Tool and method for manually opening cover of container for docking to port of sterile transfer system (of restricted environment)

Abstract

The present disclosure relates to a tool and method for manually opening a cover that is removably locked, by a rotational engagement, to an opening of a container for docking to a port of a sterile transfer system of a restricted environment.

Description

[0001] P24-181

[0002] - 1 -

[0003] TOOL AND METHOD FOR MANUALLY OPENING COVER OF CONTAINER FOR DOCKING TO PORT OF STERILE TRANSFER SYSTEM (OF RESTRICTED ENVIRONMENT)

[0004] 5 Technical Field

[0005] The present disclosure relates to a tool and method for manually opening a cover that is removably locked, by a rotational engagement, to an opening of a container for docking to a port of a sterile transfer system of a restricted environment.

[0006] 10

[0007] Background

[0008] A significant number of operations, be that in industry or scientific research, for example in the areas of pharmaceuticals, cosmetics, semiconductor manufacturing and food processing, need to be performed in restricted environments (comprising "cleanrooms" or "cleanroom environments", RABS or isolators and all collectively referred to in the context of this disclosure as "restricted environments"), be it to ensure that the materials handled therein not be contaminated or be it to ensure that hazardous substances be contained therein. For any of such restricted environments it is imperative that an undesired transfer of substances between the interior and the exterior (for example, the transfer of bacteria into a sterile environment, of dust into a dust-free environment, or of a hazardous material into the surrounding environment) be reduced to a minimum, preferably avoided entirely.

[0009] To this end, specific transfer systems have been developed, such as allowing for the sterile

[0010] 25 introduction of materials into a sterile isolator. Such a sterile transfer system (for example, the DPTE® transfer system, available from Getinge AB) typically comprises a port including a receptacle or door attached to the wall of the cleanroom or isolator. Specific containers are designed for docking to the port of the sterile transfer system and comprise a container body and a cover that is removably locked, for example by a rotational engagement, to an opening of the container / container body.

[0011] Containers for establishing a sterile connection, such as the ones offered by Getinge, ABC Transfer® and other commercial suppliers, can only be opened / closed by using the specific door of the transfer system, such door forming part of the restricted environment. The port

[0012] 35 is called "alpha-port" and the container is called "beta-container" or "beta-bag". The container (or bag - the term "container" is used throughout the present disclosure to refer to rigid or flexible devices for receiving, through an opening, products or substances, P24-181

[0013] - 2 - wherein the opening is designed to be sealingly closed by a cover through a rotatable lock mechanism) and the corresponding port work together in such a way that the container can only be opened when the container is connected to the port. It is impossible to disconnect the container when the system door is open. Such a system is heavy, bulky and

[0014] 5 requires being fixed to a rigid support or wall.

[0015] A non-limiting example of the application of a sterile transfer system and of containers for docking to the port of such sterile transfer system relates to the monitoring of environmental conditions in such restricted environments by passive and / or active air

[0016] 10 sampling, which involves placing one or more media plate / plates in an activity zone of the restricted environment (e.g. cleanroom) and expose it / them to the surrounding air such that they can capture the maximum amount of particles from the surrounding atmosphere. The unused media plates are received in a container and transferred to the restricted environment through the transfer system. After sampling, the used media plates are removed from the restricted environment, again through the transfer system in a container. However, for further processing of the used media plates at another station or workplace outside the restricted environment, the container needs to be opened to obtain access to the media plates and be able to remove the media plates from the container.

[0017] As described above, the process of opening the container is cumbersome and requires significant force, which hinders its opening apart from the corresponding port, whenever such opening might be required.

[0018] What is therefore desired is a compact system designed to perform manually the opening

[0019] 25 and closing of a closed container used for sterile connection in the context of a sterile transfer system of a restricted environment. The tool should be designed to be easy to use, for manual operation, for use in the laboratory at the end of the container use process to recover the parts stored inside the container.

[0020] Devices and methods for unscrewing a lid from a container body, for example, from a jar, are disclosed, for example, in US 2008 / 0229885 Al and US 11,691,860 B2. These devices are, however, not suitable for the opening of a beta-container insofar as the container still has to be held by hand with significant force for holding and opening still required and would result in a significant risk of injury to the user as well as of damage to the contents

[0021] 35 of such beta-container. P24-181

[0022] - 3 -

[0023] Summary

[0024] According to the present application the above object is solved by providing a tool for manually opening a cover that is removably locked, by a rotational engagement, to an

[0025] 5 opening of a container for docking to a port of a sterile transfer system, the tool comprising the features of claim 1, and a method as defined by claim 12. Preferred embodiments are defined in the dependent claims.

[0026] For the beta-containers, i.e. the containers for docking to a port of a sterile transfer

[0027] 10 systems, bayonet-type systems have proven particularly useful for pressing the container against the port and the container lid or cover to the door of the transfer port. In a bayonetsystem a series of lugs projecting laterally from around the cover's circumference towards its center fit into corresponding notches around the port opening. By twisting the container around its central axis, the lugs will be moved into and thus locked with the corresponding notches, thereby fixing / docking the container to the port.

[0028] By securing the container lid into place using an opposite-handed turning / twisting system, turning the container while fixing it to the transfer port will simultaneously result in the unscrewing, i.e. opening, of the beta-container lid. Opening the door of the transfer port will then lead to the opening of the beta-container, thereby rendering its inner volume accessible from the inside of the isolator.

[0029] To allow for a tight seal between the transfer port and the beta-container and further so that the lid of the container when attached to the door of the transfer port does not

[0030] 25 introduce contaminants into the isolator, the lid of the container is generally inserted into the container, preferably in such a way that their rims are substantially flush with each other (see Fig. 1).

[0031] The present application specifically provides a tool for manually opening a cover that is removably locked, by a rotational engagement, to an opening of a container for docking to a port of a sterile transfer system, the tool comprising

[0032] (i) a first element configured to be removably attached to (by frictional and / or formlocking engagement) the cover of the container;

[0033] (ii) a second element configured to be removably attached to an outside of a body of the

[0034] 35 container;

[0035] (iii) the first element supported for relative rotation to the second element (about a central rotation axis); and P24-181

[0036] - 4 -

[0037] (iv) a mechanical transmission mechanism for changing a manual force that is applied to an input element into a rotation of the first element relative to the second element in a range that unlocks the cover from the body of the container (optionally while the cover is retained to be attached to the first element and the second element can be

[0038] 5 removed from the body of the container).

[0039] This tool is an aid or instrument which helps a user to manually open the container in a laboratory on the bench outside a restricted environment without utilizing the port or door of the system, in particular in a situation where a sterile closing of the container is no longer

[0040] 10 a requirement.

[0041] As compared to current existing door systems which are generally heavy, fixedly attached to the wall of a clean room or to any isolator wall and are not transportable, the present tool is compact, inexpensive, lightweight and can be easily transported and placed on a bench in a laboratory. Furthermore, the present tool may without difficulty be manufactured in a variety of dimensions so as to correspond to the different sizes of available containers. For example, the present tool can easily be sized to fit currently available beta-bags having diameters of 105 mm, 190 mm, or 270 mm, but can also be adapted to any other diameters.

[0042] For example, in the context of the monitoring of environmental conditions in restricted environments by passive and / or active air sampling, the tool allows the user to easily open the container in order to recover the therein contained used media-plates for incubation.

[0043] 25 Another advantage of this tool is that the container does not need to be fixed to be held for opening while the tool ensures the rotation of the cover versus the body of the container.

[0044] Preferably, the second element is configured to be removably attached to engagement locations formed on an outer peripheral edge of the opening of the body of the container. Preferably, the second element is in the form of a bracket straddling a diameter of the opening of the body of the container and the first element.

[0045] Preferably, the first element is formed and dimensioned to be inserted into a cavity of the

[0046] 35 cover exposed to an outside thereof when locked to the opening of the container. P24-181

[0047] - 5 -

[0048] Preferably, the transmission mechanism comprises a mechanical gear train with a reduction gear ratio from the input element to the first element, and the input element for applying the manual force may be a turning knob or rotation lever connected to an input shaft of the mechanical gear train.

[0049] 5

[0050] Alternatively, the input element may comprise at least one pair of protruding handles exposed on an upper side of the second element, preferably two pairs of protruding handles spaced apart so as to be gripped by two hands of a user, one of the handles of each pair connected with the first element and the other of the pair connected to the second

[0051] 10 element, and wherein the mechanical transmission mechanism comprises a guide path for the one of the handles connected to the first element arranged such that reducing the spacing of the handles of each pair by the manual force in the form of a gripping / squeezing action by one hand induces the rotational movement of the first element relative to the second element.

[0052] The guide path in this variant may comprise a groove formed in the second element, the handle connected to the first element extending through the groove to the upper side of the second element.

[0053] Preferably, the second element comprises at least two, preferably three or more engagement sections spaced apart from each other so as to be capable of engaging with different locations distributed about the circumference of the outer peripheral edge of the opening of the body of the container without impeding the relative rotation of the cover to the container body.

[0054] 25

[0055] Preferably, the second element comprises two spaced apart holding elements for manually holding the tool by two hands of a user while attaching / removing the second element to / from the body of the container.

[0056] Preferably, the mechanical transmission mechanism comprises a stop for limiting the rotation range of the first element relative to the second element.

[0057] The present application specifically also provides a method of manually opening a cover that is removably locked, by a rotational engagement, to an opening of a body of a

[0058] 35 container for docking to a port of a sterile transfer system, the method comprising:

[0059] (a) providing a tool as described herein;

[0060] (b) attaching the second element to an outside of the body of the container; P24-181

[0061] - 6 -

[0062] (c) attaching the first element (by frictional and / or form-locking engagement) to the cover of the container;

[0063] (d) applying a manual force to the input element to induce a rotation of the first element relative to the second element in a range that unlocks the cover from the body of the

[0064] 5 container; and

[0065] (e) removing the tool from the body of the container while the cover is retained to be attached to the first element.

[0066] Brief description of the drawings

[0067] 10

[0068] Preferred embodiments will be described below by reference to the following attached exemplary schematic drawings:

[0069] Fig. 1 is a representation of a typical example of a cover of a container for docking to a port of a sterile transfer system of a restricted environment in a top view, a perspective view and in a perspective view in a state when locked to an opening of a container body.

[0070] Fig. 2 is a representation of a tool according to a first embodiment as described herein in a perspective view from above (Fig. 2a), from below (Fig. 2b) and from a side (Fig. 2c).

[0071] Fig. 3 is a representation of a sequence of steps (A) to (F) of using the tool according to the first embodiment for opening the container shown in Fig. 1.

[0072] Fig. 4 is a representation of a tool according to a second embodiment as described herein

[0073] 25 in a perspective view from below and from above, in a side view and in a top view.

[0074] Fig. 5 is a representation of a sequence of steps (A) to (D) of using the tool according to the second embodiment for opening the container shown in Fig. 1.

[0075] Fig. 6 is a representation of a tool according to a third embodiment as described herein in a top view (Fig. 6a), in a side view (Fig. 6b) and in a view from the bottom (Fig. 6c).

[0076] Fig. 7 is a representation of the tool according to the third embodiment as described herein in a perspective view from the top.

[0077] 35

[0078] Fig. 8 is a representation of the tool according to the third embodiment as described herein in a perspective view from the bottom. P24-181

[0079] - 7 -

[0080] Fig. 9 is a representation of the tool according to the third embodiment as described herein in a perspective exploded view from the top.

[0081] 5 Fig. 10 is a representation of the tool according to the third embodiment as described herein in a perspective view from the top in a state and posture just before it is attached to the container of Fig. 1.

[0082] Fig. 11 is a representation of the tool according to the third embodiment as described

[0083] 10 herein in a perspective view from the top in a state and posture after it is attached to the container of Fig. 1.

[0084] Detailed description

[0085] For the purposes of the present application, terms such as "horizontal", "vertical", "perpendicular", "parallel", and similar terms are - if not already explicitly indicated - considered to be "essentially horizontal", "essentially vertical", "essentially perpendicular", "essentially parallel", provided that this does not negatively affect functionality. Preferably, the term "essentially" is to denote a deviation of at most 10°, more preferably of at most 5°, even more preferably of at most 4° or 3°, still even more preferably of at most 2° or 1° from being horizontal, vertical, parallel and perpendicular, respectively.

[0086] The invention will be described using three embodiments of a tool for manually opening a cover that is removably locked, by a rotational engagement, to an opening of a container

[0087] 25 for docking to a port of a sterile transfer system of a restricted environment as an example.

[0088] A representation of a typical example of a container 1 for docking to the port of the sterile transfer system is shown in Fig. 1. The container 1 comprises a pot-like rigid container body

[0089] 2 defining a volume for receiving material to be transferred through the port, and a cover

[0090] 3 removably closing an opening 2b of the container body 2. The container body 2 may alternatively be in the form of a flexible or semi-rigid element.

[0091] The opening 2b of the container body 2 is surrounded by a flange or frame 2c protruding radially outward. The flange 2c includes at least two (preferably three or more and four in

[0092] 35 the example) dedicated engagement locations (in the form of lugs in the example) 2a distributed about the circumference of the outer peripheral edge or flange of the opening 2b of the body 2. The shape and dimensions of the flange and of the engagement locations P24-181

[0093] - 8 -

[0094] 2a are dictated by shape and dimensions of the transfer system and must replicate the interfaces with the receptacle / door of such system in order to achieve the tight and sealed interconnection.

[0095] 5 The cover 3 of the container is also a pot-like element dimensioned to be fit into the opening of the container body and having a flange 3b surrounding a central, axially recessed cavity 3a exposed to an outside thereof when locked to the opening 2b of the container / container body 1,2. The locking to the opening is achieved in that the flange 3b of the cover tightly sits on a peripheral rim of the opening while a number of hook-like

[0096] 10 protrusions 3c lockingly engage with mating receptacles in the opening by a rotational engagement (this may be a bayonet-type engagement / mount or a threaded engagement). The peripheral rim of the opening is axially recessed so that the upper side of the cover and container body is substantially flush when locked in place.

[0097] The inner radial wall of the recessed cavity 3a is provided with a number of engagement protrusions 3d distributed about the circumference and designed to cooperate with mating engagement features of the door of the transfer system.

[0098] A tool 4a according to a first embodiment for manually opening the cover 3 of the container 1 that is removably locked, by a rotational engagement, to the opening 2b of the container / container body 1,2 is shown in Figs. 2a-2c.

[0099] The tool 4a in general comprises a first element 5a (i.e. a lower part) configured to be removably attached, by frictional and / or form-locking engagement, to the cover 3 of the

[0100] 25 container 1, and a second element 6a (i.e. an upper part) configured to be removably attached to an outside of the body 2 of the container 1. The first element 5a is supported for relative rotation to the second element 6a about a central rotation axis 7 perpendicular to the first and second elements.

[0101] The tool 4a further comprises a mechanical transmission mechanism 9a for changing a manual force that is applied to an input element 8a into a rotation of the first element 5a relative to the second element 6a in a range that unlocks the cover 3 from the body 2 of the container 1 while the cover 3 is retained to be attached to the first element 5a and the second element 6a can be removed from the body 2 of the container 1. The term

[0102] 35 "transmission mechanism" in connection with the disclosure refers to a mechanical device which can change the speed, magnitude and / or the direction of a manual input force so as - 9 - to create the rotational force / torque necessary to rotate the cover relative to the container body to disengage their locking engagement.

[0103] The mechanical transmission mechanism may comprise two or more gears working

[0104] 5 together with a fixed gear ratio as in the first and third embodiments or may, in a simpler arrangement, comprise only a curved guide path that just changes a more or less linear motion produced by the input of manual force to a rotational motion of the first element as in the second embodiment.

[0105] 10 The first element 5a is formed as a plate-like member and is dimensioned to be inserted into the cavity 3a of the cover 3 exposed to an outside thereof when locked to the opening 2b of the container 1. To grip and fix the cover 3 by the frictional and / or form-locking engagement, for example with the engagement protrusions 3d distributed about the inner circumference of the peripheral wall of the cavity 3a, the first element 5a is provided with a number of first engagement sections or holders 30 at the opposite ends.

[0106] If more than two engagement protrusions 3d are to be fixed, the first element may be formed to have three or four of the first engagement sections or holders 30 (in which case the first element can be in the form of a triangle or rectangle in a top view with the first holders 30 at the corners, respectively).

[0107] The second element 6a is in the form of a plate-like bracket straddling, in a bridge-like manner, a diameter of the opening 2b of the body 2 of the container 1 and the first element 5a. The second element 6a is also configured to be removably attached to engagement

[0108] 25 locations 2a (the lugs in the example of the container 1 of Fig. 1) formed on an outer peripheral edge of the opening 2b of the body 2 of the container 1. To this end the second element 6a is provided with a number (at least two) of second engagement sections or holders 20 at the opposite ends of the second element that are formed to each receive a lug 2a and confine its lateral motion range when attached. If more than two engagement locations (lugs) 2a are to be fixed, the second element may be formed to have three or four of the second engagement sections or holders 20 (in which case the second element can be in the form of a triangle or rectangle in a top view with the second holders 20 at the corners, respectively).

[0109] 35 The at least two, preferably three or more second engagement sections 20 are in any case spaced apart from each other so as to be capable of engaging with different locations 2a distributed about the circumference of the outer peripheral edge of the opening 2b of the P24-181

[0110] - 10 - body 2 of the container 1 without impeding the relative rotation of the cover 3 to the container body 2.

[0111] The transmission mechanism 9a of the first embodiment (and also of the third embodiment

[0112] 5 described below) comprises a mechanical gear train 10 with a reduction gear ratio transmitting a rotational motion or torque from the input element 8a to the rotation of the first element 5a relative to the second element 6a. The input element 8a for applying the manual force for creating the rotational motion or torque is a turning knob (first embodiment shown in Figs. 2a-c) or rotation lever (third embodiment in Figs. 6a-c) connected to an input shaft 10a of the mechanical gear train 10 so as to input the torque. The turning knob or rotation lever may be exchanged between the embodiments. The rotation lever can be preferred as its larger lever arm reduces the force needed to produce the rotation of the first element in addition to the effect of the reduction ratio of the gear train.

[0113] 15

[0114] The output of the transmission mechanism 9a or gear train 10 is transmitted to the first element 5a to effect the relative rotation with respect to the second element 6a. In the first embodiment the geartrain 10 comprises a number of meshing gear wheels that are located in a space between the first element 5a and the second element 6a (see Fig. 2c). Their axles

[0115] 20 may be rotationally supported on either one of the elements. In view of the limited rotation range a sliding bearing may be sufficient for each axle, although a rolling bearing may be used as well.

[0116] Fig. 3 shows a sequence of steps (A) to (F) of using the tool 4a according to the first

[0117] 25 embodiment for opening the container 1 shown in Fig. 1. The lower part (first element) 5a of the tool 4a is positioned in the cavity 3a of the container cover 3 from above and the upper part 6a is positioned on and engaged with the outside lugs 2a of the flange or frame 2c of the container body 2:

[0118] • In step (A) the container 1 with cover 3 in place (container 1 is closed) is provided;

[0119] • In step (B) the tool 4a is placed over the top side of the container 1;

[0120] • In step (C) the lower part (first element) 5a of the tool 4a is positioned inside the cavity 3a of the container cover 3 and the upper part (second element) 6a is positioned on the outside lugs 2a of the container body 2 to engage with the lugs 2. In order to engage the first holders 30 of the first element 5a with the engagement

[0121] 35 protrusions 3d distributed about the inner circumference of the peripheral wall of the cavity 3a, the input element (knob or lever) 8a can be rotated so that the first holders 30 come into place under the engagement protrusions 3d of the cover and P24-181

[0122] - li start rotating the cover relative to the container body until the locking engagement is unlocked.

[0123] • In steps (D) and (E), when lifting the tool 4a from the container body 2, the cover 3 is removed at the same time from the container opening because it remains fixed on

[0124] 5 the first element 5a of the tool 4a.

[0125] • In step (F), the cover 3 is removed from the tool by hand, for example by turning the input element (knob or lever) 8a backwards.

[0126] The second embodiment of the tool 4b shown in Fig. 4 basically differs from the previously

[0127] 10 described first embodiment in the form of the transmission mechanism 9b for changing the manual force to the rotation of the first element 5b relative to the second element 6b.

[0128] As in the first embodiment the first and second elements 5b, 6b are plate-like brackets that are located above each other and connected with each other to be rotatable relative to each other around a central axis 7 of rotation. The first and second elements 5b, 6b are moreover provided with the holders 20,30 configured to be removably attached to engagement locations 2a (the lugs in the example of the container 1 of Fig. 1) formed on an outer peripheral edge of the opening 2b of the body 2 of the container 1 or to grip and fix the cover 3 by the frictional and / or form-locking engagement, for example with the engagement protrusions 3d as described above. The shape may be different, but the basic function is the same as in the first embodiment.

[0129] The input element 8b of the mechanical transmission mechanism 9b comprises at least one pair of protruding handles lla,llb;12a,12b exposed on an upper side of the second

[0130] 25 element 6b, preferably two pairs of protruding handles lla,llb;12a,12b spaced apart so as to be gripped by two hands of a user. One of the handles lla;12a of each pair is connected with the first element 5b and the other llb;12b of the pair is connected to the second element 6b.

[0131] The mechanical transmission mechanism 9b in this embodiment 4b comprises a guide path 13 for the one of the handles lla;12a that are connected to the first element 5b that is arranged such that reducing the spacing of the handles lla,llb;12a,12b of each pair by the manual force in the form of a gripping / squeezing action by one hand induces the rotational movement of the first element 5b relative to the second element 6b.

[0132] 35

[0133] More specifically, the guide path 13 comprises a groove 13a formed in the second element 6b and the handles lla;12a connected to the first element 5b extend through the groove P24-181

[0134] - 12 -

[0135] 13a to the upper side of the second element 6b. Thus, the portion of the handles located in the groove 13a are guided and move along the curvature to convert the more or less linear motion of the handles that are manually forced towards each other into the rotation of the first element relative to the second element.

[0136] 5

[0137] The Fig. 5 shows a sequence of steps (A) to (D) of using the tool 4b according to the second embodiment for opening the container 1 shown in Fig. 1. The lower part (first element) 5b of the tool 4b is positioned in the cavity 3a of the container cover 3 from above and the upper part 6b is positioned on and engaged with the outside lugs 2a of the flange or frame

[0138] 10 2c of the container body 2 (these steps are the same as with the first embodiment):

[0139] • In step (A) the tool 4b is placed over the container 1 and in step (B) the lower part 5b of the tool is positioned inside the cavity 3a of the container cover 3.

[0140] • In step (C) the upper part 6b is positioned on the outside lugs 2a of the container body 2.

[0141] • In step (D) the two left handles 11a, lib are gripped by the left hand and the two right handles 12a, 12b are gripped by the right hand (between thumb and index fingers). By tightening the hands, the handles will approach each other, causing the rotation of lower part 5b which leads to the cover 3 being unlocked from the opening of the body. At a stop, the cover 3 is free from the container and can either be removed as with the tool according to the first embodiment, or alternatively can be left on the container for later removal.

[0142] The third embodiment of the tool 4c shown in Figs. 6a to 6c, 7 to 11 is similar to the first embodiment in the sense that the transmission mechanism 9c also includes a geartrain 10.

[0143] 25

[0144] As in the first and second embodiment the first and second elements 5c, 6c are plate-like brackets that are located above each other and connected with each other to be rotatable relative to each other around a central axis 7 of rotation. The first and second elements 5c, 6c are moreover provided with the holders 20,30 configured to be removably attached to engagement locations 2a (the lugs in the example of the container 1 of Fig. 1) formed on an outer peripheral edge of the opening 2b of the body 2 of the container 1 or to grip and fix the cover 3 by the frictional and / or form-locking engagement, for example with the engagement protrusions 3d as described above. The shape may be different, but the basic function is the same as in the first and second embodiment.

[0145] 35

[0146] Different from the first embodiment the gear train 10 is, however, mainly located not between the first and second elements 5c, 6c but above the second element 6c in a housing P24-181

[0147] - 13 -

[0148] 16. The output of the gear train is connected to a small, toothed gear 17 that protrudes to the lower side of the second element and meshes with a curved tooth-section 18 formed inside the first element 5c (see in particular Figs. 6c and 8). Thus, manual rotation of the input element in the form of a lever 8c is input into the gear train 10 and output (after

[0149] 5 reduction) to the small, toothed gear 17 which in turn rotates, rather pivots, the first element 5c around the axis 7 about a limited range (that is determined to be just sufficient to unlock the cover 3 from the opening of the container body).

[0150] The rotation range is determined by the curved length of the tooth-section 18, and is

[0151] 10 limited when the opposite end sections 19a of a curved oval cutout 19 formed in the first element 5c abut against the small, toothed gear 17 and act as a stop.

[0152] In the tool 4c according to the third embodiment the second element 6c comprises two spaced apart holding elements 15 for firmly manually holding the tool 4c by two hands of a user while attaching / removing the tool 4c, more specifically the second element 6c to / from the body 2 of the container 1. The holding elements 15 are each in the form of a gripping bar 15a mounted between lateral lugs 15b integrally formed (by bending) from the sheet material forming the plate-like second element 6c.

[0153] The holding elements 15 allow to apply significantly higher forces to attach the tool to the outside lugs 2a of the container body and to the cover, if needed. Moreover, the tool can be more easily held at the holding elements when the input element (i.e. the lever 8c) is rotated, in particular when the cover held at the first element is to be removed from the tool or when the tool is to be removed from the cover while the cover remains on the

[0154] 25 container. It is remarked that the holding elements 15 may also be provided on the second elements 6a, 6b of the tools 4a, 4b of the first and second embodiments.

[0155] The Figs. 10 and 11 show a sequence of steps of using the tool 4c according to the third embodiment for opening the container 1 shown in Fig. 1:

[0156] The lower part (i.e. the first element 5c) of the tool 4c is positioned in the cavity 3a of the container cover 3 and the upper part (i.e. the second element 6c) is positioned on and engaged with the outside lugs 2a of the frame of the container body 2 to restrict their lateral movement. Then, the lever 8c is rotated to induce a rotation of the first element 5c (with the cover attached to it) relative to the second element 6c via the transmission

[0157] 35 mechanism 10 so that, at first, the first holders 30 provided on the opposite ends of the first element come into place underthe engagement protrusions 3d of the cover and, upon further rotation, continue rotationally driving the cover 3 relative to the container body 2 P24-181

[0158] - 14 - until the locking engagement is unlocked. Then, the cover 3 can be removed from the opening of the container body 2 together with the tool 4c and finally separated from the tool as described above in conjunction with the first embodiment.

[0159] 5 Independently of the specific configuration, the tool as described herein thus provides a method of manually opening a cover 3 that is removably locked, by a rotational engagement, to an opening 2b of a body 2 of a container 1 for docking to a port of a sterile transfer system, the method comprising the following steps:

[0160] (a) providing the tool 4a;4b;4c as described above;

[0161] (b) attaching the second element 6a;6b;6c to an outside of the body 2 of the container 1 to restrict the lateral movement of the container body;

[0162] (c) attaching the first element 5a;5b;5c of the tool to the cover 3 of the container 1 (by frictional and / or form-locking engagement, if required by an initial input of a manual force to the input element 8a;8b;8c inducing a rotation of the first element relative

[0163] 15 to the second element;

[0164] (d) applying a manual force to the input element 8a;8b;8c to induce a (further) rotation of the first element 5a;5b;5c relative to the second element 6a;6b;6c in a range that unlocks the cover 3 from the body 2 of the container 1; and

[0165] (e) removing the tool 4a;4b;4c from the body 2 of the container 1.

[0166] 20

[0167] Step (e) of the present method may be performed in such a way that the cover 3 remains attached to the tool 4a;4b;4c, particularly to the first element 5a;5b;5c, when removing the tool from the body 2 of the container 1, thereby without any additional action allowing for direct access to the interior of the container 1.

[0168] Alternatively, step (e) may be performed in such a way that the cover 3 remains on the container 1 (i.e. is not removed together with the tool 4a;4b;4c) and only the tool 4a;4b;4c is removed. Cover 3 may then in a subsequent step be manually removed from container 1. As the opening of the container 1 is frequently done in an environment with lower purity

[0169] 30 requirements this approach keeps the interior of container 1 covered for as long as possible, thereby reducing the risk of introducing contaminants.

Claims

- 15 -Claims1. A tool (4a;4b;4c) for manually opening a cover (3) that is removably locked, by a rotational engagement, to an opening (2b) of a container (1) for docking to a port of5 a sterile transfer system, the tool comprising(i) a first element (5a;5b;5c) configured to be removably attached to (by frictional and / or form-locking engagement) the cover (3) of the container (1);(ii) a second element (6a;6b;6c) configured to be removably attached to an outside of a body (2) of the container (1);10 (iii) the first element (5a;5b;5c) supported for relative rotation to the second element (6a;6b;6c) (about a central rotation axis (7)); and(iv) a mechanical transmission mechanism (9a;9b;9c) for changing a manual force that is applied to an input element (8a;8b;8c) into a rotation of the first element (5a;5b;5c) relative to the second element (6a;6b;6c) in a range that unlocks the cover (3) from the body (2) of the container (1).

2. The tool (4a;4b;4c) according to claim 1, wherein the second element (6a;6b;6c) is configured to be removably attached to engagement locations (2a) formed on an outer peripheral edge of the opening (2b) of the body (2) of the container (1).

3. The tool (4a;4b;4c) according to claim 1 or 2, wherein second element (6a;6b;6c) is in the form of a bracket straddling a diameter of the opening (2b) of the body (2) of the container (1) and the first element (5a;5b;5c).25 4. The tool (4a;4b;4c) according to any one of claims 1 to 3, wherein the first element (5a;5b;5c) is formed and dimensioned to be inserted into a cavity (3a) of the cover (3) exposed to an outside thereof when locked to the opening (2b) of the container (1).

5. The tool (4a;4c) according to any one of claims 1 to 4, wherein the transmission mechanism (9a;9c) comprises a mechanical geartrain (10) with a reduction gear ratio from the input element (8a;8c) to the first element (5a;5c).

6. The tool (4a;4c) according to claim 5, wherein the input element (8a;8c) for applying35 the manual force is a turning knob or rotation lever connected to an input shaft (10a) of the mechanical gear train (10).P24-181- 16 -7. The tool (4b) according to any one of claims 1 to 4, wherein the input element (8b) comprises at least one pair of protruding handles (lla,llb;12a,12b) exposed on an upper side of the second element (6b), preferably two pairs of protruding handles (lla,llb;12a,12b) spaced apart so as to be gripped by two hands of a user, one of5 the handles (lla;12a) of each pair connected with the first element (5b) and the other (llb;12b) of the pair connected to the second element (6b), and wherein the mechanical transmission mechanism (9b) comprises a guide path (13) for the one of the handles (lla;12a) connected to the first element (5b) arranged such that reducing the spacing of the handles (lla,llb;12a,12b) of each pair by the manual10 force in the form of a gripping / squeezing action by one hand induces the rotational movement of the first element (5b) relative to the second element (6b).

8. The tool (4b) according to claim 7, wherein the guide path (13) comprises a groove (13a) formed in the second element (6b), the handle (lla;12a) connected to the first element (5b) extending through the groove (13a) to the upper side of the second element (6b).

9. The tool (4a;4b;4c) according to any one of claims 1 to 8, wherein the second element (6a;6b:6c) comprises at least two, preferably three or more engagement sections (20) spaced apart from each other so as to be capable of engaging with different locations (2a) distributed about the circumference of the outer peripheral edge of the opening (2b) of the body (2) of the container (1) without impeding the relative rotation of the cover (3) to the container body (2).25 10. The tool (4c) according to any one of claims 1 to 9, wherein the second element (6c) comprises two spaced apart holding elements (15) for manually holding the tool (4c) by two hands of a user while attaching / removing the second element (6c) to / from the body (2) of the container (1).

11. The tool (4c) according to any one of claims 1 to 10, wherein the mechanical transmission mechanism (9c) comprises a stop (19a) for limiting the rotation range of the first element (5c) relative to the second element (6c).

12. A method of manually opening a cover (3) that is removably locked, by a rotational35 engagement, to an opening (2b) of a body (2) of a container (1) for docking to a port of a sterile transfer system, the method comprising(a) providing a tool (4a;4b;4c) as defined in any one of claims 1 to 11;P24-181- 17 -(b) attaching the second element (6a;6b;6c) to an outside of the body (2) of the container (1);(c) attaching the first element (5a;5b;5c) (by frictional and / or form-locking engagement) to the cover (3) of the container (1);5 (d) applying a manual force to the input element (8a;8b;8c) to induce a rotation of the first element (5a;5b;5c) relative to the second element (6a;6b;6c) in a range that unlocks the cover (3) from the body (2) of the container (1); and(e) removing the tool (4a;4b;4c) from the body (2) of the container (1).10 13. The method according to claim 12, wherein in step (e) the cover (3) remains on the container (1), or wherein in step (e) the cover (3) is retained attached to the first element (5a;5b;5c) and removed together with the tool (4a;4b;4c).15

Images