonstration steam penetrates with sterilisation indicator.
Alternatively, in actual sterilization process, first steam enter in body by the opening of body end, penetrate after the loose structure in body, through the steam damping structure in body, finally arrive to place the cavity of sterilisation indicator, thereby and react the effect that demonstration steam penetrates with sterilisation indicator.
The example of the material of this body can comprise can be resistance to the plastic macromolecule material of 135 ℃ of above high temperature, comprise Merlon, polyethylene terephthalate, polypropylene, polyurethane etc.Its length can be 5-30cm, and internal diameter can be 1-10cm, and wall thickness can be 1-10mm.Tubular form can be cylindrical or cuboid or polyhedron shape.
Steam damping structure
In the present invention, steam damping structure, for simulating the process challenge test of tube chamber type Sterilization load, comprises the staggered steam damping structure of laminar and the steam damping structure of helical structure form.
The steam damping structure of staggered laminar
Fig. 4 is the schematic diagram of steam damping structure according to an embodiment of the invention; And Fig. 5 is the cross-sectional schematic that is placed with the body of the steam damping structure in Fig. 4.
The steam damping structure that the lamination by interlocking shown in Fig. 4 forms is mainly comprised of support (6) and lamination (7).The effect of support (6) is that lamination (7) is arranged and is assembled into integral body according to staggered mode, so that can directly fill in the steam damping pipeline that forms zigzag in body (1).As shown in Figure 5,1 is body, 2 damping structures for staggered lamination composition.Steam often runs into when penetrating this pipeline that lamination can be stoped and recoil effect, finally along Z-shaped pipeline, enters next body region.Therefore, the quantity of lamination and the distance between lamination have determined effect that it stops steam to penetrate, and number of laminations is more, the less steam of distance more difficult the penetrating between lamination and lamination.
The material of the steam damping structure of this staggered laminar can for can be resistance to the plastic macromolecule material of 135 ℃ of above high temperature, comprise Merlon, polyethylene terephthalate, polypropylene, polyurethane etc.The diameter of the steam damping structure of described staggered laminar need to be equal to or slightly less than the internal diameter size of body, so that this steam damping structure can just fill in that body inscribe can guarantee again and inboard wall of tube body preferably sealing and stickiness, thereby prevent that steam from passing through from gap around.Its shape can be fan-shaped or square or Polyhedral, and this shape will match with the inwall of body, to guarantee good adaptation.
In one embodiment, the diameter of lamination is 5-40mm, preferably 22mm, thickness is 0.5-5mm, preferred 2mm, the quantity of lamination is 5-20 sheet, preferably 8, distance between lamination is 1-10mm, preferred 4mm, opening is 5-20mm to the distance of body, preferably 11mm, the internal diameter of opening is 0.5-5mm, preferably 2mm.The cross section of lamination is a part for circle, the 50-95% that the area of wherein said cross section is the area of a circle.The overall length of the steam damping structure of described staggered laminar is 30-80mm, preferably 40-70mm.
The steam damping structure of helical structure form
Fig. 6 is the schematic diagram of steam damping structure according to another embodiment of the invention; And Fig. 7 is the cross-sectional schematic that is placed with the body of the steam damping structure in Fig. 6.
The steam damping structure of the helical structure form in Fig. 6 is mainly comprised of pillar (8) and flight (9).All flights (9) are supported in acting as of pillar (8), are convenient to fill in body and assemble, and in body, form the pipeline of spiral, have extended the path that steam penetrates this body, playing the effect that stops steam to reach next body region.Therefore, the distance between flight has determined its effect that stops steam to penetrate, more difficult the penetrating of the less steam of distance between flight.
In the steam damping structure of described helical structure form, the overall length of the steam damping structure of helical structure form is 30-80mm, preferably 35-60mm, more preferably 38-40mm, most preferably 39mm; In the steam damping structure of described helical structure form, the thickness of each flight is 0.5-5mm, preferred 2mm, and described thickness is the vertical dimension from the top edge of single flight to lower limb; The pitch of the steam damping structure of described helical structure form is 1-10mm, preferred 4mm, described pitch is the spacing between adjacent two flights, described spacing in the lower limb of a upper flight in adjacent two flights to distance vertically between the top edge of next flight; The overall length of the steam damping structure of described helical structure form is 30-80mm, preferably 40-70mm.
The material of the steam damping structure of this helical structure form can for can be resistance to the plastic macromolecule material of 135 ℃ of above high temperature, comprise Merlon, polyethylene terephthalate, polypropylene, polyurethane etc.The diameter of the steam damping structure of described helical structure form need to be equal to or slightly less than the internal diameter size of body, so that this steam damping structure can just fill in that body inscribe can guarantee again and inboard wall of tube body preferably sealing and stickiness, prevent that steam from passing through from gap around.Its shape can be fan-shaped or square or Polyhedral, and this shape will match with the inwall of body, to guarantee good adaptation.
Sterilisation indicator
Sterilisation indicator is herein the 5th class chemical indicator according to the standard-required of ISO11140-1, and it is mainly by comprising temperature-sensitive indicating dye piece, aluminium foil, refill, plastic sheeting and label.Under steam sterilization condition, temperature-sensitive indicating dye piece can melt and creep along refill in certain vapor (steam) temperature with under the time, represents sterilizing failure when climbing to " REJECT " region, represents that sterilizing is qualified when climbing to " ACCEPT ".
Sterilisation indicator herein can be also biological indicator, this biological indicator is mainly comprised of the bacterium sheet that contains bacillus stearothermophilus, the plastic bottle that the vial of culture medium is housed and is furnished with porous plug, culture medium contains pH value fluorescent color-developing agent, and spore survival volume can affect the pH value of culture medium and reflect that by fluorescence intensity its bacterium amount shows whether sterilizing is qualified.
Porous material
In the present invention, porous material is for simulating the process challenge test of dressing type Sterilization load, can make by placing porous material: in sterilization process, steam is sequentially by opening, porous material and steam damping structure, and finally arrive sterilisation indicator, or steam sequentially passes through opening, steam damping structure and porous material, and finally arrives sterilisation indicator.
The built-in porous material of sterilization process challenge testing tube is to determine that this product detects sterilizing factor pair dressing type and loads the key factor that penetrates effect sensitivity.This material can comprise the macromolecule foam such as water suction paper card, polyethylene foam, polypropylene foam, polyurethane foam or non-woven fabrics etc., macromolecule foam or the non-woven fabrics such as preferably polyethylene foam, polypropylene foam, polyurethane foam.
The breathability of each absorbent paper card is about 50s/300ml-200s/300ml.
The density of polyethylene foam or polypropylene foam is about 0.5-1g/cc, and voidage is 1-10%, and average pore diameter is 10-50 μ m.
The density of polyurethane foam is about 0.2-0.8g/cc, and voidage is 5-20%, and average pore diameter is 50-200 μ m.
The shape of described porous material as long as and the shape of the cavity part of placing porous material consistent, can be the cylinder of cylinder or other shapes, preferred cylinder, the cavity that the internal diameter of described porous material depends on placing porous material internal diameter partly.The height of described porous material is preferably 20-100 millimeter, and particularly preferably 30-60 millimeter, most preferably is 40-50 millimeter.
Polyethylene foam can form block by sintering by polyethylene particle, and in the process of sintering, particle aggregation is shaped, but can form hole between granule and granule.
Using method
Sterilization process challenge testing tube of the present invention can and be tested for simulating the process challenge of tube chamber type Sterilization load and dressing type Sterilization load for the process challenge test of simulative tube chamber type Sterilization load, and this is loaded to whether sterilizing thoroughly judges.
Embodiment
Provide the following example further to illustrate the present invention, but described embodiment should not be interpreted as limiting the scope of the present invention by any way.
Embodiment 1: tube chamber type process challenge testing tube
Preparation tube chamber type process challenge testing tube as shown in Figure 1, its middle tube body is made by makrolon material, and thickness is 3mm, and the length of placing the cavity of steam damping structure is 52mm, and internal diameter is 18mm.Steam damping structure is staggered laminar, and it is made by makrolon material.Fig. 8 is the schematic diagram of a lamination of employing in embodiment 1, and the diameter of lamination is 18mm, and thickness is 2mm, totally 8 of laminations, and the distance between lamination is 4mm, and opening is 11mm to the distance of body, and the internal diameter of opening is 2mm.The cross section of lamination is a part for circle, and the area of the cross section of wherein said lamination is the area of a circle 75%.Sterilisation indicator is 3M 1243A the 5th class chemical indicator.
Embodiment 2: tube chamber type process challenge testing tube
As the cavity type process challenge testing tube of embodiment 1 Preparation Example 2, difference is, totally 16 of laminations, and the distance between lamination is 2mm, the length of placing the cavity of steam damping structure is 70mm.
Embodiment 3: tube chamber type process challenge testing tube
As the cavity type process challenge testing tube of embodiment 1 Preparation Example 3, difference is, the area of the cross section of described lamination is the area of a circle 90%.
Embodiment 4: tube chamber type process challenge testing tube
Preparation tube chamber type process challenge testing tube as shown in Figure 1, its middle tube body is made by makrolon material, and thickness is 3mm, and the length of placing the cavity of steam damping structure is 52mm, and internal diameter is 18mm.Steam damping structure is helical structure form, and it is made by makrolon material.Fig. 9 is the schematic diagram of a spiral of employing in embodiment 3, and the overall length of this helical structure is 39mm, and the thickness of each flight is 2mm, and the pitch of described helical structure is 4mm.Sterilisation indicator is 3M 1243A the 5th class chemical indicator.
Embodiment 5: tube chamber type process challenge testing tube
As the tube chamber type process challenge testing tube of embodiment 4 Preparation Examples 5, difference is, the pitch of described helical structure is 2mm, and the overall length of described helical structure is 60mm.
Embodiment 6: comprehensive process challenge testing tube
Preparation comprehensive process challenge testing tube as shown in Figure 2, except being provided with between steam damping structure and sterilisation indicator polyethylene foam, all the other challenge of the cavity type process with embodiment 1 testing tubes.The diameter of the polyethylene foam adopting be 25.5mm, length be 40mm, density be 0.75g/cc, porosity be 2% and bore dia be 20 μ m.
Embodiment 7: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 6 Preparation Examples 7, difference is, between steam damping structure and sterilisation indicator, be provided with polyurethane foam, the diameter of the polyurethane foam adopting be 25.5mm, length be 40mm, density be 0.3g/cc, porosity be 10% and bore dia be 50 μ m.
Embodiment 8: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 6 Preparation Examples 8, difference is, by the staggered steam damping structure of laminar and the location swap of polyethylene foam.
Embodiment 9: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 7 Preparation Examples 9, difference is, by the steam damping structure of staggered laminar and the location swap of polyurethane foam.
Embodiment 10: comprehensive process challenge testing tube
Preparation comprehensive process challenge testing tube as shown in Figure 7, except being provided with between steam damping structure and sterilisation indicator polyethylene foam, all the other challenge of the tube chamber type process with embodiment 4 testing tubes.The diameter of the polyethylene foam adopting be 25.5mm, length be 40mm, density be 0.75g/cc, porosity be 2% and bore dia be 20 μ m.
Embodiment 11: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 10 Preparation Examples 11, difference is, between steam damping structure and sterilisation indicator, be provided with polyurethane foam, the diameter of the polyurethane foam adopting be 25.5mm, length be 40mm, density be 0.3g/cc, porosity be 10% and bore dia be 50 μ m.
Embodiment 12: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 10 Preparation Examples 12, difference is, by the location swap of the steam damping structure of helical structure form and polyethylene foam.
Embodiment 13: comprehensive process challenge testing tube
As the comprehensive process challenge testing tube of embodiment 11 Preparation Examples 13, difference is, by the steam damping structure of helical structure form and the location swap of polyurethane foam.
According to the low atmospheric pressure pulsation cycling condition of recording in ISO11140-4, carry out successfully performance test across atmospheric pressure pulsation cycling condition and high atmospheric pressure pulsation cycling condition.
Embodiment 14-26:
ISO11140-4 has recorded the successful successful test condition of checking sterilizing (comprise low atmospheric pressure pulsation cycling condition, across atmospheric pressure pulsation cycling condition and high atmospheric pressure pulsation cycling condition).
Embodiment 14-25 records the process challenge testing tube providing in embodiment 1-13 respectively successful test condition according to ISO11140-4 is tested, and acquired results is listed in table 1.
As shown in Table 1, test result under the successful test condition that the sterilization process challenge testing tube providing in embodiment 1-13 is recorded at ISO11140-4 all shows " success ", that is to say that test result conforms to actual sterilizing result, meets the requirement of ISO11140-4.
Yet, common tube chamber type process challenge test products of the prior art, because only relying on longer tube chamber length, it challenges sterilization process, more difficult this body that penetrates of the sterilizing factor under across atmospheric pressure and high atmospheric pressure pulsation condition, therefore this kind of tube chamber type process challenge test products still shows failed result conventionally under successfully across atmospheric pressure and high atmospheric pressure pulsation test condition, and in fact, the sterilizing of tube chamber type apparatus of difficult sterilizing success under this condition, so the test result of these common tube chamber type process challenge test products may be false positive.
The successful test loop of table 1
| Low atmospheric pressure pulsation circulation | Across atmospheric pressure pulsation circulation | High atmospheric pressure pulsation circulation | |
| Embodiment 14 | A | A | A |
| Embodiment 15 | A | A | A |
| Embodiment 16 | A | A | A |
| Embodiment 17 | A | A | A |
| Embodiment 18 | A | A | A |
| Embodiment 19 | A | A | A |
| Embodiment 20 | A | A | A |
| Embodiment 21 | A | A | A |
| Embodiment 22 | A | A | A |
| Embodiment 23 | A | A | A |
| Embodiment 24 | A | A | A |
| Embodiment 25 | A | A | A |
| Embodiment 26 | A | A | A |
Note: test result A: test result shows " success ", meets ISO11140-4 requirement.
Embodiment 27-39:
ISO11140-4 has recorded the failure testing condition (comprise low atmospheric pressure pulsation cycling condition, across atmospheric pressure pulsation cycling condition and high atmospheric pressure pulsation cycling condition) of checking sterilizing failure.
Embodiment 27-39 records the process challenge testing tube providing in embodiment 1-13 respectively failure testing condition according to ISO11140-4 is tested, and acquired results is listed in table 2.
As shown in Table 2, test result under the failure testing condition that the sterilization process challenge testing tube providing in embodiment 1-13 is recorded at ISO11140-4 all shows " failure ", that is to say that test result conforms to actual sterilizing result, meets the requirement of ISO11140-4.
Yet common tube chamber type process challenge test products of the prior art, challenges sterilization process because it only relies on by longer tube chamber length, the more difficult cold air of revealing or injecting that captures, can not detect the air bolus of revealing or injecting in steriliser.Therefore, common tube chamber type process challenge test products may show test passes under the failure testing conditions such as " low atmospheric pressure pulsation circulation and escape of air ", " low atmospheric pressure pulsation circulation and air Injection ", so the test result of these common tube chamber type process challenge test products may be false negative.
The circulation of table 2 failure testing
Note:
Test condition 1: low atmospheric pressure pulsation circulation, the pulsation degree of depth is not enough;
Test condition 2: low atmospheric pressure pulsation circulation, simulated air leaks;
Test condition 3: low atmospheric pressure pulsation circulation, simulated air injects;
Test condition 4: across atmospheric pressure pulsation circulation, the pulsation degree of depth is not enough;
Test condition 5: across atmospheric pressure pulsation circulation, simulated air leaks;
Test condition 6: across atmospheric pressure pulsation circulation, simulated air injects;
Test condition 7: high atmospheric pressure pulsation circulation, the pulsation degree of depth is not enough;
Test condition 8: high atmospheric pressure pulsation circulation, simulated air leaks;
Test condition 9: high atmospheric pressure pulsation circulation, simulated air injects;
Test result B: test result shows " failure ", meets ISO11140-4 requirement;
Test result C: because ISO11140-4 failed call, so the experimental data of not providing.
Although above, with reference to drawings and Examples, describe the present invention in detail, it should be pointed out that and the invention is not restricted to described drawings and Examples, within not deviating from the scope of spirit of the present invention, can the present invention be changed or be changed.
Claims (16)
1. sterilization process is challenged a testing tube, and described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
The steam damping structure of staggered laminar, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator and the cavity of placement steam damping structure, and
In sterilization process, steam is sequentially by opening and steam damping structure, and finally arrives sterilisation indicator.
2. sterilization process is challenged a testing tube, and described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
The steam damping structure of staggered laminar,
Porous material, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator, the cavity of placing porous material and place the cavity of steam damping structure, and
In sterilization process, steam sequentially passes through opening, porous material and steam damping structure, and finally arrives sterilisation indicator.
3. sterilization process is challenged a testing tube, and described sterilization process challenge testing tube comprises:
Body, described body has opening in its one end,
The steam damping structure of staggered laminar,
Porous material, and
Sterilisation indicator,
Wherein said body comprises: place the transparent cavity of sterilisation indicator, the cavity of placing porous material and place the cavity of steam damping structure, and
In sterilization process, steam sequentially passes through opening, steam damping structure and porous material, and finally arrives sterilisation indicator.
4. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, wherein in the steam damping structure of described staggered laminar, the diameter of lamination is 5-40mm, thickness is 0.5-5mm, the quantity of lamination is 5-20 sheet, and the distance between lamination is 1-10mm, the overall length of the steam damping structure of described staggered laminar is 30-80mm.
5. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, wherein the cross section of lamination is a part for circle, the 50-95% that the area of wherein said cross section is the area of a circle.
6. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, the length of wherein said body is 5-30cm, and internal diameter is 1-10cm, and wall thickness is 1-10mm.
7. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, wherein said body be made by plastic macromolecule material that can resistance to 135 ℃ of above high temperature.
8. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, the material of wherein said body is selected from following one or more: Merlon, polyethylene terephthalate, polypropylene, polyurethane.
9. according to the challenge of the sterilization process described in any one testing tube in claims 1 to 3, wherein said sterilisation indicator is the 5th class chemical indicator according to the standard-required of ISO11140-1, comprises temperature-sensitive indicating dye piece, aluminium foil, refill, plastic sheeting and label.
10. according to the challenge of the sterilization process described in any one testing tube in claim 2 or 3, wherein said porous material is selected from following one or more: water suction paper card, polyethylene foam, polypropylene foam, polyurethane foam, non-woven fabrics.
11. sterilization process challenge testing tubes according to claim 10, the density of wherein said polyethylene or polypropylene foam is 0.5-1g/cc, and voidage is 1-10%, and average pore diameter is 10-50 μ m.
12. sterilization process challenge testing tubes according to claim 10, the density of wherein said polyurethane foam is 0.2-0.8g/cc, and voidage is 5-20%, and average pore diameter is 50-200 μ m.
13. sterilization process challenge testing tubes according to claim 10, wherein said porous material comprises that 10-30 opens absorbent paper card, wherein the breathability of each absorbent paper card is 50s/300ml-200s/300ml.
14. sterilization process challenge testing tubes according to claim 10, the height of wherein said porous material is 20-100 millimeter.
15. sterilization process challenge testing tubes according to claim 10, the height of wherein said porous material is 30-60 millimeter.
16. sterilization process challenge testing tubes according to claim 10, the height of wherein said porous material is 40-50 millimeter.
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| CN201110455410.1A CN102688512B (en) | 2011-12-30 | 2011-12-30 | Sterilization process challenge test tube |
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| CN106267277B (en) * | 2016-09-28 | 2022-09-09 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator detection device for monitoring the sterilization effect of lumen instruments |
| WO2020038566A2 (en) * | 2018-08-21 | 2020-02-27 | Gke Gmbh | Multi-stage process challenge device, indicator system and process challenge device 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 |
| CN111437419A (en) * | 2020-05-18 | 2020-07-24 | 衡水诺盾生物科技有限公司 | Sterilization verification device for pressure steam sterilization extremely-fast comprehensive challenge and reuse dressing |
| CN111481719A (en) * | 2020-05-18 | 2020-08-04 | 衡水诺盾生物科技有限公司 | Pressure steam sterilization extremely-fast comprehensive challenge lumen sterilization verification device |
| CN115381992A (en) * | 2022-08-29 | 2022-11-25 | 山东新华医疗器械股份有限公司 | A two-in-one verification device and verification method for a pressure steam sterilization process |
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| CN102076363A (en) * | 2008-05-05 | 2011-05-25 | 3M创新有限公司 | Sterilization process challenge device and method |
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| CN102076363A (en) * | 2008-05-05 | 2011-05-25 | 3M创新有限公司 | Sterilization process challenge device and method |
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