A material transfer system and method

Abstract

A material transfer system (10) made up of first and second mated identical ports (20, 30) in which each port (20, 30) can function as either the receiving and dispensing port for materials thus eliminating the need for separate alpha and beta ports in which the system employs a geared and cammed operating mechanism (160) for precise movement and locking, ensuring pressure stability and sterility throughout material transfer operations.

Description

[0001] Title

[0002] A Material Transfer System

[0003] Introduction

[0004] This invention relates to a material transfer system for the transfer of materials such as pharmaceutical and biotechnological powders during manufacturing processes.

[0005] Background of the Invention

[0006] The transfer of materials between vessels during manufacturing processes can present a number of challenges particularly where the materials and / or the environment must remain sterile or uncontaminated. This is particularly the case in pharmaceutical, biotechnological, medical device and food industries and the like where the transfer of dry materials such as powders, granules, pastes, flakes, crystals and structural elements such as medical device components and vial stoppers can be complex and difficult to achieve whilst maintaining a sterile or safe manufacturing process and environment.

[0007] In these fields, the seamless and safe transfer of materials from one sterile container to another is crucial. The integrity of aseptic conditions must be maintained to prevent any contamination of the materials being handled, the vessels being used and the broader environment. This is particularly vital when dealing with materials like pharmaceutical powders, which can pose significant health hazards and financial losses if not properly contained.

[0008] The pharmaceutical manufacturing industry continues to seek advancements in technology to enhance the safety, efficiency, and environmental sustainability of its processes and traditional material transfer methods often fall short, necessitating significant capital investment in sterile facilities, posing contamination risks, and introducing inefficiencies. Manufacturing processes have led to the development of direct and indirect product transfer systems. Indirect transfer systems are typically used with gloved isolators as an inlet / outlet for bagged items while direct transfer devices are mainly known for use with sterile fluids.

[0009] Known systems are also generally made up of separate interlocking alpha and beta (or passive / active) assemblies or ports for the charge and discharge vessels with the generally bulky and cumbersome beta port being mounted on a stationary vessel and the alpha port mounted on a mobile vessel. Such systems generally require considerable training for operators due to the complex nature of the interlocking elements.

[0010] An example of a direct transfer system is the split butterfly valve system and an example of an indirect transfer device includes mating ports such as rapid transfer (RTP) ports.

[0011] However, the known systems suffer from a number of disadvantages. For example, split butterfly valve systems decrease transfer efficiency as they do not present a full bore due to the butterfly valve being in the transfer path. Also particulate and contamination risk is high due to the valve being exposed to powder flow. In addition, split butterfly systems require precise positioning and significant operator force to dock the assembly (passive and active) together as the design resembles a plug and plunger creating a piston force effect that must be overcome increasing the risk of product contamination and also difficulty in undocking.

[0012] Various attempts have been made to overcome the problems associated with the split butterfly systems. For example, WO 2018 / 154321 A1 describes an alpha / beta device having a sliding gate mechanism which allows for full bore flow. However, the gates are not airtight when not docked and cannot maintain sterility unless in cleanroom environments.

[0013] In addition, the split butterfly and sliding gate systems continue to rely on alpha / beta configurations. As a result, the known devices require comprehensive training to use as incorrect use will lead to significant operational issues and product contamination - incorrect use being the primary cause of failure leading to expensive batch rejection and potential recalls in addition to presenting an operator hazard.

[0014] In addition, cleanroom spaces are generally at a premium and expensive so that the space in these contained spaces is small, making handling difficult and restricted. As actives, are heavy, bulky and expensive, the operation of cumbersome alpha / beta configurations is difficult especially where operators must employ gloved compartments in isolators.

[0015] The beta portion of the known systems also require cleaning after every batch making them expensive to operate as well as purchase and maintain. This causes significant downtime during cleaning / maintenance. Complex spare part replacement procedures also contribute to major downtime in such operations.

[0016] While known systems can be reuseable or (partially) disposable, the known disposable systems cannot be steamed in place / washed and hence can only be used with processes that require smaller flexible bag solutions.

[0017] The known systems fail to allow for sterile powder transfer without the need of a cleanroom environment or additional sterilisation at point of use prior to transfer and fail to maintain the sterility required for transportation or storage without the need to utilise an external airtight container to seal the system and contents when the product leaves the cleanroom environment. Furthermore, Occupation Exposure Bands (OEB) (containment) are increasing and the known systems cannot be used for multiple powder transfers without loss in containment levels. For multiple transfers, current systems require complex and expensive extraction systems to minimise device contamination during undocking of the alpha / beta ports - particularly for split butterfly systems.

[0018] In summary, in the pharmaceutical, biotechnological, medical device and food sectors, the seamless and secure transfer of materials from one sterile container to another is critical. Ensuring aseptic conditions throughout the process is vital to prevent contamination of the materials, containers, and surrounding environment, particularly when handling sensitive materials like pharmaceutical powders. These substances can pose substantial health risks and financial losses if they are not properly contained. Traditional powder transfer methods in pharmaceutical manufacturing often fall short of modern needs. They require significant investment in sterile facilities, introduce contamination risks, and can be inefficient. Current devices in the market struggle to maintain sterility and containment without relying on external airtight containers or cleanroom settings. Most designs are not suitable for multiple transfers without compromising containment, often requiring complex extraction systems to prevent contamination. Additionally, they typically necessitate precise alignment and considerable operator effort, which increases the risk of contamination and operational errors. Many of these devices are not fully airtight when undocked and are unable to be sterilized through standard methods like gamma or steam sterilization, which limits their utility. Comprehensive training is often required to manage the complex handling, and incorrect use can lead to batch contamination, costly downtime, and maintenance issues.

[0019] An object of the invention is to overcome at least some of the problems of the prior art.

[0020] Summary of the Invention

[0021] The invention broadly relates to a material transfer system made up of first and second mated identical ports in which each port can function as either the receiving and dispensing port for materials thus eliminating the need for separate alpha and beta ports. The ports utilise a geared and cammed operating mechanism for precise movement and locking, ensuring pressure stability and sterility throughout material transfer operations. By maintaining product sterility across transfer, sampling, transport, or storage, the material transfer system is an end-to-end solution for sterile powder and similar manufacturing processes.

[0022] According to the invention there is provided a material transfer system comprising a first material donor port, wherein the port comprises: a housing; a docking and mating mechanism in the housing configured to attach the port to a second opposite material receptor port; a coupling defining a port bore in the housing having a material in let / outlet and a material outlet / inlet, and a port door at the material outlet / inlet; wherein the second opposite material receptor port is substantially identical to the first material donor port and the housing comprises a port door isolation chamber and wherein the coupling and the port door are movable by a port door operating mechanism of a port operating mechanism between a bore open / door stowed position in which the port door is sealed in the port door isolation chamber by the coupling and a bore closed position in which the bore is sealed closed by the coupling and the port door.

[0023] In any embodiment, the port door operating mechanism comprises a port door operating mechanism gear train and / or a cam configured to drive movement of the coupling and the port door between the bore open / door stowed position and the bore closed position.

[0024] In any embodiment, the couplings of the material donor port and the material transfer port are configured to co-operate to form a seal to define a sealed throughbore in the bore open / door stowed position.

[0025] In any embodiment, the port door operating mechanism gear train and / or the cam is operable by a drive ring.

[0026] In any embodiment, the port door operating mechanism gear train comprises a drive axle assembly having a driving gear connected to a complementary main driven gear mounted on an axle disposed parallel with the longitudinal axis of the port bore.

[0027] In any embodiment, the drive axle assembly comprises a coupling gear and a door gear to affect rotation of complementary driven coupling and driven door gears connected with the coupling and the port door.

[0028] In any embodiment, the port door operating mechanism comprises a port door cam mechanism operable by the port door operating mechanism gear train.

[0029] In any embodiment, the port door operating mechanism comprises a coupling cam mechanism operable by the driven coupling gear.

[0030] In any embodiment, the coupling comprises a lining.

[0031] In any embodiment, the lining is configured to form an iris valve towards the material inlet / outlet.

[0032] In any embodiment, the lining is mounted between a fixed ring towards the material outlet / inlet and a lining rotatable ring towards the material inlet / outlet.

[0033] In any embodiment, the lining is operable by an iris valve operating mechanism to form the iris valve from the lining towards the material inlet / outlet.

[0034] In any embodiment, the port operating mechanism comprises the iris valve operating mechanism which is configured to move the iris valve between an iris valve formed / closed and iris valve unformed / open position to permit flow of material through the material transfer system.

[0035] In any embodiment, the iris valve operating mechanism is operable by an iris valve drive ring.

[0036] In any embodiment, the iris valve operating mechanism comprises an iris valve gear train communicable with the iris valve drive ring to affect rotation of the drive ring.

[0037] In any embodiment, the iris valve gear train comprises a planetary gear mechanism in the housing. In any embodiment, the iris valve operating mechanism is interconnected with the port door operating mechanism via an interlink.

[0038] In any embodiment, the port door operating mechanism gear train comprises a gear link configured to engage an oppositely disposed gear link of a second material receptor port to affect operation of the second material receptor port when attached to the first material donor port.

[0039] In any embodiment, the docking and mating mechanism comprises a slider plate on the housing movable between port locked and port released positions.

[0040] In any embodiment, the slider plate comprises spaced apart teeth and spaced apart wedges shaped and configured to engage opposing teeth and wedges when first and second ports are docked against each other.

[0041] In any embodiment, the material transfer system further comprises a port operating mechanism releasable brake operable by the docking and mating mechanism to release the port operating mechanism for operation.

[0042] In any embodiment, the releasable brake is movable in response to movement of the slider plate.

[0043] In any embodiment, the releasable brake comprises a pair of interlocking first and second members in which the first member is slotted into a drive gear on the drive ring and the second member is mounted on the slider plate.

[0044] In any embodiment, the first and second interlocking members are hook or latch like structures.

[0045] In any embodiment, the coupling forms an internal seal with the port door in the bore closed position. In any embodiment, the first material donor port and the second material receptor port comprise a seal at the material outlet / inlet configured to form an external fluid tight seal between the first and second attached ports.

[0046] In any embodiment, an internal seal is formed by abutting couplings in the bore open / door stowed position.

[0047] In any embodiment, the port door comprises a door seal to seal the port door in the bore closed position.

[0048] In any embodiment, the locking and mating mechanism comprises a guiding and locking foot to assist in locking two ports together.

[0049] In any embodiment, engaging threads are defined between the housing and the coupling via which the coupling can travel upwards and downwards in the housing upon rotation of the coupling.

[0050] In another embodiment, the invention also extends to a method of transferring material between a first donor vessel and a second receptor vessel comprising the use of a system as claimed in any preceding claim, the method comprising: attaching a first material donor port to a second material receptor port with the docking and mating mechanism such that the first and second ports are externally sealed and clamped together; moving the port doors in each port from a port bore closed position to a bore open / door stowed position by lifting the coupling off the port doors and moving the ports doors into respective isolation chambers to form a material throughbore through the first and second ports, and sealing the port doors in the port door isolation chambers by abutting the couplings.

[0051] In any embodiment, the method further comprises the step of moving an iris valve where present from an iris valve formed / closed to an iris valve unformed / open position, to permit flow of material from the material donor vessel through the throughbore to the material receptor vessel.

[0052] The invention also extends to a material transfer system comprising two substantially identical material ports, each acting as either donor or receptor ports depending on orientation, wherein the port comprises: a housing; a docking and mating mechanism in the housing configured to attach the port to the second port; a coupling defining a port bore in the housing having a material in let / outlet and a material outlet / inlet, and a port door at the material outlet / inlet; wherein the coupling and the port door are operatively linked to a port door operating mechanism configured to move said coupling and port door between:

[0053] 1 . a bore closed position, in which the coupling and the port door cooperate to form a sealed closure of the port bore, preventing material flow

[0054] 2. a bore open, door stowed position, in which the port door is securely sealed within a dedicated isolation chamber inside the same housing, and the coupling extending to the docking interface thereby opening the port bore for material transfer.

[0055] The invention also extends to a method of transferring material between a first donor vessel and a second receptor vessel comprising the use of a system as hereinbefore defined, the method comprising: attaching a first port to a second port with the docking and mating mechanism such that the first and second ports are externally sealed and clamped together; moving the port doors and coupling in each port from a port bore closed position to a bore open / door stowed position by lifting the coupling off the port doors and moving the ports doors into respective isolation chambers within respective housings; sealing the port extending the couplings to abut at a port docking interface to form a sealed material throughbore through the first and second ports; and optionally moving an iris valve where present from an iris valve formed / closed to an iris valve unformed / open position, to permit flow of material from the material donor vessel through the throughbore to the material receptor vessel.

[0056] The invention therefore provides a material transfer system for the transfer of materials, such as powders, granules, pastes, flakes, crystals, or components like vial stoppers which is configured for applications in industries where maintaining sterile processing environments is essential, such as the pharmaceutical, biotechnological, medical device and food sectors. Operation of the system consists of bringing two identical ports together, locking them securely, and rotating drive gears to allow an internal coupling to lift off its seat to in turn allow port doors to move to create a material transfer path defined by a throughbore. The couplings can then reengage or abut to seal the throughbore and an interlinked optional iris valve can be opened to allow flow of material through the sealed throughbore.

[0057] The advantages of the material transfer system of the invention are many. Importantly, when the first and second ports of the transfer system are brought together the port doors are isolated from the external environment. In addition, the transfer system and specifically each port is self-contained - each port door is isolated in its respective port unlike prior art devices where the door of the passive port abuts the door of the active port in an external chamber in the active port.

[0058] Movement of the port doors from open to closed positions in which the port doors are sealed in isolation chambers within its port shields the port doors from any transfer contamination but also shields the product from any potential contamination from the port doors. The mirrored design of the two ports provides singular units serving dual roles, which simplifies operations and reduces the need for multiple pieces of equipment, thereby enhancing user convenience and reducing the potential for error. Only one multi-functional port is required for discharge and charging reducing complexity. Users therefore require only one product on the shelf that can be utilised as required. This flexibility also allows for product sampling utilising the same port in contrast with known systems which require ports to be moved to an active position to be opened or interlocks must be bypassed for sampling operations which risks contamination.

[0059] The docking and mating mechanism is a poka-yoke design i.e. an error-proofing feature that ensures foolproof assembly and secure connections, enhancing both safety and reliability.

[0060] The internal coupling and lining of the ports serves as an active lock and seal to secure / re inforce and seal the port doors enabling material transfer i.e. the port doors maintain internal pressure as well as external pressure. The internal coupling also actively pulls open the port doors to allow the ports to maintain negative pressure and the geared or cammed movement allows the coupling to raise and lower with a singular drive ring movement. The coupling also seals the throughbore / transfer path of both coupled ports. One drive ring on either port can be used to open / close doors either clockwise or anticlockwise allowing the operator to be positioned anywhere.

[0061] The lining attached to the coupling forms an integral seal at the coupling and forms the paraboloid iris valve at the inlet port which can be formed / closed and unformed / opened upon rotation of the iris valve drive ring. The lining / iris valve also controls powder flow, preventing contact with the port doors and ensuring sterility and, due to an interlink between the drive ring and the iris valve drive ring, the iris valve is operable only when the port doors are open, eliminating the need for additional third party valves. This makes the material transfer system safer to use offering an additional layer of protection whilst reducing the cleanroom space required to operate the valve.

[0062] The iris valve is also configured to stretch tight when open but exhibits minimal strain when closed to be able to remain closed for long periods during storage. In addition, the coupling movement minimises the height required for the iris valve. Integrating the iris valve into the port of the system of the invention also allows the system to be used with flexible containers such as bags, but also rigid plastic and metal containers. Due to the absence of obstructive butterfly valves and the like, the ports of the system of the invention can also be used to increase powder yield with difficult flowing powders that require breaking and massaging during transfer.

[0063] The geared and cammed operating mechanism of the system of the invention is precision-engineered to ensure robust locking and precise movements which is crucial for maintaining sterility during transfers. This also ensures that the product can be docked effortlessly through the mechanical advantage offered by the system.

[0064] Where required, the system of the invention can be disposable following a batch transfer. This reduces cost for training operators and product maintenance, sterility risks due to incorrect maintenance or cleaning. Cleaning costs which are heavily dependent on resources such as water and chemicals are also reduced.

[0065] Due to its simplicity and mirrored port design, the material transfer system also allows for intuitive use with minimal training. After transfer, the iris valve can be closed and the port doors retracted to the closed position, preparing the system for subsequent operations without powder residue on port door faces.

[0066] The ports of the material transfer system are configured so that, unlike conventional ports, they can be formed from plastics materials. The system is also disposable, lightweight and cost-effective. The system can be constructed from durable plastics such as polyarylamide, polysulfone, or their glass-filled equivalents and can withstand sterilization methods including gamma radiation, Vaporized Hydrogen Peroxide (VHP), and steam sterilization. These materials are biocompatible and resistant to chemicals, heat, and deformation. The sealing components can be made from silicone, various rubbers, thermoplastic elastomers, polyolefins, PTFE, thermoplastic perfluoropolymer resins, urethanes, EPDM rubber, PDDF resins, and similar materials. Additionally, the system of the invention can be adapted for use in stainless steel, expanding its versatility across various applications and ensuring compatibility with rigorous sterilization requirements and cleaning agents.

[0067] The ports of the system can be steamed / washed in place (SIP / WIP) allowing it to be placed on isolators or vessels that require to be SIP / WIP with the flexibility of just disposing of the port when the process is complete. The ports are also configured to withstand up to 120°C at 1.5bar pressure when connected to form the material transfer system whereas currently only metal valves are capable of being SIP / WIP.

[0068] Brief Description of the Drawings

[0069] The invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0070] Figure 1 is a side elevation of a first embodiment of a material transfer system for the transfer of materials such as pharmaceutical powders made up of a first port and an opposite identical second port each attached to vessels with the first and second ports separated to show the teeth of the port docking and mating mechanism;

[0071] Figure 2 is a perspective view from above and one side of a port of the material transfer system of Figure 1 ;

[0072] Figure 3 is a perspective view from below of the port of Figure 2 with the translatable / slidable door-like port valve (port door) in the closed position;

[0073] Figure 4 is a perspective view from below of the port of Figure 2 with the base plate and port door removed to reveal the internal bore of the port;

[0074] Figure 5 is a perspective view from above and one side of the port door;

[0075] Figure 6 is a cross-sectional view through the port of Figure 2; Figure 7 is an exploded view of the material transfer system of Figure 1 ;

[0076] Figure 8 is a cross-sectional view through the port of Figure 2 to reveal the coupling with lining defining the internal port bore;

[0077] Figure 9 is an enlarged perspective view from above and one side of a portion of the first and second ports with the teeth of the docking and mating mechanism of the first port inserted in the complementary guide holes of the docking and mating mechanism of the second port and located adjacent the locking wedges of the second port;

[0078] Figure 10 is a side elevation of the portion of the first and second ports of Figure 9 with the bases abutting and the teeth of the first port fully inserted in the complementary guide holes of the second port adjacent the locking wedges of the second port;

[0079] Figure 11 is an enlarged view of the teeth of the first port and wedges of the second port;

[0080] Figure 12 is a side elevation of the first and second ports with the slidable teeth carrier plate of the docking and mating mechanism in the locked position to engage the teeth of the first port with the complementary wedges of the second port to sealably and securely mate the first port with the second port;

[0081] Figure 13 is a cross-sectional view through the mated first and second ports of the material transfer system showing the seal formed between the ports and with the translatable port doors of each port in a closed deployed position to sealably close the throughbore of the material transfer system;

[0082] Figure 14 is an enlarged cross-sectional view through the docking and mating mechanism of a port of Figures 10 and 11 , showing a port operating mechanism releasable brake operable by the teeth carrier plate of the docking and mating mechanism to release the port operating mechanism; Figure 15 is a perspective view from above and one side of the port of Figure 2 with the drive ring cover ring removed to reveal the drive gear, the driven coupling and driven door gears of the port door operating mechanism gear train and an interlocking member of the releasable brake;

[0083] Figure 16 is an enlarged perspective view of the interlocking members of the releasable brake and of the drive gear of Figure 15;

[0084] Figure 17 is an exploded view of the port operating mechanism and associated port door showing the gear train of the port door operating mechanism with the cover ring omitted;

[0085] Figure 18 is an enlarged perspective view of the drive axle assembly of the gear train of the port door operating mechanism with the cover ring omitted;

[0086] Figure 19 is a perspective view from above and one side of the port of Figure 18 with the iris valve operating mechanism removed and the coupling detached from the tubular body to reveal the coupling cam;

[0087] Figure 20 is a perspective view from above and one side of the port of Figure 2 with the iris valve drive ring in place and the interlink in the form of a wedge extending between the drive ring and the iris valve drive ring;

[0088] Figure 21 is a cross-sectional view through the mated first and second ports of the material transfer system with each coupling / lining of the ports, which together define the material transfer system throughbore, being retracted into a door release position from the port doors by the port operating mechanism doors in the direction indicated by the arrows to release the port door seals and allow for translational movement of the port doors into a bore open / door stored position in which the port doors are stored in port door chambers in each port; Figure 22 is a cross-sectional view through the mated first and second ports of the material transfer system of Figure 21 with each coupling / lining of the bores being returned to a throughbore sealed position by the port operating mechanism in the direction indicated by the arrows to form a sealed throughbore isolated from the port door seals and the port doors in the port door isolation chambers;

[0089] Figure 23 is a perspective view from above and one side of the material transfer system of Figure 22 showing the gear link of each port door interconnected so that actuation of either port operating mechanism actuates the other port operating mechanism;

[0090] Figure 24 is an enlarged perspective view of the interconnected gear links of Figure 23;

[0091] Figure 25 is a cross-sectional view through a second embodiment of a port of a material transfer system of the invention in which the internal coupling travels upwards and downwards upon rotation of the coupling, and

[0092] Figure 26 is an exploded view of the material transfer system of Figure 24.

[0093] Detailed Description of the Invention

[0094] Figures 1 to 24 show a first embodiment of a material transfer system of the invention generally indicated by the reference numeral 10. As shown in the drawings, the material transfer system 10 is made up of first and second mirrored i.e. identical ports 20,30 interconnected to form the material transfer system 10 and which can be connected to material vessels 40,50 in use. Being identical, the ports 20,30 are not in an alpha / beta format or passive / active format so that neither port has an element that projects into the other and is exposed to material being transferred.

[0095] As shown particularly in Figures 2 to 8, each port 20,30 can be formed from a generally cylindrical housing 60 upstanding from a base 70 provided with a base plate 75 on its lower face. The cylindrical housing 60 is made up of a tubular body 80 defining an internal port bore 90 having a material inlet / outlet 100 distal from the base 70 and an opposite material outlet / inlet 110 through the base 70 and the base plate 75. The function of the inlets / outlets 100,110 is determined by the orientation / function of each port 20,30 (i.e. whether the port has a material donor or material receptor function) and for the purposes of this description the port 20 of Figures 2 to 6 is a material donor port 20 and the port 30 of Figure 1 is a material receptor port 30 so that item 100 of the material donor port 20 is a material inlet 100 and item 110 is a material outlet 110. Conversely, item 100 of the inverted material receptor port 30 is a material outlet 100 and item 110 is a material inlet 110.

[0096] The internal port bore 90 is openable and closable by a door-like port valve 120, hereinafter referred to as a port door 120, located at the material inlet / outlet 110 which is movable between a bore open / door stowed position in which the internal port bore 90 is open and the port door is stowed and a bore closed position in which the internal port bore 90 is closed by the port door 120. As shall be explained more fully below, an optional iris valve 130 is also provided at the tubular body 80 towards the material inlet 100 distal from the base plate 75 to open and close the material inlet 100.

[0097] The port 20 is provided with a docking and mating mechanism 140 co-operable with the docking and mating mechanism 140 on the second port 30 to attach the first port 20 to the second port 30 and form the material transfer system 10 of Figure 1 in which the internal port bores 90 of the first and second ports 20,30 can be contiguously combined to form an openable / closable material throughbore 150 through which material can be passed through the material transfer system 10.

[0098] As shall be explained more fully below, following docking and mating of the first and second ports 20,30 via the docking and mating mechanisms 140, the port door 120 of each port 20,30 can be moved from the bore closed position to the bore open / door stowed position in which the port doors 120 of each port 20,30 are sealed within a port door isolation chamber 170 defined in each base 70, via a port operating mechanism 160 formed at the housing 60, to form the throughbore 150. In the present embodiment, the port operating mechanism 160 is made up of a port door operating mechanism 165 for operating the port doors 120 and an interconnected iris valve operating mechanism 166 which serves to move the iris valve 130 present at the inlet / outlet 100 of each port 20,30 between an iris valve formed / closed and iris valve unformed / open positions to permit flow of material from the material donor vessel 40, through the throughbore 150 to the material receptor vessel 50.

[0099] As shown particularly in Figures 2, 3 and 9 to 12, the docking and mating mechanism 140 is located at the base 70 and is made up of a generally rectangular slider plate 180, from which the tubular body 80 is upstanding, slidably mounted on a fixed subplate 230 between port locked and port released positions. The slider plate 180 is provided with a first side edge 190, a second opposite side edge 200, a rear edge 210, an opposite curved front edge 220, a top face 260 and a bottom face 270 covered by the base plate 75. The docking and mating mechanism 140 includes a series of spaced apart teeth 240 on the first side edge 190 and a series of complementary spaced apart wedges 250 at the second side edge 200 shaped and configured to engage the teeth 240 when the first and second ports 20,30 are docked against each other. The second side edge 200 is also provided with teeth guides 280 to automatically guide the spaced apart teeth 240 into alignment with the complementary wedges 250. In the present embodiment, the teeth guides 280 are spaced apart guide slots 280 complementary in size, shape and spacing with the series of teeth 240 to receive the teeth 240 and locate the teeth adjacent the wedges 250. As shall be explained more fully below, translational sliding movement of the slider plate 180 can be affected by urging the slider plate 180 in the direction indicated by the arrows in Figures 2 and 12 using a slider plate grip 185 on the slider plate 180 to cause opposing teeth 240 and wedges 250 to engage (see Figure 10) to mate and lock the first port 20 to the second port 30.

[0100] The base 70 is also provided with an external outer circumferential seal 300 (see Figure 3) surrounding the material outlet 110. The outer circumferential seal 300 serves to form a fluid tight pressure resistant external seal 310 between the first and second ports 20,30 when the opposing teeth 240 and wedges 250 are engaged (see Figures 12 and 13). This too shall be explained more fully below. As indicated above, once the first and second ports 20,30 are locked together by the docking and mating mechanisms 140, the material transfer system 10 can be operated by the port operating mechanism 160.

[0101] As indicated above, the material throughbore 150 of the material transfer system 10 is formed by the internal port bores 90 of the first and second ports 20,30 and, as shown particularly in Figures 13 to 24, the port operating mechanism 160 (including the port door operating mechanism 165 and the interlinked iris valve operating mechanism 166) is located at the tubular body 80 of each of the internal port bores 90 the port operating mechanisms 160 of each port 20,30 are mechanically interconnected to operate the material transfer system 10.

[0102] Each port door operating mechanism 165 is made up of a tubular coupling 320 mounted in the tubular body 80 which defines an internal port bore 90 to form the throughbore 150. The tubular couplings 320 are movable to facilitate movement of the port door 120 between the bore sealably closed and bore open / door sealably stowed positions to facilitate passage of materials through the throughbore 150 i.e. the coupling 320 is also movable between a bore open / door stowed position and a bore closed position. The coupling 320 can also include an internal tubular diaphragm-like lining 330 which lines the internal port bore 90 and extends between a lining fixed ring 340 mounted in the port bore 90 towards the material outlet 110 and a lining rotatable ring 350 mounted in the port bore 90 towards the material inlet 100. The coupling 320 with internal lining 330 forms an internal seal 321 with the port door 120 to seal the port bore 90 when the port door 120 is in the bore closed position - see Figure 13.

[0103] The port door operating mechanism 165 also includes a drive ring 360 mounted at the tubular body 80 to affect actuation of the coupling 320 when rotated in a clockwise or anti-clockwise direction. The drive ring 360 is provided with a laterally extending handle 370 to facilitate rotation. The drive ring 360 is mechanically connected to a port door operating mechanism gear train 361 which is configured to drive movement of the coupling 320 and associated lining 330 and the port door 120 of both ports 20,30 in the material transfer system 10 - see Figures 17 and 18. The door operating mechanism gear train 361 is positioned internally in the housing 60 and can be covered with a cover ring 365 to protect the door operating mechanism gear train 361 . In the present embodiment, the door operating mechanism geartrain 361 can be made up of a drive axle assembly 362 having an external toothed driving gear 430 on the drive ring 360 connected to a complementary main driven gear 441 which is mounted on a substantially vertical axle or shaft 445 disposed parallel with the longitudinal axis of the port bore 90. Also mounted on the axle 445 are a coupling gear 446 and a door gear447 which affect rotation of complementary driven coupling and driven door gears 448,449 connected with the coupling 320 and the port doors 120 upon rotation of the drive ring 360. In other embodiments of the invention, other gear train configurations may be employed. The axle 445 terminates at a gear link 450 configured to engage an oppositely disposed gear link 450 of the second port 30 in the material transfer system 10. In the present embodiment, the gear links 450 have intermeshing teeth 455 to facilitate engagement.

[0104] In other embodiments of the invention, the port door operating mechanism gear train 361 can be replaced by a cam.

[0105] The drive ring 360 of the present embodiment is mounted on the tubular body 80 which in turn surrounds the tubular coupling 320 (see Figure 19) and upwards / downwards movement of the coupling 320 is affected via a coupling cam mechanism. More particularly, in the present embodiment, the internal face of the tubular body 80 is provided with a continuous cam 420 which extends continuously along the internal surface of the tubular body 80 and is shaped to extend up and down so that cam followers 421 on the external face of the coupling 320 causes the coupling 320 and associated lining 330 to rise and descend upon rotation of the drive ring 360 in accordance with the cam 420 profile.

[0106] Rotation of the drive ring 360 affects lateral movement of the port door 120 via the port door operating mechanism 165. In the present embodiment, transfer of the port door is also cam operated via a port door cam mechanism. For example, the port door 120 can be made up of a door plate 470 defining a material outlet sealing plate 480 complementary in shape with the material outlet 110 (e.g. circular) which can form the seal 321 with the coupling 320 and lining 330 described above. The port door 120 is also provided with a door seal 125 surrounding the sealing plate 480 to seal the port door 120 in the bore closed position. A circumferential door spring 490 surrounds the door seal 125 together with oppositely disposed latches 500 engageable with complementary latch slots on the coupling 320 to facilitate detachment of the port door 120 from the door plate 470 during movement of the port door 120.

[0107] As indicated above, the door plate 470 is provided with an elongate channel-like cam 510 engageable with a cam follower 520 in the form of a pinion 520 projecting downwards from the driven door gear 449 into the cam 510 to form the port door cam mechanism to affect lateral movement of the door plate 470 between the bore open / door stowed and bore closed positions upon rotation of the drive ring 360 and the door gear 447. In the present embodiment, the door plate 470 has a generally curved edge 471 extending from a generally straight edge 472 and the cam 510 extends along the generally straight edge.

[0108] The iris valve operating mechanism 166 can also gear / cam operated and is interconnected with the port door operating mechanism 165 via an interlink 167 in the form of an interlocking wedge 167 extending between the drive ring 360 and the iris valve operating mechanism 166. As shown in the drawings, the iris valve 130 can be formed as part of the internal coupling 120 and more particularly can be formed by the lining 330. For example, where the tubular lining 330 is clamped between the fixed ring 340 and the rotatable ring 350 as previously described the rotatable ring 350 can be rotated to impart a paraboloid iris valve 130 form to the lining 330. More particularly, the iris valve operating mechanism 166 can include the fixed ring 340, the rotatable ring 350 and an iris valve drive ring 550 on the tubular body 80 (above the drive ring 360) which can be connected to the rotatable ring 350 via an iris valve gear train 380 to affect rotation of the rotatable ring 350 upon rotation of the iris valve drive ring 550. In the present embodiment, the iris valve gear train 380 is a planetary gear mechanism 380 also located in the tubular housing 60 at the iris valve drive ring 550. The planetary gear mechanism 380 is made up of an outer ring gear 390 connected to the iris valve drive ring 550, intermediate 11 planet gears 400 and a central sun gear 410 connected to the rotatable ring 350. The planetary gear mechanism 380 allows the lining 330 to be twisted at the top (at the rotatable ring 350) through the rotation of the iris valve drive ring 550 (which can also have a finger grip 551) whilst remaining in a fixed position at the fixed ring 340. This torsion causes the lining 330 (which can be formed of silicone or a similar material) to stretch and form a paraboloid form, closing up as an iris valve 130 at the material inlet 100. Accordingly, the internal lining 330 provides both sealing at the interface point of the two ports 20,30 during use, and transforms to an iris valve 330 from one end when the material transfer system 10 is closed.

[0109] As indicated above, in use, first and second ports 20,30 are engaged to form a material transfer system 10 with, for example, the first port 20 attached to a donor vessel 40 and the second port 30 attached to a receptor vessel 50. As both ports 20,30 are the same, the ports 20,30 are engaged in an opposed manner i.e. mirrored to each other.

[0110] The first and second ports 20,30 are placed and guided together via the docking and mating mechanism 140 by inserting the spaced apart teeth 240 in the opposing guide slots 290. The first and second ports 20,30 are then pressed against each other to allow for the ports 20,30 to be then locked together. This step enables the external circumferential seals 300 to seal together lightly to form the fluid tight pressure resistant external seal 310.

[0111] The docking and mating mechanism 140 can then be operated by urging the grip 185 in the direction indicated by the arrows to slide the slider plate 180 into a clamped position where opposing spaced apart teeth 240 and wedges 250 engage (see Figure 10) to clamp / lock the first port 20 to the second port 30. It should be noted that first port 20 can be locked to the second port 30 by operating the locking and mating mechanism 140 on either port 20,30. Accordingly, the sliding movement causes the wedges 250 to form a secure friction fit between the teeth 250 to securely clamp the first and second ports 20,30 together with force, allowing the material transfer system 10 to withstand pressure at the formed external seal 310 without releasing. The material transfer system 10 is therefore securely formed. Figures 14 to 16 show a port operating mechanism releasable brake 530 operable by the teeth slider plate 180 of the docking and mating mechanism 140 and interconnected with the drive ring 360 and the iris valve drive ring 550 to release the port operating mechanism 160 to allow passage of material from the donor vessel 40 through material transfer system 10. As indicated above, the docking and mating mechanism 140 is fully activated by urging the slider plate 180 into the clamped / locked position which in turn causes the releasable brake 530 to be released by lifting the releasable brake 530 thus freeing the drive ring 360 for rotational movement. More particularly, the releasable brake 530 is movable in response to movement of the slider plate 180 and is made up of a pair of interlocking first and second members 531 ,532 with the first member 531 being slotted into the drive gear 430 on the drive ring 360 and the second member 532 being mounted on the slider plate 180. In the present embodiment, the first and second interlocking members 531 ,532 are hook-like structures so that once the slider plate is fully pushed into the clamped position, the drive gear 430 is released by slightly depressing the first member 531 which is slotted into the drive gear 430 preventing rotation. The first member 531 is therefore positioned just below a taper in the drive gear 430 that allows the drive ring 360 to rotate slightly. As the drive ring 360 rotates the taper on the drive ring 360 depresses the first member 531 further down to catch into the second member 532. This prevents the two ports 20,30 from disconnecting from each other while the port doors 120 are not fully closed. The port door operating mechanism 165 is therefore free to be operated by rotating the drive ring 360 of either port 20,30 in a clockwise or anticlockwise direction. This feature facilitates operator usability and the use of the material transfer system in confined spaces.

[0112] The drive ring 360 can be rotated by gripping the handle 370 to drive the drive axle assembly 362 including the main driven gear441 , the coupling gear446 and the door gear 447. In particular, the drive axle assembly 362 drives all mechanisms through a single point of entry in the housing 60 that can be easily sealed, substantially reducing the risk of any material leaks into the ports 20,30 allowing for higher pressures and sterility to be maintained. This allows for having a one piece or unitary housing 60 and tubular body 80 as shown for example i.e. the housing 60 can therefore be configured as a single body allowing it to be easily sealed, substantially reducing the risk of any leaks to the inside of the system 10 allowing for higher pressures and sterility to be maintained. The door operating mechanism gear train 361 also reduces the effort required by the user to rotate the drive ring 360 by eliminating the need for sealing around the whole drive ring 360 perimeter thus reducing friction and allowing for smoother operation.

[0113] Different selected gear ratios on each of the main driven gear 441 , the coupling gear 446 and the door gear 447 allow for the precise motion sequencing required for operation of the port door 120 and the internal coupling 320 with a singular motion of the drive ring 360.

[0114] Rotation of the drive ring 360 therefore drives the coupling gear 446 and the driven coupling gear 448 to rotate the coupling 320 within the tubular body 80 lowering and raising the coupling 320 in accordance with the cam 421 profile. At the same time, this motion drives the driven door gear 449 to rotate the door pinion 520, allowing for the opening and closing of the port door 120 as a result of the door pinion 520 following the door cam 510 profile. Rotation of the drive ring 360 also drives the gear link 450 that interconnects both ports 20,30 allowing the one drive ring 360 movement to drive the similar movement on an opposing port 20,30 to permit either port 20,30 to be used to drive the material transfer system 10.

[0115] In more detail, rotation of the drive ring 360 lifts the internal coupling 320 off the port doors 120 concurrently on both the first and second ports 20,30. This movement releases the internal seal 321 between the port door 120 and the inner coupling 320 to allow the port door 120 to lift off its seal 125 utilising its sprung design (circumferential spring 490). As the coupling 320 rises it aids port door 120 lifting by lifting the door latches 500 e.g. via a shelf like protrusion on the coupling 320. This mechanically pulls the port door 120 if the spring 490 is unable to counteract any internal pressure in the port 20. As drive ring 360 is rotated further, door pinion 520 translates the port doors 120 from their initial closed / sealed position to the secondary open position away from the material transfer path i.e. to form the throughbore 150. The port doors 120 are therefore slid out of the latches as the door pinion 520 travels in the door cam 510 and rotation of the drive ring 360 drives the lining 330 of the coupling upwards off the port door 120 by following the lining cam 420 thus creating a door exit gap 540 between the lining 330 of each port 20,30 to facilitate movement of the port door 120 into its port isolation chamber 170.

[0116] As the drive ring 360 is rotated further, and the port door 120 reaches the end of travel, the inner coupling 320 lowers again as the coupling cam follower 421 follows the coupling cam 420 so that the coupling 320 of both ports 20,30 meet and seal together at the connection point midway between the devices to reform an internal seal 321 .

[0117] In this position, the internal seal 321 is formed by the abutting linings 330 / couplings 320 as indicated by the reference numeral 322 (Figure 16). The abutting linings 330 therefore seal both internal port bores 90 together contiguously to form the sealed throughbore 150 defining a pressure sealed and sterile material transfer path in the material transfer system 10. Full rotation to end of travel of the drive ring 360 then disengages the iris valve drive ring 550 e.g. by aligning a slot on drive ring 360 to allow the releasable brake 530 to move downwards disengaging the iris valve drive ring 550 whilst locking drive ring 360. The iris valve drive ring 550 can then be rotated and the iris valve 130 opened i.e. to allow rotation of the rotatable ring 350 to untwist the lining 330 to open the iris valve 130.

[0118] Once the transfer is complete the reverse sequence is performed. The iris valve drive ring 550 is rotated to close the iris valve 130 and seal the port bores 90 and the drive ring 360 on either port 20,30 is rotated to lift and release the internal seal 322 formed by the abutting linings 330, and start port door 120 closure in both ports 20,30 so that the port doors 120 move from the throughbore open position to the throughbore closed position. Once the port doors 120 are closed and on their respective door seals 120 each coupling 320 travels a further distance down to lock against the port door 120 to actively seal the port door 120 at the internal seal 321. The docking and mating mechanism 140 can then be released by depressing a release 186 at the slider plate grip 185 to automatically release the slider plate 180 and unclamp the first and second ports 20,30. No door seals have been contaminated and the ports 20,30 can be re-utilised to transfer more product if required without compromising sealing.

[0119] Figures 25 and 26 show a second embodiment of a port 20 of a material transfer system 10 broadly similar in operation to the port 20 of the first embodiment and like numerals indicate like parts. However, in the present embodiment, the locking and mating mechanism 140 comprises a guiding and locking foot 145 projecting from the base 70 and engageable at the opposing base 70 of a second port to assist in locking two ports together. In addition, the internal coupling 320 travels upwards and downwards in the housing 60 via engaging threads 325 defined between the housing 60 and the coupling 320 upon rotation of the coupling 320. More particularly, the movement of the transfer system 10 of the first embodiment is maintained, however the drive ring 360 directly drives movement of the port door pinion 520 in the door cam 510 and up / down movement of the coupling 320 by rotating the internal coupling 320 while the iris valve drive ring 550 directly drives opening and closing of the iris valve 130. Accordingly, more than one entry point to the housing 60 is required. As a result, the iris valve operating mechanism 166 is separate to the main internal coupling 320 and has its own section indicated by the reference numeral 168 which is directly rotated via the iris valve drive ring 550. As the iris valve drive ring 550 is rotated the lining 330 raises and contracts as the lining 330 is twisted or untwisted accordingly.

[0120] In this embodiment, as drive ring 360 is rotated, the locking force between the two ports 20,30 in the material transfer system 10 is increased effectively fully locking when the drive ring 360 is fully rotated performing the function of opening the port doors 20,30 and sealing the two ports 20,30 together. This embodiment is suitable for low pressure and non-sterile environments.

Claims

27Claims1. A material transfer system (10) comprising a first material donor port (20), wherein the first material donor port (20) comprises: a housing (60); a docking and mating mechanism (140) in the housing (60) configured to attach the first material donor port (20) to a second opposite material receptor port (30); a coupling (320) defining a port bore (90) in the housing (60) having a material inlet / outlet (100, 110) and a material outlet / inlet (100, 110), and a port door (120) at the material outlet / inlet (100, 110); wherein the second opposite material receptor port (30) is substantially identical to the first material donor port (20) and the housing (60) comprises a port door isolation chamber (170) and wherein the coupling (320) and the port door (120) are movable by a port door operating mechanism (165)of a port operating mechanism (160) between a bore open / door stowed position in which the port door (120) is sealed in the port door isolation chamber (170) by the coupling (320) and a bore closed position in which the bore (90) is sealed closed by the coupling (320) and the port door (120).

2. A material transfer system (10) as claimed in Claim 1 , wherein the port door operating mechanism (165) comprises a port door operating mechanism gear train (361) and / or a cam configured to drive movement of the coupling (320) and the port door (120) between the bore open / door stowed position and the bore closed position.

3. A material transfer system (10) as claimed in Claim 2, wherein the couplings (320) of the material donor port (20) and the material transfer port (30) are configured to co-operate to form a seal (321) to define a sealed throughbore (150) in the bore open / door stowed position”.

4. A material transfer system (10) as claimed in Claim 2 or Claim 3, wherein the port door operating mechanism gear train (361 ) and / or the cam is operable by a drive ring (361).

5. A material transfer system (10) as claimed in any of Claims 2 to 4, wherein the port door operating mechanism gear train (361 ) and / or the cam comprises a drive axle assembly (362) having a driving gear (430) connected to a complementary main driven gear (441 ) mounted on an axle (445) disposed parallel with the longitudinal axis of the port bore (90).

6. A material transfer system (10) as claimed in Claim 5, wherein the drive axle assembly (362) comprises a coupling gear (446) and a door gear (447) to affect rotation of complementary driven coupling and driven door gears (448,449) connected with the coupling (320) and the port door (120).

7. A material transfer system (10) as claimed in any of Claims 2 to 6, wherein the port door operating mechanism (165) comprises a port door cam mechanism (510) operable by the port door operating mechanism gear train.

8. A material transfer system (10) as claimed in any of Claims 2 to 7, wherein the port door operating mechanism comprises a coupling cam mechanism operable by the port door operating mechanism gear train (361).

9. A material transfer system (10) as claimed in any of Claims 1 to 8, wherein the coupling (320) comprises a lining (330).

10. A material transfer system (10) as claimed in Claim 9, wherein the lining (330) is configured to form an iris valve (130) towards the material inlet / outlet (100,110).

11. A material transfer system (10) as claimed in Claim 10, wherein the lining (330) is operable by an iris valve operating mechanism (166) to form the iris valve (130) from the lining (330) towards the material inlet / outlet (100, 110).

12. A material transfer system as claimed in Claim 11 , wherein the iris valve operating mechanism (166) is configured to move the iris valve (130) between an iris valve formed / closed and iris valve unformed / open position to permit flow of material through the material transfer system (10).

13. A material transfer system as claimed in Claim 12 wherein the iris valve operating mechanism (166) is operable by an iris valve drive ring (550).

14. A material transfer system (10) as claimed in Claim 13, wherein the iris valve operating mechanism (166) comprises an iris valve gear train (380) communicable with the iris valve drive ring (550) to affect rotation of the drive ring (550).

15. A material transfer system (10) as claimed in Claim 14, wherein the iris valve gear train (380) comprises a planetary gear mechanism (380) in the housing (60).

16. A material transfer system (10) as claimed in any of Claims 11 to 15, wherein the iris valve operating mechanism (166) is interconnected with the port door operating mechanism (165) via an interlink (167).

17. A material transfer system (10) as claimed in claimed in any of Claims 2 to 16, wherein the port door operating mechanism (165) comprises a gear link (450) configured to engage an oppositely disposed gear link (450) of a second material receptor port (30) to affect operation of the second material receptor port (30) when attached to the first material donor port (20).

18. A material transfer system as claimed in any of Claims 1 to 17, wherein the docking and mating mechanism (140) comprises a slider plate (180) on the housing (60) movable between port locked and port released positions.

19. A material transfer system (10) as claimed in Claim 18, wherein the slider plate (180) comprises spaced apart teeth (240) and spaced apart wedges (250) shaped and configured to engage opposing teeth (240) and wedges (250) when first and second ports (20,30) are docked against each other.

20. A material transfer system (10) as claimed in Claim 19, further comprising a port operating mechanism releasable brake (530) operable by the docking and mating mechanism (140) to release the port operating mechanism (160) for operation.21 . A material transfer system (10) as claimed in Claim 20, wherein the releasable brake (530) is movable in response to movement of the slider plate (180).

22. A material transfer system (10) as claimed in Claim 21 , wherein the releasable brake (530) comprises a pair of interlocking first and second members (531 ,532) in which the first member (531 ) is slotted into a drive gear (430) on the drive ring (360) and the second member (532) is mounted on the slider plate (180).

23. A material transfer system (10) as claimed in Claim 22, wherein the first and second interlocking members (531 ,532) are hook or latch like structures.

24. A material transfer system (10) as claimed in any of Claims 1 to 23, wherein the coupling (320) forms an internal seal (321 ) with the port door (120) in the bore closed position.

25. A material transfer system (10) as claimed in any of Claims 1 to 24, wherein the first material donor port (20) and the second material receptor port (30) comprise a seal (300) at the material outlet / inlet (110,120) configured to form an external fluid tight seal (310) between the first and second attached ports (20,30).3126. A material transfer system (10) as claimed in any of Claims 1 to 25, wherein an internal seal (322) is formed by abutting couplings (320) in the bore open / door stowed position.

27. A material transfer system (10) as claimed in any of Claims 1 to 26, wherein the port door (120) comprises a door seal (125) to seal the port door (120) in the bore closed position.

28. A method of transferring material between a first donor vessel (40) and a second receptor vessel (50) comprising the use of a system as claimed in any of Claims 1 to 27, the method comprising: attaching a first material donor port (20) to a second material receptor port (30) with the docking and mating mechanism (140) such that the first and second ports (20,30) are externally sealed and clamped together; moving the port doors (120) in each port (20,30) from a port bore closed position to a bore open / door stowed position by lifting the coupling (320) off the port doors (120) and moving the port doors (120) into respective isolation chambers (170) to form a material throughbore (150) through the first and second ports (20,30), and sealing the port doors (120) in the port door isolation chambers (170) by abutting the couplings (320).

29. A method of transferring material between a first donor vessel (40) and a second receptor vessel (50) as claimed in Claim 28, further comprising the step of moving an iris valve (330) from an iris valve formed / closed to an iris valve unformed / open position, to permit flow of material from the material donor vessel (40) through the throughbore (150) to the material receptor vessel (50).

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