Components for preventing unauthorized access to enclosures using work gloves

Abstract

The invention relates to a component for preventing unauthorized access to a closure device (1) by means of a work glove (3, 4) through an access portion (24) present in a port flange (2), the work glove (3, 4) being mounted on the port flange (2) in a conventional manner so that an operator can reach into a working chamber (11) of the closure device (1) in a protected manner. A plurality of port flanges (2) are usually mounted on the closure device (1) and the work glove (3, 4) is respectively fixed to the corresponding port flange (2). A machine (13) for processing items to be processed is usually arranged in the working chamber (11). In order to temporarily block the access portion (24), a locking component (5) is provided, which can be moved into a blocking position and an open position. The arrangement comprises a detection unit (62) for receiving personal data of an operator (9), the detection unit having a connection to a microcontroller (64) in order to issue a switching command to an activator (69) in the event of a correspondence between the detected personal data and the data in the microcontroller (64), so that the locking element (5) can be brought into a blocking position or moved from a blocking position into an open position and thus the access section (24) is blocked or accessible. The data of the microcontroller (64) are stored directly in the microcontroller or originate from an external control unit (8).

Description

Technical Field

[0001] The invention relates to a component for preventing unauthorized access to a closure device by means of a work glove via an access section present in a port flange. The port flange is mounted in a front window or in a wall of a closure device positioned in a housing space. Work gloves are mounted on the port flange, with which an operator can reach into a working chamber of the closure device under protective conditions. The closure device usually has a plurality of port flanges, to which the work gloves are respectively fixed. In the working chamber, a machine for processing objects to be processed, drugs or biotechnological substances is usually provided. In order to prevent unauthorized access to the working chamber of the closure device by means of a work glove via an access section present in the port flange, a locking element for temporarily blocking the access section is provided, which can be moved into a blocking position and an open position. Background Art

[0002] At the first Pharma Symposium in February 2019, Franz Ziel GmbH, D-48727 Billerbeck / Germany, presented a locking device to prevent unauthorized access to work gloves installed on isolators (see https: / / www.ziel-gmbh.com / de / newsarea / news-details / erstes-pharma-symposium-bei-der-franz-ziel-gmbh.html; Internet extract from July 18, 2019). This locking device consists of a substantially cross-shaped cover that can be placed from the outside onto the access part of the port flange and locked by means of a closing mechanism, so that only an operator with a corresponding key can remove the cover and thereby gain access.

[0003] At the ACHEMA trade fair in Frankfurt am Main in June 2018, OPTIMA pharma GmbH, D-74523 Schwäbisch Hall / Germany, and METALL+PLASTIC GmbH, D-78315 Radolfzell / Germany presented another such closure (see https: / / www.optima-packaging.com / en / press-area / press-kit-2016 / press-release-optima-pharma-and-metallplastic-achema-2018; Internet extract from 07 / 18 / 2019). In this closure, a plate-shaped cover blocks access, wherein the adjacent port flange additionally connects the cover to the crossbar. A safety sensor signals that the cover is open. When equipped with a safety closure, opening is only possible after authorization. The closure device of ROBERT BOSCH GmbH, D-70442 Stuttgart / Germany, which is published in the Achema Trend Report Pharmaceutical Packaging (see https: / / www.pharma-food.de / achema-Trendbericht-pharmaverpackungen / 3 / ; Internet extract from July 18, 2019), works in a similar way.

[0004] Finally, IMA Industria Macchine Automatiche SpA IT-40064, Ozzanodell′Emilia (Bo) / Italy discloses a locking device on an isolator for this purpose (see https: / / ima.it / pharma / machine / barrier-technology-open-closed-rabs / ; Internet extract from July 18, 2019). The access to the port flange and thus to the working gloves fixed thereto is locked by means of a lockable cover, which is equipped with a safety sensor and a safety blocking device and can only be pivoted to the side into a release position after authorization. Summary of the invention

[0005] Starting from the previously known prior art, the present invention is based on the object of providing a further developed component for preventing unauthorized access by working gloves through the access provided in the port flange into the working chamber of a closure device. Here, it is assumed that the closure device usually has a plurality of port flanges, each of which is provided with a working glove, and that a machine for processing the items to be processed is usually provided in the working chamber. This is to prevent unauthorized access by an operator as "uncontrolled human intervention" and thereby make the production of pharmaceutical products more loss-free and safer in particular and ensure comprehensive documentation of all operations on the port flange. An additional object is to design the working glove in such a way that it itself provides a locking element for protection against unauthorized access or can be used in combination with a separate locking element. SUMMARY OF THE INVENTION

[0007] In the case of a component designed to prevent unauthorized intervention in a closure device by means of a work glove through an access portion present in a port flange, the port flange is conventionally mounted in a front window or wall of a housing of a closure device positioned in a housing space. As usual, work gloves are mounted on the port flange, which enable an operator to reach into a working chamber of the closure device in a protected manner. In the case of a plurality of port flanges mounted on the closure device, the work gloves are fixed to the corresponding port flanges respectively. Usually, a machine for handling items to be processed can be present in the working chamber. In order to temporarily block the access portion, a locking component is provided, which can be moved into a blocking position and an open position. The component has a detection unit for receiving personal data of an operator, the detection unit having a connection with a microcontroller, so that in the case of a correspondence between the detected personal data and the data in the microcontroller, a switching command is issued to an activator, so that the locking component can be brought into a blocking position or moved from a blocking position to an open position, and thus the access portion is locked or accessible. The activator is directly arranged on the port flange or on the locking component. The data of the microcontroller are stored directly in the microcontroller or originate from an external control unit.

[0008] A specific embodiment of the invention is defined below: A detection unit for receiving personal data of an operator is assigned to the corresponding port flange or the corresponding closure element. In the event of a correspondence between the detected personal data and the data in the microcontroller, a switching command is sent to the activator so that the operator can place the specific closure element on the specific port flange and can bring the closure element into the blocking position or can unlock the closure element and remove it from the specific port flange, so that the access is blocked or accessible.

[0009] In a particularly advantageous embodiment, the detection unit for receiving the personal data of the operator is directly contained in the corresponding port flange or in the corresponding closure part. Alternatively, the detection unit for all relevant port flanges and closure parts of the closure device can be arranged in a mobile device, such as a tablet computer.

[0010] The detection unit is designed to receive a biometric marker of an operator, a code to be entered by an operator or electronic data of a data carrier to be provided by an operator. In this case, depending on the identification received by the detection unit from the operator, in cooperation with the microcontroller, based on data stored in the microcontroller or obtained by the control unit, the correspondingly active operator is authorized to adjust the blocking element on the relevant port flange into a blocking position or an open position by switching the activator, or to otherwise deny the operator.

[0011] Locking parts:

[0012] - directly integrated into the port flange and configured to be pivotable, expandable, shutter-like or expandable; or

[0013] - provided as a separate closure body which can be docked onto or removed from the port flange; or

[0014] -It is a detachable component of the glove, which forms a glove insert after the glove is matched.

[0015] The locking element can be designed as a closure body integrated in the port flange, wherein the locking element and the port flange are each provided with a safety sensor. Here, the two safety sensor pairs are used to detect the position of the locking element in the port flange in cooperation with an external safety relay and switch to automatic locking of the machine when the locking element is opened.

[0016] Alternatively, the locking component can be configured as a separate closure body that can be connected to or removed from the port flange. The locking component and the port flange are each provided with a safety sensor. The two safety sensors are now used to detect the position of the locking component relative to the port flange in cooperation with an external safety relay and switch to automatic locking of the machine when the locking component is spaced apart from the port flange.

[0017] In another alternative, the closure element can be designed as a closure body detachably connected to the glove insert, which can be locked on the port flange or removed from the port flange. The closure element and the port flange are each provided with a safety sensor. The two safety sensor pairs are designed to detect the position of the closure element relative to the port flange in cooperation with an external safety relay and switch to automatic locking of the machine when the closure element is spaced apart from the port flange.

[0018] A transmitter / receiver is provided in each case for the control unit and for each port flange respectively for the safety relay cooperating with the control unit. Here, the safety sensor in the port flange or in the locking element, which is designed as an active safety sensor, is used to detect whether a complementary safety sensor, which is designed as a passive safety sensor, is present. The transmitting / receiving element wirelessly supplies a signal to the transmitter / receiver indicating the absence of a passive safety sensor, which in turn forwards the absence of the passive safety sensor to the safety relay and automatically locks the machine.

[0019] The closure member - constructed as a separate closure body that can be connected to or removed from the port flange - or the port flange is provided with:

[0020] - a detection unit, a microcontroller and an activator which can be actuated manually or in a driven manner and is used to adjust the closure element into a blocking position or an open position; and optionally:

[0021] -Display and battery.

[0022] The port flange is equipped with an RFID chip, and the closure element - designed as a separate closure body that can be docked on or removed from the port flange - is provided with a transmitting / receiving element. Here, the transmitting / receiving element is used to detect this pairing when the closure element is placed on the port flange and to allow or deny the locking of the closure element based on data stored in the control unit or microcontroller.

[0023] Each working glove has an RFID chip which stores an individual serial number and preferably also the manufacturing data of the working glove, which can be read out by the transmitting / receiving element and stored in the control unit and / or the microcontroller. In addition, each new operation on the port flange and on the working glove is detected by means of the control unit and stored in the control unit for the relevant working glove, i.e. the individual history data is added.

[0024] The manufacturing data of each work glove can include: individual serial number, manufacturing date, glove size, material type, sterilization method applied and maximum use date. And the historical data of each work glove can include:

[0025] - Installation date into the port flange;

[0026] -Personal data of the installer;

[0027] - Identification of the port flange on which the installation was carried out, when, how often and by which operator the locking element on the relevant work glove was brought into the closed position or moved from the closed position into the open position;

[0028] - the time and number of cleaning cycles to be carried out in the working chamber of the enclosure, as well as the maximum permissible number of cleaning cycles;

[0029] - When and how often the relevant work gloves are leak tested;

[0030] - batches and products which are processed in the working chamber of the closed device and in the case of which the associated working gloves are used;

[0031] - Special events to be entered manually by the operator; and

[0032] - Personal data of the installer who performs the relevant removal and disposal of work gloves.

[0033] The working glove insert is constructed as an assembly that can be inserted into the port flange in an airtight manner and includes, on the one hand, a removable or openable seal and, on the other hand, a half-shell-shaped closure component that can be removed from the assembly and a working glove vacuum-packed therebetween. The glove insert provided as an assembly also has:

[0034] a fixing element which has a geometry complementary to the port flange, ie is provided in an annular or elliptical shape, and which is intended to be fixed to the port flange;

[0035] a projection which is designed to cooperate with a switchable retaining element extending from the port flange in order to temporarily fix the blocking member; and

[0036] - An RFID chip which is arranged in a fixed part of the glove insert.

[0037] Furthermore, magnetic regions may be present on the closure element, which are intended to interact with the fastening element in order to contribute to the strength of the connection between the closure element and the port flange.

[0038] Instead of a closure element, the glove insert can have a cover that is placed, and thereby also produces an assembly that can be inserted into the port flange in a gas-tight manner and includes, on the one hand, a removable or openable seal provided and, on the other hand, a hood-shaped cover that can be removed from the assembly and a working glove vacuum-packed therebetween. This embodiment of the glove insert with a cover instead of a closure element also has:

[0039] - a fixing part for fixing to the port flange; and

[0040] - An RFID chip which is arranged in a fixed part of the glove insert.

[0041] Additionally, magnetic regions can be present on the cover element, which are designed to interact with the fastening element in order to additionally temporarily fasten the cover element.

[0042] When the closure element or cover is placed on the glove insert and the seal is intact, a negative pressure exists between the seal and the glove surface in the inner volume of the glove insert. The inner volume of the glove insert, the surface of the seal facing the inner volume and the glove surface are sterile.

[0043] The free end of the glove is fastened to the fastening element and / or to the seal close to the fastening element, wherein the seal at least substantially covers the clear width of the fastening element. When the closure element or the cover is placed on the glove insert and the seal is intact, the seal is visually identifiable as a result of the negative pressure present in the glove insert and is bent concavely toward the glove insert. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In the attached figure:

[0045] Figure 1 A closure device according to the prior art is shown positioned in a housing space, with a port flange embedded in the front window of the closure device, a working glove fixed to the port flange, a locking element removed from the access portion, and an operator reaching into the working glove through the free access portion;

[0046] Figures 2A to 2F : A first embodiment of the assembly according to the invention as a schematic diagram;

[0047] Figure 2A Show Figure 1 a closure device in the embodiment of the invention with a (not visible) latching element integrated in the port flange (currently in the open position), an electronic component arranged in the port flange (wired version) and an associated control unit;

[0048] Figure 2B Show Figure 2A Enlarged details X1;

[0049] Figure 2C Shown in perspective Figure 2A Enlarged details X1;

[0050] Figure 2D Show according to Figure 2C , wherein the locking member is in a blocking position;

[0051] Figure 2E Show according to Figure 2D , wherein the locking member is in a blocked position, wireless version;

[0052] Figure 2F Show Figure 2A An example of a locking member in the form of a variable aperture member, wherein the locking member is in an open position, a wireless version;

[0053] Figures 3A to 3F : A second embodiment of the assembly according to the invention, as a schematic diagram;

[0054] Figure 3A Show Figure 1 A closure device in the invention with a separate closure element (currently in the open position), an electronic element arranged in the closure element, a wired version;

[0055] Figure 3B Shown in perspective Figure 3A Enlarged details X2;

[0056] Figure 3C Show according to Figure 3B , wherein the closure member is butted against the port flange, i.e., in a blocked position, and the compressed work glove is in the closure member;

[0057] Figure 3D A vertical cross-section diagram is shown according to Figure 3C 's diagram, wired version;

[0058] Figure 3E Show according to Figure 3C , wherein the locking member is butted against the port flange, i.e. in the blocking position, wireless version;

[0059] Figure 3F A vertical cross-section diagram is shown according to Figure 3E pictorial diagram;

[0060] Figures 4A to 4F : A third embodiment of the assembly according to the invention, as a schematic diagram;

[0061] Figure 4A Show Figure 1 A closure device in which an RFID chip is arranged on a work glove and Figure 5A The separate latching component in the, currently in the open position, wired version;

[0062] Figure 4B Show according to Figure 4A , in which the locking component is docked on the port flange, i.e. in the blocked position.

[0063] Figure 4C Show Figure 4A and 5A an enlarged locking member in;

[0064] Figure 4D Show Figure 4A Enlarged details of X3;.

[0065] Figure 4E Show Figure 1 A closure device in which an RFID chip is arranged on a work glove and Figure 5A Separate latching part in the case, currently in open position, wireless version

[0066] Figure 4F Show Figure 4E Enlarged details X4;

[0067] Figure 5A A working glove designed as an insert is shown with an intact seal and the associated latching elements arranged, i.e. in the closed position;

[0068] Figure 5B Show according to Figure 5A , wherein the locking member is disassembled, i.e., in an open position;

[0069] Fig. 6A A working glove designed as an insert is shown with an intact seal and a cover in place;

[0070] Figure 6B Show according to Fig. 6A , wherein the cover is removed;

[0071] Figures 7A to 7G : A fourth embodiment of an assembly according to the invention, comprising a working glove designed as an insert and a Figure 5A The relevant locking components as a schematic diagram;

[0072] Fig. 7A Show according to Figure 1 A closure device in a structure having an open access portion and a Figure 4A The close glove insert, wired version;

[0073] Figure 7B Show Fig. 7A Enlarged details of X5;

[0074] Figure 7C Show according to Fig. 7A a situation in which the glove insert is placed on the port flange, the seal is intact and the closure member is positioned, i.e. in the blocked position, wireless version;

[0075] Fig.7D Show Figure 7CEnlarged details of X6;

[0076] Fig. 7E Show according to Figure 7C a situation in which the glove insert is placed on the port flange and the closure member is removed, i.e. in the open position, a wireless version;

[0077] Figure 7F Show Fig. 7E Enlarged details of X7;

[0078] Figure 7G Show according to Fig. 7E a situation in which the glove insert is fixed to the port flange, the seal is pierced, the closure element is disassembled, i.e. in the open position, and the operator reaches into the working chamber of the closure device via the free access portion using the glove insert, wireless version;

[0079] Figure 8 and 9 : A hybrid form of the assembly according to the invention, as a schematic diagram;

[0080] Figure 8 The embodiment shows a locking element integrated into the port flange according to a first embodiment (presently in the open position) and a Fig. 6A A combination of a glove insert (wireless version) with a cover arranged thereon;

[0081] Fig. 9 The blocking member (currently in the blocking position) placed on the port flange according to the second embodiment and the Fig. 6A Combination of a glove insert (wired version) embedded in the port flange with a cover installed. DETAILED DESCRIPTION

[0082] With reference to the accompanying drawings, a detailed description of different embodiments of an assembly according to the invention is given below for preventing unauthorized intervention in a closure device by means of working gloves through an access present in a port flange.

[0083] The following definitions apply throughout the further description. If a reference numeral is included in a figure to clarify the illustration and a "repeated" component can be clearly identified from the figure, but is not explained in the directly related description text, then for the sake of brevity, reference should be made to its explanation in the preceding figure description.

[0084] Figure 1

[0085] Here, in principle, the prior art is presented first. A closure device 1 surrounded by a housing 10 is positioned in a receiving space 19, in the front window 12 of which a port flange 2 is arranged. The working glove 3 is fixed to the port flange 2 by means of a fixing element 30 present on the working glove. In the configuration described in the above section "Prior Art", the closure element 5 is temporarily removed from the access section 24 of the port flange 2, so that the operator 9 can introduce his arm into the interior space 32 of the working glove 3 and can thus intervene in the working chamber 11 of the closure device 1 in a protected manner through the free access section 24. The working glove 3 has an inner face 33 facing its inner space 32 and an outer face 34 facing the working chamber 11. In the working chamber 11, a machine 13 which is usually installed in the working chamber is shown, which has the function of processing the items to be processed, such as drugs or biotechnological substances.

[0086] Figures 2A to 2D

[0087] This series of figures shows an assembly for preventing unauthorized access to a closure device 1 with a working glove 3 through an access 24 present in the port flange 2 according to a first embodiment of the invention and in a wired version, with a blocking element 5 directly integrated in the port flange 2, which can be configured, for example, as a pivotable, expandable, shutter-like, expandable or iris-like device. Figures 2A-2C In the embodiment, the locking member 5 is in the open position, so that the access portion 24 is free, and Figure 2D The blocking element 5 is shown in the blocking position, and the access 24 is therefore blocked.

[0088] Component Construction

[0089] Most of the electronic components are contained in the port flange 2, namely the battery 60, the display 61, the detection unit 62, the microcontroller 64, the transmitting / receiving element 65, the passive safety sensor 66 arranged on the movable locking part 5 and the active safety sensor 21 fixed to the port flange 2. In addition, an activator 69 is installed in the port flange 2 for adjusting the locking part 5. A first cable 67 and a second cable 68 lead to the port flange 2 for signal guidance and power supply. The work glove 3 equipped with the RFID chip 36 is fixed to the port flange 2 by means of its fixing part 30 and is shown as extending rigidly into the working chamber 11 only for the purpose of explaining its shape. The control unit 8 connected to the safety relay 81 is located outside the closure device 1.

[0090] How the components work

[0091] After the protective assembly has been installed, the closure device 1 can be put into operation. To this end, the work gloves 3 are first brought into the correct position and the access 24 on the port flange 2 is closed by means of the closure element 5. The transmitting / receiving element 65 reads the serial number from the RFID chip 36 of the relevant work glove 3 and stores it in a database provided for this purpose in the control unit 8. If one of the work gloves 3 has reached its maximum use date, this is confirmed by the control unit 8. The operator 9 is instructed to install a new work glove 3. The closure device 1 starts the operating mode; the machine 13 in the working chamber 11 is operated, for example for filling with medication.

[0092] If the operator 9 now wants to enter from the access portion 24 through the port flange 2 blocked by the closure element 5, he must identify himself at the detection unit 62. The microcontroller 64 evaluates the personal data detected by the detection unit 62 for access authorization using predetermined user data from a database stored in the control unit 8. The data can also be stored individually in each microcontroller 64. The microcontroller 64 communicates wirelessly with the control unit 8, for example via WLAN, via a transmitting / receiving element 65 and transmits the corresponding data.

[0093] If the operator 9 is not authorized to access due to level, machine mode, current process step or the state of the working gloves 3 (e.g. damage), this is displayed on the display 61 and no further action is taken. If the operator 9 is authorized, the machine 13 is first stopped in a controlled manner. The release is then transmitted via the microcontroller 64 to the activator 69, which then opens the mechanical locking element 5, for example by pivoting it open or turning it open, depending on the design of the locking element. The operator 9 can now access the working chamber 11 through the access 24 with the working gloves 3.

[0094] As soon as the locking element 5 driven by the activator 69 moves toward the open position, i.e. the passive safety sensor 66 moves away from the active safety sensor 21, the active safety sensor 21 loses its signal. The active safety sensor 21 continuously transmits its signal to the safety relay 81 via the first cable 67. If the signal is interrupted, the safety relay stops the machine 13 or, if the machine has been switched off, locks the machine 13. Restarting the machine 13 is now also not possible.

[0095] When the closure element 5 is opened, the transmitting / receiving element 65 is activated by the microcontroller 64, which reads the RFID chip 36 on the relevant working glove 3 and compares its serial number with the identification stored in the control unit 8. The current intervention is then noted in the control unit 8 for the relevant port flange 2 in a database.

[0096] If a critical or impermissible condition of the working glove 3 occurs due to new use, the operator 9 is informed of this via the display 61 on the port flange 2. This information is stored in the database of the control unit 8 so that further use of the working glove 3 is no longer possible or is only possible under restricted conditions. These are to be defined individually by the system administrator. Thus, if a working glove 3 is damaged, for example due to unskilled operation at the machine 13, it can be classified as "defective and blocked for the batch".

[0097] In normal operation, the relevant electronic components are powered via the second cable 68. The built-in accumulator 60 serves as an emergency unit in the event of a power failure, so that the relevant actions on the closure device 1 can also be performed for a limited period of time.

[0098] Figure 2E and 2F

[0099] This pair of figures also relates to the components of the first embodiment, but now in a wireless version. Figure 2E In the embodiment, the locking member 5 is in the blocking position, and Figure 2F The blocking element 5 is shown provided as an iris-type element in an open position.

[0100] Component Construction

[0101] The active safety sensor 21' is still fixedly integrated on the terminal flange 2, while the passive safety sensor 66 is arranged on the movable locking part 5. The RFID chip 36 is still installed on the work glove 3, but the first cable 67 and the second cable 68 for signal guidance or power supply are no longer present. Now, a transmitter / receiver 80 is connected to the connection structure formed by the external control unit 8 and the safety relay 81.

[0102] How the components work

[0103] The working principle is basically the same as the series Figures 2A-2D The same, so that only the differences are described here, which result from the omission of the two cables 67 , 68 . The battery 60 in the port flange 2 now supplies the electronic components 61 , 62 , 64 , 65 , 21 ′ and 69 contained in the port flange 2 alone.

[0104] As soon as the locking element 5 driven by the activator 69 moves toward the open position, i.e. the passive safety sensor 66 moves away from the active safety sensor 21′, the active safety sensor 21′ loses its signal. The active safety sensor 21′ continuously transmits its signal wirelessly to the transmitter / receiver 80 via the transmitting / receiving element 65, and the transmitter / receiver 80 transmits the data to the safety relay 81 by wire. Here, too, the safety relay 81 stops the machine 13 if the signal is interrupted, or locks the machine 13 if the machine is not switched on. It is now also impossible to restart the machine 13.

[0105] Figures 3A to 3D

[0106] This series of figures shows a second embodiment and a wired version of the assembly, which has a closure member 5 which is constructed as a separate cap-shaped closure body which can be docked onto the port flange 2 or can be removed from the port flange 2. Figure 3A In +3B, the closure member 5 is in the open position, so that the access portion 24 is free and the working glove 3 can be freely extended from the port flange 2, while Figure 3C +3D shows the closure element 5 in the closed position with the blocked access 24 and the work glove 3 being compressed in the hood-shaped closure element 5 .

[0107] Component Construction

[0108] Most of the electronic components, namely the battery 60, the display 61, the detection unit 62, the microcontroller 64, the transmitting / receiving element 65, the passive safety sensor 66 and the activator 69 for locking or unlocking between the port flange 2 and the closure part 5 are now installed in the closure part 5. The first docking element 25 on the port flange 2 and the complementary second docking element 55 on the closure part 5 are used for locking. The active safety sensor 21 is located on the port flange 2, and the first cable 67 and the second cable 68 serve as signal lines and lead to the power supply. The RFID chip 22 is placed on the port flange 2, and the work glove 3 has another RFID chip 36. The closure part 5 is basically formed by a hood-shaped housing 50, which has a handle 59 to facilitate the manipulation of the closure part 5. A control unit 8 is provided on the outside of the closure device 1, which has a safety relay 81 connected to the control unit.

[0109] How the components work

[0110] This principle of action is similar to the series Figures 2A-2DVery similar, so that in order to avoid repetitions it is sufficient here to describe only the particularities which result from the now transportable closure component 5 , the activator 69 present therein and the mutually complementary first and second abutment elements 25 , 55 .

[0111] The transmitting / receiving element 65 reads the serial number from the RFID chip 36 of the relevant working glove 3 and from the RFID chip 22 of the relevant port flange 2, and stores the serial number detected by the RFID chip 36 of the working glove 3 in a database provided for this purpose in the control unit 8. The serial number detected by the RFID chips 22 of multiple port flanges 2 allows the corresponding locking components 5 to be assigned to the relevant port flanges 2. For example, if a locking component 5 is placed on a non-related port flange 2 and the locking component 5 of this port flange is placed on another port flange 2, this mix-up is recorded in the control unit 8. Depending on the embodiment, the incorrect placement is then reported on the display 62, or the new position of the locking component 5 overwrites the old position. If the locking component 5 is correctly matched and the first and second docking elements 25, 55 are aligned with each other, its locking is carried out by operating the activator 69.

[0112] If the operator 9 intends to enter from the access 24 through the port flange 2 blocked by the closure 5 and if he has been identified as authorized for entry, the machine 13 is first stopped in a controlled manner. The release is then transmitted via the microcontroller 64 to the activator 69, which then unlocks the first and second docking elements 25, 55 from each other, so that the operator 9 can remove the closure 5 and the access 24 is released for intervention in the working chamber 11 with the working gloves 3.

[0113] As soon as the locking element 5 is removed from the blocking position, i.e. the passive safety sensor 66 is also removed from the active safety sensor 21, the active safety sensor 21 loses its signal and the machine 13 is thus stopped or locked. Figures 2A-2D As described, the current intervention is detected and noted in the database for the relevant port flange 2 present in the control unit 8. As long as the port flange 2 is locked with the closure part 5, the battery 60 built into the closure part is charged from the grid via the second cable 68 and is also powered via the second cable 68. However, if the closure part 5 is unlocked and removed from the port flange 2, the battery 60 alone powers the electrical components 61, 62, 64, 65 and 69 contained in the closure part 5.

[0114] Figure 3E and 3F

[0115] This pair of figures still relates to the assembly of the second embodiment, but now in a wireless version. The closure element 5 is placed on the port flange 2 and locked thereto, so that the access 24 is blocked and the working glove 3 is compressed in the hood-shaped closure element 5 .

[0116] Component Construction

[0117] Since the first cable 67 and the second cable 68 for signal guidance and power supply are no longer present, the Figures 3A-3D , the active safety sensor 21 ′ and the passive safety sensor 66 exchange their installation positions. The passive safety sensor 66 is now fixedly integrated on the terminal flange 2, while the active safety sensor 21 ′ is now arranged in the locking part 5. The work glove 3 is again equipped with an RFID chip 36. Now, the transmitter / receiver 80 is connected to the connection structure formed by the external control unit 8 and the safety relay 81.

[0118] How the components work

[0119] This principle of action is similar to the series Figures 3A-3D Almost identical, so that repetition can be avoided and only the differences are described here, which are caused by the change in the installation position of the active safety sensor 21 ′ and the passive safety sensor 66. The battery 60 in the closure part 5 ensures complete power supply of the electronic components 21 ′, 61, 62, 64, 65 and 69 contained in the closure part.

[0120] As soon as the locking element 5 is lifted from the port flange 2 and its active safety sensor 21′ is thus removed from the passive safety sensor 66 located in the port flange 2, the active safety sensor 21′ loses its signal. The active safety sensor 21′ continuously transmits its signal wirelessly via the transmitting / receiving element 65 to the transmitter / receiver 80, which then transmits the data by wire to the safety relay 81. Due to the signal interruption, the safety relay 81 stops the machine 13 or, if the machine is not switched on, locks the machine 13.

[0121] Figures 4A to 4D

[0122] This series of figures shows a third embodiment of a wired version, in which the blocking member 5 is constructed as a separate half-shell-shaped closure body which can be docked onto the port flange 2 or removed from the port flange. Figure 4A In +4D, the closure member 5 is in the open position, so that the access portion 24 is free and the working glove 3 can be freely extended from the port flange 2, while Figure 4B The closure element 5 is shown in the closed position with the access opening 24 blocked and the working glove 3 extending into the working chamber 11 . Figure 4C Such a separate closure element 5 is shown with its structural details.

[0123] Component Construction

[0124] As per Figure 2B As shown, the port flange 2 contains all electronic components 21, 60, 61, 62, 64, 65 and 69, and the work glove 3 is fixed to the port flange 2 by its fixing part 30. As a special feature, a lever-type retaining element 28 is arranged on the port flange 2, which can be switched to the "open" and "closed" positions. The work glove 3 is also equipped with an RFID chip 36. For signal guidance and power supply, two cables 67 and 68 lead to the port flange 2. The control unit 8 is again outside the closure device 1, and the control unit has a safety relay 81 connected to the control unit. The half-shell-shaped locking part 5 is preferably made of plastic and has a curled hook-shaped protrusion 58 on its edge, a magnetic area 57 adjacent to it, and a passive safety sensor 66 arranged close to the magnetic area 57.

[0125] How the components work

[0126] Precautions for starting the device, confirming and granting access rights to the operator 9, transferring the locking element 5 into the blocking position and thus locking the access section 24, and reading the serial number from the RFID chip 36 on the work glove 3 and storing it in the database of the control unit 8 for comparison with the data according to the Figures 2A-2D . When the access portion 24 is closed, a special situation occurs when the closure member 5 is placed on the port flange 2 and when they are locked together. To this end, the retaining element 28 must first be in the "open" position, whereby the protrusion 58 can be pushed under the retaining element 28. After obtaining authorization for locking, the activator 69 then switches the retaining element 28 to the "closed" position, so that the retaining element 28 and the protrusion 58 engage with each other. The magnetic area 57 on the closure member 5 helps to strengthen the connection strength between the closure member 5 and the port flange 2.

[0127] If the operator 9 intends to enter from the access 24 via the port flange 2 blocked by the locking element 5 and the access authorization has been granted, the machine 13 is first stopped in a controlled manner. The release is then transmitted to the activator 69 via the microcontroller 64, and the retaining element 28 is then switched to the "open" position, so that the retaining element 28 and the projection 58 are disengaged, whereby the operator 9 can remove the locking element 5 and release the access 24 for intervention in the working chamber 11 with the working gloves 3. The interaction of the two safety sensors 21, 66, the signal processing and the stopping of the machine 13 in the event of a signal interruption and the detection and recording of the current intervention, including the power supply in normal operation and the function of the battery 60 built into the port flange 2 as an emergency unit in the event of a current failure, corresponds to Figures 2A-2D Description.

[0128] Figure 4E and 4F

[0129] This pair of figures still relates to the assembly of the third embodiment, but now in a wireless version. The blocking member 5 is removed from the port flange 2 , so that the access portion 24 is free and the previously authorized operator 9 can reach into the working chamber 11 using the working gloves 3 .

[0130] Component Construction

[0131] In this case, the two cables 67, 68 for signal guidance or power supply are no longer present, and power can only be provided by the battery 60 built into the terminal flange 2, while the current supply of the closure part 5 is still missing. The safety sensor 21' is integrated into the terminal flange 2 and the passive safety sensor 66 is arranged on the closure part 5. The work glove 3 is again equipped with an RFID chip 36. A transmitter / receiver 80 is again connected to the connection structure formed by the external control unit 8 and the safety relay 81.

[0132] How the components work

[0133] The battery 60 in the port flange 2 alone ensures power supply for the electronic components 21 ′, 61, 62, 64, 65 and 69 contained in the port flange 2. In addition, in accordance with FIG. Figures 4A-4DIn contrast, when the closing element 5 is removed from the port flange 2 (which can only be done after authorization has been given and the retaining element 28 has been switched to the "open" position), the following occurs: the passive safety sensor 66 arranged on the closing element 5 is displaced from the active safety sensor 21' arranged in the port flange 2, so that the latter determines a signal interruption. The active safety sensor 21' itself continuously transmits its signal wirelessly via the transmitting / receiving element 65 to the transmitter / receiver 80, which then transmits the data by wire to the safety relay 81. Due to the signal interruption, the safety relay 81 stops the machine 13 or locks it if it is not switched on.

[0134] Figures 5A to 6B

[0135] The pair of figures 5A+5B shows a glove insert 4 which comprises a working glove 3, a fastening element 40, a sealing element 41 and a closure element 5. The pair of figures 6A+6B relates to a glove insert 4 to which a cover element 7 belongs instead of a closure element 5.

[0136] According to the prior art, a conventional working glove 3 is installed in the end flange 2 of the closure device 1 (see Figure 1 ). Here, the work glove 3 is put on a mostly removable ring and is usually sealed with an O-ring. In order to prepare for the start of the production mode on the closure device 1, it is already mandatory to check the tightness of the work glove 3 - with the help of a test device - which requires additional equipment and time on site, for example in a pharmaceutical factory. In addition, the entire outer surface 34 of the work glove 3 facing the working chamber 11 must be cleaned together with the closure device 1. For this purpose, a so-called glove stretcher (see, for example, CH707655A1 of the applicant) is usually introduced into the work glove 3 in order to treat all surface areas with sufficient strength by stretching them with, for example, the H2O2 gas used. Due to the large and strongly deformed outer surface 34, a correspondingly long cleaning time is required. In particular, in the case of a closure device 1 that is operated aseptically or toxically, frequent cleaning or cleaning is required, and it is usually necessary to install a completely new work glove 3, thereby repeating the above-mentioned work expenditure. Therefore, there is an increasing need to design a work glove that provides a closure component itself to prevent unauthorized intervention, or can be used with a separate closure component, while significantly reducing the cost of the work glove 3 before use at the site where the closure device 1 of the work glove is equipped, such as at a pharmaceutical manufacturer.

[0137] Figure 5A and 5B

[0138] The pair of figures relates to a glove insert 4 which is designed as a combination which can be inserted in a gas-tight manner into a port flange 2. On the one hand, the glove insert 4 has a removable or openable seal 41 which covers an annular fixing part 40 and, on the other hand, a half-shell-shaped closure part 5 which is placed in a gas-tight manner on the fixing part 40 but is detachable. Depending on the geometry of the port flange 2, the fixing part 40 can also be provided in an elliptical shape. Between the seal 41 and the closure part 5 is a working glove 3 which is compressed and packed under vacuum. The fixing part 40 also serves to fix the open glove end and to fix the glove insert 4 on the port flange 2. The glove end can alternatively be fixed to the fixing part 40 and / or the seal 41. An RFID chip 46 is arranged in the fixing part 40, which can be written to register all new operations on the glove insert (4), including all new operations on the working glove (3). An inner face 43 and a surface 44 are drawn on the working glove 3. The inner space 42 is between the locking part 5 attached to the fixing part 40 and the inner surface 43 , while a front space 45 is defined between the seal 41 and the surface 44 .

[0139] The closure element 5 is preferably made of plastic and has a crimped hook-shaped projection 58 on its edge 51. A passive safety sensor 66 is preferably arranged near the edge 51. Optionally, a magnetic region 57 can be provided, for example adjacent to the edge 51, which can be used to suspend the closure element 5 removed from the glove insert 4 installed in the port flange 2 nearby on a suitable parking station 15 (see Figure 7G ).

[0140] The projection 58 is designed to cooperate with the switchable retaining element 28 extending from the port flange 2 in order to temporarily secure the closure member 5 against unauthorized removal (see Figure 7C +7D). The detachable form-fitting and / or force-fitting connection structure of the locking part 5 on the fixing part 40 includes, for example, a shape on the edge 51 and / or the projection 58 of the locking part 5 and a complementary shape on the fixing part 40, an adhesive between the fixing part 40 and the locking part 5, or a predetermined breaking point.

[0141] When the closure element 5 is placed sealingly on the fastening element 40 and the seal 41 is intact (see Figure 5A), a negative pressure exists in the interior space 42 and in the front space 45. At least the front space 45 together with the surface facing the front space, i.e. the surface 44 and the inner surface of the seal 41 are sterile. In the initial situation, the interior space 42 together with the facing surface, i.e. the inner surface 43 and the inside of the closure part 5 are preferably also sterile. In the initial situation, the negative pressure existing in the front space 45 leads to a concave curvature of the seal 41, which forms an advantageous visual indicator for the proper state of the glove insert 4.

[0142] If the locking member 5 is removed from the fixing member 40, but the seal 41 remains intact (see Figure 5B ), the inner space 42 is open to the atmosphere. Due to the elasticity of the working glove 3 and the seal 41, the negative pressure previously present in the front space 45 of the glove insert 4 also adapts to the atmospheric pressure, so that the previous concave curvature of the seal 41 is eliminated by the resulting pressure equalization.

[0143] The factory-pre-sterilized, packaged and substantially ready-to-install glove insert 4 significantly saves time and equipment costs on site at the closure 1, for example for the pharmaceutical manufacturer, and at the same time increases product safety. It is no longer necessary to put on the ring provided for this purpose, which is required when fixing conventional work gloves 3 in the port flange 2. The glove insert 4 with the fixing part 40 can be inserted into the port flange 2 in a very practical manner as a combination, for example by means of a gas-tight, screwable or lockable latching mechanism, a bayonet mechanism or a snap mechanism, and thereby significantly reduces the risk of installation errors at the same time. The glove insert 4 is tested for tightness during the factory manufacturing process and then vacuum-packed, wherein the retained concave curvature of the seal 41 under mechanical stress indicates a continuous tightness, i.e. a state in accordance with the regulations. In the case of the glove insert 4, the tightness check that is otherwise mandatory after installation in the case of conventional work gloves 3 can be omitted. The sterilization of the glove insert 4 already carried out at the factory by a radiation source or an inflating device results in a higher degree of cleanliness than the purification during the state of installation in the closure 1. Furthermore, the decontamination time of the installed, pre-sterilized glove insert 4 is shortened compared to conventional work gloves 3, since only the outer surface of the seal 41 of the glove insert 4 facing the working chamber 11 must be decontaminated, and no longer the entire complexly structured outer surface 34 of the work glove 3.

[0144] Fig. 6A and 6B

[0145] This pair of figures also relates to a pre-sterilized glove insert 4 which can be inserted airtightly into the port flange 2, which is similar to the previous pair of figures. Figure 5AThe difference of +5B is that a cover 7 which is simpler in function and structure is provided instead of the previously existing closure member 5. The sealing member 41, the fixing member 40 and the vacuum-compression-packed working glove 3 continue to exist, but are now covered by the shell-shaped cover 7, which is placed on the fixing member 40 in an airtight but detachable manner.

[0146] The fixing part 40 covered by the seal 41, in which the RFID chip 46 is arranged, is used again to fix the open glove end and also to fix the glove insert 4 to the port flange 2. Here, alternatively, the glove end can also be fixed to the fixing part 40 and / or the seal 41. The inner face 43 and the surface 44 and the front space 45 between the seal 41 and the surface 44 are also present. Now only the inner space 42 can be defined between the inner face 43 and the cover 7 attached to the fixing part 40. Due to the limited function of the cover 7 - it can no longer be used as a closure part 5 - the passive safety sensor 66 and the projection 58 are omitted in the case of the cover 7.

[0147] The cover 7 is also preferably made of plastic and may have a magnetic zone 77 adjacent to the edge 71 which is useful for the same purpose as the magnetic zone 57 on the closure member 5 (see Figure 7G The detachable form-locking and / or force-locking connection structure of the cover 7 on the fixing part 40 includes, for example, a shape on the edge 71 of the cover 7 and a complementary shape on the fixing part 40, an adhesive between the fixing part 40 and the cover 7, or a predetermined breaking point.

[0148] The pressure conditions in and on the glove insert 4 (when the cover 7 is sealed against the fastening element 40 and the seal 41 is intact), the concave curvature of the seal 41 adapted thereto and the sterile area (see Fig. 6A ) and in accordance with Figure 5A The glove insert 4 is equivalent to the glove insert 4 in the state. Figure 5B A similar situation applies with the cover 7 removed from the fixing part 40 and the seal 41 still intact with regard to the eliminated bend of the seal 41 and the sterile area in the front space 45 (see Figure 6B ).

[0149] Fig. 7A and 7B

[0150] This pair of figures illustrates the fourth embodiment and the wired version having the Figure 5A+5B, with a closure element 5 and a working glove 3 matched to the glove insert 4. The access 24 into the working chamber 11 is open. The glove insert 4 has not been used so far, i.e. the pre-sterilized state of the interior is maintained and the closure element 5 is arranged gas-tightly on the fixing element 40 as a detachable component, as can be seen in the concave curvature of the seal 41. The glove insert 4 is provided for installation in the port flange 2.

[0151] The port flange 2 has all the electronic components 21, 60, 61, 62, 64, 65 and 69 and the two cables 67, 68 are connected, as already described for Figure 2B +4D described. The passive safety sensor 66 is arranged on the closure part 5, and the RFID chip 46 is arranged in the fixing part 40 of the glove insert 4. In order to dock the glove insert 4 with the protrusion 58 extending from the arranged closure part 5, the holding element 28 on the port flange 2 must be in the "open" position. It is assumed that the operator 920 has found the "open" position on the holding element 28 or is authorized to trigger the switching pulse applied to the activator 69. A control unit 8 connected to a safety relay 81 is provided outside the closure device 1.

[0152] Figure 7C and 7D

[0153] This pair of diagrams shows that Figure 5A The further installation of the glove insert 4 of +5B in the port flange 2, wherein the closure element 5 is still placed gas-tightly on the fixing element 40 and the seal 41 is intact due to its concave curvature. In order to illustrate the possible range of variations in the design of the protective assembly, a wireless version is shown here. Therefore, a transmitter / receiver 80 is connected to the connection structure consisting of an external control unit 8 and a safety relay 81.

[0154] If, when the glove insert 4 is brought closer for fixing in the port flange 2, a sufficient proximity is reached between the RFID chip 46 installed in the fixing part 40 and the transmitting / receiving element 65 arranged in the port flange 2, the serial number of the glove insert 4 is read out and compared with the database in the control unit 8, after which the correct or incorrect configuration relationship between the port flange 2 and the brought-close glove insert 4 is displayed to the operator 9 on the display 61. If the configuration relationship is incorrect, the locking between the protrusion 58 and the retaining element 28 is rejected, which requires the operator 9 to take action, i.e. either to provide a suitable glove insert 4 or - if possible - to overwrite the entry in the database in order to continue the process.

[0155] If the installation itself is complete, the operator 9 must enter his identity via the detection unit 62 in order to check his authorization for the installation. If the configuration is correct and the operator 9 is authorized, the activator 69 receives a switching command via the control unit 8 and the microcontroller 64 to switch the holding element 28 into the "closed" position, whereby the protrusion 58 and the holding element 28 are locked to each other, so that the locking part 5 reaches the blocking position and cannot be removed without authorization. The use of the glove 3 in the vacuum and the insertion into the working chamber 11 are blocked. The correct insertion of the glove insert 4 into the port flange 2 is confirmed via the display 61. In particular, it is obtained in the database of the control unit 8: which glove insert 4 was installed by which operator 9 on which port flange 2 and when it was installed.

[0156] In the blocking position, the active safety sensor 21 detects the defined proximity of the passive safety sensor 66, receives the signal and transmits it wirelessly and continuously to the transmitter / receiver 80 via the transmitting / receiving element 65, but the transmitter / receiver transmits the data by wire to the safety relay 81. In the continuous signal flow, the safety relay 81 does not cause the locking of the machine 13 in the working chamber 11, and the operating mode for the closure device 1 and the machine 13 can be activated. In the next step, the working chamber 11 is decontaminated to treat the non-sterile outer surface of the seal 41.

[0157] Figures 7E to 7G

[0158] This series of figures follows the previous pair with the wireless version in terms of the structure and function of the components. Figure 7C +7D. Furthermore, the authorized removal of the closure element 5 from the glove insert 4 to establish the open position is now processed, so that the operator 9 can access the working chamber 11 through the access 24 with the working glove 3 pushed out of the glove insert 4 .

[0159] refer to Figures 2A-2D There is no need to redescribe the circuit and signal processing flow on the device side, so the following discussion is limited to using the Figure 5A +5B is the special case of the glove insert 4. It is therefore assumed that the operator 9 has obtained authorization to remove the locking element 5 from the glove insert 4, after which the retaining element 28 has been switched by the activator 69 to the "open" position, i.e. the locking between the retaining element 28 and the projection 58 is cancelled. At the latest as the locking element 5 begins to be removed from the fixing element 40, a signal interruption occurs between the passive safety sensor 66 and the active safety sensor 21 ′, which leads to the locking of the machine 13 in the working chamber 11, as has already been described several times.

[0160] After the closure element 5 has been released, it can be deposited on the parking station 15, for example, by means of the magnetic zone 57, the access to the working glove 3 is opened and the interior 42 of the receiving space 19 is open. Although sterility is lost on the inner surface 43 of the working glove 3, it is not lost in the front space 45 with the adjacent surface. The intact seal 41, which now opens out of the concave curved surface due to the atmospheric pressure acting, prevents contamination from penetrating from the working chamber 11 into the front space 45 due to the influx of gas or particles.

[0161] The operator 9 can now reach from the outside into the initially still compressed working glove 3 and stretch it in the direction of the working chamber 11, whereby the seal 41, which is now sterile on both sides, is now pierced. It may be advantageous to open the seal 41 from the inside of the working chamber 11, for example by means of a robot belonging to the machine 13. After each intervention, it is advisable to place the working glove 3 in the closure element 5 which has not yet been locked again. The closure element 5 is then placed again on the fixing element 40 and locked by the retaining element 28 and the projection 58, so that the closure element 5 is again in the closed position and can only be removed again if authorization is currently obtained, in order to allow the next intervention in the working chamber 11 with the working glove 3 through the open seal 41 and the access 24 in the port flange 2. In particular, it is acquired in the database of the control unit 8 which glove insert 4, with which working glove 3, on which port flange 2, by which operator 9, when and for how long, which closure element 5 was moved between the closed position and the open position.

[0162] Figure 8

[0163] The assembly consists of a locking component 5 (such as Figure 2F best seen in Fig. 6AThe present invention is a combination of a glove insert 4 with a cover 7 placed in a glove insert 4 installed in a port flange 2. As a wireless version, a transmitter / receiver 80 is connected to the connection structure of an external control unit 8 and a safety relay 81. The port flange 2 contains all electronic components 21', 60, 61, 62, 64, 65 and 69. It is assumed that the operator 9 has obtained authorization to bring the locking element 5 designed as a variable aperture element into the open position, which leads to a signal interruption between the passive safety sensor 66 and the active safety sensor 21' and the locking of the machine 13 in the working chamber 11. In order to enter the working chamber 11 with the pre-sterilized working glove 3 still compressed in the glove insert 4, the cover 7 arranged in a gas-tight manner on the fixing element 40 must first be removed and then the seal 41 previously cleaned on the outer surface must be penetrated by the working glove 3 pushed forward or opened in another way, for example from the inside of the working chamber 11, preferably by a robot belonging to the machine 13.

[0164] Fig. 9

[0165] The assembly consists of a cap-shaped closure element 5 placed on the port flange 2 according to the second embodiment and a Fig. 6A The invention relates to a combination of a glove insert 4 with a cover 7 which is inserted into the port flange 2. The closure part 5 is in the blocking position, the first docking element 25 of the port flange 2 is locked with the second docking element 55 of the closure part 5. As a wired version with two cables 67, 68 leading to the port flange 2, the control unit 8 is directly connected to the safety relay 81 without the connected transmitter / receiver 80. The active safety sensor 21 is arranged in the port flange 2, while the other electronic components 60, 61, 62, 64, 65, 66 and 69 are installed in the closure part 5. In order to remove the closure part 5 - to bring it to the open position - the operator 9 must first be authorized in order to then remove the cover 7 which is arranged in a gas-tight manner on the fixing part 40. Finally, the operator 9 can freely penetrate the seal 41 with the work glove 3 and reach into the working chamber 11 in order to work there, for example on the locked machine 13.

Claims

1. An arrangement for preventing unauthorized access to a closure device (1) by means of working gloves through an access opening (24) present in a port flange (2), wherein: a) the port flange (2) is mounted in a front window (12) or in a wall of a housing (10) of a closure device (1) positioned in a receiving space (19); b) working gloves are mounted on the port flange (2), said working gloves enabling the operator (9) to reach into the working chamber (11) of the closure device (1) in a protected manner; c) When a plurality of port flanges (2) are mounted on the closure device (1), the working gloves are fixed to the corresponding port flanges (2) respectively; d) a machine (13) for processing the items to be processed can be present in the working chamber (11); and e) a locking element (5) is provided for temporarily blocking the access portion (24), the locking element being movable into a blocking position and an open position, It is characterized in that f) a detection unit (62) is provided for receiving personal data of an operator (9), said detection unit having a connection to a microcontroller (64) in order to issue a switching command to an activator (69) in the event of a correspondence between the detected personal data and data in the microcontroller (64), so that the locking element (5) can be brought into a blocking position or moved from a blocking position into an open position, and thus the access section (24) is blocked or accessible; g) the activator (69) is arranged directly on the port flange (2) or on the locking member (5) or on the front window (12); and h) data of the microcontroller (64) are stored directly in the microcontroller or originate from an external control unit (8), The working glove (3) is matched to form an assembly in the form of a glove insert (4) which can be airtightly embedded in the port flange (2), and comprises, on the one hand, a removable or openable seal (41), and, on the other hand, a half-shell-shaped closure component (5) which can be detached from the assembly and the working glove (3) vacuum-packed therebetween, and a) the free end of the glove (3) is fixed to the fixing part (40) and / or to the sealing part (41) close to the fixing part (40), wherein the sealing part (41) at least substantially covers the clear width of the fixing part (40); and b) When the closure element (5) or the cover element (7) is placed on the glove insert (4) and the seal (41) is intact, the seal (41) is bent concavely toward the glove insert (4) in a visually recognizable manner due to the negative pressure prevailing in the glove insert.

2. The assembly according to claim 1, characterized in that The closure member (5) is constructed as a separate closure body that can be connected to or removed from the port flange (2) and is provided with or the port flange (2) is provided with: ja) detection unit (62); jb) microcontroller (64); and jc) an activator (69) which can be operated manually or in a driven manner and is used to adjust the locking element (5) to a blocking position or an open position; and optionally provided with: jd) a display (61) and a battery (60).

3. The assembly according to claim 1, characterized in that a) the port flange (2) has an RFID chip (22); and b) The closure component (5) is constructed as a separate closure body that can be connected to the port flange (2) or removed from the port flange and is provided with a transmitting / receiving element (65); wherein: c) The transmitting / receiving element (65) is used to detect the pairing when the closure element (5) is placed on the port flange (2) and to allow or deny the locking of the closure element (5) depending on the data stored in the control unit (8) or microcontroller (64).

4. The assembly according to claim 1, characterized in that a) a detection unit (62) for receiving personal data of an operator (9) is assigned to the corresponding port flange (2) or the corresponding closure element (5); and b) in the event of a correspondence between the detected personal data and the data in the microcontroller (64), a switching command is sent to the activator (69) so that the operator (9) can place the specific locking component (5) on the specific port flange (2) and can bring the locking component to a blocking position or can unlock the locking component and remove it from the specific port flange (2), so that the access part (24) is locked or accessible.

5. The assembly according to any one of claims 1 to 4, characterized in that A detection unit (62) for receiving personal data of an operator (9): a) exists in the corresponding port flange (2); or b) is present in the corresponding locking member (5); or c) All relevant port flanges ( 2 ) and closure components ( 5 ) for the closure device ( 1 ) are present in the mobile device.

6. The assembly according to any one of claims 1 to 4, characterized in that The locking component (5) a) is directly integrated into the port flange (2) and is designed to be pivotable, expandable, shutter-like or expandable; or b) provided as a separate closure body which can be connected to or removed from the port flange (2); or c) is a detachable component of the glove (3), which forms a glove insert (4) after the glove is matched.

7. The assembly according to claim 6, characterized in that a) the closing component (5) which is configured as a closing body integrated in the port flange (2) and the port flange (2) are each provided with a safety sensor; and b) The two safety sensor pairs are used to detect the position of the locking element (5) in the connection flange (2) in cooperation with an external safety relay (81) and to switch to automatic locking of the machine (13) when the locking element (5) is opened.

8. The assembly according to claim 6, characterized in that a) the closing component (5) and the port flange (2) are each provided with a safety sensor and are constructed as a separate closing body that can be connected to or removed from the port flange; and b) The two safety sensors are used to detect the position of the locking element (5) relative to the terminal flange (2) in cooperation with an external safety relay (81) and to switch to automatic locking of the machine (13) when the locking element (5) is spaced apart from the terminal flange (2).

9. The assembly according to claim 6, characterized in that a) a closure element (5) which is designed as a closure body detachably connected to the glove insert (4) and a port flange (2) are each provided with a safety sensor, the closure body being capable of being locked on the port flange (2) or being capable of being removed from the port flange; and b) The two safety sensor pairs are used to detect the position of the locking element (5) relative to the connection flange (2) in cooperation with an external safety relay (81) and to switch to automatic locking of the machine (13) when the locking element (5) is spaced apart from the connection flange (2).

10. An assembly according to any one of claims 7 to 9, characterized in that a) the control unit (8) and the safety relay (81) cooperating with the control unit for each terminal flange (2) are each provided with a transmitter / receiver (80); and b) An active safety sensor in the port flange (2) or in the locking component (5) is used to detect whether a complementary passive safety sensor is present, wherein a transmitting / receiving element (65) wirelessly provides a signal to a transmitter / receiver (80) to indicate the absence of a passive safety sensor, whereupon the transmitter / receiver (80) forwards the absence of a passive safety sensor to a safety relay (81) and automatically locks the machine (13).

11. The assembly according to claim 10, characterized in that a) each working glove has an RFID chip which stores an individual serial number which can be read by a transmitting / receiving element (65) and stored in a control unit (8) and / or a microcontroller (64); b) Each new operation on the port flange ( 2 ) and on the working glove is detected by means of the control unit ( 8 ) and stored in the control unit with respect to the relevant working glove, ie the individual history data is added.

12. The assembly according to claim 11, characterized in that a) The manufacturing data of each work glove can include: aa) individual serial number; ab) date of manufacture; ac) Glove size; ad) type of material; ae) the sterilization method used; af) the maximum date of use; and b) The historical data of each work glove can include: ba) Date of installation into the port flange (2); bb) personal data of installers; bc) identification of the end flange (2) on which the installation is to be carried out; bd) when, how often and by which operator (9) the closure element (5) on the relevant work glove is brought into the closed position or moved from the closed position into the open position; b) the times and number of times a decontamination cycle is carried out in the working chamber (11) of the enclosure (1), as well as the maximum permissible number of decontamination cycles; bf) the time and frequency of leak testing of the relevant work gloves; bg) batches and products which are processed in the working chamber (11) of the closed device (1) and in the case of which the relevant working gloves are used; bh) special events to be entered manually by the operator (9); and bi) Personal data of the installer who carries out the relevant removal and disposal of the work gloves.

13. An assembly according to any one of claims 7, 11 and 12, characterized in that The port flange (2) is provided with: a) a detection unit (62); b) a microcontroller (64); and c) an activator (69) which can be operated manually or in a driven manner and is used to adjust the closure element (5) into a blocking position or an open position; and optionally provided with: d) a display (61) and a battery (60).

14. The assembly according to any one of claims 1 to 4, characterized in that a) the detection unit (62) is designed to receive electronic data from a biomarker of an operator (9), a code to be input by the operator (9) or a data carrier to be provided by the operator (9); and b) the identification received by the detection unit (62) from the operator (9) in cooperation with the microcontroller (64) authorizes the corresponding active operator (9) to adjust the locking component (5) on the relevant port flange (2) to a blocking position or an open position by switching the activator (69) or otherwise deny the operator based on data stored in the microcontroller (64) or obtained via the control unit (8).

15. The assembly according to claim 1, characterized in that The glove insert (4) provided as a combination also has: a) an annular or oval fixing part (40) for fixing on the port flange (2); b) a projection (58) which is designed to cooperate with a switchable retaining element (28) extending from the port flange (2) in order to temporarily fix the blocking member (5); and c) An RFID chip (46) which is arranged in the fastening part (40) of the glove insert (4).

16. The assembly according to claim 1 or 15, characterized in that When the closure element (5) is placed on the glove insert (4) and the seal (41) is in an intact state, a negative pressure prevails in the inner volume of the glove insert (4) between the seal (41) and the surface (44), and the inner volume together with the surface of the seal (41) facing the inner volume and the surface (44) are sterile.

17. The assembly according to claim 1, characterized in that The working glove is matched to form an assembly in the form of a glove insert (4) which can be airtightly embedded in the port flange (2), and includes, on the one hand, a removable or openable seal (41), and, on the other hand, a cover (7) which can be detached from the assembly and a working glove (3) vacuum-packed therebetween.

18. The assembly according to claim 17, characterized in that When the cover (7) is placed on the glove insert (4) and the seal (41) is in an intact state, there is a negative pressure between the seal (41) and the surface (44), and the interior volume together with the surface of the seal (41) facing the interior volume and the surface (44) are sterile.

19. Assembly according to claim 17 or 18, characterized in that The glove insert (4) provided as a combination also has: a) a fixing component (40) for fixing on the port flange (2); b) an RFID chip (46) disposed in a fixed component (40) of the glove insert (4); and c) Optionally, a magnetic region (77) is provided on the cover (7), which is designed to interact with the fastening element (40) in order to temporarily additionally fasten the cover (7).

20. The assembly according to claim 5, characterized in that The mobile device is a tablet computer.

21. The assembly according to claim 11, characterized in that The RFID chip additionally stores production data of the working glove, which can be read out via a transmitting / receiving element (65) and stored in the control unit (8) and / or in the microcontroller (64).

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