Patent Application
20190030524
The invention relates to an isolator (clean room device), in particular for pharmaceutical and/or chemical applications, with an isolator space having a double wall, wherein the double wall comprises at least one transparent outer wall panel preferably formed from glass or a transparent plastic and, spaced apart from the latter, a transparent inner wall panel preferably formed from a glass or a transparent plastic, which wall panels delimit an intermediate space, in particular for conducting gas, and with at least one glove port assigned to the double wall, comprising means for the detachable fixing a glove for reaching through the double wall to manually engage in the isolator space, wherein the glove port comprises a preferably transparent channel ring surrounding a reach-through channel, which channel ring extends from the outer wall panel in the direction of the inner wall panel, wherein the outer wall panel and the inner wall panel are arranged adjustable, in particular swivellable, relative to one another for easier replacement of the glove, and wherein the means for the detachable fixing of the glove in a region between the outer wall panel and the inner wall panel are arranged outside the reach-through channel. The channel ring is preferably constituted either integral with the outer wall panel and thus fixedly connected to the latter or alternatively fixed gas-tight to the outer wall panel, in particular in the region of or inside an outer wall panel opening. The isolator preferably comprises a decontamination device, preferably comprising a vaporisation device, for creating the clean room conditions by means of a decontamination agent, such as for example hydrogen peroxide. Furthermore, the device preferably comprises a fresh air conditioning system.
Furthermore, the invention relates to an isolator system, which comprises, apart from an isolator according to the invention, a glove detachably fixed to the glove port.
Moreover, the invention relates to a method for the detachable fixing of a glove to a glove port of an isolator according to the invention.
Isolators are used for example in the pharmaceutical and chemical industry in order to carry out critical processes, for example sterilisation and/or filling and/or production processes, in an isolator space (clean room) delimited or formed by the isolator. Depending on the application with the isolators, the product is protected against external, atmospheric influences or operatives of an isolator are protected during the processing of hazardous products, in particular products harmful to health. In order that operatives can reach manually into the isolator space from outside, isolators are usually provided with so-called glove ports (glove connections), to which usually elastomer gloves can be fixed detachably, which form a separation barrier between the isolator space and the world outside. Such isolators are also referred to as a glove box or chamber. For good product protection or operative protection, it must be ensured that the glove is fixed securely and gas-tight to the glove port.
Various systems have proved to be effective in practice for the detachable fixing of gloves to the glove port of isolators.
A system is hitherto preferred by the applicant, wherein the glove is fixed to an inner ring arranged tightly inside the channel ring, which inner ring reduces the free cross-section of the channel ring. This system has the advantage that a glove replacement is possible during operation of the isolator, since a new glove provided with an inner ring and introduced for example via a lock during operation of the isolator is introduced from inside into the channel ring by means of a suitable tool and the old glove with the associated inner ring is thus removed to the exterior, wherein the new glove with the inner ring closes the channel in the channel ring. The known system requires an additional fixing step for fixing the glove to an inner ring, for which purpose screw connections of the inner ring can be loosened and the glove can be received in a clamping manner.
Alternative known systems do not provide for replaceability of a glove during operation. A system is known to the applicant from practice, wherein the glove can be fixed to a fixing connection piece extending outwards from the outer wall panel and aligned with the channel ring and can then be pulled inside through the channel ring. Here, however, it is necessary to ensure in a time-consuming way that the glove cannot slip off from the outer fixing connection piece when force is exerted by an operative in the insertion direction during operation. Moreover, the glove, as explained, is guided through the interior of the channel ring, so that a free view through the channel ring, which is transparent in the known embodiment, is restricted considerably by the glove itself. A further problem of the known embodiment consists in the fact that, in the case of a tightness test to be performed regularly, wherein the glove is tested for tightness by inflation and measurement of the pressure loss with the aid of a so-called test disc, which is inserted into the channel ring for this purpose, precisely the critical fixing region of the glove located on the outside of the isolator cannot be tested.
A so-called glove box is known from GB 1 273 926 A, which comprises a complex glove replacement system so that a glove can be replaced during the operation of the glove box. The glove replacement is extremely time-consuming and the construction is complex.
A double-wall handling device is known from DE 694 26 116 T2, wherein the double wall can be reached through by two gloves engaging into one another. An outer of the gloves is fixed in an outer region of the outer wall, whilst an inner glove is fixed to an outer side of the inner wall.
DE 10 2004 030 766 A1 describes a testing system and a method for measuring the tightness of gloves, wherein a glove fixed in a region outside the outer wall is provided for reaching through a double wall.
US 2012/0 023 721 A1 describes a complex system for fixing gloves to a containment.
US 2004/0 168 341 A1 describes a system with a plurality of gloves fixed to an outer region.
US 2008/0 314 744 A1 describes a glove box, wherein a double wall of a glove box is reached through.
Proceeding from the aforementioned prior art, therefore, the invention is based on specifying an improved isolator constituted as a glove box, which on the one hand is characterised by a convenient and moreover secure (tight) fixing option for the glove to the glove port and it is nonetheless ensured that the glove can be completely tested for tightness in a regular tightness test. Despite the aforementioned requirements, it should preferably be ensured that the reach-through channel has a large free cross-section, which in particular is not narrowed by an inner ring. Furthermore, the problem consists in specifying an isolator system with an isolator thus improved as well as a method for a convenient and secure glove replacement on such an isolator.
This problem is solved with regard to the isolator with the features disclosed herein.
With regard to the isolator system, the problem is solved with the features disclosed herein.
With regard to the method, the problem is solved with the features disclosed herein.
Advantageous developments of the invention are specified in the sub-claims. All combinations of at least two features disclosed in the description, the claims and/or the figures fall within the scope of the invention. To avoid repetition, features disclosed according to the device are also intended also to be disclosed as being according to the method and can be claimed. Equally, features disclosed according to the method are also deemed to be disclosed as being according to the device and can be claimed.
The idea underlying the invention is to enable an easy and secure fixing of the glove to the glove port, by the fact that the means for the detachable fixing of the glove are arranged in a region between the outer wall panel and the inner wall panel outside the reach-through channel. In other words, provision is made according to the invention such that the glove can be fixed in a region outside the reach-through channel, in particular in the intermediate space, in any event between the outer and inner wall panel, i.e. in a region sealed off by the outer wall panel from the surroundings/atmosphere, through which region gas present inside the isolator space, for example sterile air and/or decontamination agent, for example hydrogen peroxide vapour, flows in a circulation mode and/or during a rinsing operation. The fixing of the glove in this region is accompanied by at least two advantages. On the one hand, the glove can be fixed in a straightforward manner after providing accessibility, in particular after opening of the outer wall panel, without an inner ring required in the prior art and arranged inside the channel ring being required, for example by simply pulling the glove over the channel ring in the direction of the outer wall panel. Moreover, it is advantageous that, with the fixing method according to the invention, the entire glove, in particular also in its fixing region, can be tested for tightness using conventional test devices, in particular test discs, which can be arranged in a sealing manner inside the channel ring in order to inflate the glove and to monitor any pressure loss, since said fixing region is located in a region outside the outer wall panel, unlike solutions known from the prior art. A further advantage consists in the fact that, with the method of fixing according to the invention, an inner ring is not required, which would reduce the free cross-sectional area of the reach-through channel, more precisely of the channel ring, as a result of which the freedom of movement (larger free cross-sectional area) for an operative is substantially improved. Especially when the channel ring is constituted transparent, which is preferable, for example made of glass or a transparent plastic such as polymethyl methacrylate, the operative can see much better at an oblique angle through the channel ring into the isolator space than is possible with prior art solutions, since the direction of vision is not covered or blocked by a glove passed through the channel ring as in the prior art.
In order to increase the safety against undesired detachment of the glove, in particular from the channel ring or some other dummy part, provision is advantageously made according to the invention such that the means for the detachable fixing comprise a securing ring, preferably constituted as an elastomer ring, for example an O-ring, for clamping around the glove and preferably at the same time the channel ring in the region between the outer wall panel and the inner wall panel, wherein this securing ring is pushed, preferably after fixing of the glove, for example in an aforementioned annular groove, or after engagement over an aforementioned annular bead, from the inside over the glove, in particular such that the glove is additionally clamped, in particular directly against the channel ring or the aforementioned other fixing device (in particular a pull-over device).
In order to increase the safety further, provision is also advantageously made according to the invention such that retention means are assigned to the securing ring, that the securing ring is thus arranged relative to the inner wall panel in such a way that the inner wall panel, preferably forming a retaining stop for the securing ring, prevents slipping off of the securing ring from the glove in the direction of the interior (isolator space). To put it another way, the securing ring and the inner wall panel are or can be preferably arranged relative to one another in the operating state in such a way that the securing ring is prevented from slipping off by striking against the inner wall panel. It is particularly preferable for this purpose if the channel ring or another fixing device (in particular a pull-over device) extends at least approximately up to a passage opening in the inner wall panel, very particular preferably into this passage opening or still more preferably some way into the isolator space through this passage opening.
The employed generic term “isolator” is understood in a preferred broad consideration to mean any clean room constellation, in particular apart from conventional isolators, also so-called RABS, which are constituted as so-called glove boxes, in order to be able to reach from outside into a clean room atmosphere inside the clean space (isolator space), and which are provided with a double panel arrangement to delimit the insulator space or clean room, to which a glove port is assigned in order to be able to reach manually from outside through the double panel arrangement (double wall) into the isolator space. It is preferably an isolator for pharmaceutical and/or chemical applications with a decontamination device, in particular comprising an H2O2 evaporator.
In principle, it is possible to provide, in addition to the channel ring, a pull-over dummy part, in particular in the region of the intermediate space or between the outer wall panel and the inner wall panel, by means of which pull-over dummy part the glove can be pulled over in particular in the direction of the outer wall panel for its fixing. Particular preference is given, however, to a measure provided in a development of the invention, according to which the channel ring is designed to directly receive an engagement-side (i.e. rear-side) end of the glove (fixing end) by being pulled over the latter.
Overall, it is advantageous if the means for the detachable fixing of the glove are arranged on the outer circumference of the channel ring and still more preferably are formed at least partially by the outer circumference of the channel ring itself. The means are preferably arranged offset at a distance from the outer wall panel in the direction of the inner wall panel in order to maximise the free viewing area through the channel ring (with a preferred, but not imperative transparent embodiment). In order to design the glove replacement in a particularly convenient manner, provision is advantageously made within the scope of the invention such that the outer wall panel and the inner wall panel are adjustable, in particular swivellable, relative to one another, in order that the glove can be fixed, after the spacing of the wall panels apart from one another, to the means for the detachable fixing of the glove, in particular directly to the channel ring. The outer wall panel and the inner wall panel are preferably arranged parallel to one another during the operating status of the isolator. Irrespective of whether the outer wall panel and the inner wall panel are adjustable, in particular swivellable, relative to one another, it is preferable if the inner wall panel and the outer wall panel, preferably jointly, are components of an adjustable, in particular swivellable door, through which it is possible to reach into the isolator space (with the opened door) when not in operation.
It has proved to be particularly advantageous if an annular groove, in particular open outwards in the direction of the intermediate space, for the, in particular, clamping accommodation of an, in particular, engagement end-side glove bead ring is arranged on a side of the outer wall panel facing the isolator space, in particular directly in the outer circumference of the channel ring or alternatively in a fixing device fixed for example to the channel ring and provided in addition to the channel ring. In addition or as an alternative to the provision of an annular groove, an annular bead which can be pulled over by means of the glove bead ring, in particular in the direction of the outer wall panel, can be provided, for example directly at the outer circumference of the channel ring or of a device additionally provided, wherein the annular groove and the annular bead are intended to ensure good clamping capacity and a secure fit of the glove. In addition or as an alternative to an annular groove or an annular bead, the means for the detachable fixing can comprise other or additional fixing options, for example a fixing device, in particular in the region between the inner and the outer wall panel.
In order to ensure a good fit of the securing ring, in particular at the outer circumference of the channel ring or the retaining dummy part (in each case above or outside the glove), provision is advantageously made in a development of the invention such that a retaining groove, in particular open in the direction of the intermediate space, is assigned to the securing ring, in particular in the outer circumference of the channel ring or an optional additional retaining dummy part, wherein the glove runs through or engages over the retaining groove when the glove is fixed. In addition or as an alternative to a retaining groove (annular groove), a retaining bead can be provided, which prevents slipping-off or a movement of the securing ring in the direction of the inner wall panel. For the preferred case of the provision of an annular groove and/or an annular bead for the glove bead, it is preferable if the retaining groove and/or the retaining bead for the securing ring is located in a region between the annular groove or annular bead and the inner wall panel, in particular in the outer circumference of the channel ring or the additional fixing device.
As already indicated, an opening (passage opening) is preferably located in the inner wall panel, which opening is aligned with the reach-through channel surrounded by the channel ring, in order to be able to reach through by means of the glove. The channel ring preferably extends at least approximately from the outer wall panel up to this opening, still more preferably into the opening and very particularly preferably beyond the opening into the isolator space. It is preferable if any remaining annular gap between the, for example, circular or oval-contoured channel ring elongated in the engagement direction is dimensioned such that an aforementioned, optional securing ring can strike in the edge region of the opening in the inner wall panel or can be retained by such an edge region.
Provision is made within the scope of the method according to the invention such that the glove, in particular made of an elastomer material and/or comprising five fingers and/or an end-side glove annular bead is fixed, in particular with an engagement-side end, preferably comprising the aforementioned glove annular bead, outside the reach-through channel in the region between the outer and the inner wall panel, in particular in the intermediate region, to the glove port, preferably directly at the outer circumference of the channel ring. It is particularly expedient if, for this purpose, the outer and the inner wall panel are moved away from one another, in particular swivelled away, in order to be able to pull the glove over in the direction of the inside of the outer wall panel, for example directly onto the channel ring then comprising a free end or an additionally provided dummy part, in particular with the glove annular bead into an annular groove or over an annular bead. Provision is made according to the invention such that the glove is additionally secured by a securing ring, which is placed, in particular clamped, around the glove, in particular into a corresponding retaining groove or behind a corresponding retaining bead, preferably also from the direction of a free end of the channel ring, wherein an original relative position of the wall panels relative to one another, in particular in parallel, is adjusted after the fixing has taken place and after a preferred passing of the glove through a passage opening of the inner wall. The inner wall panel secures the securing ring against slipping off in this relative position.
Further advantages, features and details of the invention emerge from the following description of preferred examples of embodiment and with the aid of the drawings.
In the figures:
Identical elements and elements with the same function are denoted by the same reference symbols in the figures.
A detail of an isolator 1, for example for pharmaceutical applications, is shown in
Glove port 3 comprises, for example, an oval-contoured channel ring 10 made from a transparent, colourless plastic material, which extends from outer wall panel 8 in the direction of inner wall panel 7 and, as will be explained in further detail below, some way through the latter or an opening 11 provided therein into isolator space 5. Oval-contoured channel ring 10 directly delimits with inner circumference 12 a reach-through channel 13, through which an operative can reach from outside into glove 4 and can thus reach into double wall 2 without risk to products or operatives. Channel ring 10 is fixed tightly in the region of an opening edge of an opening 14, which is aligned with opening 11 at outer wall panel 8.
In the following, a preferred detail structure of the isolator constituted according to the concept of the invention according to
Glove port 3 is shown in detail in
It can be seen that an annular groove 17 spaced apart from outer wall panel 8 in the direction of inner wall panel 7 is provided at the outer circumference of channel ring 10, inside which annular groove an end-side glove bead 18 is accommodated in a clamping manner. For this purpose, glove 4 is pulled from inside in the direction of outer wall panel 8 over free end 16 of channel ring 10.
A further retaining groove 19 constituted as an annular groove is located between annular groove 17 and inner wall panel 7, in which further retaining groove a securing ring 20 constituted as an elastomer O-ring is accommodated in a clamping manner. This retaining groove 19 is penetrated by a circumferential portion of glove 4 axially along an engagement direction E for an operative, so that this portion of glove 4 is pressed or clamped by securing ring 20 against the outer circumference of channel ring 10, more precisely against the groove base of retaining groove 19. Securing ring 20 is thus located axially along engagement direction E between rear bead-shaped end or glove annular bead 18 of glove 4 and an opening edge 21 of opening 11 (passage opening) of inner wall panel 7, which thus forms a stop for securing ring 20 and prevents the latter from slipping off in the direction of isolator space 5.
Inner wall panel 7 is swivellable relative to outer wall panel 8 (not represented), so that channel ring 10 or its free end fixed to outer wall panel 8 can swivel backwards out of inner wall panel 7 or opening 11, in order thus to be able to remove securing ring 20 and to pull off glove 4 and then to pull on a new glove 4 and to secure it again with securing ring 20. In addition to the relatively swivellable arrangement of wall panels 7, 8 with respect to one another, wall panels 7, 8 are arranged so as to be swivellable jointly relative to a further (not shown) wall section (housing section) of isolator space 5, in order thus to facilitate the possibility of access when glove 4 is being replaced and at the same time to be able to reach into isolator space 5 via a larger opening when not in operation.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2016 101 195.9 | Jan 2016 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2017/050523 | 1/12/2017 | WO | 00 |
