WO2022208099A1 - Method of filling pharmaceutical containers - Google Patents
Method of filling pharmaceutical containers Download PDFInfo
- Publication number
- WO2022208099A1 WO2022208099A1 PCT/GB2022/050817 GB2022050817W WO2022208099A1 WO 2022208099 A1 WO2022208099 A1 WO 2022208099A1 GB 2022050817 W GB2022050817 W GB 2022050817W WO 2022208099 A1 WO2022208099 A1 WO 2022208099A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- nested
- containers
- closures
- closure
- filling
- Prior art date
Links
- 238000011049 filling Methods 0.000 title claims abstract description 93
- 238000000034 method Methods 0.000 title claims abstract description 70
- 238000012546 transfer Methods 0.000 claims abstract description 62
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 29
- 229940127557 pharmaceutical product Drugs 0.000 claims abstract description 29
- 238000007789 sealing Methods 0.000 claims abstract description 11
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 238000012371 Aseptic Filling Methods 0.000 abstract 1
- 238000011109 contamination Methods 0.000 description 6
- 239000003814 drug Substances 0.000 description 5
- 238000005429 filling process Methods 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000000853 adhesive Substances 0.000 description 4
- 230000001070 adhesive effect Effects 0.000 description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- 239000004411 aluminium Substances 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 206010073310 Occupational exposures Diseases 0.000 description 1
- 238000012865 aseptic processing Methods 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- 238000005202 decontamination Methods 0.000 description 1
- 230000003588 decontaminative effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 231100000675 occupational exposure Toxicity 0.000 description 1
- 230000036515 potency Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000009516 primary packaging Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 238000004260 weight control Methods 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
- B65B43/42—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
- B65B43/46—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation using grippers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
- B65B43/42—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
- B65B43/54—Means for supporting containers or receptacles during the filling operation
- B65B43/59—Means for supporting containers or receptacles during the filling operation vertically movable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/027—Packaging in aseptic chambers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/161—Sealing filled ampoules
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
Definitions
- the present invention relates to methods for filling and sealing of pharmaceutical containers.
- the invention relates to methods for filling and sealing of pharmaceutical containers within a controlled environment chamber in a Ready-To- Use (RTU) format, e.g. in tubs and/or nests.
- RTU Ready-To- Use
- the invention also relates to filled and sealed pharmaceutical containers, e.g. vials, syringes, cartridges and the like, prepared by the method herein described.
- Injectable pharmaceuticals are often packed in vials.
- Such vials are typically formed of glass and have a cylindrical neck with a flanged top.
- the neck is usually sealed by means of a closure, such as a rubber stopper and an aluminium seal, crimp cap or ferrule which is locked in place in order to permanently seal the pharmaceutical container, e.g. vial, syringe, cartridge, etc.
- More recently alternative assemblies have been developed, including pre-sterilised ready-to-use nested containers examples of which include the Schott iQ® range: cartriQ® RTU cartridges; adaptiQ® RTU vials and syriQ® pre-fillable RTU syringes; and press-fit closures, examples of which include: West Daikyo’s PLASCAPTM press- fit closure plus stopper; and ARaymond-Life RayDyLyo® press-fit closures; and nested stoppers for example Westar® nested stoppers.
- Isolator technology which provides a solid barrier between a process and the workforce, can be used in dosage manufacturing in order to minimise human contact.
- the use of automation is increasingly important in dosage manufacturing.
- equipment for filling and sealing pharmaceutical containers such as, e.g. vials, syringes, and the like, has been designed to process individual containers.
- Such processes typically used vibratory techniques for the supply of means for sealing the pharmaceutical containers, e.g. elastomeric closures, aluminium crimp caps, and the like.
- conventional processing equipment for multiple pharmaceutical containers employ conveyor belts, and the like, which themselves present particular challenges to cleanability and sterility.
- closures e.g. stoppers (usually elastomeric stoppers) and caps (usually aluminium crimp caps).
- closures usually elastomeric stoppers
- caps usually aluminium crimp caps
- US patent No. 10,196,161 describes a method for filling multiple containers with a pharmaceutical product is, which comprises a container nest holding the multiple containers and a closure nest holding multiple closures, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures.
- the nests are configured to allow multiple closures and containers to be simultaneously aligned and closed simultaneously.
- Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers.
- a method of aseptically filling a plurality of nested containers with a pharmaceutical product and applying closures to filled pharmaceutical containers, in an aseptically controlled environment comprising: optionally decontaminating the plurality of nested containers and nested closures in a transfer chamber; moving the decontaminated plurality of nested containers and nested closures from the transfer chamber into an aseptic covering removal zone; removing any coverings from the plurality of nested containers to provide a plurality of uncovered nested containers and uncovered nested closures; locating the uncovered nested containers laterally adjacent to a plurality of nested closures on a shuttle, e.g.
- a lateral or linear shuttle by use of a first manipulator; moving the uncovered nested containers and uncovered nested closures to an aseptically controlled filling zone; transferring the uncovered nested containers and closures to a multi-nest holder attached to a manipulator; locating the uncovered nested containers laterally adjacent to a plurality of nested closures in the multi-nest holder; filling the uncovered nested containers with a pharmaceutical product to provide a nest of filled containers; removing a closure from the nest of closures into a closure transfer device; moving the nest of filled containers beneath the closure transfer device; and removing a closure from the closure transfer device and placing into or onto the filled container thereby sealing the filled container.
- the method of the invention may optionally include a step of decontaminating the plurality of nested containers and/or nested closures, e.g. by treating the plurality of nested containers and/or nested closures with a sterilising medium, for example, treating with e-beam or vaporised hydrogen peroxide.
- a sterilising medium for example, treating with e-beam or vaporised hydrogen peroxide.
- NTT no-touch-transfer
- NTT is essentially a protective aseptic transfer process where pre-sterilised nested containers, closures and tubs are packaged in bags so the contents remain sterile and are only exposed in an aseptic processing environment as they are removed from the bags.
- a pre-requisite of NTT is that the pre-sterilised container primary packaging is sterile. It will be understood that when the method of the invention utilises pre sterilised containers in an NTT environment, the decontamination step will generally not be required.
- tubs containing a plurality of nested containers and/or nested closures may be loaded onto racks located on a moveable wall, turntable, and the like, such that the plurality of nested containers can be moved from the loading area to a covering removal zone.
- the transfer chamber or loading area and the covering removal zone will be separated by a moveable wall.
- the moveable wall may be provided with means, e.g. racks, for supporting the tubs housing the nested containers and/or the nested closures.
- the moveable wall may be provided with a means for supporting the tubs on both sides of the wall.
- the moveable wall may include means for supporting the tubs that is integral to the moveable wall.
- the means for supporting the tubs may comprise a plurality of shelving rods, such that a pair of shelving rods may act to support a tub.
- the plurality of shelving rods may be arranged such that the rods are located on both sides of the wall.
- the arrangement of means for supporting the tubs on both sides of the moveable wall means that the nested containers and/or nested closures can be loaded onto both sides of the wall.
- the wall will be rotatable about an axis, e.g.
- a tub of nested containers placed on the means for supporting tubs in the loading area may be transferred to the covering removal zone by rotation of the wall.
- a first side of the wall and its accompanying integral means for supporting tubs will be exposed to the loading area and upon rotation of the wall, the first side of the wall and its accompanying integral means for supporting tubs will be exposed to the covering removal zone, thus transferring any tubs of nested containers from the loading area to the covering removal zone.
- the second side of the wall can be loaded and decontaminated whilst the first side, in the covering removal zone, is being unloaded.
- the covering removal zone will generally be aseptic. Furthermore, in order to minimise any exposure to contamination, the covering removal zone will be a sealed aseptic zone and may be remotely operated or robotically operated.
- a manipulator may be operated, e.g. robotically operated, to remove the tub of covered nested containers, or a tub of nested closures, from the wall; and to move the tub to a covering removal apparatus.
- covering removal shall include removal of any covers and/or any liners that are in place on the nested containers.
- the covering removal zone may include means for heating the tub, nested containers and/or nested closures. Covers over the tub, nested containers and/or nested closures are generally held on by an adhesive. Thus, it may be advantageous to pre-heat the adhesive in order to soften it. Softening the adhesive will generally, inter alia , make the cover easier to peel away; and may reduce particulate contamination introduction when breaking the seal created by the adhesive.
- the nested containers and/or nested closures are removed from the uncovered tubs and moved to an aseptically controlled filling zone by a shuttle or such like. It is desirable that the nested containers and/or nested closures are removed from the tubs, as the tubs themselves can be a source of contamination.
- the shuttle is a linear transfer system or unit, or conveyor, capable of carrying multiple nests, typically two, in and out of the filling zone.
- the nested containers and nested closures are subsequently transferred onto second manipulator wherein the uncovered nested containers are positioned beneath a plurality of uncovered nested closures.
- the term “beneath” should be interpreted broadly, in that, the nested containers need not be directly beneath the nested closures, but the nest of containers should be positioned lower than the nest of closures in order to facilitate the placement of the closures into the filled containers.
- the uncovered nested containers are positioned beneath the plurality of uncovered nested closures. In another embodiment of the invention the uncovered nested containers are positioned alongside the plurality of uncovered nested closures.
- the uncovered nested containers are each filled by a pharmaceutical product dispensing system.
- a preferred dispensing system is a liquid filling needle dispensing system.
- the dispensing of the pharmaceutical product may comprise dispensing the pharmaceutical product from a single needle, i.e. filling a single container at a time.
- the dispensing system will comprise dispensing into a plurality of containers simultaneously from a corresponding plurality of dispensing needles. It will be understood that there is generally described herein a method of filling liquid pharmaceuticals into containers, it is within the scope of the present invention for the pharmaceutical to be in solid for, e.g. in powder form.
- the nested containers and closures will be transferred from the linear shuttle into a double or multi-nest holder.
- the nest holder will be mounted on or adjacent the manipulator.
- the nest holder may be mounted directly onto the manipulator; alternatively, the manipulator may itself be provided with a platform, e.g. a turntable, a replicated tub, or the like, on which the nest holder may be positioned.
- the manipulator may grip the nest directly, e.g. by means of a fork arrangement.
- the nests are arranged at multi-levels/different vertical positions to allow a closure cradle to pass under the nest of closures and over the containers.
- the closures may be dropped or pushed down from the nest into the closure cradle; or in another embodiment, the closures may be picked up or pushed up from the nest or tray into the cradle or cradles.
- the apparatus may include more than one cradle, but in use, the apparatus will use one cradle per closure, i.e. a cradle may manipulate one closure at a time repeatedly.
- the nest transfers to the manipulator may be by a linear actuator or second articulating arm with a nest gripping head comprising typically of a matrix of suction cups that can hold the nest in position during a vertical transfer.
- the manipulator moves the nested containers to predetermined positions such that they are aligned with the filling needle or needles.
- manipulator as used herein will be understood by the person skilled in the art.
- manipulators shall include, but shall not be limited to, an articulating arm, a SCARA (Selective Compliance Assembly Robot Arm), a Cartesian robot, a six axis robot, and the like.
- the method of aseptically filling a plurality of nested containers with a pharmaceutical product may comprise the use of more than one manipulator.
- the manipulators may be the same or different, for example all manipulators may comprise an articulating arm, or may comprise a mixture or combination of articulating arms, SCARAs, etc.
- the nests When positioned, the nests will be held stationary in a lateral dimension, e.g. stationary from side to side or backwards and forwards, whilst the containers are filled.
- the manipulator is capable of moving the nest in a lateral plane, e.g. from side to side or backwards and forwards, but, generally, not up or down, in order to move to the next container for filling to take place.
- the manipulator may optionally be capable of moving the nests vertically during filling and in between fills, but generally the manipulator will keep the nests stationary.
- the filling needles may be moved predominantly vertically by a manipulator.
- a closure is allocated for each respectively filled container.
- a closure pusher e.g. a push-rod exerts a force against a nested closure removing the closure from the nest and into a closure transfer device.
- the removal of the closure from the nest into the closure transfer device may occur separately, sequentially or simultaneously with the filling of the container.
- the closure transfer device may be a transfer cradle or pocket adapted to carry the closure, or it may be a collector adapted to grasp and pick up the closure, such as a gripper or a suction cup.
- the closure transfer device is a transfer cradle adapted to carry the closure.
- the closure transfer device is a collector adapted to grasp and pick up the closure.
- vial closures can be supplied in trays.
- a closure will be picked from a tray and placed into the transfer device before being pushed out of the transfer device into the pharmaceutical container.
- the container nest and the closure nest are positioned adjacent to one another and positioned at a similar level vertically.
- the closures may either be pulled into the transfer device with an arm and suction cup arrangement or the closures may be picked and placed into the top of the arm. In both cases the arm sits above the tray, unlike the push through nests.
- closures are picked from the tray with a push-rod with integrated gripper, grippers, suction cup or suction cups. This then allows the closures to be placed or pushed onto the container with the same device.
- the closure cradle is held stationary whilst the nest holder, containing filled containers is moved by the manipulator to a position where a filled container is located beneath a closure transfer device in which a closure is housed.
- a closure pusher is operated to remove the closure from the closure transfer device, being securely pushed into the filled container, thereby sealing the container.
- the nest holder and the nest of closures are positioned alongside one another, i.e. in the same vertical plane, the nest holder and the nest of closures are moved laterally by the manipulator and the filling needle or needles and the closure transfer cradle are stationary in a substantially horizontal plane, but are capable of being manipulated in the vertical plane, i.e. up and down. It is within the scope of the present invention for multiple containers to be filled and closed simultaneously. However, in one embodiment of the invention an array of containers, e.g. a selected group of containers, typically 2 or 5, in a nest holder is filled and closed before the next array of containers is filled. Such an arrangement is advantageous since, inter alia , there is generally no delay in filling the container and securing the closure.
- the method of the invention may further comprise returning the filled containers to the transfer chamber and terminating the spatial communication between the transfer chamber and the first controlled environment chamber.
- the containers prefferably be only partially closed by only partially inserting a closure into a container.
- Such partial closure allows for lyophilizing the pharmaceutical product in the container if desirables.
- Lyophilizing the pharmaceutical product may comprise lyophilizing the pharmaceutical product in a stoppering apparatus having an interior that may be isolated from the interior of the first controlled environment enclosure.
- the partially closing of the first plurality of containers may comprise simultaneously partially closing at least a portion of the first plurality of containers.
- partially closing the first plurality of containers may comprise partially closing all the containers in the container nest separately, sequentially or simultaneously.
- the plurality of the aseptic closures retained by the closure nest may be used to either fully or partially seal the pharmaceutical product into the containers.
- the plurality of containers may be equal in number to the number of aseptic closures releasably suspended by the closure nest. Two or more containers may be filled simultaneously.
- the empty and filled containers may optionally be positioned on a weigh cell whilst in or out of the nest, so that the contents of the containers may be measured, e.g. operating under conditions of real time weight control.
- a sealed container filled with a pharmaceutical product using the method as herein described.
- an apparatus suitable for aseptically filling a plurality of nested containers with a pharmaceutical product in an aseptically controlled environment comprising: a transfer chamber for housing a plurality of nested containers and nested closures; a covering removal zone; and an aseptically controlled filling zone; wherein the covering removal zone is provided with means for removing any coverings from the plurality of nested containers and nested closures to provide a plurality of uncovered nested containers and nested closures; and wherein the covering removal zone is provided with means for moving the uncovered nested containers and uncovered nested closures to the aseptically controlled filling zone; and the aseptically controlled filling zone is provided with means for filling the nested containers with a pharmaceutical product; and with means for fitting closures to the filled containers; wherein, in use, the means for filling and the means for fitting closures are substantially laterally stationary wherein the filled nested containers and the nested closures are moveable
- means may be provided for locating the uncovered nested containers laterally adjacent to a plurality of nested closures on a shuttle, e.g. by use of a manipulator.
- Means may be provided for transferring the uncovered nested containers and closures to a multi-nest holder e.g. by use of the manipulator herein described or by a second manipulator. Means may be provided for locating the uncovered nested containers laterally adjacent to a plurality of nested closures in the multi-nest holder.
- a manipulator will collect the tub of nested containers and/or closures from the tub library and transfer the tub to the covering removal zone in order to have the covering removed. Once the covering is removed the tub is placed in a holding rack until a second manipulator removes any liner (if present, any lining is usually positioned underneath the covering). This second manipulator may also remove the nest from the tub, ready for moving into the filling zone. It is desirable for the tub not to be transferred into the filling zone in order to avoid any unnecessary risk of contamination.
- a closure transfer cradle is novel per se. Therefore, according to a further aspect of the invention there is provided a filling mechanism, suitable for use with an apparatus as herein described, wherein the filling mechanism comprises manipulator suitable for holding a closure cradle in a stationary position whilst a nest holder, containing filled containers, is moved by the manipulator to a position where a filled container is located beneath a closure transfer cradle in which a closure is housed.
- a filling apparatus as herein described wherein the filling apparatus comprises: a transfer chamber for housing a plurality of nested containers and nested closures; a covering removal zone; and an aseptically controlled filling zone; and wherein a rotatable wall separates the transfer chamber and the covering removal zone.
- the apparatus may optionally include means for decontaminating the plurality of nested containers and nested closures.
- Figures 1(a) and 1(b) are perspective views of the filling apparatus
- Figure 2 is a plan view of the filling apparatus
- Figures 3(a) and 3(b) are perspective views of the filling apparatus with the moveable wall in a partially rotated position
- Figure 4 is a plan view of the filling apparatus with the moveable wall in a partially rotated position
- Figures 5(a) and 5(b) are perspective views of the filling apparatus in an aseptic housing
- Figures 6(a) to 6(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned below the nested closures; and Figures 7(a) to 7(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned alongside the nested closures.
- a filling apparatus (1) comprises a loading zone (2), a covering removal zone (3) and a filling zone (4).
- the loading zone (2) includes a rotatably mounted wall (5), wherein the wall (5) is provided with a plurality of shelving rods (6), wherein each pair of shelving rods (6) is capable of supporting a tub (7).
- Each tub (7) will be filled with containers (for filling) or closures (not shown).
- a first manipulator (8) e.g. an articulated robotic arm, collects the tubs (7), moving each tub (7) from the loading zone (2) to the covering removal zone (3).
- the first manipulator (8) operates to remove the tub (7) and transfers the tub (7) to a covering removal apparatus (9).
- the covering removal zone (3) may include means (not shown) for heating the tub (7).
- covering removal apparatus (9) removes any covering from the tub (7), including any liner (not shown) to expose a nest of containers (10) or a nest of closures (11).
- the first manipulator (8) transfers an uncovered tub (7a) holding a nest of containers (10) or a nest of closures (11) to a shuttle (12), which transfers the uncovered tub (7a) into the filling zone (4).
- a filling apparatus (1) comprises a loading zone (2), a covering removal zone (3) and a filling zone (4).
- a rotatably mounted wall (5) is located around a vertically mounted spindle (13).
- the rotatable wall (5) is capable of delivering sealed tubs (7) from the loading zone (2) to the covering removal zone (3), such that the filling process may be more of a continuous process rather than a batch process.
- a filling apparatus (1) may be located in a housing (14), which includes inspection doors (15a, b and c).
- FIGS. 6(a) to 6(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned beneath the nested closures.
- FIG.(a) illustrates Step 1: Align caps with cap pushers #1 and #6 (row 1, position 1 and row 1, position 6);
- Figure 6(b) illustrates Step 2: Push caps #1 and #6 into cradle
- Figure 6(c) illustrates Step 3: Lift cap pushers leaving caps in cradle
- Figure 6(d) illustrates Step 4: Align caps above containers #1 and #6 (... that were filled last cycle);
- Figure 6(e) illustrates Step 5: Simultaneously push caps onto containers, with force reaction support from below, and lift vials being filled out of the nest on weigh cells;
- Figure 6(f) illustrates Step 6: Lift cap pushers and filling needles lower cap supports and weigh cells;
- FIG. 6(g) illustrates Step 7: Align cap pushers above caps #2 and #7;
- FIG. 6(h) illustrates Step 8: Push caps #2 and #1 into cradle
- Figure 6(i) illustrates Step 9: Lift cap pushers leaving caps in cradle
- FIG. 6(j) illustrates Step 10: Align caps above vials #2 and #1 (... that were filled last cycle);
- FIG. 6(k) illustrates Step 11: Simultaneously push caps onto containers, with force reaction support from below, and lift containers being filled out of the tray on weigh cells;
- FIG.(1) illustrates Step 12: Lift cap pushers and filling needles lower cap supports and weigh cells;
- FIG. 6(m) illustrates Step 13: Align cap pushers above caps #3 and #8;
- Figure 6(n) illustrates a close up view of the nested containers and nested closures.
- FIGS 7(a) to 7(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, analogous to the steps of Figures 6(a) to 6(n), wherein the nested containers are positioned alongside the nested closures.
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP22724833.3A EP4313772A1 (en) | 2021-04-01 | 2022-03-31 | Method of filling pharmaceutical containers |
US18/553,654 US20240199249A1 (en) | 2021-04-01 | 2022-03-31 | Method of filling pharmaceutical containers |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB2104761.8A GB202104761D0 (en) | 2021-04-01 | 2021-04-01 | Method of Filling Pharmaceutical Containers |
GB2104761.8 | 2021-04-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2022208099A1 true WO2022208099A1 (en) | 2022-10-06 |
Family
ID=75883553
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2022/050817 WO2022208099A1 (en) | 2021-04-01 | 2022-03-31 | Method of filling pharmaceutical containers |
Country Status (4)
Country | Link |
---|---|
US (1) | US20240199249A1 (en) |
EP (1) | EP4313772A1 (en) |
GB (1) | GB202104761D0 (en) |
WO (1) | WO2022208099A1 (en) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005014116A1 (en) * | 2003-09-21 | 2006-09-28 | Inova Pharma Systems Gmbh | Filling control device for nested containers, has sealing station, to immediately seal containers filled in filling station |
US10196161B2 (en) | 2013-08-16 | 2019-02-05 | Vanrx Pharmasystems Inc. | Method for filling pharmaceutical containers |
-
2021
- 2021-04-01 GB GBGB2104761.8A patent/GB202104761D0/en not_active Ceased
-
2022
- 2022-03-31 EP EP22724833.3A patent/EP4313772A1/en active Pending
- 2022-03-31 WO PCT/GB2022/050817 patent/WO2022208099A1/en active Application Filing
- 2022-03-31 US US18/553,654 patent/US20240199249A1/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005014116A1 (en) * | 2003-09-21 | 2006-09-28 | Inova Pharma Systems Gmbh | Filling control device for nested containers, has sealing station, to immediately seal containers filled in filling station |
US10196161B2 (en) | 2013-08-16 | 2019-02-05 | Vanrx Pharmasystems Inc. | Method for filling pharmaceutical containers |
Also Published As
Publication number | Publication date |
---|---|
US20240199249A1 (en) | 2024-06-20 |
EP4313772A1 (en) | 2024-02-07 |
GB202104761D0 (en) | 2021-05-19 |
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