TRANSFER DEVICE

A transfer device having an active member 10 comprising a main body 12 having an inlet 14 and an outlet 16 that can communicate with one another such that material may pass therethrough by means of a moveable/extendable conduit 18 moveable between a stowed configuration in which the inlet 14 and outlet 16 are not directly linked and an extended configuration in which the conduit extends between the outlet 16 and inlet 14 and in which the outlet 16 and inlet 14 are in communication with one another via the conduit 18 and material may pass therebetween via the conduit 18.

The present invention relates to a transfer device and method for transferring material.

More particularly, the invention relates to apparatus and method for assisting in material transfer during manufacturing processes which may be undertaken in a traditional clean room or in an isolation and/or containment system employed for operator and/or product protection.

The transfer of material from one aseptic vessel to another poses a number of problems particularly concerning maintenance of the aseptic environment to prevent the contamination of the material being transferred, the vessels themselves and the surrounding environment in which operators of such transfer devices may be located to effect the transfer of material.

The maintenance of sterility is of fundamental concern in many manufacturing processes, to safeguard against contamination of products being manufactured in the process. Exemplary industries using aseptic production in a traditional manner or in isolation and/or containment facilities include pharmaceutical, medical device, biotechnological and food industries.

Particular difficulty can arise where material for use in manufacture is required to be transferred from one sterile enclosure to another.

Developments in containment facilities led to the introduction of direct and indirect transfer devices. An example of a direct transfer device is a split butterfly valve system and an example of an indirect transfer device includes mating ports, otherwise known as rapid transfer (RTP) ports. Both transfer devices enable material to be transferred from one area to the other without contaminating the material or the surrounding environment.

However, these known ports are not without disadvantage. Commonly, the required location in the process enclosure is provided with a port which engages sealingly with a corresponding port of a transfer container. The mated ports can then be opened to enable material to be transferred from one area to another.

Such known transfer ports give rise to problems particularly when used in aseptic transfers. The presence of the seal or seals is an area of potential contamination which can be present on the exposed perimeter of the seals. Material to be transferred can easily come into contact with exposed sections of the seals compromising the sterility and containment of the material and/or the process enclosure.

Furthermore, known transfer ports are often large or cumbersome for operators to manipulate, often requiring complex lifting equipment which is difficult to manoeuvre and operate in processing environments.

The applicant has appreciated that further improvements can be made to transfer devices to ameliorate one or more problems associated with the prior art.

In accordance with a first aspect of the present invention, there is provided a transfer device comprising an active and a passive member capable of mating and creating a seal therebetween such that two members may be releasably secured and sealed to one another,each member having a housing having a port and a door for selectively opening or closing the port to control the movement of material therethrough, and maintain a sterile environment, wherein the door has a first configuration in which the door is secured to the port and a seal is formed therebetween and the door is closed, and a second configuration wherein the seal is released and the door is open,wherein the housing of the active member further comprises an outlet that is capable of communicating with port of the active member by means of a conduit moveable relative to the active member housing, said conduit moveable within the housing between a stowed configuration in which the port and outlet are not in communication with one another and an extended configuration in which the port and outlet are in communication with one another via the conduit such that material may pass therethrough.

The present invention avoids issues associated with the prior art including size and weight of valve elements and issues associated with pressure changes and airflow in the active and/or passive element which may cause displacement of any stray material, such as powders, covering elements of the device, such as the doors, which might jeopardise containment and sterility. Furthermore, the present invention avoids the need for heavy and/or cumbersome lifting equipment to move the active and/or passive members to facilitate communication between the passive port and the outlet of the active member.

The present invention may be for use in controlling the flow of a materials that are sterile, or require handling or processing in a sterile or aseptic environment. Materials may include powders, tablets, capsules or items used in conjunction with the storage or delivery of such products, stoppers, vials, flexible bags and/or bottles.

The present invention may be suitable for use at sterilising temperatures. Sterilising temperature may be at least 90° C. at 1 bar pressure. Advantageously, sterilising temperature may be from about 90° C. to 200° C. at 1 bar. An example of conditions satisfying sterilising temperature in accordance with the present invention includes fluid at a temperature of 120° C. at 1 bar, for example.

Media suitable for sterilising include any one or more of the following: steam, Hydrogen Peroxide, Chlorine Dioxide and/or bio-decontaminating media. Advantageously the media is a fluid. More advantageously, the fluid is a gas.

The features of the present invention facilitate its use in microbiological processes owing to the excellent sealing properties conferred by the features of the passive member.

In accordance with a further aspect of the present invention, there is provided a transfer device comprising an active and a passive member capable of mating such that two members to be releasably secured to one another,each member having a port and a door for selectively opening or closing the port to control the movement of material therethrough,wherein one of the doors has a male mating member comprising a protrusion and the other door has a complimentarily shaped female mating member,wherein the protrusion has a moveable element that is displaceable to change the profile of the protrusion to facilitate releasable mating and unlocking of the two doors to facilitate opening thereof.

The applicants have overcome the difficulty associated with first removing the active door and then unlock and remove the passive door. To reduce the complexity of the mechanisms the applicants combined the unlocking of the doors with the joining of the doors.

FIGS.1to8show an active member10of the transfer system comprising a main body12having an inlet14and an outlet16that can communicate with one another such that material may pass therethrough by means of a moveable/extendable conduit18moveable between a stowed configuration (FIG.3) in which the inlet14and outlet16are not directly linked and an extended configuration (FIG.4) in which the conduit extends between the outlet16and inlet14and in which the outlet16and inlet14are in communication with one another via the conduit18and material may pass therebetween via the conduit18.

The main body12has a substantially triangular transverse section having a planar upper20and lower22surface and a sidewall24extending therebetween defining a main body chamber therebetween.

In one corner of the triangular main body12is located the inlet14in the upper surface20being a circular aperture having associated therewith an active locking ring32, sterilising ring both extending perpendicularly to the upper plane of the body and being cylindrical members.

Associated with the inlet14is a door30(FIG.4) capable of being moved from a closed configuration in which the door30covers the inlet14and the opening is closed and an open configuration in which the door30is open and the inlet14free to permit the flow of material therethrough. It will be appreciated that the main body12may be any suitable shape to provide sufficient internal space within the housing to accommodate the doors of the active and passive member when they are connected to one another and moved out of the flowpath.

In addition, associated with the inlet14is the active locking ring32which is sized and shaped to cooperate with a complementarily shaped passive member100so that the active10and passive100may be selectively secured together.

The conduit18comprises a cylindrical body40to which is connected an extendible sidewall member42which permits the conduit18to be capable of extending between a stowed and deployed configuration. One end44of the flexible sidewall member42is proximal to the outlet16of the main body/housing12and secured thereto whilst its free end46is associated with the cylindrical body40which can selectively extend through the inlet14and a portion of the interior of the passive element/member100. The cylindrical body has a circumferential collar41that is connected to an actuating arm43to move the conduit between its stowed and extended configurations.

The outlet16comprises a circular aperture50having a cylindrical sidewall52extending in a plane perpendicular to the transverse plane of the main body/housing and having a circumferential outlet flange54. The flange54and sidewall52permit downstream processing equipment to be easily attached thereto for material to flow through or into.

(FIGS.5and6) The passive member/element100has a cylindrical main housing102and an opening selectively closable by a door104. The main housing102has a cylindrical liner106which provides a sealing boundary to other elements of the transfer system, a smooth passageway for the transfer of material and one contact surface for material being transferred such that subsequent transfer operations may be conducted with a different liner where appropriate such that it is possible in such an instance to avoid the necessity for a complete clean down/sterilisation of all processing equipment; rather, the liner need simply be replaced with a different, sterilised liner. Upstream of the opening is a longitudinally extending sidewall108that has at one end, distal to the opening closable by door104, a flange110which permits upstream processing equipment to be easily attached thereto. Upstream of the door104is an integrated valve closure member111that is moveable to selectively permit or prevent the flow of material. During material transfer, the valve will be closed until the active and passive members are secured together and their respective doors are moved out of the flow path and transfer is desired. The valve closure ember may then be moved to its open configuration to permit material transfer.

Selectively closing or opening the inlet14is door30having a centrally disposed locking key60which comprises a hexagonal drive having a lower portion64and an upper portion66being rotatable up to 30 degrees (FIGS.7aandb). The door104of a passive member/element100has a complementarily shaped recess112to receive the hexagonal drive. Rotation of the upper portion66of the hexagonal drive (FIG.7b) results in misalignment of the two portions and entraps the top half in an undercut114in the passive door104. It is this entrapment that holds them together and the reverse locking action would also realign the hexagons and allow the doors to be separated. It will be appreciated that other polygonally shaped drives may be used successfully, such as for example, drives having cross sections selected from the group comprising: triangular, square, pentagonal, heptagonal, octagonal, nonagonal, decagonal etc.

The passive door104has an internal biasing mechanism a plurality of locking tabs120that are moveably mounted on a carrier130. The locking tabs are moveable between an extended configuration where they co-operate with a circumferential channel131in inner sidewall face of the housing of the passive member and lock the door preventing it from being removed and a retracted configuration where the locking tabs are housed within the carrier130so that they do not extend beyond its circumference and the door is capable of being opened/removed.

The biasing mechanism squeezes the passive door104onto the underside of the passive liner106to ensure a sterile seal. Only when the hexagonal drive on the active door30is pushed up inside the passive door104does it overcome the biasing force. Now that the biasing force is rendered ineffective, it is easy to rotate the drive and unlock the door by means of displacing the locking tabs120from their extended configuration (FIG.8a) to their retracted configuration (FIG.8b).

FIG.9a to c show a passive member100and the various stages associated with release of the seal to permit the door to be unlocked and moved to allow the port to communicate with the port of the active member to permit the passage of material therethrough.

FIG.9a shows the passive door104secured and sealed to the passive member housing106. The passive member has a rubber lining106having two lips122,124that engage with the passive door104and the internal face of the inlet14of the housing of the active member10, respectively. The two lips122,124are designed in such a way to allow for tolerance variation while ensuring an adequate seal and minimise forces for docking or undocking.

The liner is a replaceable component and manufactured from a resiliently deformable material such as an elastomer, including silicone, for example. The liner has a shorter working lifespan compared with other components of the device and is intended to be replaced once a sufficiently pressurised seal is no longer possible. This ensures that a suitably flexible material may be used to manufacture the linerto form a seal between components.

FIG.9b shows the internal biasing mechanism in the passive door100overcome to displace the carrier130upon which are moveably mounted the locking tabs120away from the opening of the port and the passive door body and the underside of the passive liner106.

FIG.9c shows the locking tabs120in their retracted configuration whereby the drive has been rotated to enable the removal of the passive door from the flow path to facilitate material transfer.

FIG.10a to e show the centrally disposed locking key60of the active member door which comprises a hexagonal drive having a lower portion64and an upper portion66being rotatable up to 30 degrees and the complementarily shaped recess112of the passive door104in its various configurations during the mating of the doors and unlocking of the passive door.

FIG.10a shows the hexagonal drive with the upper portion66and lower portion aligned and the passive door104having the complementarily shaped recess112being presented thereto.

FIG.10b shows the hexagonal drive inserted into and received by the recess.

FIG.10c shows the hexagonal drive having been displaced in a first direction, parallel with the longitudinal axis of the port of the passive member to release the seal between the underside of the liner106and the carrier130of the locking tabs120between the underside of the liner106and the carrier130within the passive door. Without this step, the torque required to release the seal to open the passive door would be too great.

FIG.10d shows the hexagonal drive displaced in a second direction, rotating a portion of the hexagonal drive whereby the hexagonal drive adopts a first configuration wherein the upper portion66is rotated 30 degrees to misalign with the upper portion of the hexagonal drive to secure the active and passive doors together.

FIG.10e shows the hexagonal drive displaced into a second configuration whereby the lower portion64and the upper portion66rotate and cooperate with the recess112of the passive door to displace the locking tabs from the extended to their retracted configuration to facilitate removal of the doors.