JP3247712B2 - Small pre-vacuum steam sterilization test pack - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to the sterilization of pharmaceutical and surgical products, and to test packs which can be processed through a convenient sterilization cycle of a pre-vacuum steam sterilizer to suppress the specific operation of the sterilizer. It is about.

[0002]

BACKGROUND OF THE INVENTION In the sterilization of medical supplies and instruments by steam, such medical supplies and instruments are usually assembled into bundles and packs and placed in a steam sterilization chamber that is operated with an appropriate sterilization cycle. An individual package can include deposited towels, medical supplies, sponges, similar materials, and the like, and can include the required quantity of surgical instruments and tools for a particular surgical procedure.

[0003] Today's steam sterilization methods involve placing such a pack in a sterilizer, evacuating air from the sterilizer, and maintaining the required temperature for a selected period of time, typically 270-276 ° F.
(132-135 ° C.) with the introduction of saturated steam at the required pressure to produce a temperature. A pre-vacuum sterilizer operated in this manner frequently replaces the previously used down-drain or gravity air-exhaust sterilizers. An important advantage of the pre-vacuum method is that the elimination of air prior to the introduction of steam allows for rapid permeation of the steam through the surgical pack. Air elimination is necessary for all steam sterilizers because the air trapped in the package prevents sterilization of the interior portion of the packed air pocket. The pre-vacuum method greatly reduces the time required for vapor permeation in a typical sterilization cycle, and the pre-vacuum sterilizer has a relatively short cycle (exposure time of 4 minutes at 134 ° C.).
In operation today. The operation of such a sterilizer is described in "Prevacuum High Temperature Sterilization", Chapter VI, published by Charles C. Thomas of Springfield, Illinois.
It is clearly described in John J. Perkins's sterilization principles and methods of health sciences.

However, the ability to sterilize for a short time is
It is based on the assumption that air is properly exhausted from the sterilizer. This includes the expectation that there will be no leakage of air from the sterilizer or vacuum line that allows the introduction of air after the vacuum has been applied, by appropriately operating the vacuum device to first discharge the sterilization chamber. During routine use, the sterilizer must be tested on a periodic (daily) basis to ensure that wear of certain sterilizer components is ultimately based on air leaks and that the vacuum system is working properly. There is.

[0005] In 1961, a test method was proposed by Jay Dick et al. And suggested a protocol to determine that the sterilizer had the proper sequence of operation and that the vacuum device was properly operated. The test method is described by Jay H. Bowie of the Department of Microbiology at Royal Inharmary, Edinburgh, Scotland, et al. As described in that article, residual air in the sterilizer when steam is introduced is swept into the pack, usually at the center of the pack, by steam pressure.
Air trapped in the pack prevents proper vapor transmission.

In accordance with the Bowie and Dick protocol, an autoclave (autoclave) tape is used in combination with a wrap of surgical towels to test the operating value of the sterilizer as a routine. An autoclave tape is an adhesive tape having a surface printed with a line of a chemical mixture having a property of changing color from white to black when exposed to steam at an appropriate temperature for an appropriate time. According to Bowie and Dick's protocol, such tapes are placed on a cross-shaped fabric sheet, and then the fabric sheet is placed in a folded surgical towel wrap.
The whole assembly is placed in a sterilizer. After the cruciform tape has been tested to determine that the vapor has completely penetrated the towel wrap, the sterilizer is operated on a normal cycle at 133-134 ° C with an exposure time of 3 minutes and 30 seconds. A constant color change indicates the passage of vapor, and an incompletely changed indicator color will fail.

This protocol is widely used today and includes Arlington, V. 22209, Suit 60
2, 1901 North American Medical Equipment Promotion Association of North Hollint Myer Drive (AAMI). As described in Section 6.7 of this publication, entitled "Pre-Steam Sterilizer Residual Air Test", this test uses a 100% cotton mint bag, which is cleanly washed. However, excessive drying was not ironed to affect the test results, but was folded into a 9 x 12 inch (228.6 x 304.8 mm) shape and 10 to 11 inches (254 to 279.4 m).
m). The details of the Bowie and Dick method are described in the above-mentioned recommendation service. Sterilizer performance standards in other parts of the world require different pack configurations to test the required sterilizer efficiency. For example, a test pack that makes a trial accepted in the United States would be unsuitable in Europe, while a test pack that was deemed appropriate in Europe would be an overkill trial for a US sterilizer.

[0008] Testing a pre-vacuum sterilizer according to the Bowie and Dick protocol has a number of important disadvantages. First, the tests are routinely performed by the hospital's sterilization department and are subject to various conditions of the Bowie and Dick protocol, including the type and condition of towels and other fabrics used, and age and similar. (Which have a significant effect on test results) varies widely from day to day and from facility to facility. Second, the implementation of the Bowie and Dick protocol is relatively inconvenient, expensive to wash the towels because they cannot be washed again and reused later, and the assembly of test facilities and the like reduces hospital costs. High. In addition, some hospitals use single-use disposable fabrics for treatments to completely eliminate washing and complicate the proper introduction of the Bowie and Dick protocol.

Proposals have been made to allow the use of test sheets without the use of a convenient stack of cotton towels according to the Bowie and Dick protocol. As shown in the Bowie and Dick protocol description, sterilizers often exhibit various forms of shortcomings. The main drawbacks of this are: (1) the initial evacuation is inadequate and air remains in the pack; (2) the air leaks from the sterilization chamber or vacuum device and the Is to come in again. A number of different harmonizing actions have been found to design test packs that eliminate such disadvantages as well as others.

For example, test packs with low porosity or large bulk are highly expensive in order to magnify the drawbacks of vacuum devices that prevent a sufficient vacuum from being formed in the first place. It is more appropriate to show the disadvantages of this type than those having porosity or low bulk. When a vacuum is drawn, the air in the test pack will be drawn out of the pack. The low porosity and very bulky material surrounding the test sheet increases the difficulty of removing such air and increases the likelihood that the test pack will exhibit defects.

[0011] On the other hand, disadvantages caused by leakage include the introduction of air into the sterilizer after the vacuum has been evacuated. In this situation, the relationship between the porosity of the material surrounding the test sheet and the sensitivity of the test is reversed. If the material of the test sheet is low in porosity and bulk, then the air introduced into the sterilizer after the vacuum has been evacuated, as in the case of a leak, is also less likely to re-enter the test pack. Thus, for disadvantages based on air leakage after a sufficient vacuum has been drawn, the low porosity material surrounding the test sheet makes it more difficult for air to leak into the pack and such test packs Also exhibit a drawback.

In order to properly test the sterilizer, the test pack must be properly tailored to the vacuum equipment used as a guideline to the attempt provided by the now accepted towel pack standards of the Bowie and Dick protocol. Attempts are not excessive. It may be necessary to design a relatively small and inexpensive disposable test pack that achieves a sterilizer attempt that is comparable to that provided by the accepted Bowie and Dick protocol.

Examples of various attempts to provide Bowie and Dick type test packs without the use of towels are disclosed in US Pat. Nos. 4,486,387, 4,576,795, 4,579,715 and 4,579,715. No. 4,596,696, No. 4,6
This is a multi-layer test pack described in Japanese Patent Application No. 92,307. For example, according to U.S. Pat. No. 4,486,387, a multi-layer disposable test pack is selected which is surrounded by a set of disposable non-perforated sheet materials placed on top of and below a test sheet. Consisting of a sterile test sheet having a limited area capable of changing color in response to vapor pressure under exposure conditions. The innermost sheet of material forms the inner core portion surrounding the test sheet, and the porosity and bulk of the inner core portion and the porosity of the outer shell portion make the required attempt at the sterilizer necessary. Choose to decide.

The test pack of US Pat. No. 4,486,387 is designed to be used in accordance with accepted Bowie and Dick protocols, and is placed in a similar empty sterilization chamber for continuous processing with a predetermined cycle. It is taken out. The test pack is then opened and the internal test sheet is reviewed for evidence of improper vapor transmission and air bubbles and similar defects. The presence of such drawbacks indicates a drawback of vacuum or other equipment in the sterilizer that requires evacuation and replacement. The tests are intended to be performed on a daily basis with internal test sheets forming a permanent record of such tests. The non-woven sheet material and the rest of the pack are disposable after a single use.

[0015] Such a test pack provides for common sterilizer defect detection in a manner comparable to the Bowie and Dick protocol. Nevertheless, these multi-layer test packs seem to be fully satisfactory. Such a complex arrangement is necessary to arrange a large number of sheets in an appropriate order, and therefore, is wrapped or packaged in an external container having a defined degree of tension. The complexity of the construction and care required to combine the sheets adds to the manufacturing costs. A typical multi-layer test pack is about 5x5 in the United States
X 7/8 inch (127 x 127 x 22.2 mm) and in Europe about 5 x 4 x 1 inch (127 x 101.6 mm)
Test packs are actually smaller than the towel packs required by Bowie and Dick's protocol and are relatively bulky when accumulated in large quantities in daily tests. Thus, a need remains for test packs consisting of a small number of sheets, thereby reducing the complexity of construction and care required for assembling the test pack, and thus the overall manufacturing costs. In addition, a need remains for test packs that are somewhat smaller than those available today, so that test packs do not become bulky when the test packs accumulate in large quantities for daily testing.

Some conventional multi-layer test packs use non-porous sheets that reduce the vapor or air permeability so that the overall size of the test pack can be reduced without compromising the efforts presented for sterilizers. The non-porous layer used and added significantly reduces the permeability of the test pack, and generally only one such sheet is used on each side of the test sheet (ie, one non-porous sheet). Are interposed between the test sheet and each end face of the bundle). Only one such non-perforated sheet should be used between the test sheet and the end face of the bundle, and if more than one test sheet is used, each non-perforated sheet will be a multiple perforated sheet. It is a common idea that the effect of the non-perforated sheet is so strong that it is separated by a gap.

Accordingly, it is an object of the present invention to mimic the normal pack air exhaust and vapor permeation conditions described in the Bowie and Dick protocol to determine the appropriate approach for testing residual air in a pre-vacuum sterilizer. It is an object of the present invention to provide a relatively small, inexpensive and disposable test pack for use in a pre-vacuum steam sterilizer so as to determine that the sterilizer operates according to appropriate criteria.

Another object of the present invention is to provide a repeatable and consistent standard for testing the sequence of sterilizer operation from sterilizer to sterilizer on a daily basis, as well as assembly and use of hospital linens and washing by hospital personnel. It is an object of the present invention to provide a test pack for a pre-vacuum sterilizer that does not require a test.

Another object of the present invention is to provide a test pack that uses fewer layers than other comparable multilayer test packs.

Yet another object of the invention is to provide at least one
It is an object of the present invention to provide a test pack that is smaller than conventional multi-layer test packs that perform similar attempts in two dimensions, preferably two or three dimensions.

[0021]

SUMMARY OF THE INVENTION It is seen that the above related objects of the present invention are obtained in a small pre-vacuum steam sterilization test pack for testing the efficiency of the vacuum system of a steam sterilizer to produce a vacuum. . The test pack consists of a bundle of layers and a perforated sheet that are folded over around the bundle to maintain integrity. The bundle has a pair of end faces including a top face and a bottom face, a plurality of layers between the end faces, and an edge between the top face and the bottom face. In particular, the bundle has one perforated test sheet with a vapor sensitive indicator ink printed on its surface, placed between the layers of the bundle to indicate the efficiency of the vacuum device of the sterilizer. The bundle also has a plurality of selected perforated layers above and below the test sheet in the bundle. In addition, the bundle
At least one pair of non-porous, gas impermeable layers are disposed between the test sheet and the end face and are separated from the test sheet and the end face by at least one perforated sheet. The set of non-porous layers has at least one non-porous layer and 2
Separated by one or more perforated layers, the number, location and spacing of the non-perforated layers is based on a pre-designed degree of efficiency.

In the preferred embodiment, the pair of non-porous layers
Closer to the test sheet than to one end face,
And it is separated from one end face by more perforated layers than it is from the test sheet. The non-porous layers of a pair of non-porous layers are actually separated by one other than one of the perforated layers, the non-porous layers of the set of non-porous layers being on opposite sides of one perforated layer. Are optimally arranged, for example, stacked. The bundle has a plurality of sets of non-porous layers, at least one of the sets of non-porous layers being disposed on opposite sides of the test sheet. The bundle has three sets of non-porous layers disposed on both sides of the test sheet, each of the three sets of non-porous layers comprising at least one of the two non-porous layers and three sets of these layers. Separated from adjacent non-porous layers.

The non-porous layers are gas impermeable plastics, each non-porous layer being thinner than one of the perforated layers. A pair of non-porous layers limit the release of gas from the bundle through the bundle as the steam enters the bundle during operation of the sterilizer, and the test sheet against steam as an indication of the efficiency of the sterilizer vacuum system. Achieve the exposure of the indicator ink.

Other objects, features and advantages of the present invention are:
The following detailed description of the preferred embodiment of the invention, as recommended and illustrated, will become more apparent when taken with reference to the accompanying drawings.

[0025]

DETAILED DESCRIPTION OF THE INVENTION A test pack in accordance with the present invention is commonly comparable to Bowie and Dick's protocols by constructing a plurality of disposable sheets of material above and below the appropriate test sheet. Provide for the detection of sterilization defects. Therefore, such test packs can be used for "Once-October" without the use of a regular cotton towel stack according to Bowie and Dick's protocol.
It allows the use of test sheets such as "Once-A-Day" sheets (commercially available from Proper Manufacturing).

Referring now to the drawings, and in particular to FIGS. 1, 2, and 4, a pre-vacuum steam sterilization test pack in accordance with the present invention, designated by the numeral 10, is illustrated. The possibly disposable test pack 10 is designed to test the efficiency of the vacuum device of a steam sterilizer to produce a vacuum.
In this basic feature, the test pack 10
And a perforated wrap 14 such as an elastic sheet or box around the bundle 12 to maintain integrity.

In particular, the bundle 12 has a pair of end faces including a top face 20 and a bottom face 22, a plurality of nonwoven layers 24 between the top face 20 and the bottom face 22, and opposing faces between the top face 20 and the bottom face 22. Margin 26
And

The bundle 12 has a sterile test sheet 30 of the type well known in the art. The test sheet 30 generally comprises a relatively perforated rectangular sheet of paper having vapor sensing ink printed on top on a test pattern formed to cover most of the sheet surface. A suitable test sheet for this is the "Once a Day" test sheet manufactured by Proper Manufacturing, Inc., 36-04, Skillman Avenue, Long Island, NY.

The ink portion of the test sheet 30 can be changed from white to black by being exposed to steam at a required temperature for a required period. The change in color from white to black occurs under sufficient time, and insufficient vapor exposure results in only a partial development, or change, of the ink from white to black. This partial change is due to the white, brown or similar light spots visible on the test sheet, indicating an insufficient value of vacuum equipment efficiency. Test sheets of this type are generally known to those skilled in the art and are used in place of the cruciform sterile tape strips described in earlier Bowie and Dick test methods.

The bundle 12 has a plurality of porous layers above and below the test sheet 30, that is, a porous sheet 32. The perforated sheet 32 preferably has the same shape as the generally rectangular test sheet 30. A wide variety of perforated sheets 32 can be used, or all perforated sheets except the test sheet 30 can be identical. Preferably, different perforated sheets, for example a mixture of thick perforated sheets and thin perforated sheets, are
Used above and below. For example, each thick perforated sheet is 3,
214 pounds per 2,000 square feet (278.7 m ²
A suitable basis weight of 17.16 kg per sheet, a suitable thickness of about 0.02 inches per sheet,
Each light perforated sheet has a Gurley permeability of approximately 12 to 35 seconds per square inch per 20 oz. Cylinder (approximately 12 to 35 seconds at 6.45 cm ² per 568 g cylinder sheet). 3,000 square feet per 178 lbs (278.7m ² per 80.8
1 kg), a suitable thickness of about 0.02 inches per sheet, and about 1.2 to 2.0 cubic feet per square foot per minute per sheet (0.3).
66 to 0.610 m ³ / m ² / min). At the same time, the other perforated paper which is obvious is perforated layer,
That is, it can be used for the perforated sheet 32.

Fraser air permeability, Maryland, 0
Air permeability measurement of the sheet material as measured by a Fraser Differential Air Permeability Meter manufactured by Fraser Precision Instruments, Oakmont Avenue 210, 2760 Geysersburg. This measurement of air permeability is based on the main pressure difference as measured by a pressure gauge. The measured air permeability is 0.5
It is given in inches (12.7 cm) of water pressure and at the rate of air per square foot per minute (cubic feet).

Another common measure of air permeability of a sheet material is:
A Gurley method that measures the time required for 100 milliliters of air to pass through a unit square inch area of a test material at a given pressure. Obviously, the Fraser air permeability given here in cubic feet per square foot per minute can be represented by other standard measurements. The air permeability of the deposited perforated material used here is substantially linear, so if the individual sheet material is 90 cubic feet / square foot / minute (27.45 m ³ / m ² /
), A stack of 10 sheets of such a material would be 1/10 of the air permeability of an individual sheet.
Having an air permeability of 9 cubic feet / square foot / minute (2.75 m ³ / m ² / minute).

According to the present invention, the bundle 12 includes at least one pair of non-porous gas-impermeable layers 40 provided between the test sheet 30 and at least one or each of the top surface 20 and the bottom surface 22 which are end surfaces of the bundle. Is further provided. Each non-porous layer 40 is at least partially made of a gas impermeable film-forming polymeric material, such as polypropylene, nylon, polyester, polycarbonate or similar material, which can withstand the heat and humidity characteristics of the steam sterilizer, and Is preferred. The non-porous layer 40 can be self-contained, that is, a sheet that is self-supported by the layer itself, but only the film laminated to the surface of the perforated sheet by means known to those of skill in the art as shown. It is suitable. For example, a plastic film can be thermally bonded to a perforated sheet as described above to form a sheet having a perforated sheet 32 and a non-perforated layer 40, or an adhesive such as acrylic, silicone, rubber, or the like. It can be laminated on a perforated sheet using a similar adhesive. The non-porous layer 40 is typically laminated to a low air permeability 214 base paper to facilitate handling during the assembly process, but can also be laminated to a high air permeability 178 base paper. The non-porous layer 40 itself is preferably 1-3 mils (0.0254-0.0762 mm) thick when it is difficult to handle thin sheets, with thicker sheets making it more difficult to test packs. The preferred thickness is 2.3 mils (0.0584).
mm). This material does not exhibit any air permeability when measuring Fraser or Gurley air permeability.

It is a limitation to the present invention that the set of perforated sheets 40 is separated from both the test sheets 30 and the end faces 20, 22 of the bundle 12 by at least one perforated sheet 32. The placement of the set of perforated sheets 40 immediately adjacent to the test sheet 30 requires an attempt for a test pack, and the placement of the set of perforated sheets 40 directly opposite the end faces 20, 22 of the bundle 12 is not critical. The set of non-perforated sheets 40 cannot be located away from the test sheet 30 to provide the desired effect on test pack trials. Preferably, the test sheet 30 and the end face 20 of the bundle 12
The set of non-porous sheets 40 disposed between one of the sheets 22 is disposed closer to the test sheet 30 than to the end faces 20,22 and from the end face by a greater number of non-perforated sheets 32 than from the test sheets 30. Separated. Since the non-perforated sheet 40 is close to the test sheet 30 and some of the large number of perforated sheets 32 separate the non-perforated sheet 40 from the test sheet 30, the effect of the set of non-perforated sheets 40 is great and the test pack Attempts by 10 will be more severe.

The non-perforated sheet 4 is formed by at least one of the two perforated sheets 32 and two of the perforated sheets 32 which are neglected for the purpose of eliminating the interval between the sheets.
It is a limitation to the present invention that zero sets of non-perforated sheets 40 are separated. The set of perforated sheets 40 may need to be in direct contact, ie, not separated by at least one perforated sheet 32, or the set of perforated sheets 40 may be a large number of two perforated sheets 32 or more. , The non-perforated sheet 40 cannot provide the required effect. Preferably, the perforated sheets of the set of perforated sheets 40 are separated by substantially one perforated sheet 32. The effect is even more important if the non-perforated sheets 40 are not separated, and the more stringent the attempt made by the test pack 10, all other factors are equal. It is particularly preferable that a set of non-perforated sheets 40 is disposed on both sides of one perforated sheet 32, for example, there is a laminate in which one perforated sheet 32 is sandwiched between a pair of perforated sheets 40. It is.

Preferably, the bundle 12 has a set of a plurality of non-perforated sheets 40 as described above. Bundle 12 is test sheet 3
At least 1 when generally symmetric about the 0 plane
Suitably, a set of non-perforated sheets 40 is arranged on both sides of the test sheet 30. For some harsh attempts, at least a plurality of sets of non-perforated sheets 40 are placed on both sides of the test sheet 30 intermediate the test sheet 30 and one of the end faces 20,22 of the bundle 12. As you can see, Bundle 1
In particular, if the number of the non-perforated sheets 40 provided between the test sheet 30 and each of the end surfaces 20 and 22 is large, the test using the test pack 10 becomes more severe.

Accordingly, a pre-designed design in which the number, position and spacing of the non-perforated sheets 40 are designed to influence the indicated attempt and to use the test pack as a line separating the pass and fail of the attempt. It must be understood that it is based on the degree of effect.

The wrap 14 is a conventional autoclave indicator tape 5 to maintain the components of the bundle 12 in the required relationship.
A normal central supply room wrap sheet that can be held in place by the two is suitable. The bundle 12 is assembled separately from the wrapping sheet to form the test pack 10, or
Or assembled on top of a long wrapper sheet, then the wrapper sheet is wrapped around bundle 12 in a conventional manner and secured by autoclaving indicator tape 52.
Alternatively, the wrapper 14 can be a box made of solid bleached sulfuric acid cardboard of appropriate density, and the assembled bundle 12 can be placed at the top end of the box to close the box.

Referring now to FIG. 3, the test pack 10
One of the end faces of the test pack 10, parallel to the end faces 20, 22 of the bundle 12, on a protrusion (not shown) above the drain 60 of the empty sterilizer 50 adjacent to the door 62 of the sterilizer 50. Are used in the usual arrangement. The test pack 10 consisting of the bundle 12 and the wrap 14 is
The test pack itself can be placed in a double packaging or packaged in an outer package. It will be appreciated that the test pack 10 of the present invention can be used to test types of pre-vacuum steam sterilizers, including high vacuum pulsed pre-vacuum steam sterilizers.

Although each perforated sheet 40 is thinner than the perforated sheet 32, during operation of the sterilizer the steam enters the bundle and indicates the effect of the vacuum device of the sterilizer on the test sheet 30 against the vapor. When forming the indicator ink exposure, the set of non-perforated sheets 40 limits gas leakage from the bundle passing through the bundle. The set of non-perforated sheets 40 is generally sufficient for perforated sheets of about 20 mils (about 0.5080 mm) to be about 2 mils (about 0.0508 mm) thinner perforated sheets. It is effective.

An attempt to pass non-condensable gas and vapor is equal to the passage of non-condensable gas and vapor provided by a set of perforated sheets 30 (with or without holes) in a series of perforated sheets 30. To reduce the overall number of non-woven layers 24 of the bundle 12 according to the present invention so that the height of the test pack 1 is lower than a normal multi-layer test pack.
0 can be configured. Thus, the height of the test pack 10 according to the present invention may be about 9/16 or 3 / from a conventional multi-layer test pack of about 7/8 or 1 inch (about 22.2 or 25.4 mm) in the United States or Europe. Each can be as low as 4 inches (approximately 14.3 or 19.8 mm), and even more so. Bundle 1
2 can reduce the size of the plane of the nonwoven layer 24, that is, the width and length. Therefore, the test pack 10 according to the present invention may be 5 × 5 inches (127 × 127 mm) or 5.5 × 5.5 inches (139.7 × 139.7 mm),
Layer dimensions of about 4 × 4 inches (101.6 mm) can be achieved, substantially smaller than the multilayer test packs used today in the United States and abroad, and even more so.

As indicated above, it is preferred that the disposable test pack 10 respond to sterilization device defects in such a way that it can be compared to cotton towels prepared according to the Bowie and Dick protocol. The preferred embodiment of the present invention achieves this required purpose. In particular, the test is performed in a specially modified pre-vacuum sterilizer that has been modified to produce a condition that is equal to the sterilizer defect in a controllable and reproducible manner.
The pre-vacuum sterilizer has a manually controlled vacuum pump that allows the degree of vacuum to be drawn into the device and an adjustable vacuum piston driven air injector. Incomplete air removal
This can be done by shutting off the pre-vacuum sequence of the sterilizer. Air leaks are created in a predictable and reproducible manner by a manually operated micrometered needle valve.
The results are evaluated by the color change shown on the test sheets obtained by the test pack described here, the standard towel pack and other commercially available pre-assembled packs.

The test sheet 30 is designed to be visually evaluated in a conventional manner in a device such as that used in the Bowie and Dick protocol. To measure the quantity, the color change to be tested on the chemical indicator sheet is set at a 10 mm orifice (Gardner, Silver Spring, MD / Model XL-20 from Neotec Instrumentation Division of Pacific Scientific). It is determined by the attached reflectometer. This instrument, which uses a green filter, measures the reflectivity of the color change from white to black and uses the American Society for Testing and Materials (ASTM).
1977). The upper limit of the reflectance scale is determined by the appropriate commercially available once-
A 79 is measured on the unexposed white sheet using the "A-D" test sheet and 8.5 on a fully exposed black sheet. The surface area of the incompletely exposed portion of the test sheet is measured by calculating the area of the oval that clearly defines the area around the incompletely exposed area.

The tests show that, in the main reaction range, the effect of two common defects in the test sheet is substantially the same as the test pack of the present invention and the test pack prepared according to the usual Bowie and Dick protocol. It is shown that.

Referring to FIG. 5, a typical multi-layer test pack used in the United States has a total of 18 layers (17 sheets) between the test sheet and each end face of the bundle, resulting in overall dimensions. (L x W x H) is about 5 x 5 x 7/8 inch (1
27 × 127 × 22.2 mm). Since the bundle of a multi-layer test pack is generally symmetrical around the test sheet, only a portion of the bundle for one side of the test sheet is schematically illustrated, with the test sheet located to the left of the schematic. The end face of the bundle is on the right side of the schematic diagram. A typical bundle is schematically illustrated in FIG. 5A, where the numbers in the squares indicate the number of low permeable 214 base paper sheets and the numbers in the circles indicate the high permeable. Degree 178 indicates the number of base paper sheets, L indicates a low-permeability 214 base paper sheet having a non-perforated sheet on the side facing the bundle and the surface, and the opposite L indicates the side facing the test sheet. Shows a low-permeability 214 base paper having a low-permeability layer having a non-perforated sheet, and a combination of L and reverse L represents a low-permeability 214 base paper having a non-perforated sheet on each of opposing surfaces. ing.

A suitable US multi-layer test pack according to the present invention having a bundle schematically shown in FIG.
A shows substantially the same approach as the conventional multi-layer test pack of No. A, having a total of 13 layers (11 sheets) between the test sheet and each end face, about 4 × 4 × 9. / 16
It has an overall dimension of inches (101.4 × 101.4 × 14.28 mm). The U.S. equivalent bundle according to the present invention is therefore smaller, one inch (25.4 mm) smaller and one inch (25.4 mm) less than a typical U.S. test pack.
It will be appreciated that it is 5.4 mm smaller and less than 1/4 inch (6.35 mm) tall.

The test pack according to the invention having the bundle schematically shown in FIG. 5C is almost as good as the test pack of FIG. Requires additional layers (i.e., 14 layers or 12 sheets). The test pack according to the invention having the bundle schematically shown in FIG. 5D is slightly smaller than the test pack of FIG. 5C having the same number of layers.

In the bundle of FIG. 5A, test sheet 3
0 and a single non-porous layer 40 between the end faces 20, 22;
In the bundle of FIG. 5B, there is a pair of non-porous layers 40 separated only by the perforated sheet 32, and in the bundle of FIG. There is a pair of non-perforated sheets 32 separated by two sheets, and in the bundle of FIG. 5D, a pair of non-perforated layers 40 separated by two perforated sheets 32 and having an empty gap between the two sheets are formed. It will be understood that there is.

Referring now to FIG. 6, a typical multi-layer test pack for use in Europe (a more stringent approach than in the United States is used) has a total of 22 layers between the test sheet and each end face ( 20 sheets) and an overall dimension of about 5 x 4 x 1 inch (127 x 101.6 x 25.4 mm). The bundle is schematically illustrated in FIG.

The multi-layer test pack for Europe according to the invention having the bundle schematically illustrated in FIG.
The same approach is shown substantially as a bundle, but uses only a total of 18 layers (15 sheets) between the test sheet and each end face, and is approximately 4 x 4 x 3/4 inches (101. 6 × 10
(1.6 x 19.1 mm). The same bundle for Europe according to the invention is smaller and one inch (25.4 m) longer than the standard multi-layer test pack bundle for Europe.
m), it will be appreciated that the height is 1/4 inch (6.4 mm) smaller.

The multi-layer test pack according to the invention having the bundle schematically illustrated in FIG. 6C is, but not at all, identical to the test pack of FIG.
In need.

In the normal European test pack of FIG. 6A, as the terminology is defined here, the two non-porous layers are 10 perforated layers (a set of non-porous layers 40). It is to be understood that there is no "perforated layer set" when separated by a non-porous layer, especially up to two or more perforated layers).
The test pack according to the invention with the bundle of FIG. 6B has a sheet of perforated sheets with a non-porous layer on one side (similar to the bundle of FIG. 5B) and The test pack according to the invention with a bundle of C has two sets of non-porous layers separated by a perforated sheet, with an air gap between the two sheets (bundle of C in FIG. 5). the same as). FIG.
The outermost non-porous layer 40 of the B and C bundles of FIG.
The closest non-porous layer 40 (3
(There are no two perforated layers 32)
The innermost perforated layer 40 (separated from the test sheet 30 only by a single perforated layer 32) is separated from the next outer perforated layer 40 by two perforated layers 32, and thus It will be understood that "one pair" is suitable as part of a pair of non-porous layers 40 and "three pairs". The three sets of non-porous layers 40 conform to the convention that three adjacent sets of non-porous layers 40 are separated by at least one other than two perforated layers 32 (air gap between sheets). Does not consider the purpose of this rule).

Compared to conventional considerations, small test packs can be made with reduced dimensions (one-axis, preferably two- or three-axis), and at least a pair of non-porous layers are placed in close proximity. The above-described embodiment shows that the same approach is still substantially maintained.

In summary, the present invention mimics the air exhaust and vapor permeation conditions of a conventional test pack described in the Bowie and Dick protocol to determine an appropriate attempt for a residual air test in a pre-vacuum sterilizer. This provides a small and inexpensive disposable test pack for use in a pre-vacuum steam sterilizer to determine when the sterilizer will work according to formal standards. The test pack provides repeatable and consistent standards for testing the sterilizer operation sequence from sterilizer to sterilizer on a daily basis, without assembling by hospital personnel, and also reduces hospital linen and roundleigh in initial use. No need to use. The test pack according to the invention uses fewer layers than other comparable multi-layer test packs, and thus
It is at least one-dimensional, preferably two-dimensional, or even three-dimensional, much smaller than a conventional multi-layer test pack attempting a similar attempt.

While the preferred embodiment of the invention has been illustrated and described in detail, various modifications and improvements will be readily apparent to those skilled in the art. Therefore, the appended claims should be construed broadly and consistently with the spirit and scope of the invention described herein.

[Brief description of the drawings]

FIG. 1 is an exploded schematic view of a test pack according to the present invention.

FIG. 2 is a schematic diagram of a test pack.

FIG. 3 is a schematic side view of a test pack in a sterilizer.

FIG. 4 is a sectional view of a test pack.

FIG. 5A is a schematic diagram of a typical bundle used in a multi-layer test pack suitable for use in the United States, and B, C and D are bundles of approximately equivalent small multi-layer test packs according to the present invention. FIG.

FIG. 6A is a schematic diagram of a typical bundle used in a multi-layer test pack suitable for use in Europe, and B and C are schematic diagrams of a bundle of approximately equivalent small multi-layer test packs according to the present invention. FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Test pack 12 Bundle 14 Wrapping 20 Top surface 22 Bottom surface 24 Nonwoven layer 26 Edge 30 Test sheet 40 Non-porous layer 52 Indicator

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int. Cl. ⁷ , DB name) G01N 33/00 A61L 2/06 A61L 2/26

Claims (14)

(57) [Claims] (A) A bundle having a pair of end surfaces including a top surface and a bottom surface, a plurality of layers between the end surfaces, and an edge between the top surface and the bottom surface, wherein the bundle comprises: (i) a perforated test sheet with a vapor sensing indicator ink positioned between the layers of the bundle to indicate the efficiency of the vacuum device of the sterilizer; and (ii) a plurality of test sheets in the bundle above and below the test sheet. A selectable perforated layer;
(iii) located between the test sheet and one of the end faces and separated from the test sheet and the one end face by at least one perforated layer and separated by at least one and the two perforated layers; A bundle having at least one set of non-porous gas impermeable layers whose number, position and spacing are based on a predetermined degree of efficiency; (B) folded over the bundle to maintain integrity A small pre-vacuum steam sterilization test pack for testing the efficiency of the vacuum device of the steam sterilizer to produce a vacuum, comprising a perforated layer. 2. The bundle is about 4 × 4 inches (about 101.6 × 1
2. The test pack according to claim 1, which has a layer of 0.16 mm). 3. The test pack according to claim 1, wherein the pair of non-porous layers are closer to the test sheet than one end surface. 4. The test pack of claim 1, wherein the pair of non-perforated layers are separated from one end face by more perforated layers than are separated from the test sheet. 5. The test pack of claim 1, wherein the non-porous layers of the pair of non-porous layers are separated by only one of the perforated layers. 6. The test pack according to claim 5, wherein the non-porous layers of the set of non-porous layers are arranged on both sides of one perforated layer. 7. The test pack of claim 1, wherein the bundle has a plurality of sets of non-porous layers. 8. The test pack according to claim 7, wherein at least one of the set of non-porous layers is arranged on both sides of the test sheet. 9. At least three sets of non-porous layers are disposed on each side of the test sheet, each of the three sets of non-porous layers being at least one of the two non-porous layers and three sets of these two layers. 9. The test pack of claim 8, wherein the test pack is spaced from adjacent non-porous layers. 10. The test pack of claim 1, wherein each non-perforated layer is thinner than one of the perforated layers. 11. The test pack according to claim 1, wherein the non-porous layer is a gas-impermeable plastic. 12. A pair of non-porous layers limit the release of gas from the bundle through the bundle as the steam enters the bundle during operation of the sterilizer, and provide an indication of the efficiency of the sterilizer vacuum system. The test pack according to claim 1, wherein the test sheet achieves an exposure amount of the indicator ink on the test sheet. 13. (A) a pair of end faces including a top face and a bottom face;
A bundle having a plurality of layers between the end surfaces and an edge between the top and bottom surfaces, the bundle comprising: (i) between the layers of the bundle to indicate the efficiency of the vacuum device of the sterilizer; A perforated test sheet positioned and printed with a vapor sensing indicator ink; (ii) a plurality of selectable perforated layers in the stack above and below the test sheet; and (iii) one of the test sheet and the end face. And between the test sheet and one end face separated by at least one perforated layer and between one end face by more perforated layers than by the test sheet. And multiple sets of non-porous gas impermeable layers based on the pre-designed degree of efficiency with the location and non-porous layer spacing; (B) folded over the bundle to maintain integrity The set of perforated layers, consisting of a perforated layer, forms a bundle when steam enters the bundle during operation of the sterilizer. Achieve the exposure of the test sheet indicator to steam as an indication of the efficiency of the sterilizer vacuum device by limiting the escape of gas from the bundle through the steam sterilizer vacuum device efficiency to produce a vacuum Small pre-vacuum steam sterilization test pack for testing. 14. At least three sets of non-porous layers are disposed on each side of the test sheet, wherein each set of three non-porous layers comprises three sets of adjacent non-porous layers other than at least one of the perforated layers. 14. The test pack of claim 13, separated from the layers.