METHOD FOR THE STERILIZATION OF GLOVES

Description

[0001] The invention relates to a method for sterilizing gloves according to the preamble of claim 1. Gloves intended for use, for example, in filling lines for parenteral products designed according to the so-called RABS (Restricted Access Barrier System) technology or in Class A cleanroom areas, 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 to avoid excessive damage to the rubber material of the gloves. However, successful sterilization is only guaranteed if the steam penetrates to the inner fingertips. Therefore, care must be taken to ensure that, firstly, the air and / or non-condensable gases contained in the gloves are removed, and secondly, that the steam reaches all contact surfaces, including the fingertips of the glove, as quickly as possible.This also allows for the achievement of this goal. Wire frames are known for this purpose, onto which a glove is placed before being exposed to steam in the sterilization chamber.

[0002] From DE 1 300 634 A a device for preparing rubber gloves for medical use is known, which has a hollow glove frame adapted to the glove shape, onto which the glove to be sterilized is placed.

[0003] US 2 340 206 A describes a method for steam sterilization of gloves in which an insertion device is inserted into the glove and the glove with the insertion device is placed in a steam sterilization chamber and sterilization steam is then introduced into the chamber.

[0004] US Patent 3,166,439 A discloses a device for gloves which comprises a base body and finger bodies and onto which the glove can be stretched during cleaning.

[0005] From DE 14 92 319 A1 a processing plant for rubber gloves is known, in which a station for putting the gloves onto a glove rack is provided.

[0006] From DE 20 2010 010 331 U1, a sterilizable polyolefin bag is known, the material of which has a vapor-permeable layer and a film formed essentially of polyolefin. The container can also be designed as a glove.

[0007] US Patent 8,966,781 B1 describes a rack with multiple holders for different parts of sporting equipment that can be cleaned, for example by steam, while they are arranged on the rack.

[0008] From WO 2009 / 072800 A2, a device for drying and sterilizing rubber gloves is known. It comprises a finger support for gloves with a finger part and a wrist part that are inserted into the rubber gloves.

[0009] CH 707 655 A1 describes a stretching device for temporarily expanding a work glove installed in a containment.

[0010] A disinfection device for rubber gloves is known from KR 101 497 060 B1. The device comprises a housing with a disinfection element integrated into the housing, which disinfects the inserted rubber glove. It includes an inner and outer reversible element, each attached to both ends of the inserted rubber gloves, allowing the two sides to be crossed.

[0011] The disadvantages of current glove sterilization methods are their large footprint and the time-consuming process of mounting the gloves on wire racks. Future sterilization processes, on the other hand, will require significantly higher capacities.

[0012] The invention is therefore based on the objective of improving a steam sterilization method in such a way that the capacity can be increased while maintaining the reliability of complete sterilization.

[0013] This problem is solved according to the invention with the features of claim 1.

[0014] Advantageous embodiments of the invention are the subject of the dependent claims.

[0015] The invention is based on the consideration that the capacity of steam sterilization of gloves using 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 arranged on wire racks within the chamber. Furthermore, arranging a glove on a wire rack takes a relatively long time. It would therefore be desirable to make the sterilization process more space-efficient and with a reduced handling time.

[0016] As has now been recognized, an increase in capacity can be achieved by forming an insert or insertion device, essentially conforming to the inner shape of the glove, from a steam-permeable material and inserting it into the glove for sterilization. As investigations by the applicant have shown, reliable and effective sterilization occurs when the insert is placed inside the glove and fills its entire inner contour. Because the insert is made of steam-permeable material, the steam can fill the entire interior of the glove and also reach the fingertips.

[0017] The process includes the following steps: a) Providing a glove; b) Inserting an insertion device, in particular a flexible one, into the glove, which has a contour that is substantially congruent with an inner contour of the glove and has a base body made of or formed from a vapor-permeable material; c) Placing the glove with the inserted insertion device in a steam sterilization chamber; d) Introducing sterilizing steam into the steam sterilization chamber, wherein the insertion device is inserted into the glove in such a way that it covers substantially the entire inner contour of the glove.

[0018] Preferably, in step b2), which is carried out before step c), the glove, including the insertion device, is folded according to, in particular according to, a required configuration. The configuration describes how many times and in which layering of the folded parts the glove is to be folded.

[0019] Possible configurations include single and double folded or nested variants.

[0020] The steam used for sterilization is preferably saturated steam, preferably with a temperature between 120 and 135 °C. The corresponding saturated steam pressure is preferably determined from the saturated steam table.

[0021] The glove to be sterilized is advantageously made primarily of rubber, CSM, EPDM, rubber-like materials, or related materials. Depending on the design, the gloves can be single-use or reusable.

[0022] When inserting the insertion device into the glove, the glove is preferably at least partially fixed in space while the insertion device is pushed into it.

[0023] According to the invention, after the insertion device is placed inside the glove, the glove is folded at least once. Preferably, a separating layer or element is placed or inserted between the outer surfaces of the gloves that will be in contact after folding, in order to prevent the outer, contacting glove areas or surfaces from sticking together. This prevents the outer glove surfaces from touching. The separating layer ensures that these surfaces can also be reliably reached by the sterilizing steam. The respective separating layer is preferably made of the same material as the insertion device. In particular, the preferred materials specified for the insertion device are suitable for this purpose.

[0024] Studies have shown that even when folded, and especially with complex folding configurations, complete steam sterilization is achieved because the insertion device ensures that the sterilizing steam reaches the entire inner surface of the glove. This saves space while simultaneously guaranteeing sterility, allowing for the demonstrably safe sterilization of a larger quantity of gloves. The folding can be performed in various configurations. The configuration describes how many times and in what order the folded parts of the glove are to be folded. Possible configurations include single and double folds, as well as inverted versions.

[0025] Capacity can be increased while maintaining reliable complete sterilization, particularly by folding the glove including the insertion device. This means that the insertion device is fully integrated into the glove while it is being folded.

[0026] According to the invention, the material from which the insertion device is essentially manufactured consists of at least a single layer of flexible, vapor-permeable plastic material that can be sterilized by steam, in particular saturated steam. The material is preferably formed or structured with such a fine pore structure that the vapor molecules can penetrate or diffuse through it in a controlled manner. In this way, the steam can penetrate the insertion device and reach the entire inner surface of the glove to be sterilized. The material is particularly flexible and not rigid, and in particular also elastic. This distinguishes it from known frames, especially those made of wood or metal, onto which the glove to be sterilized is placed. The flexibility of the material prevents damage to the glove during insertion.

[0027] According to the invention, the insertion device is flexible and preferably flat. It preferably has a thickness in the range of 10 to 300 µm. In the case of multi-layered material, the layers are preferably joined or welded together by a sealing seam.

[0028] The plastic material preferably consists of thermally treated fiber material and / or nonwoven fabric. The fiber material and / or nonwoven fabric preferably comprises fibers of thermoplastics or microfine polytetrafluoroethylene and / or mixtures thereof, which have been treated, particularly thermally, to ensure vapor permeability, especially to saturated vapor. As long as vapor permeability is ensured, the individual layers can have different basis weights.

[0029] The material or plastic material preferably comprises porous vapor-permeable materials made of polyethylene, polyolefins and / or their mixtures (polyblends), in particular a fiber material and / or nonwoven fabric, especially with thermally treated fibers.

[0030] The insertion device is preferably made of Tyvek® or porous polyolefin-based plastic material, or the material is preferably selected as Tyvek® or porous polyolefin-based plastic material.

[0031] In a first preferred embodiment, the insertion device is designed as a single layer. This layer has the inner contour of the glove to be sterilized.

[0032] To facilitate insertion of the insertion device into the glove to be sterilized, the insertion device preferably has insertion elements or guide elements that are inserted into the fingers of the glove. Each insertion element is preferably attached to a fingertip of the insertion device's contour, so that preferably a total of five insertion elements are provided. Each insertion element is advantageously shaped like a thimble. To insert the insertion device into the glove, the user can grasp an insertion element with their fingertips and move their fingertip into the tip of the respective glove finger. In this way, it is reliably ensured that the insertion device covers the entire inner contour of the glove or overlaps it spatially.

[0033] In a second preferred embodiment, the insertion device is designed with at least two layers, each layer being at least partially connected to at least one further layer at an edge region.

[0034] The insertion device is preferably designed in the form of a glove.

[0035] Advantageously, the insertion device is designed with two layers, and the two layers are bonded together to form a glove. This design allows for easy insertion into the glove to be sterilized. The user slips the insertion device over their glove like a glove and then puts on the glove to be sterilized. The insertion device essentially acts as an inner glove for the glove being sterilized. This pulling-on process also ensures that the insertion device completely covers the inner contour of the glove.

[0036] The two layers are preferably joined by welding and / or as a seam.

[0037] In both the single-layer and the double-layer glove-shaped insertion devices, the insertion into the glove to be sterilized can be carried out automatically, preferably by means of a robot or a machine.

[0038] Also described is an insertion device made of a vapor-permeable material and having the contour of a glove. The advantageous embodiments of the insertion device in the method are considered advantageous embodiments of the insertion device.

[0039] Preferably, the insertion device is designed as a single layer, preferably featuring receiving or insertion elements at the fingertips, each preferably in the shape of a thimble. The user can place the receiving elements onto their fingertips and then insert the insertion device into the glove to be sterilized. This ensures that the insertion device fills the entire finger.

[0040] In another preferred embodiment, the insertion device is made in two layers, resembling a glove, with the two layers joined together, in particular by welding or sewing. Unlike known sterilizable containers into which the item to be sterilized is placed or which are themselves to be sterilized, the insertion device enables the steam sterilization of another item, namely a glove, by being inserted into it. The insertion device and the item to be sterilized, in particular the glove, are preferably arranged in a folded configuration. For this reason, the insertion device is made entirely of steam-permeable material: the steam must reach all inner surfaces of the glove to be sterilized and should not be prevented from doing so by steam-impermeable surfaces.

[0041] A sterilization combination with a glove and an insertion device as described above is also described.

[0042] Also described is a sterilization device with a chamber for steam sterilization and at least one insertion device as described above.

[0043] The advantages of the invention lie particularly in the fact that it enables secure and reliable sterilization of a glove, preferably in a folded configuration, right down to the fingertips. The proposed materials are already approved for steam sterilization. Inserting a device into a glove can be done very quickly, allowing for a highly efficient sterilization process. By using fingertip attachments, reliable sterilization right down to the fingertips can be ensured even with a single-layer device. With a device designed as a glove or inner glove, the user can insert it into the glove to be sterilized particularly quickly and easily.

[0044] An embodiment of the invention is explained in more detail with reference to a drawing. The drawing shows, in a highly schematic representation: FIG. 1 an insertion device which is designed as a single layer in a preferred embodiment; FIG. 2 the insertion device according to FIG. 1 in an enlarged view; FIG. 3 an insertion device which is designed in two layers, in a preferred embodiment; and FIG. 4 a glove which is to be sterilized.

[0045] Identical parts are marked with the same reference symbols in all figures.

[0046] One in FIG. 1 The illustrated insertion device 2 has a single-layer base body 6. The base body 6 has a hand section 10 and preferably a forearm section 14. The hand section 10 has the contour of a human hand with five finger sections 20, 24, 28, 32, 36, wherein finger section 20 has the contour of a thumb and finger sections 24, 28, 26 are preferably modeled after the contours of the index finger, middle finger, ring finger, and little finger. At the end of each finger section 20, 24, 28, 32, 36 facing away from the forearm section 14, a guide element 44, 48, 52, 56, 60 or receiving element is preferably attached to the base body, which is designed to receive a human fingertip. The respective guide element 44, 48, 52, 56, 60 is preferably designed in the form of a thimble. It preferably has a hollow-shaped area which at least partially accommodates the fingertip of the finger.

[0047] In other preferred embodiments, only one or fewer than five guide elements 44, 48, 52, 56, 60 may be provided. In this case, at least one guide element can be used to guide the insertion device into the glove to be sterilized, preferably guiding the corresponding guide element into the finger of the glove, while the other finger areas are inserted into the respective fingers of the glove without a guide element. In other preferred embodiments, no guide elements are present.

[0048] The base body 6, and thus essentially the insertion device 2, is made of a vapor-permeable material, preferably at least a single-layer vapor-permeable plastic material that can be sterilized by hot steam. The plastic material preferably consists of thermally treated fiber material and / or nonwoven fabric. The fiber material and / or nonwoven fabric preferably comprises fibers of thermoplastics or microfine polytetrafluoroethylene and / or mixtures thereof, which have been treated, particularly thermally, to ensure vapor permeability. The base body 6 and the insertion device 2 are particularly preferably made of Tyvek® or a porous polyolefin-based plastic material. The respective guide elements 44, 48, 52, 56, 60 are preferably made of vapor-permeable material and preferably of the same material as the base body 6.It is preferably connected to the base body 6 by a sealing seam using thermal welding. The insertion device 2 is used for sterilization in the glove 100 to be sterilized (see . FIG. 4 ) introduced by guiding the guide elements into the fingertips 44, 48, 52, 56, 60 of the glove 100.

[0049] An insertion device 2 in a second preferred embodiment is in FIG. 3 The base body 6 comprises a first layer 70 and a second layer 76. Each layer 70, 76 essentially follows the contours of the hand and forearm. The two layers 70, 76 are welded together at two seams 80, 84. This gives the insertion device 2 the form of a glove. During sterilization, it essentially acts as an inner glove for the glove being sterilized. The preferred materials for this embodiment of the insertion device 2 are the same as those used in the embodiment according to [reference to be added]. FIG. 1 materials described.

[0050] In FIG. 4 An example of a glove 100, which is to be sterilized, is shown. The glove 100 has a forearm area 106 and a hand area 110. The hand area has finger parts 120, 124, 128, 132, 136, which terminate in fingertips.

[0051] For steam sterilization, a glove (size 100) is provided. The in FIG. 1 The illustrated insertion device 2 is inserted into the glove 100. For this purpose, the insertion device 2 is inserted into the glove 100 such that finger areas 20, 24, 28, 32, 26 lie within finger areas 120, 124, 128, 132, 126 of the glove 100. The forearm area 14 lies as close as possible to the forearm area 106 of the glove 100.

[0052] The insertion device 2 according to FIG. 3 The hand is inserted into the glove 100 by guiding it into the insertion device 2 and wearing the glove on the hand and forearm like a glove. Together with the insertion device 2, the hand is then guided into the glove 100, which is preferably held or spatially fixed during this process, so that the fingers are inserted in finger areas 120, 124, 128, 132, and 136. The hand is then withdrawn from the insertion device 2.

[0053] In a preferred embodiment, the glove 100 is folded before the introduction of sterilizing steam. It can be folded once or multiple times. This folding is possible because the material of the insertion device is foldable and therefore correspondingly flexible.

[0054] After at least one glove 100 with an inserted insertion device 2 has been positioned or placed in the steam sterilization chamber, sterilizing steam is introduced into the chamber.

[0055] The glove 100 is preferably arranged in the sterilization chamber stretched out or folded flat, either once or multiple times. Alternatively, the gloves are cassetteted, i.e., placed side by side on preferably flat racks, which increases the number of gloves 100 that can be arranged in the chamber in a space-saving manner.

[0056] After the gloves 100 are placed in the sterilization chamber, steam, preferably saturated steam in the temperature range of T = 120-135 °C, is introduced into the sterilization chamber.

[0057] The illustrated insertion devices 2 are preferably used for both left and right gloves. The proportions shown in the FIGS. are not to scale and can be selected differently or even omitted depending on the glove to be sterilized. For example, the forearm area 14 can be completely or partially omitted or be longer than shown. The illustrated invention may include modifications and alterations that are still encompassed by the concept according to the invention. All details can be replaced by technically equivalent elements. Shapes, designs, and materials can be adapted to specific requirements without departing from the scope of the claims.

[0058] A method for steam sterilization of gloves (100) is intended to increase capacity while ensuring reliable complete sterilization. It comprises the following steps: a) Providing a glove (100); b) Inserting an insertion device (2) into the glove (100); c) Depositing the glove (100) with the insertion device (2) inserted into a steam sterilization chamber; d) Introducing sterilizing steam into the steam sterilization chamber, wherein the insertion device (2) has a contour that is substantially congruent with an inner contour of the glove (100) and has a base body (6) made of steam-permeable material, and wherein the insertion device (2) is inserted into the glove (100) such that it covers substantially the entire inner contour of the glove (100).

Claims

1. A method for the steam sterilisation of gloves (100), comprising the steps a) provision of a glove (100); b) introduction of an insertion device (2) into the glove (100); c) placement of the glove (100) with the introduced insertion device (2) into a steam sterilisation chamber; d) supplying of sterilising steam into the steam sterilisation chamber, wherein the insertion device (2) has a contour that is congruent in shape to the inner contour of the glove (100), characterised in that the insertion device (2) is flexible in design and comprises a basic body (6) made of a steam-permeable material, and wherein the insertion device (2) is introduced into the glove (100) in such a way that it occupies the entire inner contour of the glove (100), and wherein after introduction of the insertion device (2) into the glove (100), the glove (100) is folded at least once and wherein the material consists of a least single-layer steam-permeable synthetic material that can be sterilised by steam.

2. The method according to claim 1, wherein the synthetic material consists of thermally treated fibre material and / or non-woven material.

3. The method according to claim 2, wherein the fibre material and / or the non-woven material comprises thermoplastic or microfine polytetrafluorethylene fibres and / or mixtures thereof, which have been treated, in particular thermally, so that permeability to steam results.

4. The method according to any one of claims 1 to 3, wherein the insertion device (2) is designed in one layer.

5. The method according to claim 4, wherein the insertion device (2) comprises introducing elements (44, 48, 52, 56, 60) which are inserted into the fingers of the glove (100).

6. The method according to any one of claims 1 to 3, wherein the insertion device (2) is designed in at least two layers, wherein each layer (70, 76) is connected to at least one other layer (70, 76) at least partially in a marginal area (80, 84).

7. The method according to claim 6, wherein the insertion device (2) is designed in the shape of a glove.

8. The method according to claim 7, wherein the insertion device is designed in two layers, and the two layers (70, 76) are connected to each other in such a way that they form a glove.

9. The method according to claim 8, wherein the connection between the two layers (70, 76) is formed by welding or as a seam.