WO2014169897A1 - Vorrichtung zum einbringen einer definierten menge eines zweiten pulvers in einen prozessbehälter - Google Patents

Vorrichtung zum einbringen einer definierten menge eines zweiten pulvers in einen prozessbehälter Download PDF

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Publication number
WO2014169897A1
WO2014169897A1 PCT/DE2014/100012 DE2014100012W WO2014169897A1 WO 2014169897 A1 WO2014169897 A1 WO 2014169897A1 DE 2014100012 W DE2014100012 W DE 2014100012W WO 2014169897 A1 WO2014169897 A1 WO 2014169897A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
powder
piston
closure
transport unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/DE2014/100012
Other languages
German (de)
English (en)
French (fr)
Inventor
Heinz Pritzke
Wolfgang Knorr
Reiner Wurst
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glatt Systemtechnik GmbH
Harro Hofliger Verpackungsmaschinen GmbH
Original Assignee
Glatt Systemtechnik GmbH
Harro Hofliger Verpackungsmaschinen GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glatt Systemtechnik GmbH, Harro Hofliger Verpackungsmaschinen GmbH filed Critical Glatt Systemtechnik GmbH
Priority to IN2508MUN2014 priority Critical patent/IN2014MN02508A/en
Priority to EP14709530.1A priority patent/EP2986952B1/de
Priority to CA2874544A priority patent/CA2874544C/en
Publication of WO2014169897A1 publication Critical patent/WO2014169897A1/de
Priority to IL236415A priority patent/IL236415B/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04Methods of, or means for, filling the material into the containers or receptacles
    • B65B1/06Methods of, or means for, filling the material into the containers or receptacles by gravity flow
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B65B1/36Devices or methods for controlling or determining the quantity or quality or the material fed or filled by volumetric devices or methods
    • B65B1/38Devices or methods for controlling or determining the quantity or quality or the material fed or filled by volumetric devices or methods by pistons co-operating with measuring chambers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/28Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with stationary measuring chambers having constant volume during measurement
    • G01F11/282Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with stationary measuring chambers having constant volume during measurement for fluent solid material not provided for in G01F11/34, G01F11/40, G01F11/46
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/003Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it for fluent solid material

Definitions

  • the invention relates to a device for introducing a defined amount of a second powder into a process container in which there is a first powder or a powder mixture, wherein a coupling flange with a closure flap is provided on the process container.
  • the device is provided in particular for the introduction of small and very small amounts of powdery substances into larger process vessels, in particular the admixture of small amounts of powdered pharmaceutical active ingredients to main components already present in a process vessel, such as lactose or corn starch.
  • the invention is particularly suitable for containment applications of active and / or sterile applications. According to the prior art, the addition of certain components in mixing container is known to be done by simply filling through a lid opening.
  • An acting according to the principle of gravity dosing is, for example, in
  • the respective halves of the coupling each include a valve that can be opened when the coupling halves are properly connected together and that must be moved to a fully closed condition before the respective halves of the coupling can be separated from each other
  • EP 0 447 023 B1 describes a dry separation for lines with 2 separately operable valve flaps.
  • the invention has for its object to provide a device with a loss and contamination-free entry of very small amounts of powdery substances is made possible in larger process container.
  • the entry should be made with simple means and a high dosing accuracy.
  • the invention is intended to be particularly suitable for containment applications of active and / or sterile applications.
  • the second powder can be introduced into a tubular cartridge which can be displaceably mounted in a transport unit.
  • the transport unit has a connecting flange with a closing flap, wherein the connecting flange can be connected to the coupling flange such that the two closing flaps can be opened.
  • the cartridge can be moved inside the transport unit through the opened flaps.
  • the front discharge opening of the cartridge or the end of a contained delivery piston should preferably extend into the plane of the inner wall of the process container.
  • the coupling flange may consist of a connecting piece and a flap valve. Both parts can be firmly or detachably connected to each other.
  • the connecting flange can consist of a cartridge receptacle and a flap valve. Both parts can also be firmly or detachably connected to each other.
  • the cartridge consists of a cartridge sleeve, in the inner powder chamber of the delivery piston is arranged on the conveyor side by means of an actuable piston rod slidably.
  • the cartridge is closable together on the container side by a closure piston displaceably arranged on the same piston rod.
  • the cartridge consists of a cartridge sleeve, in the inner powder chamber, a double piston is slidably mounted.
  • the delivery piston can be displaced by means of a piston rod 1, whereas the cartridge is closable on the container side by a closure piston displaceably arranged by means of a second piston rod 2. Both pistons can be operated separately from each other.
  • a particular embodiment of the invention relates to a cartridge which consists of a cartridge sleeve in which a cartridge core which can be rotated axially by at least 100 ° is arranged. Over the entire length of the cartridge core extends a powder chamber, in which a delivery piston is displaceably arranged by means of a piston rod.
  • the cartridge sleeve has an emptying opening on the container side. To empty the cartridge, the powder chamber is rotated so far beyond the discharge opening that the two openings correspond so far until the powder can be emptied into the process container.
  • a preferred embodiment is realized in a device in which the cartridge consists of a cartridge case, in the side of a Drehversehl uss is integrable, with which a discharge opening of the cartridge by means of an actuating lever is closed.
  • the cartridge case is preferably formed oval. This embodiment has the advantage that no separate closure piston is required.
  • the amount of product that can be dispensed or drained from the cartridge is determined by the stroke and diameter of the powder chamber.
  • the entire transport unit can be removed and transported in a separate location. Therefore, a flexible protective cover should be attached to the connecting flange so that the protective cover completely encloses the inserted cartridge. The purpose is to keep the system closed, even if the cartridge is removed from the transport unit before it is filled, and that no special sealing between the cartridge and the cartridge receptacle is required.
  • the connecting flange of the transport unit and the coupling flange are connected to one another, their respective closing flaps sealingly sealing each other and should be able to pivot together.
  • the outer sides of the flaps remain powder-free. This secures operator security in the sense of containment.
  • the cartridge can be closed at its discharge opening with a pierceable membrane.
  • the membrane is made of a material which is one of the components of the powder to be mixed in the process vessel. If the membrane were made of other materials, such as paper or plastics, it had to be ensured that no foreign substances could be introduced into the process container which could lead to undesired additives or soiling.
  • the device can be designed such that the delivery piston is coupled via a detachable connection to a drive, which effects automatic metering or emptying.
  • the drive can be an electric or servopneumatic drive.
  • FIG. 1 is a sectional view of a device according to the invention with a connection unit and a decoupled transport unit into which a cartridge is pushed to the still closed shutter,
  • FIG. 6a, 6b perspective view of a device with a screw cap
  • a containment system for example, in a 60I process container 1 in which there are about 20 kg of powdery substances of one or more main components, for example lactose or corn starch, about 20 g of powdered active substances are mixed.
  • FIG. 1 A first embodiment is shown in FIG.
  • the device according to FIG. 1 shows on the left a coupling flange 2 and on the right a transport unit with an inserted cartridge 4.
  • the transport unit simultaneously serves as a means of transport from the filling complex to the dosing station for the process container 1.
  • Cartridges with a very small diameter are used for the smallest amounts to be dosed.
  • the stroke and the diameter of the delivery piston 8 and the inner diameter of the powder chamber 1 1 determine the amount of product that can be metered or emptied from the cartridge.
  • an approximately 190 mm long cartridge with an inner diameter of the cartridge sleeve 12 of 34 mm is used.
  • the transport unit has a connecting flange 6, which is formed in two parts for manufacturing and cleaning reasons. It consists of a cartridge receptacle 10 and a flap valve 25 according to the principle according to EP 0 447 023 B1. Both parts are releasably connected to each other by means of a clamp 20.
  • the cartridge receptacle 10 has a bore for receiving the cartridge 4. Through this hole, the exactly filled cartridge 4 can be pushed through the open shutter 7 of the flap valve 25 therethrough. In Fig. 1, the cartridge 4 is pushed only to the closure flap 7, wherein the closure flap 7 and the protective cover 19 closes the connecting flange 6 for safe transport.
  • the closure flap 7 of the flap valve 25 can be operated by means of a lever mechanism 23.
  • the coupling flange 2 remains as a permanent connection unit on the process container 1.
  • the coupling flange 2 is preferably formed in two parts to allow easy production and to better cleaning of both parts. It consists in this embodiment of a fitting 17 and a flap valve 24 according to the principle according to EP 0 447 023 B1. Both parts are detachably connected to each other by means of a clamp 20.
  • the connector 17 is attached to the process container 1, that the inside is part of the process container. It can for example be welded or screwed.
  • the connection piece 17 has a bore 22, up to which the cartridge 4 can be pushed through the opened closure flap 3 of the flap valve 24 to the inner wall of the process container 1. In Fig. 1, the closure flap 3 is still shown closed.
  • the connector 17 has a shoulder 26 which serves as a stop for the cartridge sleeve 12.
  • the diameter of the discharge opening 18 corresponds to the outer diameter of the cartridge 4th
  • the flaps 3.7 of the two flap valves 24,25 are jointly operated by means of the lever mechanism 23 in the assembled state. After opening the closing flaps 3, 7, a passage for the cartridge 4 is made possible above and below the closing flaps 3, 7.
  • the two holes in the connector 17 and in the cartridge receptacle 10 for receiving the cartridge 4 must correspond accordingly. This is ensured by conventional fixings for positioning, for example centering pins.
  • an axial coupling of two parallel flanges takes place according to the principle described in DE 20 2009 018 738 IM, wherein the end faces of the two flanges for coupling are pressed against each other axially and by means of a coupling sleeve 21 which can be operated by an actuating lever 27 be fixed.
  • the cartridge 4 consists of a cartridge sleeve 12, in the inner powder chamber 11 of which the delivery piston 8 is arranged on the delivery side displaceable by means of an actuatable piston rod 5.
  • the cartridge 4 is closable together on the container side by a closure piston 15 arranged on the same piston rod 5.
  • a groove is incorporated into the cartridge receptacle 10 into which a flexible protective cover 19 can be fastened by means of a retaining ring 28 such that it extends around the handle 9 of the extended piston rod 5 of the cartridge 4 is enough.
  • the protective cover 19 consists of a transparent plastic film.
  • the operation is as follows: After the separate filling of the cartridge 4 with the required amount of product described in Fig. 7, the entire transport unit is connected in the manner described above to the corresponding flap valve 24 of the coupling flange 2 and secured with the coupling sleeve 21. Subsequently, the two flaps 3 and 7 are opened and the cartridge 4 pushed so far into the coupling flange 2 that the cartridge sleeve 12 abuts with its stop 1 30 on the shoulder 26. The cartridge sleeve 12 and the front of the closure piston 15 close the bore 18 in the process container 1. Then, the process start and the dosage of the main powder component can be done.
  • the piston rod with the closure piston 15 and the delivery piston 8 is pressed by means of the handle 9 in the direction of process container until the handle stop 29 abuts the cartridge sleeve 12 and the front end of the delivery piston 8 in the plane of the inner Wall of the process container 1 completes.
  • the piston rod 5 and the closure piston 15 located thereon protrude into the process container. Since the point of entry is below the filling level in the process vessel 1, the powder to be dispensed is entrained and homogeneously distributed by the powder mixture of the main components already contained in the process vessel 1 in the mixing process which takes place in the process vessel.
  • the piston rod 5 is pulled back into the cartridge 4. Thereafter, the cartridge 4 is retracted until the stop 2 31 abuts the cartridge receptacle 10 and the two flaps 3 and 7 can be closed.
  • the transport unit After the decoupling of the two flanges, the transport unit is transported away to the Wederbehellung the cartridge 4.
  • FIG. 2 shows a cartridge 4 with a double piston solution.
  • the filling of the cartridge 4 and the introduction into the transport unit through the two flap valves 25 and 24 and the connector 17 to the inner wall of the process container success analogous to the embodiment of FIG. 1.
  • the cartridge used 4 has within its cartridge sleeve 12 again a closure piston 15th and a delivery piston 8.
  • both pistons can be actuated, each with its own piston rod.
  • the inner closure piston 15 is attached to the inner piston rod 2 14 and operated by means of the right grip part 9b.
  • the delivery piston 8 is attached to the outer piston rod 1 and can be operated by means of the left grip part 9a.
  • FIGS. 3a to 3d show the mode of operation of a double piston solution described in FIG. In Fig. 3a, the filled and closed with the closure piston 15 cartridge 4 is inserted to the shutter 7.
  • FIG. 3b the cartridge 4 pierces the flap valves 25 and 24 when the flaps 3 and 7 are open.
  • the plunger 15 still closes the emptying opening 18.
  • the two pistons are still in the same position as in FIG. 3a.
  • Fig. 3d it can be seen that the closure piston 15 can be withdrawn after emptying separated from the delivery piston 8.
  • the closure piston 15 may only be withdrawn until shortly before the delivery piston 8, so that no product quantities remain between the pistons.
  • the process is terminated, the process container 1 emptied and the cartridge 4 withdrawn as described in Fig. 1.
  • a special embodiment for a cartridge 4 is shown.
  • Within a cartridge sleeve 12 there is a cartridge core 16 which can be rotated axially by at least 100 °.
  • the powder chamber 11 extends over the entire length of the cartridge core 16.
  • the delivery piston 8 is arranged displaceably in the powder chamber 11 by means of the piston rod 5. 4 shows the cartridge 4 in the closed state.
  • the cartridge core 16 is rotated until the powder chamber 11 coincides with the opening 32 located in the end face of the cartridge sleeve 12 and releases the powder material contained in the process container.
  • the delivery piston 8 is pushed to the handle stop 29 on the cartridge core 16 that the front the end of the delivery piston 8 terminates in the plane of the inner wall of the process container 1.
  • the cartridge 4 described here likewise has a length of 190 mm and an inner diameter of the cartridge sleeve 12 of 34 mm. However, since the powder chamber 1 1 has only a diameter of 12mm, a more accurate metering of much smaller doses can be achieved.
  • the cartridge 4 can be used and used as in the aforementioned examples in the transport unit and the coupling flange.
  • FIGS. 5 and 6a and 6b A further embodiment of the device according to the invention can be seen from FIGS. 5 and 6a and 6b.
  • a variant is shown in which inside the cartridge sleeve 12 in the manner described above, a round delivery piston 8 by means of a piston rod 5 and a handle 9 attached thereto is slidably disposed.
  • On the handle 9 is a handle stop 29, which is positioned so that the inserted delivery piston 8, as seen in Fig. 5, in the deflated state with its front end in the plane of the inner wall of the process container 1 closes.
  • the tubular cartridge 4 shown here has an oval cartridge sleeve 12, in the lateral shape of a Drehversehl uss 33 is integrated.
  • the twist-lock consists of a shaft integrated in the lateral shaping, at the front end of which a closing flap is provided. At the rear end of the shaft is an actuating lever 34, by means of which the closure flap can be swiveled over the emptying opening 18 and completely close it.
  • both the connector 17 and the cartridge receptacle 10 have an internal oval shape, which corresponds to the contour of the cartridge sleeve 12 and allows the insertion of the cartridge 4.
  • This embodiment has the advantage that a separate closure piston is no longer required. After dosing, no closure piston remains in the process container and the discharge opening 18 can be closed.
  • the cartridge 4 can be removed in this embodiment only after emptying of the process container 1.
  • FIG. 7 shows a transport unit connected to a filling complex, FIG. in which a cartridge with a rotary closure 33 of FIG. 5 is used.
  • the Be Schollkomplex consists of a glove box, a weighing system with a cartridge receptacle and a Mikrodosiersystem for filling.
  • connection flange 35 At the filling complex there is a fixed connection flange 35, to which a flap valve 24 formed in the above-mentioned manner has been fastened by means of a clamp 20.
  • the two flaps 3 and 7 are opened via their lever mechanism. Since the connection flange 35 on the filling system has no shoulder 26, the emptied cartridge 4 can then be pushed and removed through the two closing flaps 3 and 7 of the flap valves 25 and 24 into the filling complex. In FIG. 7, the empty cartridge 4 is pushed straight out of the transport unit into the filling complex when the rotary closure 33 is closed. There it can be cleaned and refilled under containment conditions. The return of the filled cartridge 4 in the transport unit takes place in the reverse order.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • General Physics & Mathematics (AREA)
  • Quality & Reliability (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Package Specialized In Special Use (AREA)
  • Accessories For Mixers (AREA)
PCT/DE2014/100012 2013-04-19 2014-01-20 Vorrichtung zum einbringen einer definierten menge eines zweiten pulvers in einen prozessbehälter Ceased WO2014169897A1 (de)

Priority Applications (4)

Application Number Priority Date Filing Date Title
IN2508MUN2014 IN2014MN02508A (https=) 2013-04-19 2014-01-20
EP14709530.1A EP2986952B1 (de) 2013-04-19 2014-01-20 Vorrichtung zum einbringen einer definierten menge eines zweiten pulvers in einen prozessbehälter
CA2874544A CA2874544C (en) 2013-04-19 2014-01-20 Device for introducing a defined amount of second powder into a process container
IL236415A IL236415B (en) 2013-04-19 2014-12-23 A device for introducing a specified amount of dust into a procedure vessel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013104003.9 2013-04-19
DE102013104003.9A DE102013104003B3 (de) 2013-04-19 2013-04-19 Vorrichtung zum Einbringen einer definierten Menge eines zweiten Pulvers in einen Prozessbehälter

Publications (1)

Publication Number Publication Date
WO2014169897A1 true WO2014169897A1 (de) 2014-10-23

Family

ID=50153597

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2014/100012 Ceased WO2014169897A1 (de) 2013-04-19 2014-01-20 Vorrichtung zum einbringen einer definierten menge eines zweiten pulvers in einen prozessbehälter

Country Status (7)

Country Link
US (1) US9033005B2 (https=)
EP (1) EP2986952B1 (https=)
CA (1) CA2874544C (https=)
DE (1) DE102013104003B3 (https=)
IL (1) IL236415B (https=)
IN (1) IN2014MN02508A (https=)
WO (1) WO2014169897A1 (https=)

Cited By (4)

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Publication number Priority date Publication date Assignee Title
WO2017205392A1 (en) 2016-05-24 2017-11-30 Amgen Inc. Pegylated carfilzomib compounds
WO2018027021A1 (en) 2016-08-05 2018-02-08 Amgen Inc. Synthesis of (s)-2-amino-4-methyl-1-((r)-2-methyloxirane-2-yl)-pentan-1-one and pharmaceutically acceptable salts thereof
WO2019099715A1 (en) 2017-11-16 2019-05-23 Amgen Inc. Stable compositions of pegylated carfilzomib compounds
WO2025035020A2 (en) 2023-08-09 2025-02-13 Amgen Inc. Methods of using carfilzomib

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102013104003B3 (de) * 2013-04-19 2014-03-13 Glatt Systemtechnik Gmbh Vorrichtung zum Einbringen einer definierten Menge eines zweiten Pulvers in einen Prozessbehälter
JP6630359B2 (ja) 2015-07-29 2020-01-15 株式会社Fuji 部品実装機
WO2025253016A1 (en) * 2024-06-07 2025-12-11 Gea Process Engineering Nv A powder injection device, method, and system for injecting powder

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IL236415B (en) 2018-02-28
US20140311627A1 (en) 2014-10-23
US9033005B2 (en) 2015-05-19
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