Combination of rack for holding a plurality of settle plates and bracket, unit / module and method for bidirectional transfer of settle plates to / from cleanroom environment

Abstract

The present application relates to a combination of a rack for holding a plurality of settle plates and a bracket and to a unit / module, and a method for bidirectional transfer of settle plates to and / or from a cleanroom environment through a sterile transfer port.

Description

[0001] COMBINATION OF RACK FOR HOLDING A PLURALITY OF SETTLE PLATES AND BRACKET, UNIT / MODULE AND METHOD FOR BIDIRECTIONAL TRANSFER OF SETTLE PLATES TO / FROM CLEANROOM ENVIRONMENT

[0002] Technical Field

[0003] The present application relates to a combination of a rack for holding a plurality of settle plates and a bracket, and to a unit / module, and a method for bidirectional transfer of settle plates to and / or from a cleanroom environment through a sterile transfer port.

[0004] Background

[0005] In order to monitor environmental conditions in classified environments, for example closed clean processing areas (referred to as "cleanroom" or "cleanroom environment" in the following description and comprising cleanrooms, RABS ("Restricted Access Barrier System"), or isolators) which are engineered spaces that maintain a very low concentration of airborne particulates and are frequently used in scientific research and in industrial production involving pharmaceutical, cosmetics, semiconductor or food processing, it is common practice in passive air sampling to place one or more media plate / plates in an activity zone of the cleanroom and expose it / them to the surrounding air such that they can capture the maximum amount of particles in the surrounding air. Larger particles tend to settle faster on the plates due to gravitational force. Smaller particles take some time in settling due to factors such as air currents. The microorganisms from the air may settle on the settle plates alone or in colonies.

[0006] In active monitoring of air in cleanroom environments a microbial air sampler is used to force air into or onto a collection medium over a specified period of time. The collection medium can be a common petri-dish, for example including a nutrient agar-based test (culture) media or other suitable test (culture) media depending on the need. The collection media, for example in the form of the petri-dishes, media plates or settle plates, also termed settling plates, contact plates or sedimentation plates, either lockable or non- lockable, and commonly in a range of 50 mm to 120 mm diameter (the terms will be used interchangeably in this specification and the term "settle plates" will be used to generally denote such products), have to be transferred, potentially repeatedly, into the cleanroom environment and removed therefrom for further handling and evaluation. This is commonly done in a manual process wherein one or more settle plates are conveyed manually through a sterile transfer port into the interior of the cleanroom and after use again withdrawn from the interior of the cleanroom. However, the manual handling of the settle plates involves a high risk of contamination when handling the settle plate after a lid, cover or seal has been opened, and a non-secure transfer of the settle plates during the introduction, installation, removal and further handling, in particular when a plurality of them is handled at once as a set or batch or group, for example in a stack. Maintaining several settle plates in a group during a sequence of processing steps is moreover a complex task and requires measures like taping or bundling several petri-dishes together and / or marking them.

[0007] Further, the individual standard settle plates as such are not particularly suitable for automated handling in batches or stacks as they typically consist of a media plate holding the nutrient media and a lid or cover releasably covering the plate, said lid or cover frequently only rather loosely placed onto such plate. It is difficult for automated handling equipment to securely grip, hold and transfer the smooth cylindrical peripheral surfaces of the media plate and / or lid / cover as they require a defined position and orientation for gripping, and there is a high risk that lids are inadvertently opened, displaced or removed from their media plates during handling at the various stages of the process, thereby compromising the detection result.

[0008] WO 2022 / 084356 Al, WO 2022 / 084358 Al and WO 2022 / 084360 Al disclose various examples of racks for holding a plurality or a batch of settle plates for the transfer to and from a cleanroom which are designed to facilitate automated handling of the individual settle plates by means of robots inside the cleanroom environment and still allow, if required, a manual handling in the process, either inside the cleanroom or outside. However, designing the racks suitable for automatic handling requires rather large tolerances for holding portions of the settle plates and defining simple insertion paths to balance the limited motion capabilities of typical handling robots and the criticality of the handling process. Therefore, the holding force imparted on the settle plates in such a rack is, in tendency, reduced. This, on the other hand, increases the risk of inadvertent removal of settle plates during manual handling outside a completely automated handling system, in particular when the racks with batches of settle plates are manually handled, forexample when the racks are transferred to and within microbiological labs for incubation and further processing.

[0009] US 5,833,067 A discloses a computer disk storage and transporting caddy. DE 22 07 417 Al discloses a container for the storage of tapes, film rolls or diapositives.

[0010] US 2005 / 045522 Al discloses a storage tray for transporting, storing, and presenting dies used for die cutting and embossing applications.

[0011] However, neither of the cited documents relates to the safe storage and transport of settle plates and / or petri dishes.

[0012] Another issue encountered with handling settle plates in batches using racks of the aforementioned types is linked to the practice of placing data labels on the individual settle plates for identification purposes. If the settle plates are rotated in their holding portions of the rack during transportation, automatic scanning and reading of the labels may become difficult or faulty. This problem is frequently addressed by a rotating 2D barcode reader capable of 360° scanning, whereupon the settle plates are placed so as to enable the barcode reader to clearly identify the respective plate. However, in some environments, particularly the spatially constrained environments of an isolator, due to a lack of available space it is not possible to install such a rotating 2D barcode reader. In such a case a robot must repeatedly grip a settle plate in order to align it with the reader or a manual intervention may become necessary. Such procedures increase the risk of plate droppage or breakage and are in any case time consuming and impact the process efficiency.

[0013] What is desired is an at least partly or preferably fully automated process that can use standard media or settle plates available on the market, preferably the so-called petri- dishes, that further reduces human handling steps for introducing, installing and removing the media plates into and from the production areas and further stages of the evaluation processes, and that increases the level of safety against accidental breakage, contamination and incidents that have a negative influence on the process efficiency. In particular, the transfer of the settle plates in a batch into and from a cleanroom environment should be realized without breaking containment or sterility.

[0014] Summary

[0015] According to the present application this object is solved by providing a combination of a rack for holding a plurality of settle plates and a bracket for mechanically securing the settle plates in the rack with the features of claim 1, a unit / module for bidirectional transfer of settle plates to / from a cleanroom environment through a sterile transfer port with the features of claim 14, and a method for bidirectionally transferring settle plates to / from a cleanroom environment through a sterile transfer port with the features of claim 15. Preferred embodiments are defined in the dependent claims.

[0016] The present application specifically provides for a combination of a rack for holding a plurality of settle plates and a bracket for mechanically securing the settle plates in the rack, wherein the rack comprises a main body with a plurality of adjacent and spaced apart holding portions each configured to receive and support, in a substantially parallel orientation that is substantially perpendicularto a longitudinal direction of the rack, a settle plate, wherein each holding portion includes positioning features for positioning the settle plate in the holding portion and allowing insertion of the settle plate from a lateral side of the rack in a direction substantially perpendicular to the longitudinal direction of the rack, and wherein the bracket is configured to be releasably mechanically attached to the rack so as to straddle, in the attached posture, a number of the settle plates at the lateral side of the rack and mechanically secure the number of the settle plates in the rack.

[0017] The provision of the bracket as a mechanical safety measure selectively improves the proper storage and positioning of the complete batch of settle plates in a rack in situations where the plates are not to be processed or handled individually. As such the bracket as disclosed herein secures the settle plate handling against incidents like falling, lid opening, rotation, breakage, contamination which is relevant for the manual handling of the batch in the rack but also for automated handling and reading systems as the settle plates remain centered and in the accurate angular position. Thus, the bracket as disclosed herein secures the manual and automatic handling of batches of settle plates used to perform viable air monitoring in a classified or not classified environment.

[0018] Since the present combination of a rack and a bracket provides for a possibility to aseptically transfer a larger number of settle plates in a bound group or batch into and out of cleanroom environments, it reduces operator traffic inside controlled facilities, thus, decreasing the risk for cross-contamination of processes and final products.

[0019] Further, the addition and integration of the bracket can be made using a large variety of existing rack designs like those disclosed in WO 2022 / 084356 Al, WO 2022 / 084358 Al and WO 2022 / 084360 Al as a basis without substantially altering the design or handling properties. Preferably, the releasable mechanical attachment of the bracket to the rack comprises a form-locking engagement between a fastener formed at one of the brackets and the rack and a mating receptacle formed on the other of the bracket and the rack. In this case the fastener can be designed to be elastically biased into an engagement posture, the elastic bias being designed so as to be overcome by two fingers of a hand of a user.

[0020] The easy removal of the bracket by the one-handed operation without tools is important to facilitate the handling by a user wearing gloves while the risk of an inadvertent removal, i.e. if the rack hits an obstacle or falls down, is avoided or at least is significantly reduced.

[0021] Preferably, the bracket has a form of an elongated U comprising an axially extending central bridge part, wherein the fastener comprises fastener parts at opposite axial ends of the bridge part that protrude from the bridge part in a radial / transverse direction. At least one of the fastener parts, preferably both, respectively may be side-release clips.

[0022] Such side release clips may be embodied in a form where at least one of the fastener parts, preferably both, respectively comprises a pair of elastic retainer arms protruding outward and away from a tip region of an insertion section that is configured to be inserted into the receptacle including an opening in the rack by elastically deforming the pair of retainer arms and providing a mechanical engagement with the rack, preferably at a periphery of the opening, in the inserted state.

[0023] Further, the elastic retainer arms of the pair may be formed so as to be elastically deformable by two fingers of a hand of a user to remove the mechanical engagement and allow withdrawal of the insertion section from the respective opening in the rack.

[0024] The elastic retainer arms of the fastener parts at the opposite axial ends of the bridge part may be interconnected by links that may extend substantially parallel to each other and along the axial direction of the bridge part on both lateral sides thereof with a gap. Developing this concept further, the fastener parts may be formed such that mechanically forcing the links towards each other transverse to the gap by two fingers of a hand of a user simultaneously elastically deforms the elastic retainer arms at both ends to remove their mechanical engagement and allow withdrawal of the insertion sections from the respective openings in the rack.

[0025] These structures further support the aim that the bracket may be relatively easily and intuitively removed by user interaction, even wearing gloves, but that an inadvertent or accidental removal is avoided. At the same time the design may be relatively simply integrated into existing designs of racks for multiple settle plates.

[0026] Preferably, the rack has a gripping section, separate from the bracket, for allowing holding of the rack without interfering with the settle plates and the bracket.

[0027] Using the dedicated gripping section in addition and separate from the bracket allows safe handling of the rack in any process without the risk of inadvertently removing the safety bracket.

[0028] Preferably, the rack and / or the bracket has a marking section for attaching or storing information / data related to the settle plates in the rack. The dedicated marking sections allow to locate data / information, for example in the form of an RFID tag or chip or a barcode, related to all the settle plates of the rack at a central and easily accessible location for quick, efficient and reliable automatic reading and writing (if provided by the technology chosen).

[0029] Preferably, the combination of the rack and bracket further comprises a docking adapter integrated with or configured to be removably attached to the rack and to be mounted to a receptacle or door of a sterile transfer system so as to present the rack in an orientation that allows removal / insertion of settle plates from / into the holding portions of the rack from the lateral side of the rack facing an opening of the receptacle or door, in the direction substantially perpendicular to the longitudinal direction of the rack.

[0030] The docking adapter provides the possibility to selectively integrate the rack (with the bracket) into the movable external component of the sterile transfer system, for example the DPTE® transfer system that is widely used and is recognized as being a safe method for bidirectional transfer in aseptic or toxic working areas, without breaking containment or sterility. The port of this transfer system is fixedly integrated onto the wall of a cleanroom, filling line, or isolator and is designed to functionally cooperate with the mating receptacle or door of an external packaging unit or container (in the DPTE® transfer system called a "beta bag") to aseptically transferthe content of the packaging, in this case the combination of the rack and bracket, into and out from the cleanroom environment. The provision of the adapter facilitates mechanical integration of the rack into such a system without the need to redesign the rack as such, as only the interfaces with the rack and the receptacle / door must be replicated on the adapter. Further, the use of a separate adapter opens the option to re-use the adapter (after decontamination / sterilisation) and to functionally combine a multitude of rack designs with different transfer systems with only limited design changes.

[0031] Preferably, the rack and / or the docking adapter has a storage section for holding the bracket in a stand-by position where it does not obstruct insertion of the settle plates into the holding portions from the lateral side of the rack.

[0032] The dedicated storage position for the bracket on the rack and / or the docking adapter presents the bracket in a ready to use posture so that, upon removal of the rack from the cleanroom, for example in a laboratory, the bracket may be promptly positioned to safeguard against the removal of the settle plates from the rack. Prior to deployment, the bracket is positioned within a zone of the rack and / or the docking adapter that does not interfere with the handling process of the settle plates effected by the robot in the cleanroom, is always maintained in the sterile environment together with the rack, and remains easily accessible for human intervention.

[0033] On the basis of this embodiment integrating the docking adapter into the combination of the rack and bracket as disclosed herein, the present application also provides for a unit / module for bidirectional transfer of settle plates to and / or from a cleanroom environment through a sterile transfer port of a sterile transfer system, the unit comprising a receptacle or door of the sterile transfer system configured to be removably attached to a mating receptacle of the transfer port of the sterile transfer system wherein the rack is removably mounted to the receptacle or door through the docking adapter so that the settle plates can be removed / inserted from / into the holding portions of the rack from the lateral side of the rack facing an opening of the receptacle or door, in the direction substantially perpendicular to the longitudinal direction of the rack, while the receptacle or door is attached to the mating receptacle of the transfer port, and container, preferably in the form of a flexible bag, connected to the receptacle or door and sealing the combination of the rack and the bracket from an environment.

[0034] With this unit, settle plates do not need to be placed into an isolator to be decontaminated before use, eliminating an entire step in the process and keeping a number of settle plates available for use at any time. Unlike traditional methods, where single-bagged plates are decontaminated and stored in the isolator, limiting space and often interrupting workflow, with the unit, settle plates in the rack are mounted to the isolator's port and may be used directly in an uninterrupted workflow since they may be prepared already gamma- irradiated (ready-to-use). In addition to safety and efficiency, the process also frees up time and saves money.

[0035] Finally, the present application also provides for a method of bidirectionally transferring settle plates to / from a cleanroom environment through a sterile transfer port, the method comprising, preferably in sequence, the steps of (a) providing a unit / module as mentioned before and loading the holding portions of the rack with a number of settle plates, (b) mounting the receptacle or door to a mating receptacle of the transfer port, (c) bringing the transfer port to an open state, (d) sequentially removing / returning the settle plates from / into the holding portions of the rack from the lateral side of the rack facing an opening of the receptacle or door in the direction substantially perpendicular to the longitudinal direction of the rack, (e) bringing the transfer port to a closed state and removing the receptacle or door from the mating receptacle of the transfer port, (f) releasably mechanically attaching the bracket to the rack so as to straddle, in the attached posture, the number of the settle plates at the lateral side of the rack and mechanically secure the number of the settle plates in the rack, and (g) dismounting the rack from the receptacle or door.

[0036] The present application accordingly provides for a rack for holding a plurality of settle plates that is compatible with environmental monitoring in a fully automated process. Due to the provision of the rack, it in particular allows an accurate positioning and holding together of a set or batch of settle plates in the rack during all the steps or stages of the monitoring process, including packaging and shipment, during introduction into the cleanroom environment or production area, setting in the loading and unloading area, grabbing of individual petri-dishes using a gripper or robot arm for transferring the settle plates to critical areas for passive or active air monitoring, during removal from the cleanroom environment or production area, during incubation, reading and / or storage. Due to the provision of the bracket the settle plates are safely retained in the rack in their respective proper positions and orientations even if the rack is transported to or from process locations outside the cleanroom environment.

[0037] Brief description of the drawings

[0038] Preferred embodiments will be described below by reference to the following attached exemplary schematic and non-limiting drawings: Figure 1 is a perspective view of a combination of a rack for holding a plurality of settle plates and a bracket according to a first exemplary embodiment in three stages of use (empty rack with bracket in place, empty rack with bracket completely separated, rack with settle plates and bracket partially attached).

[0039] Figure 2 is a perspective view of the combination of the rack for holding a plurality of settle plates and the bracket according to the first exemplary embodiment in a receptacle of a sterile transfer system in three stages of use (rack with settle plates and bracket completely attached, rack with settle plates and bracket attached, rack with settle plates and bracket attached and separated from docking adaptor of receptacle).

[0040] Figure 3 is a perspective view of a combination of a rack for holding a plurality of settle plates and a bracket according to a second exemplary embodiment in a vertical orientation.

[0041] Figure 4 is a perspective partial view of the detail of the fastener of the bracket of the second exemplary embodiment received in an insertion section of the rack.

[0042] Figure 5 is a perspective view of a combination of the rack for holding a plurality of settle plates and the bracket, schematically represented, according to the second exemplary embodiment in a receptacle of a sterile transfer system in a state where the bracket is stored in a storage section of the rack.

[0043] Figure 6 is a perspective view from the lateral side of an insertion direction of the detail of an alignment feature of the holding portion for the settle plate of the rack of the second exemplary embodiment

[0044] Figure 7 is a perspective view of the detail of the alignment feature for the settle plate and of the opening of the receptacle for the bracket of the rack of the second exemplary embodiment with the settle plate received in the holding portion.

[0045] Figure 8 is a top view from an axial end of the rack of the second exemplary embodiment in a situation where one settle plate is fully received in the holding portion and another settle plate is placed just in front of an entry into the holding portion.

[0046] Figure 9 is a side view of the rack of the second exemplary embodiment in a situation where plural settle plates are fully received in the holding portions and another settle plate is placed just in front of an entry into the holding portion. Figure 10 is a side view of two further variants of the bracket for use in conjunction with the second exemplary embodiment.

[0047] Figures 11 and 12 are other side views of the fastener parts of the two further variants of the bracket of Figure 10.

[0048] Detailed description

[0049] 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, and perpendicular, respectively.

[0050] The present combination of rack and bracket will be described using two embodiments of the rack 1 and bracket 30 as examples. Similar views of the rack and bracket of the embodiments are distinguished by adding the letter "a" or "b" to the reference sign "1" for the rack and "30" for the bracket. Two further variants of the bracket are identified by adding the letter "c" or "d" to the reference sign "30" for the bracket. Thus, where reference is made to rack and bracket without adding the letter "a", "b", "c" or "d", the description is applicable to all embodiments even if no specific figure of that embodiment is provided unless explicitly stated otherwise.

[0051] The embodiments of the rack 1 (la, lb) as defined herein for holding a plurality of settle plates P as shown in the figures generally comprise a main body or base 2 in the form of a three-dimensional frame with a plurality of adjacent and regularly spaced apart holding portions 3 which are each configured to receive and support, in a substantially parallel orientation that is substantially perpendicular to a longitudinal direction X of the rack 1, an individual settle plate P wherein the holding portions 3 are aligned adjacent to each other in the longitudinal direction X (see Figures 1 to 3, 5, 9 where a plurality of settle plates P are placed in the rack and Figures 1 and 9 where the direction X is indicated).

[0052] Each holding portion 3 includes positioning features 4 for positioning the settle plate P in the holding portion 3 in a defined orientation and allowing insertion of the settle plate P from a lateral front side in an insertion direction that is substantially perpendicular to the longitudinal direction X. The lateral front side is the top side as shown in Figure 1 and the bottom side in the upside-down orientation of the rack as shown in Figure 9.

[0053] Each holding portion 3 and its positioning features 4 respectively comprises a pair of separation elements 11 that are adjacent to each other but spaced apart from each other in the longitudinal direction X to define therebetween a slot or shelf configured to receive, in a removable manner, the settle plate P. For reasons of clarity it is noted that such separation element 4 may be "shared" between two directly adjacent holding portions 3. In the embodiments the slots are arranged so as to be aligned in the axial direction X to form an aligned stack of a row of settle plates but without direct contact of the settle plates with each other. Alternative arrangements with a laterally staggered arrangement in two or more substantially parallel rows of aligned settle plates are possible, but not shown in the drawing.

[0054] The separation elements 11 defining the spaced apart holding portions 3 are interconnected by a pair of lateral supporting beams 2a that are part of the main body or base 2 and are spaced apart in a width direction Y (see Figure 1) that is perpendicular to the longitudinal direction X. The lateral supporting beams 2a extend in the longitudinal direction X of the rack 1 so as to be substantially parallel to each other (see Figures 1 and 3, for example). The supporting beams 2a accordingly carry therebetween a plurality of the separation elements 11 to form a frame- or cradle-like self-supporting structure of the rack 1 that has sufficient stiffness or rigidity in order to avoid bending or distortion of the rack during handling.

[0055] Each separation element 11 comprises a pair of base parts that are respectively integrally formed with a respective supporting beam 2a of the main body or base 2, and a substantially inverted U-shaped elastic tab protruding from the base parts and configured to releasably engage, preferably at an extreme or free tip end of each tab, with a rim / edge of the settle plate P when the same is placed in the slot. The rim / edge of the settle plate P may be that of a plate or of a lid and petri-dishes as examples of settle plates commonly have such rims or edges extending about a periphery on the top / or bottom. Some of the elastic tabs may also engage with a flat surface of the plate or lid by elastically pressing against the surface.

[0056] While the rack la of the first embodiment has roughly U-shaped tabs with a single central tip end aligned with a central plane of symmetry along the longitudinal direction X, the rack lb of the second embodiment has tabs with a roughly M-shape that has two tip ends spaced apart in a transverse direction from a central plane of symmetry along the longitudinal direction X. However, there may be multiple elastic tabs in different orientations and shapes engaging with different positions of the settle plates.

[0057] The main body or base 2, too, may have a different structure as long as it has a plurality of adjacent and spaced apart holding portions 3 each configured to receive and support, in a substantially parallel orientation that is substantially perpendicular to the longitudinal direction X of the rack 1, an individual settle plate P. Further, each holding portion 3 includes positioning features 4 for positioning the settle plate P in the holding portion 3 and allowing, by means of a gripper of a manipulating device / robot or by a pair of fingers of a user, insertion of the settle plate P from a lateral side of the rack 1 in a direction substantially perpendicular to the longitudinal direction X of the rack 1.

[0058] The supporting beams 2a also provide a possibility of holding the rack 1 by hand or by external grippers without the risk of getting in contact with settle plates P in the rack. In addition, the rack 1 may have an additional dedicated gripping section 41 for allowing holding of the rack 1 without interfering with the settle plates P and a bracket 30 that will be described further below.

[0059] In the exemplary embodiments the dedicated gripping section 41 is a bridge-like connection connecting between the supporting beams 2a that protrudes, with an increased flat horizontal face, in the axial direction of the rack 1.

[0060] As an essential aspect the present application provides - mating with the rack 1 - for a bracket, that could be also termed a buckle or clip 30 (30a, 30b, 30c, 30d) that is configured to be releasably mechanically attached to the rack 1 so as to straddle, in the attached posture, a number of the settle plates P (all or a subgroup) at the lateral side of the rack 1 and to mechanically secure the number of the settle plates P in the rack 1 against inadvertent removal or dislodging.

[0061] The releasable mechanical attachment of the bracket 30 to the rack 1 comprises a formlocking engagement between a fastener 31 formed at one of the brackets 30 and the rack 1 and a mating receptacle 38 formed on the other of the bracket 30 and the rack 1. The term "fastener" in the context of the disclosure comprises the features that are provided to removably attach the bracket to the rack and may comprise suitable components at one or both sides of the bracket, examples of which will be described below, and the components on the two sides must not necessarily be identical in structure.

[0062] In the first embodiment the bracket 30 has a form of an elongated U comprising an axially extending central bridge part 32 and the fastener 31 comprises fastener parts 31a, 31b at opposite axial ends of the bridge part 32 that protrude from the bridge part 32.

[0063] The fastener parts 31a, 31b are formed as hooks protruding downward from the bridge part and have their hook section oriented inwards. The hook sections are formed so as to engage with the top ends of the outermost separation elements 11 when the bracket 30a is placed onto the upper end of the settle plates as shown on the right side in Figure 1, in part by the elastic deformation of the separation elements 11 and in part by the elastic deformation of the hooks. The separation elements thus serve as receptacles 38 for the fastener parts. As such, the fastener 31, more specifically the fastener parts 31a, 31b, are elastically biased into an engagement posture and the elastic bias is designed so as to be overcome by two fingers of a hand of a user pressing one or both of the outermost separation elements 11 inward.

[0064] As the bracket 30a is held against the settle plates under a certain tension in order to secure their position, it will pop upward once one of the hook sections is disengaged from the separation element 11. The tension of the bracket and / or a contact surface thereof facing the settle plates with increased friction helps maintaining the settle plates and the bracket in place. The contact surface may be provided with a surface roughing or a material like rubber that has increased friction and / or a certain elasticity.

[0065] The upper side of the bracket 30a may be provided with a surface forming a defined marking section 43 for attaching or storing information / data related to the settle plates P in the rack 1 in the form of a bar code or color code, a data matrix or a RFID. The marking section 43 may be formed on an expanded section of the central bridge part 32 as shown in Figure 1. The lateral sides of the expanded section are slightly curved or concave so as to provide defined gripping sections 32a for the fingers of a hand of a user.

[0066] In the second embodiment shown in Figures 3 and 4 the bracket 30,30b also has a form of an elongated U comprising an axially extending central bridge part 32 and the fastener 31 comprises fastener parts 31a, 31b at opposite axial ends of the bridge part 32 that protrude laterally away from the bridge part 32. Here, too, the fastener 31 is elastically biased into an engagement posture, and the elastic bias is designed so as to be overcome by two fingers of a hand of a user, too.

[0067] To realize such releasable connection at least one of the fastener parts 31a, 31b, preferably both, respectively is / are formed as side-release clips. More specifically, at least one of the fastener parts 31a, 31b, preferably both, respectively comprises a pair of elastic retainer arms 33a, 33b protruding outward and away from a tip region 34 of an insertion section 35 that is configured to be inserted into the receptacle 38 in the form of an elongated opening 38a in the rack 1 by elastically deforming the pair of retainer arms 33a, 33b and providing a form-locking mechanical engagement with the rack 1.

[0068] The elongated opening 38a is formed in a central part of the outermost separation elements 11 in the longitudinal direction of the rack, which central part is located between the two tip ends spaced apart in the transverse direction. Accordingly, the elastic retainer arms 33a, 33b of the pair are formed so as to be elastically deformable by two fingers of a hand of a user pressing them from the side to remove the mechanical engagement and allow withdrawal of the insertion section 35 from the respective opening 38a in the separation elements 11 of the rack 1.

[0069] The upper side of the bracket 30b, too, may be provided with a surface forming a defined marking section 43 for attaching or storing information / data related to the settle plates P in the rack 1.

[0070] In the second embodiment the form-locking engagement between the elastic retainer arms 33a, 33b of the bracket 30b and the rack 1, more specifically the receptacle 38 is made in that end portions of the retainer arms rest against a periphery of the opening 38a in the inserted state. Thus, in order to unlock the insertion section 35, the retainer arms must be pressed towards each other on the side below the central part of the separation elements 11.

[0071] In a modification of the bracket 30c shown in Figure 10 on the left side and in more detail in Figure 11 the elastic retainer arms 33a, 33b are formed such that they extend through the opening 38a in the central part in the inserted state and continue to the upper side. The form-locking engagement in this case is effected by a pair of opposed notches 37a, 37b formed in the retainer arms that engage with the peripheral edge of the opening 38a when the insertion section 35 is inserted. In this case the retainer arms can be pressed towards each other on the side above the central part of the separation elements 11, which is advantageous as it requires less force due to the larger lever arm and is more intuitive. This also reduces the risks of damage to gloves in a standard glove-isolator or in case any manual intervention and handling is required.

[0072] In a further modification of the bracket 30d shown in Figure 10 on the right side and in more detail in Figure 12 the elastic retainer arms 33a, 33b are formed such that they extend through the opening 38a in the central part in the inserted state and continue to the upper side. Unlike in the case of the modification of the bracket 30c the elastic retainer arms 33a, 33b of the fastener parts 31a, 31b at the opposite axial ends of the bridge part 32 are interconnected by links 36a, 36b that extend along the axial direction of the bridge part 32 on both lateral sides thereof with a gap 39 to the bridge part 32. Accordingly, the fastener parts 31a, 31b are formed such that mechanically forcing the links 36a, 36b towards each other transverse to the gap 39 by two fingers of a hand of a user at an approximately central portion between the axial ends of the bracket elastically deforms the elastic retainer arms 33a, 33b at both ends to remove the mechanical engagement of the notches 37a, 37b with the peripheral edge of the respective opening 38a and allows simultaneous withdrawal of both the insertion sections 35 from the respective openings 38a in the rack 1.

[0073] Similar to the first embodiment approximately central portions on the lateral sides of the bridge part 32 or of the links 36a, 36b are slightly curved or concave so as to provide defined gripping sections 32a for the fingers of a hand of a user.

[0074] As shown in Figures 3, 6, 7, 8 and 9 using the second embodiment as an example the positioning features 4 for positioning the settle plates P in the holding portions 3 may, in addition to the separation elements 11, also include further positioning arms 12 that protrude from the main body or base 2 and are formed with contours B to define the lateral position of the settle plates P in the respective holding portions 3. In the example and as in particularshown in Figures 6 and 7 the positioning arms 12 are formed with an axial stopper 13 and with a radial stopper 14 that engage with surfaces of the settle plates to limit their motion in conjunction with the separation elements 11 and snugly fit the settle plate into the holding portion 3. The positioning arms 12 are elastic and the force required to deform them to the outside to allow the settle plate to pass the radial stopper 14 is determined according to the circumstances. The radial stopper 14 is located slightly further to the lateral side from which the settle plates are inserted as compared to a center of the holding portion so that they also support the bracket to prevent rotation of the settle plates and / or inadvertent removal to the lateral side (see Figure 8 in particular). The separation elements 11, on the other hand, may be provided with contours A and C in the form of ramped or inclined leading edges that guide or funnel the movement of the settling plates into the holding portions 3. The various contours on the rack afford that the robot may have increased flexibility in the X, Y and Z directions and still can safely unload or reload the settle plates from / to the rack.

[0075] As shown in Figures 2 and 5 the present application may further provide, for use in conjunction with the combination of the rack with the bracket, for a docking adapter 51 integrated with or configured to be removably attached to the rack 1. The docking adapter 51 is configured to be mounted to a receptacle or door 50 of a sterile transfer system (for example the DPTE® transfer system) so as to present the rack 1 in an orientation that allows removal / insertion of settle plates P from / into the holding portions 3 of the rack 1 from the lateral side of the rack 1 facing an opening 52 of the receptacle or door 50, in the direction substantially perpendicular to the longitudinal direction X of the rack 1.

[0076] The shape of the docking adapter 51 is dictated by shape of the transfer system and must replicate the interfaces with the rack and the receptacle / door of such system. In the present example the docking adapter 51 is a pot-like frame that is centered within the flange-like receptacle or door 50 by a number of arms or prongs 53 distributed about the center of the door 50 and removably connected or suspended from mounting points in the door 50. The rack is removably attached to a bottom of the docking adapter 51 in an orientation that allows removal of the settle plates from the holding portions 3 (if the bracket 30 is removed).

[0077] The receptacle or door of the transfer system, the docking adapter and the rack with the bracket may be combined to form a unit / module for bidirectional transfer of settle plates P to / from a cleanroom environment through a sterile transfer port of the sterile transfer system in that these components are presterilized and received in a sealed container, preferably in the form of a flexible bag, connected to the receptacle or door.

[0078] The docking adapter provides the possibility to selectively integrate the rack (with the bracket) into the movable external component of the sterile transfer system, for example the DPTE® transfer system that is widely used and is recognized as being a safe method for bidirectional transfer in aseptic or toxic working areas, without breaking containment or sterility. The port of this transfer system is fixedly integrated onto the wall of a cleanroom, filling line, or isolator and is designed to functionally cooperate with the mating receptacle or door of an external packaging unit or container (in the DPTE® transfer system called a "beta bag") to aseptically transferthe content of the packaging, in this case the combination of the rack and bracket, into and out from the cleanroom environment. The provision of the adapter facilitates mechanical integration of the rack into such a system without the need to redesign the rack as such, as only the interfaces with the rack and the receptacle / door must be replicated on the adapter. Further, the use of a separate adapter opens the option to re-use the adapter (after decontamination / sterilisation) and to functionally combine a multitude of rack designs with different transfer systems with only limited design changes.

[0079] As shown in Figure 5 the docking adapter 51 may have a storage section 40 for holding the bracket 30,30b in a stand-by position where it does not obstruct insertion of the settle plates P into the holding portions 3 from the lateral side of the rack 1. Such storage section for the bracket may alternatively or also be provided on the rack 1 where it does not obstruct insertion of the settle plates P into the holding portions 3. The arrangement of the storage section 40 as shown such that the bracket 30,30b, when mounted, straddles the gripping section 41 of the base 2 of the rack 1 provides the additional advantage that separation of the rack 1 from the docking adapter 51 necessarily requires the prior removal of the bracket 30b so that a user will likely not forget to attach the bracket to the rack at this point in the process.

[0080] The rack 1 and the bracket 30 may be integrally formed from any suitable material, preferably plastic, preferably by injection molding. Other manufacturing processes are available, including 3D printing. Metal in the form of cast metal or sheet metal or 3D- printed metal is available if the rack / bracket is designed for multi-use that requires sterilization between uses.

[0081] The rack may be formed from different elements that are interconnected, for example a pair of the lateral supporting beams 2a connected to plural separation elements 11, either fixed and not separable (i.e. by glueing or welding) or releasably (by a form-locking engagement or by mechanical fasteners like screws). In this structure different sizes of the rack for different numbers of petri-dishes to be grouped can be easily configured by providing supporting beams 2a of different lengths and configured to be connected to identical separation elements 11 in the desired spacing.

[0082] The bracket, too, may be formed from different elements that are interconnected, for example the central bridge part 32 and a pair of the fastener parts 31a, 31b. A marking section 42,43 for attaching or storing information / data related to the settle plates P in the rack 1 in the form of a bar code or color code, a data matrix or a RFID may be provided on the rack 1 and / or on the bracket 30 and / or directly on the settle plates P. The marking section 42 of the rack 1 may be placed on a front or rear surface of the separate dedicated gripping section 41.

[0083] Based on the information / data - as is known per se, for example from WO 2022 / 084356 Al - all critical process data may be recorded for tracing and documenting purposes and linked through an integrated RFID-type system or via an external system, for example cloud-based.

Claims

Claims1. A combination of a rack (1) for holding a plurality of settle plates (P) and a bracket (30) for mechanically securing the settle plates (P) in the rack (1), wherein the rack (l) comprises a main body (2) with a plurality of adjacent and spaced apart holding portions (3) each configured to receive and support, in a substantially parallel orientation that is substantially perpendicular to a longitudinal direction (X) of the rack (1), a settle plate (P), wherein each holding portion (3) includes positioning features (4) for positioning the settle plate (P) in the holding portion (3) and allowing insertion of the settle plate (P) from a lateral side of the rack (1) in a direction substantially perpendicular to the longitudinal direction (X) of the rack (1), and wherein the bracket (30) is configured to be releasably mechanically attached to the rack (1) so as to straddle, in the attached posture, a number of the settle plates (P) at the lateral side of the rack (1) and mechanically secure the number of the settle plates (P) in the rack (1).

2. The combination according to claim 1, wherein the releasable mechanical attachment of the bracket (30) to the rack (1) comprises a form-locking engagement between a fastener (31) formed at one of the brackets (30) and the rack (1) and a mating receptacle (38) formed on the other of the bracket (30) and the rack (1).

3. The combination according to claim 2, wherein the fastener (31) is elastically biased into an engagement posture, the elastic bias being designed so as to be overcome by two fingers of a hand of a user.

4. The combination according to claim 2 or claim 3, wherein the bracket (30) has a form of an elongated U comprising an axially extending central bridge part (32), wherein the fastener (31) comprises fastener parts (31a, 31b) at opposite axial ends of the bridge part (32) that protrude from the bridge part (32).

5. The combination according to claim 4, wherein at least one of the fastener parts (31a, 31b), preferably both, respectively is / are side-release clips.

6. The combination according to claim 4 or claim 5, wherein at least one of the fastener parts (31a, 31b), preferably both, respectively comprises a pairof elastic retainer arms (33a, 33b) protruding outward and away from a tip region (34) of an insertion section(35) that is configured to be inserted into the receptacle (38) including an opening (38a) in the rack (1) by elastically deforming the pair of retainer arms (33a, 33b) and providing a mechanical engagement with the rack (1), preferably at a periphery of the opening (38a), in the inserted state.

7. The combination according to claim 6, wherein the elastic retainer arms (33a, 33b) of the pair are formed so as to be elastically deformable by two fingers of a hand of a user to remove the mechanical engagement and allow withdrawal of the insertion section (35) from the respective opening (38a) in the rack (1).

8. The combination according to claim 6 or claim 7, wherein the elastic retainer arms (33a, 33b) of the fastener parts (31a, 31b) at the opposite axial ends of the bridge part (32) are interconnected by links (36a, 36b) that extend along the axial direction of the bridge part (32) on both lateral sides thereof with a gap (39).

9. The combination according to claim 8, wherein the fastener parts (31a, 31b) are formed such that mechanically forcing the links (36a, 36b) towards each other transverse to the gap (39) by two fingers of a hand of a user elastically deforms the elastic retainer arms (33a, 33b) to remove their mechanical engagement and allow withdrawal of the insertion sections (35) from the respective openings (38a) in the rack (1).

10. The combination according to any one of claims 1 to 9, wherein the rack (1) has a gripping section (41), separate from the bracket (30), for allowing holding of the rack (1) without interfering with the settle plates (P) and the bracket (30).

11. The combination according to any one of claims 1 to 10, wherein the rack (1) and / or the bracket (30) has a marking section (42;43) for attaching or storing information / data related to the settle plates (P) in the rack (1).

12. The combination according to any one of claims 1 to 11, further comprising a docking adapter (51) integrated with or configured to be removably attached to the rack (1) and to be mounted to a receptacle or door (50) of a sterile transfer system so as to present the rack (1) in an orientation that allows removal / insertion of settle plates (P) from / into the holding portions (3) of the rack (1) from the lateral side of the rack (1) facing an opening (52) of the receptacle or door (50), in the direction substantially perpendicular to the longitudinal direction (X) of the rack (1).

13. The combination according to any one of claims 1 to 12, wherein the rack (1) and / or the docking adapter (51) has a storage section (40) for holding the bracket (30) in a stand-by position where it does not obstruct insertion of the settle plates (P) into the holding portions (3) from the lateral side of the rack (1).

14. A unit / module for bidirectional transfer of settle plates (P) to / from a cleanroom environment through a sterile transfer port of a sterile transfer system, the unit comprising:(i) a receptacle or door (50) of the sterile transfer system configured to be removably attached to a mating receptacle of the transfer port of the sterile transfer system;(ii) a combination of a rack (1) and a bracket (30) as defined by claim 12 or claim 13 in combination with claim 12, wherein the rack (1) is removably mounted to the receptacle or door (50) through the docking adapter (51) so that the settle plates (P) can be removed / inserted from / into the holding portions (3) of the rack (1) from the lateral side of the rack (1) facing an opening (52) of the receptacle or door (50), in the direction substantially perpendicular to the longitudinal direction (X) of the rack (1), while the receptacle or door (50) is attached to the mating receptacle of the transfer port; and(iii) a container, preferably in the form of a flexible bag, connected to the receptacle or door (50) and sealing the combination of the rack (1) and the bracket (30) from an environment.

15. A method of bidirectionally transferring settle plates (P) to and / or from a cleanroom environment through a sterile transfer port, the method comprising, preferably in sequence, the following steps of:(a) providing a unit / module as defined by claim 14 and loading the holding portions (3) of the rack (1) with a number of settle plates (P);(b) mounting the receptacle or door (50) to a mating receptacle of the transfer port;(c) bringing the transfer port to an open state;(d) sequentially removing / returning the settle plates (P) from / into the holding portions (3) of the rack (1) from the lateral side of the rack (1) facing an opening (52) of the receptacle or door (50) in the direction substantially perpendicular to the longitudinal direction (X) of the rack (1);(e) bringing the transfer port to a closed state and removing the receptacle or door (50) from the mating receptacle of the transfer port;(f) releasably mechanically attaching the bracket (30) to the rack (1) so as to straddle, in the attached posture, the number of the settle plates (P) at the lateral side of the rack (1) and mechanically secure the number of the settle plates (P) in the rack (1); and(g) dismounting the rack (1) from the receptacle or door (50).

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