EP2789329B1 - A device for providing fluid to a receptacle - Google Patents
A device for providing fluid to a receptacle Download PDFInfo
- Publication number
- EP2789329B1 EP2789329B1 EP14175968.8A EP14175968A EP2789329B1 EP 2789329 B1 EP2789329 B1 EP 2789329B1 EP 14175968 A EP14175968 A EP 14175968A EP 2789329 B1 EP2789329 B1 EP 2789329B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- receptacle
- gas
- connector
- volume
- 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.)
- Active
Links
- 239000012530 fluid Substances 0.000 title claims description 20
- 239000000126 substance Substances 0.000 claims description 20
- 239000000463 material Substances 0.000 claims description 7
- 238000004140 cleaning Methods 0.000 claims description 5
- 230000035515 penetration Effects 0.000 claims description 5
- 230000001105 regulatory effect Effects 0.000 claims description 4
- 238000012546 transfer Methods 0.000 claims description 3
- 239000007789 gas Substances 0.000 description 81
- 239000003814 drug Substances 0.000 description 34
- 229940079593 drug Drugs 0.000 description 27
- 239000002245 particle Substances 0.000 description 16
- 239000007788 liquid Substances 0.000 description 13
- 230000008878 coupling Effects 0.000 description 10
- 238000010168 coupling process Methods 0.000 description 10
- 238000005859 coupling reaction Methods 0.000 description 10
- 238000002360 preparation method Methods 0.000 description 9
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- 238000011109 contamination Methods 0.000 description 6
- 238000002347 injection Methods 0.000 description 6
- 239000007924 injection Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 244000005700 microbiome Species 0.000 description 6
- 230000001954 sterilising effect Effects 0.000 description 6
- 239000012528 membrane Substances 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 230000003247 decreasing effect Effects 0.000 description 4
- 238000013022 venting Methods 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 231100000433 cytotoxic Toxicity 0.000 description 2
- 230000001472 cytotoxic effect Effects 0.000 description 2
- 231100001261 hazardous Toxicity 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 208000032484 Accidental exposure to product Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 206010073310 Occupational exposures Diseases 0.000 description 1
- 231100000818 accidental exposure Toxicity 0.000 description 1
- 231100000599 cytotoxic agent Toxicity 0.000 description 1
- 239000002619 cytotoxin Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 231100000675 occupational exposure Toxicity 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2068—Venting means
- A61J1/2075—Venting means for external venting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2079—Filtering means
- A61J1/2082—Filtering means for gas filtration
Definitions
- the invention relates to a device for providing cleaned fluid i.e. gas and/or liquid to a receptacle according to the preamble of claim 1.
- the invention can be implemented in aseptic preparation of drugs, for example for providing sterilized/cleaned air to a medical receptacle, such as a bottle or vial, with the purpose of drawing a solution or another liquid used in medicine applications out from the medical receptacle.
- a medical receptacle such as a bottle or vial
- a known problem associated with the preparation of drug solutions is the fact that medical bottles or vials normally are made of a non-compressible material, such as glass or plastic. To enable the vial to be drained off, air has to flow into the vial so as to avoid negative pressure in the vial which negative pressure would otherwise counteract or prevent further transportation of liquid from the vial to another receptacle such as syringe.
- a system for providing sterilized gas is disclosed in WO 00/35517 .
- a flexible bag containing sterilised gas is provided.
- the bag has an opening covered by a gas and liquid-impervious membrane which can be punctured by a needle in order to draw the sterilised gas out from the bag for further transportation of the gas to a bottle.
- a bottle connector is arranged on the current bottle and the bottle connector has a pressure compensation means for receiving gas.
- WO 02/11794 a system for providing cleaned gas is described.
- This system works with an injection syringe and an air filter to be attached to a connection nozzle of the syringe.
- the container of the syringe is charged with air which has been forced through the filter so as to clean the air.
- the air filter is removed and the syringe is connected to a coupling means (injector device) which in turn is connected to a capping means (bottle connector) arranged on a bottle.
- the capping means has a pressure-equalisation chamber whose volume can vary.
- the cleaned gas in the syringe is transferred from the syringe to the bottle and to the pressure-equalisation chamber arranged on the capping means. Thereafter the substance in the bottle can be drawn out from the bottle by means of the syringe and the coupling means, while the cleaned gas flows from the pressure-equalisation chamber into the bottle.
- the prior art system described in WO 02/11794 has drawbacks.
- the system requires an adapter provided with an air filter being connected to and removed from a syringe in order to fill the pressure-equalisation chamber before the medical substance can be drawn from the bottle.
- the air filter is fixedly attached to a syringe.
- a conventional syringe can not be used.
- the cleaned gas has to be drawn from the environment and subsequently transferred to the bottle and the pressure-equalisation chamber before the medical substance can be drawn from the bottle.
- WO 84/04672 concerns a device for ventilating and pressure balancing the interior of a sealed vessel containing a substance which is to be taken out from said vessel e.g. by an injection syringe, said vessel being provided with a closure means comprising a sealing member through which a puncturing member, e.g. a needle can be passed for entering the interior of said vessel.
- the closure means or a connection means attachable onto said vessel is provided with ventilating means arranged to provide a communication between the interior of the vessel and a closed container or alternatively the atmosphere via a filter.
- JP 2002 238979 aims to provide a double-ended needle capable of simply and speedily preparing a drug of a powder formulation.
- the double-ended needle comprises one side needle part to pierce a port of a container filled with a dilute liquid, and another needle part to pierce a port of a container filled with the drug.
- the double-ended needle further comprises a liquid sending passage penetrating through interiors of the one needle part and the other needle part, and a venting passage for allowing gases in and out of the container to flow so that the venting passage is formed from either the one needle part or the other needle part.
- the venting passage has a port section to which a sending means and a suction means are attachable and detachable.
- WO 2007/120641 discloses a vial adaptor for removing liquid contents from a vial, which includes a piercing member and a bag.
- the bag can be contained within the piercing member such that the bag is introduced to the vial when the vial adaptor is coupled with the vial.
- the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial.
- a vial includes a bag for regulating pressure within the vial as liquid is removed therefrom.
- a vial adaptor is coupled with the vial in order to remove the liquid.
- the bag expands within the vial, and in other embodiments, the bag contracts within the vial.
- An object of the invention is to provide a device for providing cleaned and/or sterilized fluid of the kind referred to in the introduction where at least one problem of such prior art devices discussed above is reduced to a substantial extent.
- the invention aims to indicate how to provide sterilized/cleaned fluid in a rational and safe way during preparation of drugs.
- the invention is based on the insight that sterilized/cleaned air is advantageously provided by a connector system itself, rather than utilising additional equipments to fill an expansion container comprised in a connector system during drug preparation.
- a container has to be filled with the fluid either during manufacturing of the device or by the user, and these two options result in two aspects of the invention.
- the object is achieved by a device according to claim 1.
- a connector and a container which form an integrated unit, wherein the connector is provided with a first means for connection to a receptacle, and the integrated unit is provided with a filter for cleaning fluid passing the filter during filling the container with fluid, before connection of the connector to a receptacle, no syringe provided with an air filter adapter or an air filter fixedly attached to the syringe is needed for transferring cleaned fluid into for example a vial before conveyance of a substance out of the vial.
- a conventional syringe can be used for conveyance of a substance out from the receptacle as soon as the connector is arranged on the receptacle.
- the device can have a decreased volume which could result in smaller package and save shipment costs.
- a cleaned fluid suitable for aseptic preparation of drugs can be achieved by filtering the fluid.
- the device 1 can be used for providing cleaned and/or sterilized gas, for example air, to a receptacle and thereby facilitate conveyance of a substance out of the receptacle.
- a substance can be various solutions and liquids constituting drugs, for example cytotoxic drugs and antibiotics, for use in the field of medicine.
- the device comprises a connector 2 and a container 3 which form an integrated unit 4.
- the connector 2 is provided with a first means 5 for connection to a receptacle or in other words a first connector portion 5 for connection to a receptacle.
- the container 3 is pre-filled or adapted to be pre-filled with a cleaned and/or sterilized gas to be transferred from the container 3 to a receptacle, which is connectable with the connector 2, during conveyance of a substance out of the receptacle.
- a medicine receptacle such as a bottle or vial 6, and the exploded view in figure 4 .
- pre-filled is meant the container being already filled with gas before it is used for providing gas to a receptacle.
- the device is suitably already filled when delivered to the user, and preferably the container is filled during or after manufacture of the device for example just before or at the moment when the device is enclosed by a package or packing.
- cleaned gas is meant that the gas has been filtered by a removable filter to remove particles and/or viable micro-organisms to such an extent that the gas is classified to be aseptic and accepted by the relevant authority and/or any standards.
- the degree of purity can be expressed in the largest particles allowed to pass the removable filter for a given flow rate of gas. In some cases no or very few particles having a size exceeding 5 ⁇ m are allowed to be present in the cleaned gas. However, the allowed particle size is determined by the requirements in the current application. Some drug treatments require that substantially all particles having a size exceeding 0.15 ⁇ m are removed from the gas by the removable particulate air filter. As an example, a removable filter with the mesh size 0.2 ⁇ m can be used to remove substantially all particles and micro organisms of that size or larger.
- sterilized gas By the expression “sterilized” gas is meant that the gas has been subjected to a sterilization method to remove viable micro-organisms, which method is accepted for the current product by the relevant authority.
- Current regulations in Europe for medical devices to be designated “STERILE” may be found in the European standard EN 556-1. Other regulations may exist in other countries.
- the sterilization can be ethylene oxide sterilization, sterilisation by irradiation, or (moist) heat sterilization or any other accepted method.
- the European standard requirements imply that the theoretical probability of there being a viable micro-organism present on/in the sterilized device shall be equal to or less than 1x10 -6 .
- the gas is sterilized, it is not always necessary to clean the gas according to the cleaning process as described above, although such cleaning and the sterilization can be combined. However, other methods can be used to remove particles etc. from the gas if required or the sterilization process itself may be sufficient to bring the gas into a state where the gas is to be considered as both cleaned and sterilized.
- the first connection means 5 can be designed for connection to a receptacle, such as the neck of a vial.
- the first connection means 5 is constituted by a ring-shaped portion 7 for enclosing the neck 8 of the vial 6.
- the ring-shaped portion 7 has slits 9 so as to form flanges 10 which protrude downwardly.
- the flanges 10 can be provided with hooks 11 or barbs for gripping around the neck 8 of the vial 6.
- the connector 2 is suitably provided with a second means 12 for connection to a transfer member 13 (see figures 3 and 4 ), such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6.
- the connector 2 is suitably provided with a second connector portion 12.
- the second connection means 12 can comprise a luer lock coupling or bayonet coupling to enable an injector device to be connected to the connector.
- both the injector device and the connector are provided with a membrane so as to create a double membrane coupling between the injector and the current device.
- the amount of gas, preferably air, provided by the pre-filled container should be adapted to the volume of the receptacle which is to be drained off.
- the volume of the gas when being in the receptacle should preferably correspond to the volume of the receptacle so as to enable the receptacle to be completely drained off. This implies that the volume of the cleaned or sterilized gas in the pre-filled container is preferably approximately equal to or larger than the volume of the receptacle provided that the pressure of the gas is substantially the same in the receptacle as in the container.
- the volume of the gas should be in the interval 1-100 cm 3 at atmospheric pressure.
- the connector 2 is preferably provided with a piercing member, such as a hollow needle 14 (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
- a piercing member such as a hollow needle 14 (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
- the expression “needle” is meant to comprise spikes and similar components for penetration of such a closing in order to create a channel between the container 3 and the receptacle 6 to which the connector 2 is connected.
- gas contained in the container 3 can be transferred from the container to the receptacle 6, i.e. gas can flow from the container 3 to the receptacle 6.
- the connector 2 and the container 3 form an integrated unit 4. This implies that the connector and the container are made in one piece or the connector 2 and the container 3 can be coupled to each other so as to form an integral unit 4. Different types of coupling means known from prior art can be used as long as an airtight, or at least a substantially airtight connection can be obtained between the current components 2, 3.
- the volume of the container 3 can be variable so as to allow the gas to flow from the container 3 to a receptacle 6.
- the container 3 is suitably made of a compressible material to make the volume of the container variable.
- the container can comprise a first portion 17 made by a relatively rigid material which first portion 17 is coupled to the connector 2, and a second portion 18 made by a relatively flexible material attached to the first portion 17.
- the container 3 can be designed to have a flexible portion, such as a bellow which is compressible and extendable.
- the container or the flexible portion of the container, comprises a displaceable spring-loaded element, such as an axial spring-loaded element, that is arranged to allow fluid to flow into the container/ flexible portion of the container.
- the displaceable spring-loaded element is for example constrained between two flanged ends of the flexible portion.
- the spring(s) of the spring-loaded element is/are highly compressed.
- the spring(s) may be arranged on the inside or outside of the flexible portion or they may be integrally formed with the flexible portion.
- the displaceable spring-loaded element may be arranged to be disconnected from the container/flexible portion of the container once the container/flexible portion of the container has been filled to the desired amount.
- the flexible portion of the container may be arranged to be detachable from the remaining part of the container, whereby the flexible portion may be filled with fluid before and/or after it has been attached to the remaining part of the container.
- the volume of the container 3 can be increased and decreased, respectively.
- the device illustrated in figure 1 comprises a compressible container
- the container can have a cylinder and a piston arranged therein so as to enable the volume of the container to be changed.
- the container comprises locking means to prevent fluid from flowing into the container, during the transportation of the device, for example, or at any other time when the device is not in use.
- the container 3 can be pressurized by cleaned or sterilized gas to cause an overpressure in the container.
- An overpressure allows gas to flow from the container 3 to a receptacle 6 connected to the connector and the container.
- the overpressure is suitably adapted to the size of the receptacle to which the connector is to be connected to ensure the receptacle can be completely drained off in a subsequent step.
- the pressure in the filled container can be for example in the interval from 1atm to 2atm.
- the device comprises any means, such as a valve, for allowing the gas to flow from the container after the device has been connected to the receptacle and during conveyance of a substance out of the receptacle.
- a device 1' according to the invention is illustrated.
- the device can be used for providing cleaned gas to a receptacle and thereby facilitate conveyance of a substance out of the receptacle.
- a substance can be various solutions and liquids constituting drugs, for example cytotoxic drugs or antibiotics, for use in the field of medicine.
- the device comprises a connector 2' and a container 3' which form an integrated unit 4'.
- the connector 2' is provided with a first means 5' for connection to a receptacle 6' or in other words a first connector portion 5'. See also figure 7 illustrating the device connected to a medicine bottle or vial 6', and the exploded view in figure 8 .
- the first connection means 5' can be designed for connection to a bottle, such as the neck of a vial.
- the first connection means 5' is constituted by a ring-shaped portion 7' for enclosing the neck 8' of the vial 6'.
- the ring-shaped portion 7' has slits 9' so as to form flanges 10' which protrude downwardly.
- the flanges 10' can be provided with hooks 11' or barbs for gripping around the neck 8' of the vial 6'.
- the connector 2' is suitably provided with a second means 12' for connection to a transfer member 13', such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6'.
- a transfer member 13' such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6'.
- the connector 2' is suitably provided with a second connector portion 12'.
- the second connection means 12' can comprise a luer lock coupling or bayonet coupling to enable an injection device to be connected.
- both the injector device and the connector are suitably provided with a membrane so as to create a double membrane coupling between the injector and the current device.
- the connector 2' is preferably provided with a piercing member, such as a hollow needle 14' (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
- a piercing member such as a hollow needle 14' (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
- the expression “needle” is meant to comprise spikes and similar components for penetration of such a closing in order to create a channel between the container 3' and the receptacle 6' to which the connector 2' is connected.
- a channel or passage 15' in the needle 14' gas contained in the container 3' can be transferred from the container to the receptacle 6', i.e. gas can flow from the container 3' to the receptacle 6'.
- the connector 2' and the container 3' form an integrated unit 4'.
- Different types of coupling means 16' known from prior art can be used as long as an airtight or at least a substantially airtight connection can be obtained between the current components 2', 3'.
- the container 3' has to be filled with gas before connection of the connector 2' to a receptacle 6'.
- the volume of the container 3' is preferably variable.
- the container can comprise a first portion 17' made by a relatively rigid material which first portion is coupled to the connector 2', and a second portion 18' made by a relatively flexible material attached to the first portion 17'.
- the second portion 18' can be extensible by manipulation of for example a handle 20' arranged at the end of the container 3'.
- the volume of the container 3' can be increased and decreased, respectively.
- the container 3' can be designed to have a flexible portion, such as a bellow which is compressible and extendable by affecting the container manually.
- the container 3' is preferably provided with said handle 20' for regulating the volume of the container 3'.
- the volume of the container is preferably variable as illustrated, there may be other ways to fill the container while at the same time ensuring the gas passes a removable filter 21'.
- the gas container could be constituted by a sealed vacuum-packed flexible bag whose seal can be broken to allow gas to flow into the bag.
- the gas container is rigid or semi-rigid and pressurized gas is used to fill the container.
- the amount of gas, preferably air, provided by the pre-filled container should be adapted to the volume of the receptacle which is to be drained off.
- the volume of the gas when being in the receptacle should preferably correspond to the volume of the receptacle so as to enable the receptacle to be completely drained off. This implies that the volume of the cleaned or sterilized gas in the pre-filled container is preferably approximately equal to or larger than the volume of the receptacle provided that the pressure of the gas is substantially the same in the receptacle as in the container.
- the volume of the gas should be in the interval 1-100 cm 3 at atmospheric pressure.
- the integrated unit 4' is provided with the removable filter 21', such as a removable particulate air filter for cleaning gas passing the filter 21' during filling the container 3' with gas, preferably by increasing the volume of the container 3', before connection of the connector 2' to a receptacle 6'.
- the removable filter hereinafter called particulate air filter 21'
- the removable particulate air filter 21' can be arranged in different ways, according to the embodiment illustrated in figure 5 and 6 the removable particulate air filter 21' is arranged on the connector 2'.
- the removable particulate air filter 21' is arranged to be removed from the integrated unit 4' after the container 3' has been filled with cleaned gas. Subsequently to filling the container 3' the removable particulate air filter 21' is removed and the connector 2' is to be connected to the receptacle 6'.
- cleaned gas is meant that the gas has been filtered by a removable filter to remove particles and/or viable micro-organisms to such an extent that the gas is classified to be aseptic and accepted by the relevant authority and/or any standards.
- the degree of purity can be expressed in the largest particles allowed to pass the removable filter for a given flow rate. In some cases no or very few particles having a size exceeding 5 ⁇ m are allowed to be present in the cleaned gas. However, the allowed particle size is determined by the requirements in the current application. Some drug treatments require that substantially all particles having a size exceeding 0.15 ⁇ m are removed from the gas by the removable particulate air filter. As an example, a removable filter with the mesh size 0.2 ⁇ m can be used to remove substantially all particles and micro organisms of that size or larger.
- the removable particulate air filter 21' is preferably designed as a needle shield 22' for the tip of needle 14'.
- the removable filter can be arranged to at least partially cover or surround the tip of the needle 14'. This implies that the removable particulate air filter 21' cleans the gas and at the same time the removable particulate air filter 21' functions as a protection during handling of the device 1'. Furthermore, such a needle tip shield 22' protects the sterile package enclosing the device during transport and storage of the device.
- any contamination particles removed from the gas and collected in the removable particulate air filter 21' are removed from the integrated unit 4'.
- one and the same channel can be used for both filling the container 3' with cleaned gas and transferring the cleaned gas from the container 3' to a receptacle 6'.
- the particulate air filter 21' since the particulate air filter 21' is not to be removed before interconnection of the connector 2' and the receptacle 6' to each other, the particulate air filter 21' has to be arranged so as to avoid contamination during transportation of the gas from the container 3' to the receptacle 6'.
- the integrated unit 4' can be provided with a first channel 23' for filling the container 3' with cleaned gas and a second channel 15' for transferring the cleaned gas to a receptacle. Otherwise, i.e.
- the particulate air filter if the particulate air filter is to be left, and one and the same channel is used for transportation of gas in both directions; the particles collected in the particulate air filter could possibly release from the particulate air filter and be unintentionally brought into the receptacle 6' by the gas flow.
- Such a contamination can be prevented by providing a removable air filter or by providing different openings/channels for transportation of gas into and out of the container 3', respectively.
- a lid 26' can be arranged on the integrated unit 4' for covering the particulate air filter 21' so as to prevent further communication between the interior of the integrated unit 4' and the environment via the particulate air filter 21' after filling the container 3'. Firstly, the container 3' is filled with the cleaned gas and thereafter the lid 26' is mounted on the integrated unit 4' to cover the particulate air filter 21' and prevent further gas transportation through the air particle filter 21'. Thereafter, the integrated unit 4' and the receptacle 6' are to be interconnected and the subsequent manipulations can be safely executed.
- the lid 26' has the function of preventing transportation of liquid, gas or any vapour in the direction from the integrated unit 4' to the environment so as to counteract that any undesired substance in the receptacle 6' escapes to the environment.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP17170133.7A EP3222265B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
ES14175968.8T ES2600952T3 (es) | 2007-06-13 | 2007-06-13 | Un dispositivo para proporcionar fluido a un receptáculo |
EP14175968.8A EP2789329B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP15198205.5A EP3009121B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14175968.8A EP2789329B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
PCT/SE2007/050416 WO2008153460A1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP07748576.1A EP2155143B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP07748576.1A Division EP2155143B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP07748576.1A Division-Into EP2155143B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Related Child Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15198205.5A Division EP3009121B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP15198205.5A Division-Into EP3009121B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP17170133.7A Division EP3222265B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2789329A1 EP2789329A1 (en) | 2014-10-15 |
EP2789329B1 true EP2789329B1 (en) | 2016-08-03 |
Family
ID=40129933
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17170133.7A Active EP3222265B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP07748576.1A Active EP2155143B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP15198205.5A Active EP3009121B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP14175968.8A Active EP2789329B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Family Applications Before (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17170133.7A Active EP3222265B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP07748576.1A Active EP2155143B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
EP15198205.5A Active EP3009121B1 (en) | 2007-06-13 | 2007-06-13 | A device for providing fluid to a receptacle |
Country Status (5)
Country | Link |
---|---|
EP (4) | EP3222265B1 (es) |
JP (1) | JP5091313B2 (es) |
CA (2) | CA2707342C (es) |
ES (4) | ES2600952T3 (es) |
WO (1) | WO2008153460A1 (es) |
Families Citing this family (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7547300B2 (en) | 2006-04-12 | 2009-06-16 | Icu Medical, Inc. | Vial adaptor for regulating pressure |
EP4119121A1 (en) | 2011-08-18 | 2023-01-18 | ICU Medical, Inc. | Pressure-regulating vial adaptors |
US9707335B2 (en) | 2011-09-02 | 2017-07-18 | Unitract Syringe Pty Ltd | Drive mechanism for drug delivery pumps with integrated status indication |
CN106955394B (zh) | 2011-09-02 | 2020-02-04 | 尤尼特拉克特注射器控股有限公司 | 用于具有积体式状态指示的药品输送帮浦的驱动机构 |
JP6130377B2 (ja) | 2011-09-02 | 2017-05-17 | ユニトラクト シリンジ プロプライエタリイ リミテッドUnitract Syringe Pty Ltd | 薬剤送達ポンプ用の挿入機構 |
US9814832B2 (en) | 2011-09-02 | 2017-11-14 | Unl Holdings Llc | Drive mechanism for drug delivery pumps with integrated status indication |
US11173244B2 (en) | 2011-09-02 | 2021-11-16 | Unl Holdings Llc | Drive mechanism for drug delivery pumps with integrated status indication |
BR112014005482A2 (pt) | 2011-09-13 | 2017-04-04 | Unitract Syringe Pty Ltd | conexão de via de passagem de fluido estéril a recipientes de fármacos para bombas de administração de fármaco |
WO2013142618A1 (en) | 2012-03-22 | 2013-09-26 | Icu Medical, Inc. | Pressure-regulating vial adaptors |
US9579258B2 (en) | 2012-04-02 | 2017-02-28 | Kobayashi & Co., Ltd. | Drug delivery device |
US9566215B2 (en) | 2012-04-02 | 2017-02-14 | Kobayashi & Co., Ltd. | Drug delivery device |
US10251996B2 (en) | 2012-08-29 | 2019-04-09 | Unl Holdings Llc | Variable rate controlled delivery drive mechanisms for drug delivery pumps |
CA2899000C (en) * | 2013-01-23 | 2022-07-12 | Icu Medical, Inc. | Pressure-regulating vial adaptors |
US9089475B2 (en) | 2013-01-23 | 2015-07-28 | Icu Medical, Inc. | Pressure-regulating vial adaptors |
US9802030B2 (en) | 2013-01-25 | 2017-10-31 | Unl Holdings Llc | Integrated sliding seal fluid pathway connection and drug containers for drug delivery pumps |
USD723157S1 (en) | 2013-03-12 | 2015-02-24 | Unitract Syringe Pty Ltd | Drug delivery pump |
CA2918381C (en) | 2013-07-19 | 2023-01-17 | Icu Medical, Inc. | Pressure-regulating fluid transfer systems and methods |
AU2015277135B2 (en) | 2014-06-20 | 2020-02-20 | Icu Medical, Inc. | Pressure-regulating vial adaptors |
CA2962643A1 (en) | 2014-09-29 | 2016-04-07 | Unitract Syringe Pty Ltd | Rigid needle insertion mechanism for a drug delivery pump |
EP3274020B1 (en) * | 2015-03-26 | 2021-03-24 | Enable Injections, Inc. | Pressurized gas powered medicament transfer and re-suspension apparatus and method |
WO2017132588A1 (en) | 2016-01-29 | 2017-08-03 | Icu Medical, Inc. | Pressure-regulating vial adaptors |
WO2018029520A1 (en) | 2016-08-08 | 2018-02-15 | Unitract Syringe Pty Ltd | Drug delivery device and method for connecting a fluid flowpath |
EP3518860A4 (en) | 2016-09-30 | 2020-06-10 | ICU Medical, Inc. | DEVICES AND METHODS FOR ACCESSING PRESSURE REGULATING VIALS |
US11224555B2 (en) | 2018-04-23 | 2022-01-18 | Hospira, Inc. | Access and vapor containment system for a drug vial and method of making and using same |
EP4051207B1 (en) * | 2019-10-31 | 2024-07-10 | Nacatur International Import Export S.r.l. | Safety assembly for the reconstitution, the taking and the infusion of pharmacological liquids |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS5841966Y2 (ja) * | 1979-04-27 | 1983-09-22 | 株式会社 ミドリ十字 | 医療用移注用具 |
SE434700B (sv) * | 1983-05-20 | 1984-08-13 | Bengt Gustavsson | Anordning for lufttet overforing av substans fran ett kerl till ett annat |
JPH0829793B2 (ja) * | 1987-11-07 | 1996-03-27 | 大阪エヤゾール工業株式会社 | 押出し容器 |
US5017186A (en) | 1989-07-11 | 1991-05-21 | Arnold Victor A | Device and method for maintaining sterility of multi-dose medicament vials |
SE513225C2 (sv) | 1998-12-03 | 2000-08-07 | Carmel Pharma Ab | Arrangemang, förfarande och gasbehållare för steril eller aseptisk hantering |
SE517084C2 (sv) | 2000-08-10 | 2002-04-09 | Carmel Pharma Ab | Förfarande och anordningar vid aseptisk beredning |
JP2002238979A (ja) * | 2001-02-16 | 2002-08-27 | Jms Co Ltd | 両頭針 |
US6715520B2 (en) * | 2001-10-11 | 2004-04-06 | Carmel Pharma Ab | Method and assembly for fluid transfer |
AU2006348410B2 (en) * | 2005-11-07 | 2011-12-15 | Industrie Borla S.P.A. | Vented safe handling vial adapter |
JP5317957B2 (ja) * | 2006-04-12 | 2013-10-16 | アイシーユー・メディカル・インコーポレーテッド | ビンアダプターおよび圧力を調整するためのビン |
-
2007
- 2007-06-13 WO PCT/SE2007/050416 patent/WO2008153460A1/en active Application Filing
- 2007-06-13 EP EP17170133.7A patent/EP3222265B1/en active Active
- 2007-06-13 EP EP07748576.1A patent/EP2155143B1/en active Active
- 2007-06-13 ES ES14175968.8T patent/ES2600952T3/es active Active
- 2007-06-13 ES ES15198205.5T patent/ES2627304T3/es active Active
- 2007-06-13 JP JP2010512112A patent/JP5091313B2/ja active Active
- 2007-06-13 CA CA2707342A patent/CA2707342C/en active Active
- 2007-06-13 EP EP15198205.5A patent/EP3009121B1/en active Active
- 2007-06-13 CA CA2924477A patent/CA2924477C/en active Active
- 2007-06-13 EP EP14175968.8A patent/EP2789329B1/en active Active
- 2007-06-13 ES ES17170133T patent/ES2772838T3/es active Active
- 2007-06-13 ES ES07748576.1T patent/ES2550675T3/es active Active
Also Published As
Publication number | Publication date |
---|---|
WO2008153460A1 (en) | 2008-12-18 |
ES2627304T3 (es) | 2017-07-27 |
EP3009121B1 (en) | 2017-05-10 |
EP2155143A1 (en) | 2010-02-24 |
JP5091313B2 (ja) | 2012-12-05 |
CA2707342C (en) | 2016-06-07 |
CA2924477A1 (en) | 2008-12-18 |
ES2550675T3 (es) | 2015-11-11 |
JP2010528810A (ja) | 2010-08-26 |
EP2155143B1 (en) | 2015-08-19 |
EP3222265B1 (en) | 2020-01-08 |
EP2789329A1 (en) | 2014-10-15 |
ES2600952T3 (es) | 2017-02-13 |
EP3222265A1 (en) | 2017-09-27 |
ES2772838T3 (es) | 2020-07-08 |
EP3009121A1 (en) | 2016-04-20 |
CA2924477C (en) | 2019-05-14 |
EP2155143A4 (en) | 2013-08-14 |
CA2707342A1 (en) | 2008-12-18 |
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