Procedure for sterilizing gloves

Abstract

Method for steam sterilization of gloves (100), comprising the steps a) providing a glove (100); b) inserting an insertion device (2) into the glove (100) which has a contour that is essentially congruent in shape with an inner contour of the glove (100) and has a base body (6) made of vapor-permeable material, and wherein the insertion device (2) is formed with at least two layers, and wherein each layer (70, 76) is at least partially connected to at least one further layer (70, 76) at an edge region (80, 84), and wherein the insertion device (2) is formed in the form of a glove, and wherein the insertion device (2) is inserted into the glove (100) in such a way that it occupies essentially the entire inner contour of the glove (100), and wherein the material consists of at least one layer of vapor-permeable and steam-sterilizable plastic material, and wherein the plastic material consists of thermally treated fiber material and / or nonwoven fabric; c) depositing the glove (100) with the insertion device (2) inserted in a steam sterilization chamber; d) introducing sterilizing steam into the steam sterilization chamber, wherein after the introduction device (2) has been introduced into the glove (100), the glove (100) is folded several times and arranged lying flat in the steam sterilization chamber, and wherein a separating element is placed between the outer regions of the gloves (100) which touch each other after folding in order to prevent the outer contacting regions of the gloves from sticking together.

Description

The invention relates to a method for sterilizing gloves.Gloves which are used, for example, in filling systems for parenteralia which are designed according to the so-called RABS technology (Restricted Access Barrier System) or are to be used in clean room class A sector must be sterilized before use. For this purpose, they are usually exposed to sterilizing steam in a steam sterilization chamber. A short sterilization time is very important in order not to damage the rubber material of the gloves too much. However, the sterilization success is ensured only when the steam penetrates into the inner fingertips. Accordingly, care must be taken that, on the one hand, the air and / or non-condensable gases located in the gloves are removed and, on the other hand, the vapor can also penetrate to all contact surfaces as far as the fingertips of the glove or can also reach them in the shortest possible time. For this purpose, wire racks are known on which a glove is fitted before it is exposed to steam in the sterilisation chamber.DE 1 300 634 A discloses an apparatus for preparing rubber gloves for medical use, which apparatus has a hollow glove frame adapted to the shape of the glove, onto which the glove to be sterilized is drawn.DE 12 22 212 A describes an apparatus for drying, powdering and sterilizing rubber gloves for medical use, comprising a hollow glove frame into which air is introduced by means of a blower box.DE 20 2010 010 331 U1 discloses a sterilizable polyolefin bag, the material of which comprises the one vapor-permeable layer and a film formed substantially from polyolefin. The container can also be formed from glove.Disadvantages of the known methods for sterilizing gloves are the high space requirement and the time-consuming fitting of the gloves with the wire frames. Future sterilization processes, on the other hand, require high capacities.The object of the invention is therefore to improve a method for steam sterilization to the effect that the capacity can be increased with simultaneous reliability of the complete sterilizationThis object is achieved according to the invention with the features of claim 1.Advantageous embodiments of the invention are the subject matter of the dependent claims.The invention is based on the consideration that the capacity in steam sterilization of gloves in known methods is limited by two essential factors. Due to the limited volume of the sterilization chamber, only a small number of gloves can be placed on wire racks in the chamber. Moreover, arranging a glove on a wire frame takes a relatively long time. It would therefore be desirable to make the sterilization process more space-saving and with reduced handling time.As has now been recognized, capacity enhancement can be achieved by forming a liner having substantially the inner shape of the glove from a vapor permeable material and placed in the glove for sterilization. As tests by the applicant have shown, a reliable and reliable sterilization takes place when the insert is inserted into the glove and fills its entire inner contour. Since the insert is made of a vapor-permeable material, the vapor can fill the entire inner region of the glove and also enter the fingertips.The steam used for sterilization is preferably saturated steam, preferably with a temperature between 120-135° C. The corresponding pressure of the saturated steam is preferably obtained from the saturated steam table.The glove to be sterilized is advantageously made essentially of rubber, CSM, EPDM, rubber-like materials or related materials. Depending on the embodiment, the gloves can be designed to be disposable (single use) or reusable.The glove is folded several times. Preferably, a separating layer or a separating element is placed or inserted between the outer regions of the gloves that touch each other after the folding in order to prevent the outer, touching glove regions or surfaces from sticking together. In this way, the outer glove surfaces are prevented from touching. The result of the separating layer is that these surfaces can also be reliably reached by the sterilizing steam. The respective separating layer is preferably manufactured from the same material as the introduction device. The preferred materials specified in the introduction device are particularly suitable for this purpose. Studies have shown that complete steam sterilization is possible even in the folded state, since the introduction device also then enables the sterilizing steam to reach the entire inner surface of the glove. This achieves a saving in space, so that a larger quantity of gloves can be sterilized simultaneously.The material from which the introduction device is substantially manufactured consists according to the invention of at least single-layer steam-permeable plastic material which can be sterilized by steam, in particular saturated steam. In the case of multilayer material, the layers are preferably joined or welded to one another by a sealing seam.According to the invention, the plastic material consists of thermally treated fiber material and / or nonwoven fabric. The fiber material and / or the nonwoven preferably comprises fibers of thermoplastics or microfine polytetrafluoroethylene and / or of mixtures thereof which have been treated, in particular thermally, in such a way that a vapor permeability, in particular to saturated vapor, is provided. As long as there is vapor permeability, the individual layers can have different weights per unit area.The material or plastic material preferably comprises porous vapor-permeable materials made of polyethylene, polyolefins and / or their mixed materials (polyblends), in particular a fiber material and / or nonwoven, in particular with thermally treated fibers.The introduction device is preferably manufactured from Tyvek® or porous plastic material based on polyolefin or the material is preferably selected as Tyvek® or porous plastic material based on polyolefin.In a first preferred embodiment, the introduction device is of single-layer design. This layer has the inner contour of the glove to be sterilized.In order to facilitate the introduction of the introduction device into the glove to be sterilized, the introduction device preferably has introduction elements or guide elements which are introduced into the fingers of the glove. The respective insertion element is preferably each attached to a fingertip of the contour of the insertion device, so that preferably a total of five insertion elements are provided. The respective insertion element is advantageously designed in the manner of a finger hat. For inserting the insertion device into the glove, the user can each pick up an insertion element with his fingertips and move his fingertip into the tip of the respective glove finger. In this way, it is reliably achieved that the introduction device covers the entire inner contour of the glove or spatially overlaps it.In a second preferred embodiment, the introduction device is at least two-ply, wherein each ply is connected to one another at least partially at an edge region by at least one further ply.The introduction device is preferably designed in the form of a glove.Advantageously, the introduction device is configured in two layers and the two layers are connected to one another in such a way that they form a glove. Such a configuration allows a comfortable insertion into the glove to be sterilized. The user wipes the applicator like a glove and then wipes the glove to be sterilized. The introduction device functions as it were as an inner glove for the glove to be sterilized. This covering process can also ensure that the introduction device completely covers the inner contour of the glove.The connection of the two layers is preferably formed by welding.Both in the case of the single-layer and in the case of the double-layer, glove-shaped introduction device, the introduction into the glove to be sterilized can take place automatically, preferably by means of a robot or a machine.Also described is an introducing device which is formed from a vapor-permeable material and has the contour of a glove. The embodiments of the introduction device that are advantageous in the method are advantageous embodiments of the introduction device.The introduction device is preferably of single-layer design, wherein it preferably has receiving elements or introduction elements at the fingertips, which receiving elements are preferably each designed in the form of a pick-up. The user can place the receiving elements on his fingertips and then insert the introduction device into the glove to be sterilized. In this way, it is ensured that the introduction device fills the entire fingers.In another preferred embodiment, the introduction device is designed in two layers in the manner of a glove, in which the two layers are connected to one another, in particular welded. In contrast to known sterilizable containers, in which the object to be sterilized is introduced or which themselves are to be sterilized, the introduction device first enables the steam sterilization of another object, namely a glove, by being introduced into the latter. For this reason, the introducing device is made entirely of vapor-permeable material: the vapor must reach all inner surfaces of the glove to be sterilized and should not be prevented by vapor-impermeable surfaces.A sterilization combination with a glove and an introduction device described above is also described.Also described is a sterilization device having a chamber for steam sterilization and at least one introduction device described above.The advantages of the invention lie in particular in the fact that a reliable and reliable sterilization of a glove up to the fingertips is made possible. The proposed materials are already approved for steam sterilization. The fitting of a glove with an introduction device can take place very quickly, so that the sterilization process can be carried out very effectively. When receiving elements for fingertips are used, reliable sterilization up to the fingertips can also be ensured in a single-layer introduction device. In the case of an introduction device designed as a glove or inner glove, the user can introduce the introduction device into the glove to be sterilized particularly quickly and comfortably.An exemplary embodiment of the invention is explained in more detail with reference to a drawing. In this figure, a highly schematic representation shows: FIG. 1 shows an introduction device which is of single-layer design in a preferred embodiment; FIG. 2 shows the introduction device according to FIG. 1 in an enlarged illustration; FIG. 3 shows an introduction device which is configured in two layers, in a preferred embodiment; and FIG. 4 shows a glove to be sterilized.Identical parts are provided with the same reference numerals in all figures.An introduction device 2 illustrated in FIG. 1 has a single-layer base body 6. The base body 6 has a hand region 10 and preferably a forearm region 14. the hand region 10 has the contour of a human hand with five finger regions 20, 24, 28, 32, 36, wherein the finger region 20 has the contour of a thumb and the finger regions 24, 28, 2, 26 are preferably reproduced from the contours of index finger, middle finger, ring finger and small finger. In the end at the respective finger region 20, 24, 28, 32, 36 remote from the forearm part 14, a guide element 44, 48, 52, 56, 60 or receiving element is attached to the base body, which is designed to receive a human finger tip. For this purpose, the respective guide element 44, 48, 52, 56, 60 is preferably designed in the manner of a finger hat. It preferably has a hollow-body-shaped region which at least partially accommodates the finger tip of the finger.In other preferred embodiments, only one or less than five guide elements 44, 48, 52, 56, 60 can also be provided. In this case, the at least one guide element can be used to guide the introduction device into the glove to be sterilized and preferably to guide the corresponding guide element into the finger of the glove, while the other finger regions without guide element are brought into the respective finger of the glove.The base body 6 and thus substantially the introduction device 2 is produced from a vapor-permeable material, preferably at least single-layer vapor-permeable and heat-steam-sterilisable plastics material. The plastic material preferably consists of thermally treated fiber material and / or nonwoven fabric. The fiber material and / or the nonwoven preferably comprises fibers of thermoplastics or microfine polytetrafluoroethylene and / or of mixtures thereof, which have been treated, in particular thermally, in such a way that vapor permeability is provided. Particularly preferably, the base body 6 or the introduction device 2 are produced from Tyvek® or porous plastic material based on polyolefin. The respective guide element 44, 48, 52, 56, 60 is preferably manufactured from a vapor-permeable material and is preferably manufactured from the same material as the base body 6. It is preferably connected to the base body 6 by a sealing seam by means of thermal welding. For sterilization, the introduction device 2 is introduced into the glove 100 to be sterilized (see FIG. 4 ) by guiding the guide elements into the fingertips 44, 48, 52, 56, 60 of the glove 100.An introduction device 2 in a second preferred embodiment is illustrated in FIG. 3. The base body 6 comprises a first layer 70 and a second layer 76. the respective layer 70, 76 essentially has the contour of the hand and forearm. The two layers 70, 76 are welded to one another at two seams 80, 84. As a result, the introduction device 2 is designed as a glove. During sterilization, it forms an inner glove for the glove to be sterilized. The preferred materials for this embodiment of the introducing device 2 are the same as the materials described in connection with the embodiment according to FIG. 1.In FIG. 4, a glove 100 to be sterilized is exemplarily shown. Glove 100 includes forearm portion 106 and hand portion 110. The hand region has finger parts 120, 124, 128, 132, 136 which open into fingertips.A glove 100 is provided for steam sterilization. The introduction device 2 shown in FIG. 1 is introduced into it. For this purpose, the introduction device 2 is introduced into the glove 100 in such a way that the finger regions 20, 24, 28, 32, 26 lie in the finger regions 120, 124, 128, 132, 126 of the glove 100. The forearm region 14 is situated as congruently as possible in the forearm region 106 of the glove 100.The insertion device 2 according to FIG. 3 is introduced into the glove 100 by guiding the hand into the insertion device 2 and carrying the latter on the hand and forearm like a glove. Together with the introduction device 2, the hand is then guided into the glove 100, so that the fingers are introduced into the finger regions 120, 124, 128, 132, 136. The hand is then pulled out of the introduction device 2 again.The glove 100 is folded according to the invention before introduction of sterilization vapor.After at least one glove 100 with the introduction device 2 introduced has been positioned in or placed in the steam sterilization chamber, sterilizing steam is introduced into the chamber.According to the invention, the glove 100 is arranged in the sterilization chamber in a multiply folded flat manner. Alternatively, the gloves are cast, i.e. applied next to one another on preferably flat racks, whereby the number of gloves 100 that can be arranged in the chamber can be increased in a space-saving manner.After the gloves 100 have been arranged in the sterilization chamber, steam, preferably saturated steam in the temperature range of T=120-135° C., is introduced into the sterilization chamber.The illustrated introducing devices 2 are preferably used for both left and right gloves. The proportions shown in the FIGS. are not true to scale and can also be chosen differently or else omitted depending on the glove to be sterilized. Thus, for example, the forearm region 14 can be completely or partially missing or can also be configured to be longer than shown.

Claims

Method for steam sterilization of gloves (100), comprising the steps a) providing a glove (100); b) introducing an introduction device (2) which has a contour which is substantially shape-consistent with an inner contour of the glove (100) and has a base body (6) which is manufactured from steam-permeable material into the glove (100), and wherein the introduction device (2) is formed at least in two layers, and wherein each layer (70, 76) is connected to at least one further layer (70, 76) at least partially at an edge region (80, 84), and wherein the introduction device (2) is formed in the shape of a glove, and wherein the introduction device (2) is introduced into the glove (100) in such a way that it takes substantially the entire inner contour of the glove (100), and wherein the material consists of at least single-layer, steam-permeable and steam-sterilisable plastic material, and wherein the plastic material consists of thermally treated fibre material and / or nonwoven fabric; c) depositing the glove (100) with the introduction device (2) introduced in a steam sterilisation chamber; d) introducing sterilisation steam into the steam sterilisation chamber, wherein after introduction of the introduction device (2) into the glove (100) the glove (100) is arranged in a multiply folded flat position in the steam sterilisation chamber, and wherein in each case a separating element is placed between the outer regions of the gloves (100) contacting one another after the folding in order to prevent adhesion of the outer contacting glove regions.The method according to claim 1, wherein the fiber material and / or the nonwoven fabric comprises fibers of thermoplastics or microfine polytetrafluoroethylene and / or of mixtures thereof which have been treated in such a way that a vapor permeability is given.Method according to claim 1, wherein the introduction device (2) is configured in two layers and the two layers (70, 76) are connected to one another in such a way that they form a glove.The method of claim 3, wherein the bonding of the two plies (70, 76) is formed by welding.

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