WO2010052489A1

WO2010052489A1 - Method of contained transfer and transfer sleeve

Info

Publication number: WO2010052489A1
Application number: PCT/GB2009/051476
Authority: WO
Inventors: Neal Hanley; Clive Mellor
Original assignee: Neal Hanley; Clive Mellor
Priority date: 2008-11-07
Filing date: 2009-11-03
Publication date: 2010-05-14
Also published as: GB2465180A; GB2465180B; GB0820394D0

Abstract

A method of contained flexible transfer from a vessel is provided using a transfer sleeve(10). The method comprises fitting the transfer sleeve (10) to a port of the vessel wherein the transfer sleeve comprises an end region (22) that extends between a distal aperture (12) and an opening that opens to the rest of the transfer sleeve(10). The transfer sleeve (10) is fitted to the vessel by forming a first seal between the distal aperture (12) and the port. The end region (22) is then scrunched up and a second seal formed between the opening and the port. A transfer operation is then completed. Advantageously, during the transfer operation, the end region(22) remains substantially untouched by material. The second seal is then removed and the end region (22) un-ravelled. The transfer sleeve (10) can then be cut through the relatively clean end region (22).

Description

METHOD OF CONTAINED TRANSFER AND TRANSFER SLEEVE

The present invention relates generally to contained transfer methods and in particular although not exclusively to contained transfer methods for transferring material from a charging vessel, and to a transfer sleeve for facilitating such methods.

It is necessary in many industries to facilitate the contained transfer of material from a vessel. For instance, in pharmaceutical manufacturing, a charging vessel has a discharge port for discharging material. During the manufacturing process, the port needs to be temporarily coupled to a feed port on a receiving vessel. The temporary coupling of the two ports needs to be achieved in a contained manner, such that material can be transferred from the charging vessel to the receiving vessel with limited exposure of the material to the general environment. Once the material has been transferred, the temporary coupling needs to be removed, with limited exposure of any residual material from the transfer process. Subsequent material transfers can then take place.

EP1728717 discloses a contained flexible transfer method wherein a discharge flange on a discharge port has a plurality of attaching points for attaching one end of a charging sleeve. A discharge valve on the process container can then be opened to allow particles to flow into the charging sleeve. When the transfer process is completed, the transfer sleeve is closed and separated along the closure. Accordingly, the charging sleeve forms a stub on the bottom of the discharge port. In order to allow further transfer processes, a second charging sleeve is placed over the stub of the first charging sleeve and attached to an attaching point of the plurality of attaching points disposed above the attaching point of the first transfer sleeve.

It is an aim of the present invention to address at least one of the above or other disadvantages.

According to the present invention there is provided a method and apparatus as set forth in the appended claims. Other features of the invention will be apparent from the dependent claims, and the description which follows.

According to a first aspect of the present invention, there is provided a method of contained transfer from a vessel. The method comprises fitting a transfer sleeve to a port of the vessel wherein the transfer sleeve comprises a first end region that extends between a distal aperture and an opening that opens to the rest of the transfer sleeve. The transfer sleeve is fitted to the vessel by forming a first seal between the distal aperture and the port. The first end region is then scrunched up and a second seal formed between the opening and the port. A transfer operation is then completed. Advantageously, during the transfer operation, the first end region remains substantially untouched by material. For instance, because the first end region is not exposed during the transfer operation, material can not become stuck to or lost within these surfaces.

Preferably the method includes removing the second seal to expose the first end region. The first end region being relatively clean. The first end region may be exposed by un-ravelling it from the port. The transfer sleeve may then be cut through the relatively clean end region.

Advantageously, the method provides a high containment. For instance, loss of containment from cutting through a part of the transfer sleeve that has been exposed to material being transferred during the transfer process is reduced.

According to a second aspect of the present invention there is provided a transfer sleeve having an at least partially flexible first end region. The first end region extending between a distal aperture and an opening that opens to the rest of the transfer sleeve. In use the distal aperture forms a first seal with a vessel's port and the opening forms a second seal with the vessel's port. The first end region includes a manipulatable portion that has a first side and a second side, the first side being manipulatable by the second side.

In exemplary embodiments, the distal aperture includes a resilient member. The resilient member may be sized so that, when fitted to the port, it exerts an inward pressure on the transfer sleeve in order to achieve the first seal. The inward pressure may be constant about the area of the seal. The resilient member may be integrally formed with the transfer sleeve. To complement the resilient member, preferably the port includes a corresponding receiving feature to locate the resilient member on the port. The resilient member may comprise an o- ring. The receiving feature may comprise a groove e.g. an annular groove. Here the method comprises the step of fitting the o-ring to the groove in order to form the first seal.

In exemplary embodiments, the second seal is formed between the opening and a distal end of the port, suitably the opening comprises a section having a larger cross-sectional area towards the distal aperture than at the opening to the rest of the transfer sleeve. The section may therefore comprise a tapered section. Here the method comprises the step of scrunching up the end region until a reduced cross-sectional area of the section abuts the distal end of the port, the abutment forming the second seal. Suitably, the method subsequently comprises arranging a clamp about the distal end of the port, the clamp holding the section in place relative to the port in order to maintain the seal. Here the method subsequently comprises removing the clamp in order to remove the second seal. In exemplary embodiments, the port includes a plurality of receiving features. Each receiving feature is suitable to allow the first seal to be formed therewith. Accordingly, the method comprises fitting a first transfer sleeve to one of the plurality of receiving features. Suitably, the transfer sleeve is fitted to the closest available receiving feature to the distal end of the port. Following the step of cutting through the end region, the transfer sleeve becomes separated into two portions. One portion remains as a stub on the port. The other portion can be removed. The stub continues to provide a contained cover over the port whilst in place. Consequently, the method optionally includes the step of removing a stub from a previous transfer sleeve in between the steps making the first and second seals. The end region may include at least one manipulatable portion. The manipulatable portion is formed between the distal aperture and opening. Here, the method comprises the optional step of manipulating a manipulatable portion of the end region between the steps of making the first and second seals. The manipulatable portion is formed on the end region. The manipulatable portion has an inwardly facing side an outwardly facing side. During the transfer process the inwardly facing side is exposed to material. The step of manipulating the manipulatable portion may comprise manipulating the outwardly facing side. The outwardly facing side may be manipulated in order to remove the stub from sealing the port. The stub may be contained within the manipulatable portion. The manipulatable portion may comprise a sample sleeve. The sample sleeve may extend outwardly from an aperture in the end region. The sample sleeve may comprise an enclosed flexible area. The step of manipulating the manipulatable portion may comprise inverting the sample sleeve through the aperture in order to access inside the end region. The method may comprise re-inverting the sample sleeve. When re- inverting the sample sleeve, the stub from a previous transfer sleeve may be moved into the enclosed flexible area.

In the exemplary embodiments the transfer sleeve transfers material from a charging vessel to a receiving vessel. Here the transfer sleeve is fitted to a port on each vessel to form a flexible conduit between the two ports. Consequently, the transfer sleeve includes a first end region and a second end region. Each end region is fitted to the respective port as here in described. The transfer sleeve may include a mid-section that joins the two end regions. The mid-section and two end regions form a flexible conduit. Where each opening comprises a section such as a tapered section, the flexible conduit comprises the end regions, mid-section and sections in between. The mid-section may comprise a smaller cross-sectional area than each distal aperture.

Suitably, the method comprises the step of fitting a subsequent transfer sleeve in order to conduct a subsequent transfer process. Optionally a connection collar may be attached to the port. Here the method comprises attaching the connection collar to the port before fitting the transfer sleeve. The connection collar may include the plurality of receiving features. This allows an overbagging method to be used on existing machines. Alternatively the connection collar may be integrally formed with the port. The connection collar may include a fluid supply. The fluid supply may be a compressed air supply. The method may therefore comprise opening the fluid supply after a seal has been formed. The method may comprise monitoring the pressure of the fluid within the transfer sleeve. The method may comprise re-fitting the transfer sleeve, should the monitored pressure reduce. The connection collar may also include a cleaning device. The cleaning device may wet internal faces of one or more of the port, collar and transfer sleeve.

For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example, to the accompanying diagrammatic drawings in which:

Figure 1 shows a front perspective view of a transfer sleeve according to an example embodiment.

Figure 2 shows a front view of a charging vessel located above a receiving vessel ready for a contained flexible transfer operation.

Figures 3 to 13 show process steps for the contained flexible transfer operation according to an example embodiment.

Figure 14 shows an optional process step for the contained flexible transfer operation.

Figure 15 shows a cross-sectional view through a connection collar for use in an optional process step for the contained flexible transfer operation.

A transfer sleeve 10 for use in a contained flexible transfer method is shown in Figure 1. The transfer sleeve 10 is fabricated from a continuous piece of flexible material such as Low Density Polyethylene (LDPE) or Liner Low Density Polytheylene (LLDPE). It is preferable for the transfer sleeve 10 to be at least partially transparent so that an operator may view the transfer operation. The transfer sleeve has a first distal aperture 12 and a second distal aperture 14. The first distal aperture 12 and the second distal aperture 14 are substantially circular and include an integral resilient means. The resilient means are shown as o-rings 16 and 18. Each o-ring is integrally formed with the transfer sleeve 10 by placing the o-ring about the transfer sleeve 10 so that the transfer sleeve extends to either side of the o-ring. The transfer sleeve 10 can then be folded back over itself and secured to a portion of the transfer sleeve in order to encapsulate the o-ring and form each distal aperture. The first distal aperture 12 and second distal aperture 14 are joined by a continuous flexible conduit shown here as a generally tubular section 20. The tubular section 20 has end regions 22, 24 that have a larger diameter than a mid section 26. The end regions 22, 24 and mid section 26 each have a substantially constant cross-section. The end regions 22, 24 are joined to the mid section 26 by openings such as tapered sections 28, 30 respectively. Accordingly, each tapered section has a narrowing cross-section towards the mid section. Each end region 22, 24 includes a manipulatable portion that can be manipulated by an operators hand. Suitably, the manipulatable portion is a sample sleeve 32. Each sample sleeve 32 extends from an aperture 34 in the respective end region 22, 24. Accordingly, the aperture 34 is positioned between each o-ring 16, 18 and each tapered section 28, 30. Each sample sleeve 32 forms an enclosed flexible space. Here, each sample sleeve 32 comprises a flexible tube 34 having a closed distal end 36.

In use, the transfer sleeve 10 facilitates the contained transfer of material from one vessel to another. As will be herein described, each distal aperture 12, 14 is fitted over a connection collar of each vessel in a sealing manner. Each sample sleeve 32 can then be inverted through each aperture 34 in order to access inside of the transfer sleeve 10. For instance, the sample sleeve may be used to withdraw a sample of material from within the vessel or to remove a stub of a previous transfer sleeve. The end regions 22, 24 of the transfer sleeve 10 can then be scrunched so that the tapered sections 28, 30 locate on each connection collar to provide a second seal. A clamp 40 (see Figure 3) is then placed over each connection collar to maintain the seal between each connection collar and tapered sections. Accordingly, the mid section 26 provides a continuous enclosed conduit between the two vessels. The vessels can then be opened to allow material to transfer between the vessels. When the transfer is complete and the vessels closed, the transfer sleeve 10 can be separated in any well known manner. Consequently, stubs are left over each connection collar. Accordingly, material can be transferred between vessels without exposing operators to material inside the vessels.

The contained flexible transfer method will now be described in more detail.

As shown in Figure 2, a charging vessel 100 is arranged over a receiving vessel 200. The charging vessel 100 comprises an enclosed container 102. The enclosed container 102 contains material to be transferred to the receiving vessel 200. At the bottom of the enclosed container 102 is an exit aperture 104 that is opened and closed by a control valve (not shown). Extending downwardly and away from the exit aperture is a connection collar 106. The connection collar is generally cylindrically shaped and includes a plurality of connection points. Here each connection point comprises an annular groove 108. The receiving vessel 200 comprises an enclosed container 202. The receiving vessel may be any piece of equipment that a material needs to be transferred to, for instance an IBC (Intermediate Bulk Container) such as a tablet coater, mill, blender or fluid bed dryer. At the top of the enclosed container 202 is an entrance aperture 204. The entrance aperture 204 is opened and closed by a control valve (not shown). Extending upwardly and away from the entrance aperture is a connection collar 206. The connection collar 206 is substantially the same as the connection collar 106 on the charging vessel and again includes a plurality of annular grooves 208.

As shown in Figure 3, a transfer sleeve 10 as herein described is arranged between each connection collar 106, 206 of the charging and receiving vessels 100, 200. Clamps 40 are also prepared for use during the contained flexible transfer.

Each distal aperture 12, 14 of the transfer sleeve 10 is then sealed about each respective connection collar 106, 206. As shown in Figure 4, the o-ring 16 of the first opening 12 is snapped into the lowermost available groove 106a of the plurality of grooves 106. That is the o-ring is fitted into the groove 106 that is closest to the connection collar's distal end. Because the o-ring is integral to the transfer sleeve, there is no need for additional process steps in first arranging an o-ring about the connection collar. Moreover, the integral o-ring also ensures that the transfer sleeve is sealed at the correct location. For instance, because the o-ring 16 is integral to the transfer sleeve 10, it is not possible to place the o-ring over the transfer sleeve such that from the front and to an operator's perspective, the o-ring is contacting the transfer sleeve but from the back the transfer sleeve has slipped down and the o-ring is not in contact. The o-ring is resilient and sized so as to exert an inwardly radial pressure when located in a groove of the plurality of grooves 106. Consequently, when not fitted about a connection collar, the o-ring 16 gathers the opening 12 into a diameter smaller than that of the groove 106a. In order to fit the transfer sleeve on to the connection collar, the o-ring 16 is expanded and pulled over the connection collar. The groove 106a provides a receiving feature for the o- ring 16. When fitted in place, the o-ring 16 presses the transfer sleeve against the annular groove 106a to form a seal.

Whilst the fitting of the first distal aperture to the connection collar 106 has been described, the description applies equally to the fitting of the second distal aperture to the connection collar 206.

If, as shown in Figure 4, the transfer sleeve is the first to be fitted to the respective connection collar (i.e. where no previous stub needs to be removed), each end region 22, 24 is scrunched up and gathered onto the connection collar 106, 206. In this way each tapered section can be pulled up against the distal end 1 10, 210 of each connection collar. A seal between the tapered section and a distal end of each connection collar is therefore made. A clamp 40 is then placed over the distal end of each connection collar in order to prevent the transfer sleeve from unravelling and also to prevent material from landing on the distal ends 110, 210. The clamps 40 comprise two semi-circular parts hingedly joined at one side 42 and lockably joinable on the other 44. The parts combine to provide a circular aperture 46 that has a smaller diameter than the inside of the connection collar. This enables the transfer sleeve to protrude over the distal end 110, 210. A flanged portion of the collar co-operates with a flanged portion of the clamp in order to lock the clamp to the connection collar.

As shown in Figure 5, once the first and second openings form a secondary seal on the connection collars and the clamps are arranged in place, material can be transferred by first opening the control valve of the receiving vessel using handle 220 and then opening the control valve of the charging vessel using handle 120. In this example, material moves under the feed of gravity. When the desired amount of material has been transferred, the charging vessel's control valve is closed followed by the receiving vessels control valve, as shown in Figure 6. The clamps 40 can then also be removed.

Following removal of the clamps 40, the end regions 22, 24 can be unravelled from the connection collars (Figure 7). This reveals a cleaner, internal section of the transfer sleeve that has been untouched by the flow of materials between the two vessels. As shown in Figure 8, the transfer sleeve is necked (gathered together in a tight twist) at a location on each end region 22, 24 and separated using a double crimp technique. The containment level of the double crimp technique is improved due to the separation being formed through the end region that has been untouched by the material transfer. It is preferable for the separation to be made between the o-ring and sample sleeve as this leaves the minimum amount of the transfer sleeve remaining on each connection collar. The remaining part of the transfer sleeve is herein referred to as a stub 60. The stubs remain in place to provide containment of any residual material left internally on each containment collar.

A middle 62 of the transfer sleeve is disposed of and the vessels cleaned or transferred for onwards use.

At a further point along the production process, should the same vessel or another vessel require charging the charging vessel 100 and receiving vessel 200 are re-positioned on top of each other (Figure 9). As can be seen, the stubs are still in place over each connection collar.

A second (and each subsequent) transfer sleeve 10 is fitted about the connection collars as herein before described (Figure 10). However, since the stubs 60 of the first transfer sleeve occupy the annular groove 108a closest to the distal end 110, each o-ring of the second transfer sleeve is fitted to the next available annular groove 108b. Furthermore, before scrunching up the end regions an operative inverts the sample sleeves and uses their hands to reach through and pull each stub 60 from the connection collars (Figure 1 1 ). As shown in Figure 12, the stubs are pulled through so that the sample sleeves re-invert and the stubs are then contained within the sample sleeve. The end regions are then scrunched up to bring the tapered sections into sealing contact with the connection collars and the clamps attached as before (Figure 13). A subsequent transfer process can then take place as described. When the second transfer sleeve is removed, stubs covering each connection collar again remain in place. The stubs of the first transfer sleeve are moved with the removed middle section of the transfer sleeve. Such a subsequent fitting of a transfer sleeve may be referred to as an overbagging technique. The overbagging technique can be repeated for a number of times dependent on the number of free annular grooves remaining.

One connection collar, shown in Figure 14 as the connection collar 106, may include a compressed air inlet. As shown in Figure 14, a portable pressure tank 300 is connected to the compressed air inlet. Accordingly, the integrity of the transfer sleeve and the seals can be checked before opening the control valves and starting each transfer. For example, once the transfer sleeve is in place the compressed air inlet can be opened to fill the transfer sleeve and pressurise it to a determined pressure (20mBar). The gauge can then be monitored for a time to check that the system is sufficiently presure tight. If pressure is lost, the transfer sleeve is leaking and can be re-fitted or replaced.

In order to allow the contained flexible transfer method to be used on existing equipment, connection collars can be retro-fitted to existing equipment by simply clamping the collars to outlet points as shown in Figure 15. Moreover, the connection collars may also include a cleaning spray nozzle 400 so that internal surfaces can be wetted during cleaning operations.

Whilst the foregoing has been described in relation to a substantially tubular transfer sleeve, it will be appreciated that such sleeves may be of other shapes. Moreover, the sample sleeves may be shaped to ease use, for instance they may be glove shaped. Furthermore, multiple sample sleeves may be included for process wherein one or more samples may additionally be needed. In some cases, the sample sleeves may have tools or cleaning equipment placed in them before being attached to the collar. It will also be appreciated that whilst the foregoing has been described in relation to a transfer process from one container to another, the invention could equally be applied to a charging a closed flexible liner. For instance, a charging sleeve may be a closed bag portion accessed by first end region substantially according to the above described embodiments. Thus, rather than charging one container from another, the method comprises charging the bag portion. The bag portion may then be sealed and transferred to a remote location. Alternatively, the closed flexible liner may be attached to an active port via the first end region.

Attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

Claims

1. A method of contained transfer from a vessel, the method comprising the steps of:

fitting a transfer sleeve to a port of the vessel wherein the transfer sleeve comprises an end region that extends between a distal aperture and an opening that opens to the rest of the transfer sleeve, the transfer sleeve being fitted to the vessel by forming a first seal between the distal aperture and the port;

the end region subsequently being scrunched up and a second seal formed between the opening and the port; and

subsequently performing a transfer operation.

2. The method as claimed in Claim 1 , wherein the method comprises removing the second seal and un-ravelling the end region.

3. The method as claimed in Claim 2, wherein the method comprises subsequently cutting the transfer sleeve through the relatively clean end region.

4. The method as claimed in any preceding claim, wherein the transfer sleeve comprises an integral resilient member and the port includes at least one receiving feature, the method comprising fitting the resilient member to the receiving feature in order to form at least one of the seals.

5. The method as claimed in any preceding claim, wherein the opening comprises a section having a larger cross-sectional area towards the distal aperture, the method comprising scrunching up the end region until a reduced cross-sectional area of the section abuts a distal end of the port in order to form the second seal.

6. The method as claimed in Claim 5, wherein the method comprises holding the reduced cross-sectional area of the section in sealing contact with the distal end of the port by arranging a clamp about the port.

7. The method as claimed in Claim 6, wherein the method comprises removing the clamp before removing the second seal.

8. The method as claimed in any preceding claim, wherein the transfer sleeve includes a manipulatable portion formed between the distal aperture and the opening, the method comprising using the manipulatable portion to remove a stub of a previous transfer sleeve between the steps of forming the first and second seals.

9. The method as claimed in any preceding claim, wherein the method comprises transferring material from a charging vessel to a receiving vessel, the transfer sleeve comprising a second end region substantially the same as the first end region and the transfer sleeve forming a conduit between the first and second distal apertures, the method comprising fitting the second end region to a port of the receiving vessel.

10. The method as claimed in any preceding claim, wherein the method comprises the step of fitting one or more subsequent transfer sleeves in order to conduct one or more subsequent transfer processes.

11. A transfer sleeve having an at least partially flexible first end region, the end region extending between a distal aperture and an opening that opens to the rest of the transfer sleeve, wherein, , the distal aperture is suitable for forming a first seal with a vessel's port and the opening is suitable for forming a second seal with the vessel's port;

characterised in that:

the transfer sleeve includes a manipulatable portion between the distal aperture and the opening.

12. The transfer sleeve as claimed in Claim 11 , wherein the transfer sleeve includes at least one integral resilient member for forming at least one of the seals.

13. The transfer sleeve as claimed in Claim 11 or Claim 12, wherein the opening comprises a section having a larger cross-sectional area towards the distal aperture.

14. The transfer sleeve as claimed in any of Claims 11 to 13, wherein the transfer sleeve forms a conduit including a second end region substantially the same as the first.

15. The transfer sleeve as claimed in Claim 14, wherein the transfer sleeve comprises a mid section between the opening of the first end region and the opening of the second end region.