EP2592005A1 - System zur Überführung gefährlicher Flüssigkeiten in Fläschchen - Google Patents

System zur Überführung gefährlicher Flüssigkeiten in Fläschchen Download PDF

Info

Publication number
EP2592005A1
EP2592005A1 EP11189064.6A EP11189064A EP2592005A1 EP 2592005 A1 EP2592005 A1 EP 2592005A1 EP 11189064 A EP11189064 A EP 11189064A EP 2592005 A1 EP2592005 A1 EP 2592005A1
Authority
EP
European Patent Office
Prior art keywords
container
septum
needles
delivery
container holder
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.)
Withdrawn
Application number
EP11189064.6A
Other languages
English (en)
French (fr)
Inventor
Mathias Nobst
Thomas Nauser
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.)
Eidgenoessische Technische Hochschule Zurich ETHZ
Original Assignee
Eidgenoessische Technische Hochschule Zurich ETHZ
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 Eidgenoessische Technische Hochschule Zurich ETHZ filed Critical Eidgenoessische Technische Hochschule Zurich ETHZ
Priority to EP11189064.6A priority Critical patent/EP2592005A1/de
Priority to PCT/EP2012/004722 priority patent/WO2013072042A1/en
Publication of EP2592005A1 publication Critical patent/EP2592005A1/de
Withdrawn legal-status Critical Current

Links

Images

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
    • 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
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/10—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
    • B65B3/12—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
    • 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
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B65B39/12—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers movable towards or away from container or wrapper during filling or depositing
    • 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
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B65B2039/009—Multiple outlets
    • 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
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/04—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
    • B65B31/08—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzle being adapted to pierce the container or wrapper

Definitions

  • the present invention relates to an apparatus for dispensing a hazardous fluid into a container, especially a vial closed with a septum, with the features of the preamble of claim 1. Furthermore a method for dispensing such hazardous fluids is disclosed as well as a delivering system comprising said apparatus.
  • the prior art comprises a number of solutions to dispense a fluid, especially a biohazardous or radioactive fluid into a container.
  • the dispensing operation is usually conducted within a protected enclosure, usually made of concrete or of lead in a steel frame as usual in radiopharmacy, having shielded windows and manipulators operated by remote control, used to handle these hazardous especially biologically dangerous or radioactive materials.
  • a protected enclosure is named hot cell, especially within the technologies of dispensing radioactive materials but will be used within this specification in the same way for handling bio-hazards.
  • US 2010/218846 provides a method and apparatus for a contamination-free transfer of a hazardous liquid from one container to another.
  • the aim of this teaching is to avoid any leakage of the liquid or air contaminated by the liquid or vapors of the liquid to the surrounding volume wherein the needles are located within a housing, crossing a first septum and being adapted to pierce a second septum, provided in a predefined distance from the first septum of the device.
  • said second septum is in contact with a third septum being part of a vial adaptor, which is attached to the vial which has to receive the hazardous fluid.
  • TW 440 879B discloses a liquid target transfer apparatus for the production of radioactive isotopes in the vicinity of a cyclotron.
  • the apparatus is adapted to deliver a high accurate volume of liquid to a so-called hot cell.
  • the system provides an overflow which contaminates the hot cell.
  • KR 100 677 664B provides an automatic injection device for a medical supply solution which is poured into a capsule.
  • the system comprises a hot cell and a mechanism to move the capsule or capsule parts with a specific discharge unit.
  • EP 1 860 665 Al discloses a double needle element for dispensing radioactive fluids, comprising a supporting body through which a pair of needles is fixedly accommodated and reaches into a connection cavity.
  • US 4,659,925 provides a high pressure radioisotope injection system. This material is provided within a vial in a shipping container. The vial is pierced by two needles as fluid carrying lines and the radioactive material is then transferred via one needle to a previously evacuated pressure flask. The needles are surrounded by a cylindrical extension which ensures, that the needles will be correctly oriented and effectively pierce the septum of the vial.
  • the lower protection block is connected to a support which houses the needles.
  • the present invention has the object to standardize radionuclide delivery, minimize the footprint, decrease the time for delivery, and improve radiation safety by developing an automated system, especially a delivery system, which uses standard lead or tungsten containers for radioactive materials. It is then a further advantage that these standard containers can directly be used for shipping.
  • An apparatus for dispensing a hazardous fluid into a container, especially a vial closed with a container septum comprises a body within which at least two hollow needles are positioned above a delivery septum. It further comprises a container holder adapted to receive a container within an inner space. During and for delivery of such a fluid into the container the distal portions of the needles, i.e. the tips and the adjacent shaft portion of the needles, are adapted to be advanced across the delivery septum and across the container septum of a container positioned in the container holder.
  • the container holder comprises a closure surface and the body comprises a complementary closure surface, which can be moved into sealing contact.
  • the apparatus comprises a driving means, which can be a motor or a hand driven displacement unit, adapted to provide a relative movement of the container holder against the body until the closure surfaces meet turning the inner space holding the container into a sealed space.
  • a second additional relative movement of the needles against the container holder allows the distal portions of the needles to first cross the delivery septum and subsequently cross the container septum only after the creation of the sealed inner space by the first movement.
  • This relative movement can be combined through providing the closure surface of the body by a piston adapted to be displaced by the complementary closure surface of the container holder against a conservative counter force.
  • a force can especially be the force of a spring provided in the body pretensioning the piston.
  • the container holder and a piston as a complementary closure surface of the body are caused to approach by a driving means until said closure surfaces contact, turning the inner space of the container into a sealed space.
  • a further relative movement of two needles against the container holder allows the distal portions of the needles to first cross the delivery septum and subsequently cross the container septum, both only after the creation of the sealed inner space. This effectively reduces the volume of the hot cell and allows for decontamination and evacuation of this space through a third conduit after a suitable check.
  • the needles are fixedly positioned inside body above the delivery septum in the non-filling position of the piston. if the container holder is moved upwards against the body the delivery septum and the container septum of a container are pierced by at least two needles.
  • the driving means and the driving unit providing the two relative movements are combined into one single drive by a counterforce by a spring that presses the piston on the container holder thereby effectively controlling the relative movement of the fixed needles in versus the delivery septum.
  • the system according to the invention has the advantage that it is designed as a self-contained unit constructed from a minimum number of components.
  • there are four parts including a rigid support, two actuators for a precise control over horizontal and vertical movement, preferably having a precision higher than 0.05 millimeter, a shielding container, usually lead or tungsten, in the case of delivery of radioactive fluids, and a delivery system according to an embodiment of the invention.
  • the entire unit of a first embodiment has 1000 millimeter in length, 400 millimeter width and approximately 600 millimeter high.
  • the delivery system according to this embodiment can accommodate standard 3 - 10 milliliter penicillin vials but can be easily customized to hold all common vials and sizes of lead/tungsten containers.
  • the unit operates on a 110/230 V AC power socket. To keep the costs low this unit uses standard industrial materials. It is clear that the room requirements, especially in length and width can even be significantly reduced, e.g. by 50 percent each, thus allowing for a small sized secure environment which can be easily maintained, dismounted and cleaned.
  • the automated process using the system according to the embodiment reduced the time required between end of bombardment of the material and a shipment ready product to less than 5 minutes by combination of previously separate steps of delivery and contamination testing into one. Decontamination was also automated and, as the unit requires no user intervention, radiation exposure was reduced. The footprint of the whole unit is 10 times smaller than a conventional hot-cell as a comparative example.
  • the commercial shielding container and the delivery system form a liquid/gas tight entity. It is easy to check this volume for contaminations and, if necessary, also easy to decontaminate.
  • the volume of the delivery system was minimized and is dependent mainly on the size of the vial containers. Compared to a standard research hot cell the size of the delivery system, including shielding and wiring, was reduced by a factor of ten. Due to the easy construction and the abdication of not necessary electronics the control cabinet was reduced from more then 300 clamps to less then 50.
  • Key benefits of the system are: 10 times smaller than an average hot cell; 5 times less electrical clamps; faster delivery of isotopes; less radiation exposure for user; lower production cost; small number of and easily exchangeable commercial parts leading to low maintenance cost, both with respect to labor cost and consumables cost; portable system due to its size; and finally easily adaption to a custom production site.
  • the shielding container and the delivery system form a liquid/gas tight entity. It is easy to check this volume for contaminations and if it is necessary also easy to decontaminate.
  • the body closure surface comprises a downward extension that houses the delivery septum, the free inner volume space of the hot cell can be further reduced, it creates a better seal during displacement of the container holder inside the inner wall of the body and the needles are protected more easily behind the delivery septum.
  • a septum in the context of the present technology is a dividing membrane between two cavities in a mechanical device, intended to be pierced by hollow needles to deliver fluids from one side of the cavity into the other, here a vial or container. After the advancing of the needles to effect the delivery and the following retracting movement of the needles the septum is and remains fluid tight and essentially gas tight.
  • Fig. 1 shows a schematical perspective general view on the central injection unit 10 from below, having in the embodiment of Fig. 1 a circular cylindrical hollow main body 11.
  • Fig. 1 shows the central injection unit 10 during delivery, i.e. in a situation when the lower part of the unit 10 is always sealed by the container holder 40 of Fig. 2 .
  • Said body 11 is closed by a lower ring cover 12 and an upper cover 13.
  • the embodiment according to Fig. 1 comprises a number of circumferentially arranged screws 14 to close the two covers 12 and 13 on the respective free end of the hollow cylinder body 11.
  • the lower cover 12 provides a ring formed rim providing an inner wall 15.
  • Said inner wall 15 surrounds a free space, into which the upper portion of the protective container holder 40 according to Fig. 2 can be introduced.
  • the body 11 needs not to be cylindrical and can be block-shaped or having a different form. It is important that there is a lower surface 16 as explained below which is provided as an upper closure of the space surrounded by the inner wall 15.
  • the horizontal surface 16 is built as a disc with a frustoconical elevation 17.
  • an injection cap closure 20 is located which has a lower closing surface 21 comprising of a delivery septum.
  • Septum 21 can be of any flexible material allowing to be pierced by hollow needles 22, 23 and 24 allowing for a fluid-tight and gas-tight surface, when the needles 22, 23 and 24 are retracted behind delivery septum 21.
  • Needles 22, 23 and 24 are especially needles suitable to deliver small amounts of a fluid and may have any convenient diameter given by a specific application, here usually 0,8 millimeter outer diameter. If in delivery position, the three needles are not positioned at the same length below the septum. As will be show below in connection with the further drawings needles 22 and 24 both have essentially the same lower end position in the delivery mode, whereas needle 23 is shorter or is not provided at all.
  • the needles 22, 23 and 24 are oriented parallel one to another and along the main longitudinal axis of the cylinder body 10, in other words perpendicular to the lower surfaces 12, 16 and septum 21.
  • the three needles 22, 23 and 24 are positioned according to Fig. 1 . Else they are retracted behind and above the septum 21.
  • the injection closure cap 20 may comprise of a crimp cover comprising an inner septum 21 or of a septum holder with thread to be screwed on a complementary thread on the lower surface of the frustoconical elevation 17.
  • Septum 21 is shown as lowest surface; usually it is provided as a membrane positioned and held below a rim against a complementary rim surface. Once the needle tips are retracted behind the septum 21, it provides a gas- and liquid-tight interface between a potentially contaminated area and the environment. The main benefit of a septum 21 is therefore shielding the environment from contamination stemming from the needles and is therefore an integral safety component of the system.
  • Fig. 2 shows a view, partially as a cross-section, of the lower part of the injection unit 10 with its piston 60 providing the lower surface 16 and the frustoconical extension 17 which extends into a container holder 40.
  • Same reference numerals are used throughout all drawings to represent the same or similar features.
  • Container holder 40 is preferably a tungsten or lead body if a radioactive fluid is to be delivered. Said cylindrical body has a lower standing surface 41 which surface will be used as interface surface for any delivery and/or dispensing unit of the device.
  • the container throughout the following description mentioned as vial 30, is initially positioned inside the container holder 40 in a charging position safely apart from the injection unit 10. Then a drive unit connected below the surface 41 moves the container holder 40 carrying the empty vial 30 to the position shown in Fig. 2 , i.e. below the injection unit 10. Then the container holder 40 is moved up to the cylindrical injection unit 10 to fill the vial 30.
  • a protective cover shields the operator from radiation from vial 30 in the container holder 40 during all movements before the shielding lid of the container holder is closed and secured.
  • the injection unit 10 may move and the container holder 40 may be fixed. In most applications, however, it is preferred to separate the charging and discharging station from the filling point for safety reasons.
  • a drive (not shown in the drawings) which pushes the container holder 40 vertically into position in the injection unit 10.
  • a horizontal drive that positions container holder 40 and/or the vial 30 exactly below injection unit 10 and moves it from there back to the (dis)charge position after the filling process is over.
  • the container holder 40 comprises an inner wall 42 e.g. defining a cylindrical wall, allowing to create an inner cylindrical space 100 within which the vial 30 can be positioned and transported.
  • an inner wall 42 e.g. defining a cylindrical wall, allowing to create an inner cylindrical space 100 within which the vial 30 can be positioned and transported.
  • the free room between the outer wall of the vial and the inner wall 42 of the container holder 40 is rather small in volume and the vial 30 stands on the lower surface 43 of this room 100.
  • Said surface can be simply flat or can have indentations to fix the vial 30 at a preferred position.
  • a typical vial 30 is shown having a neck portion 31 and a crimp cover 32.
  • Said crimp cover comprises a vial septum 33.
  • Fig. 2 and 3 show a similar crimp cover 20 on the cone 17.
  • Crimp cover 20 can be attached on the corresponding neck 25 in analogy to cover 32 on neck 31.
  • a threaded cover or any suitable holder may be used to fix septum 21 and/or 33 to its place.
  • FIG. 3 shows a detail of Fig. 2 according to the larger circle in Fig. 2.
  • Fig. 4 shows a further detail of Fig. 2 according to the smaller circle.
  • Figs. 2 to 4 show that space 100 is defined through the cavity created between the frustoconical elevation 17 and the opening space inside container holder 40.
  • a seal On the upper end of the container holder 40, i.e. the upper rim 44 there is a seal, here provided by a circular O-ring visualized in Fig. 4 by space 45 which is intended to accommodate a seal ring.
  • said upper surface 44 of container holder 40 In the filling position as shown in Fig. 2 said upper surface 44 of container holder 40 is in direct and sealing contact with the lower surface 16 of piston 60.
  • Vial septum 33 of vial 30 in the container holder is positioned in a predefined delivery distance from the delivery septum 21.
  • the container holder 40 is pushed upwards by a drive preferredly pushing on its upper surface 44 against the surface 16 of the movable 60 which is pushed back against surface 44 by a passive counter force provided by a spring positioned behind the piston 60, thus ensuring a tight seal. More constructional details will be explained below with Fig. 7 and 8 .
  • a hydraulic or another active counter force might be used.
  • a passive counter force element by a spring improves the safety of the device, as will be seen in connection with the preferred mode of operation of the device according to the invention.
  • needles 22 and 24 are extending far enough through the septum 21 of the injection device 10 to pierce also septum 33 of the vial 30 to enter the inner volume 34 of the vial. Therefore, if there is any pressure buildup in a conduit leading to needle 22 then any volume which passes through needle 22 will fill the vial 30 while this liquid will replace the corresponding volume of previous material, usually gas, inside the volume 34 whereas said gas in the vial 30 will be pressure relieved through the second needle 24.
  • the conduit attached to the proximal end of needle 24 may be connected to a vacuum pump and any sort of safety equipment - container, disinfection equipment or appropriate filter - to prevent a contamination of the environment by the exhaust of the vial.
  • the vial may be flushed by any suitable gas to decontaminate the exhaust line from radioactive gas. Again, the exhaust may be trapped/decontaminated by said methods.
  • the third needle 23 is positioned with its lower end 26 in space 100. Septa 21 and 33 are not in contact and said lower end 26 is positioned between the two septa. It penetrates delivery septum 21 but is too short to contact vial septum 33.
  • needle connector 122 of needle 22 communicates via vial space 34 with the needle connector 124 of needle 24.
  • aliquots of liquid are usually relocated through capillaries by pressurized gas.
  • Injection unit 10 and vial 30 therefore need to be protected by a pressure release line.
  • Upper end of needle 23 is in direct unilateral contact with space 100. This contact may be used to evacuate/flush said space or alternatively to apply chemical treatment for decontamination (in case of biohazard load).
  • Fig. 5 shows the position of the needles 22, 23 and 24 within the injector unit in the moving situation.
  • the container holder 40 is still in the same position relative to the septum 21 and piston 60 as in the fill position ( Fig.4 ).
  • the only difference is that needles 22, 23 and 24 are retracted and are guided within hollow steel tubes 222, 223 and 224, respectively.
  • Steel tubes 222, 223 and 224 are used as needle guides.
  • the tubes 222, 223 and 224 as shown in Fig. 9 are fixed in wall 51 and also ensure correct alignment of piston 60.
  • the bores in piston 60 are large enough to allow the needle guides to slide easily within.
  • the pistion 60, conical extension 17 plus neck 25 are thick enough for the guides to stay within the bores during all movements of the pistion without touching or penetrating septum 21.
  • the distance between the piston 60 and the lower container holder 40 is well defined by the contact of the closure surfaces. This allows for a predefined distance between delivery septum 21 and vial septum 33.
  • Fig. 5 shows piston 60 as part of the injection unit 10.
  • Said piston 60 comprises two circumferential grooves 61 intended to receive O-rings, i.e. sealing rings, to provide an airtight sealed inner space 100. These sealing rings and the intermediate bearing sealing surface are positioned against the inner wall 15 of the injection unit 10.
  • Fig. 6 shows a detail view of Fig. 5 .
  • Delivery septum 21 and vial septum are in a predefined distance. This allows positioning of needle 23 in the space 100 during the filling and check position, so that the content of space 100 can be checked through this material connection with a suitable detector.
  • the third needle can be omitted and a direct checking valve can be provided in piston 60, i.e. allowing a connection between surface 16 and space 100 to check the content for contamination. Then, instead of checking and cleaning space 100 through needle 23, this would be conducted through volume 51 behind piston 60 or by a separate connection to an appropriate tubing.
  • the relative position of needles 22, 24 and 23 may be different than shown in the Figures.
  • a separate driving unit (as will be shown below in the present case a spring in room 71/72) for needles 22 and 24 and a separate motorized drive to move needle 23 behind delivery septum 21 may be installed.
  • Fig. 7 shows the injection unit 10 of Fig. 1 in a partial cross-section view in a non-filling position.
  • Fig. 8 shows the injection unit 10 of Fig. 1 in the same partial cross-section view but in a filling position.
  • Fig. 7 shows the upper closure 13, being a cover plate screwed to the wall of body 11.
  • a seal for example a silicon flat gasket 59, provides for a sealing element against the environment.
  • Within the body 11 is provided a horizontal supporting wall 51.
  • piston 60 is provided inside hollow space 51.
  • Piston 60 preferably comprises two circumferential grooves 61 to accommodate sealing rings.
  • the lower plate 12 secures the piston 60 against the force of the compression spring as explained in the following paragraphs.
  • cover plate 13 and cover ring 12 are fixed by easily accessible screws: a) Top side, cover plate 13: Inside, the geometry/length of virtually any commercially available needle 22, 23 and 24 can be adjusted easily to any commercially available vial 30, for example: standard luer needles are pushed into the needle guide. The needle can then be fixed in position at correct penetration depth by a simple screw (not visible in the figures). This technical detail helps to be independent of specific suppliers and ensure flexibility for future requirements (i.e. specific vials, specific needle materials) as all components that are in direct contact with the liquid to be dispensed can be easily and cheaply replaced. b) Bottom side: The piston seals 61 will have to be replaced from time to time and ring 12 then can to be removed by a simple mechanical action.
  • the inner supporting wall 51 separates the inside volume 52 of the body 11 into two parts which have received the same reference numeral 52 since they are connected through a bore 53 within the supporting wall 51.
  • Piston 60 is adapted to move perpendicular to supporting wall 51. Piston 60 comprises the lower surface 16 as well as the central frustoconical extension 17.
  • the lower inside space 52 between the supporting wall 51 and piston 60 houses a compression spring (not shown in the drawings), extending directly or indirectly against piston 60 from above.
  • room 72 in Fig.7 provides the space for the semi relaxed compression spring inside and room 71 in Fig. 8 provides for the space of the compressed spring.
  • an extension spring or any other means providing a storage of potential energy preferably a conservative storage means, which has no active drives.
  • a simple energy storage means can comprise a hydraulic connection of the piston with a fluid reservoir lifting subsequently a sequence of weights.
  • Fig. 9 shows a perspective view into the central injection unit like Fig. 1 from below, but with piston 60 removed.
  • the drawing provides a clear view onto the intermediate wall 51.
  • Lower rim 54 of the body 11 is not covered by lower rim cover 12. Therefore, threaded bores 114 are visible, receiving screws 14 as shown above.
  • screws 14 it is possible to replace in the various embodiments screws 14 by rivets, or lower rim cover 12 can be clamped on surface 54. It is an advantage to be able to retrieve piston 60 to replace sealing rings and to access the spring room above it.
  • guiding tubes 222, 223 and 224 are fixed. Tubes 222, 223 and 224 receive the needles 22, 23 and 24 extending beyond the tubes as shown in Fig. 9 .
  • Two mounting holes 55 are shown, usually provided to attach tubes 222, 223 and 224 within respective bores for these tubes in wall 51. It is noted that the stiff and rigid steel tubes 222, 223 and 224, oriented parallel one to another and oriented perpendicular to wall 51 and piston 60 provide an additional guiding surface for piston 60, since the free ends of the tubes are preferably mounted in corresponding guiding holes in piston 60 with the proviso that the free needle tips can extend below the frustoconical extension 17 to cross septum 21.
  • Fig. 10 shows a flow chart of the general process executed for charging a vial with an embodiment of the invention according to Fig. 1 to 9 ; and Fig. 11 shows a flowchart for the movement interlock handling. They are used to explain the method of use of a system having an apparatus according to the invention.
  • the initial position shows the container holder 40 in a loading station, where it receives - in a loading step 200 - the empty vial 30.
  • regulatory bodies usually require the container holder 40 to be covered by a shielding lid, closing the space 100 towards the upper space and protecting personnel.
  • a drive moves the container holder towards the fill position in a charging step 210 after pressing a fill position button. During this displacement the optional shielding lid is removed and intermittently stored. Pushing the unload button allows to revert the movement towards the starting position.
  • the vacuum check step is conducted.
  • the needle 23 is attached to a vacuum pump and the applied suction empties the space 100 of the gas it contains. Since the volume 34 of vial 30 is not connected, only the space 100 is emptied during vacuum check step 220. There are two possible results: Either the intended vacuum level is reached, and then the container holder space 100 is sealed air-tight against the environment. Or the closing is not perfect. If not then an error signal is issued and an error mode 230 is entered and all container movements are locked. It is then possible to retract the container holder 40 following specific emergency rules. If the vial would be broken at that stage, then there would be a connection with the vial space 34 and thus via the needles 22 and 24 until relevant valves.
  • Radioactive traces could be detected by a contamination meter or the (unusual) decreasing of the vacuum at needle 23 or the increasing (unusual) vacuum in the branches of needles 22 and 24 could be detected by a separate pressure gauge. Needle 23 can also be used as disinfection needle and introduce a disinfectant into space 100.
  • the building safety check step 240 is executed.
  • This building safety comprises the decision, if the delivery can be requested. This includes for example, that room ventilation is ok, that exhaust filters (if needed) are present, that authorization for the use of the dispensing unit has been given, that waste containers are ready if radioactive gases have to be pumped off, or any other process the customer or regulatory bodies acknowledge appropriate to ensure safe and proper use.
  • the "ok" interlock-signal by building safety is usually given by a potential free contact.
  • box 250 is ready and an interlock (best engineered as a potential free contact, i.e. a relay) is asserted to signal to the sending machine "ready for delivery".
  • the sending apparatus is provided with an additional interlock input (potential free contact) which blocks the moving unit and therefore locks the container safely in its position until the sending apparatus unlocks the moving unit again after the delivery process is over. This prevents any putative handling or hardware error to result in a hazardous situation.
  • Step 250 comprises the delivery action, i.e. actuating the sending apparatus, e.g. a cyclotron, for deliverance of the radioactive fluid. This fluid is brought through a conduit into the needle 22 and guided into the container.
  • Fluid measurements are made upstream of the apparatus or the displaced gas volume can be checked which leaves through needle 24. During this time the vacuum or under-pressure in space 100 through needle 23 is preferably maintained. Delivery usually happens through vial-fill and vent-valves being opened electronically bringing needles 22, 24 and vial space 34 into the circuit of the filling apparatus.
  • a delivery check step 260 is conducted. This comprises of checking the radioactivity through the evacuated gas through needle 23, which would identify a breaking of the vial 34 or any other leakage problem, e.g. of septum 33. If not, than the error mode 230 is asserted.
  • space 100 is evacuated via needle 23 to a very low pressure and the vacuum valve is then closed and pressure monitored by a pressure gauge. Any spilled liquid with an appreciable vapor pressure, a contamination hazard, would then evaporate and the pressure in the space would immediately rise and indicate contamination of space 100 by a liquid. If contamination of space 100 is found or assumed, the space can be thoroughly decontaminated by continuous evacuation.
  • the container holder 40 and the space 100 is flushed with air or an inert gas before the container holder 40 is lowered through activation of the corresponding drive.
  • Compression spring pushes back the piston 60 inside the cylinder 11 and starts to relax. Piston slides further downwards and presses the vial downwards of the needles 22 and 24. The piston 60 slides over the vial-fill- and vial-vent-needles 22 and 24 and the vacuum/decontamination needle 23 and brings them back behind the delivery septum 21.
  • the vial 30 falls back into the container holder 40 and the needles 22, 23, 24 or any additional needle for venting/disinfecting/decontamination, which may be provided as a fourth or fifth needle, will be sealed inside of the cylinder space from the container. At that point the seal between piston 60 and container holder 40 is still intact and space 100 isolated from the environment. Container holder 40 exits the lower rim 12 and only now the seal between piston 60 and container holder 40 is broken. Now piston 60 is sealing the needles and the inside of cylinder 11 against the environment, i.e. a seal in the other direction.
  • the body 10 comprises a lower outer rim wall 11, 15 extending beyond the body closure surface, provide by wall 16 and piston 60, wherein the corresponding container holder 40 has an outer circumference allowing entering the inner space of the body 10 created by the lower outer rim wall.
  • the container holder 40 is moved back to the loading, here unloading position in an unloading step.
  • An additional measurement of e.g. radioactivity of the vial 30 can be performed before replacing the intermittently stored cover and bringing the container holder back to the starting position.
  • Measurements of the system integrates the radioactivity and gives feedback to the user for values above a defined threshold, signaling a problem with the delivery, the cause for which could e.g. be a broken vial. If, for whatever reason, a contamination occurs, it is automatically removed by the system, e.g. through needle 23, blocking the respective delivery unit until the decontamination is complete. Even when a delivery fails, the system continues working normally after automatic decontamination. While manual delivery requires a test wiping at the end, this step is obviated by the automated monitoring as it yields information about residual activity in the system.
  • Fig. 11 shows the movement steps of the active drive for the single displacements as loading, unloading, filling or measurement, upon giving the order in an order step 300.
  • the electronic unit initially checks, if the container (holder) 40 is present at that place in a position check step 310. If not, there is no operation 330. If yes and if there is no other error pending 320 and the safety check 340 is positive, then the delivery check step is conducted. This relates to the fact that no displacement of the container holder in whatever direction has to be allowed during delivery. Therefore the answer on a movement order 300 during delivery is assertion of an error relay 360. Otherwise the movement 370 is executed.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP11189064.6A 2011-11-14 2011-11-14 System zur Überführung gefährlicher Flüssigkeiten in Fläschchen Withdrawn EP2592005A1 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP11189064.6A EP2592005A1 (de) 2011-11-14 2011-11-14 System zur Überführung gefährlicher Flüssigkeiten in Fläschchen
PCT/EP2012/004722 WO2013072042A1 (en) 2011-11-14 2012-11-14 Apparatus for dispensing a hazardous fluid into a container

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11189064.6A EP2592005A1 (de) 2011-11-14 2011-11-14 System zur Überführung gefährlicher Flüssigkeiten in Fläschchen

Publications (1)

Publication Number Publication Date
EP2592005A1 true EP2592005A1 (de) 2013-05-15

Family

ID=47191694

Family Applications (1)

Application Number Title Priority Date Filing Date
EP11189064.6A Withdrawn EP2592005A1 (de) 2011-11-14 2011-11-14 System zur Überführung gefährlicher Flüssigkeiten in Fläschchen

Country Status (2)

Country Link
EP (1) EP2592005A1 (de)
WO (1) WO2013072042A1 (de)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200115073A1 (en) * 2018-10-16 2020-04-16 Airgraft Inc. Methods and systems for filling a prepackaged container
US10721971B2 (en) 2018-09-18 2020-07-28 Airgraft Inc. Methods and systems for vaporizer security and traceability management
US11129410B2 (en) 2018-10-16 2021-09-28 Airgraft Inc. Variable-viscosity carrier vaporizers with enhanced thermal and hydrodynamic properties
US20230339631A1 (en) * 2022-04-21 2023-10-26 Curium Us Llc Systems and methods for producing a radioactive drug product using a dispensing unit
US12063981B2 (en) 2019-08-13 2024-08-20 Airgraft Inc. Methods and systems for heating carrier material using a vaporizer

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11186389B2 (en) 2018-06-14 2021-11-30 Curium Us Llc Evacuation/fill station for radioactive fluid container production

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3477192A (en) * 1967-03-02 1969-11-11 American Cyanamid Co Container filling process
US4659925A (en) 1984-03-15 1987-04-21 Atomic Energy Of Canada Limited High pressure well radioisotope injection system
US4939940A (en) * 1989-01-17 1990-07-10 General Electric Company Post-accident sample station needle seal
TW440879B (en) 1999-11-24 2001-06-16 Inst Of Nuclear Energy Res Roc A liquid transfer apparatus for radioisotope production
KR100677664B1 (ko) 2005-09-28 2007-02-02 이정희 캡슐에 주입되는 의약품용액의 자동주입장치
EP1860665A1 (de) 2006-05-23 2007-11-28 Comecer S.p.A. Doppelnadelelement zum Abgeben von radioaktiven Flüssigkeiten
US20100218846A1 (en) 2007-04-23 2010-09-02 Plastmed Ltd. Method and apparatus for contamination-free transfer of a hazardous drug

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3477192A (en) * 1967-03-02 1969-11-11 American Cyanamid Co Container filling process
US4659925A (en) 1984-03-15 1987-04-21 Atomic Energy Of Canada Limited High pressure well radioisotope injection system
US4939940A (en) * 1989-01-17 1990-07-10 General Electric Company Post-accident sample station needle seal
TW440879B (en) 1999-11-24 2001-06-16 Inst Of Nuclear Energy Res Roc A liquid transfer apparatus for radioisotope production
KR100677664B1 (ko) 2005-09-28 2007-02-02 이정희 캡슐에 주입되는 의약품용액의 자동주입장치
EP1860665A1 (de) 2006-05-23 2007-11-28 Comecer S.p.A. Doppelnadelelement zum Abgeben von radioaktiven Flüssigkeiten
US20100218846A1 (en) 2007-04-23 2010-09-02 Plastmed Ltd. Method and apparatus for contamination-free transfer of a hazardous drug

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10721971B2 (en) 2018-09-18 2020-07-28 Airgraft Inc. Methods and systems for vaporizer security and traceability management
US11406136B2 (en) 2018-09-18 2022-08-09 Airgraft Inc. Methods and systems for vaporizer security and traceability management
US12011047B2 (en) 2018-09-18 2024-06-18 Airgraft Inc. Methods and systems for vaporizer security and traceability management
US20200115073A1 (en) * 2018-10-16 2020-04-16 Airgraft Inc. Methods and systems for filling a prepackaged container
US10822123B2 (en) * 2018-10-16 2020-11-03 Airgraft Inc. Methods and systems for filling a prepackaged container
US11129410B2 (en) 2018-10-16 2021-09-28 Airgraft Inc. Variable-viscosity carrier vaporizers with enhanced thermal and hydrodynamic properties
US11390403B2 (en) 2018-10-16 2022-07-19 Airgraft Inc. Methods and systems for filling a prepackaged container
US12063981B2 (en) 2019-08-13 2024-08-20 Airgraft Inc. Methods and systems for heating carrier material using a vaporizer
US20230339631A1 (en) * 2022-04-21 2023-10-26 Curium Us Llc Systems and methods for producing a radioactive drug product using a dispensing unit
US11851221B2 (en) * 2022-04-21 2023-12-26 Curium Us Llc Systems and methods for producing a radioactive drug product using a dispensing unit

Also Published As

Publication number Publication date
WO2013072042A1 (en) 2013-05-23

Similar Documents

Publication Publication Date Title
EP2592005A1 (de) System zur Überführung gefährlicher Flüssigkeiten in Fläschchen
CN108291858B (zh) 取样器皿和取样系统以及相关的操作方法
JP5357751B2 (ja) 少なくとも１つの核燃料集合体をコンテナに装填するキャスク、捕捉手段及び装填方法
JP7420709B2 (ja) ポータブルクリーンルーム、ポータブルクリーンルームの製造方法及びポータブルクリーンルームの中の薬剤容器に充填するための方法
RU2619747C2 (ru) Игла с затвором и способ
US20050203329A1 (en) Dispensing and injection system for radiopharmaceuticals
US20080087353A1 (en) Apparatus and method for needle filling and laser resealing
US20120325365A1 (en) Automated syringe filler and loading apparatus
EP1945172A2 (de) Verfahren und system zur herstellung eines radiopharmazeutischen kits
CA2810290A1 (en) Method and system for delivering and metering liquid sterilant
JP6382716B2 (ja) 有害廃棄物を封止可能な容器内に移送するための充填デバイス、システム、および方法
CA2834872C (en) Filling container and method for storing hazardous waste material
KR20140110833A (ko) 제어된 환경 인클로저 내에 유체 경로를 보호 및 보호 해제하는 방법
US20210275709A1 (en) Arrangement for the Contamination-Free Introduction of a Sterile Object from a Container into a Containment and Method Therefor
US12077330B2 (en) Filling device for filling containers in a single-use isolator
JP6654647B2 (ja) 放射性トレーサを合成するための装置、該装置を含む設備、および該装置を用いて放射性トレーサを得る方法
JP3199440B2 (ja) 遮蔽区域内の流体のサンプリングを行う装置
CN114651170A (zh) 化学品取样装置
JP6443154B2 (ja) 液体サンプリング装置
JP2007159464A (ja) 液体採取装置
KR100216067B1 (ko) 밀폐 용기 속에 들어있는 유체를 밀착되어 있는 엔클로저 밖으로 옮기기 위한 공정 및 장치
CN216084343U (zh) 放射性废物的整备线
CN109689350B (zh) 核用热等静压机
CN113744911A (zh) 放射性废物的整备线及整备方法
JP6276779B2 (ja) 原子炉の中で生成される材料を採取および貯蔵するためのシステムおよび方法

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20131116