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WO2019096987A1 - Dispositif et procédé de prélèvement d'un échantillon à partir d'un récipient - Google Patents

Dispositif et procédé de prélèvement d'un échantillon à partir d'un récipient Download PDF

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Publication number
WO2019096987A1
WO2019096987A1 PCT/EP2018/081544 EP2018081544W WO2019096987A1 WO 2019096987 A1 WO2019096987 A1 WO 2019096987A1 EP 2018081544 W EP2018081544 W EP 2018081544W WO 2019096987 A1 WO2019096987 A1 WO 2019096987A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
hose
tube
section
piston
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/EP2018/081544
Other languages
German (de)
English (en)
Inventor
Christian Grimm
Jochen Scholz
Sebastian Ruhl
Thorsten Adams
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.)
Sartorius Stedim Biotech GmbH
Original Assignee
Sartorius Stedim Biotech 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 Sartorius Stedim Biotech GmbH filed Critical Sartorius Stedim Biotech GmbH
Publication of WO2019096987A1 publication Critical patent/WO2019096987A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/28—Constructional details, e.g. recesses, hinges disposable or single use
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
    • C12M37/04—Seals
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/18—Devices for withdrawing samples in the liquid or fluent state with provision for splitting samples into portions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N2001/1031—Sampling from special places
    • G01N2001/1037—Sampling from special places from an enclosure (hazardous waste, radioactive)

Definitions

  • the invention relates to a device for taking a sample from a container.
  • the invention further relates to a method for taking a sample from a container.
  • EP 1 637 584 B1 discloses a bag which serves as a culture reactor and which has a finger area with a plurality of finger-like indentations projecting upwards into the interior of the bag. For sampling, such an invagination can be slipped down on the outside of the finger area and separated with the sample contained therein.
  • the protuberance the bag facing the end of the protuberance
  • two spaced sealing areas With the lower sealing area, the interior of the protuberance, together with the sample therein, is sealed off from the area of the bottom, while with the upper sealing area, the remaining bag and its culture are likewise sealed off from the protuberance in a sterile manner. Thereafter, the left between the sealing areas intermediate area by cutting, shearing or welding off or separating from the finger region of the bag without thereby rendering the culture in the protuberance or the interior of the bag non-sterile with the remaining culture.
  • the object of the invention is to reduce the manual workload in the sampling from a container and the associated limitations.
  • a multiple aseptic sampling from a (flexible) disposable container should be made possible in a simple manner.
  • the device according to the invention for taking a sample from a container comprises a connecting piece, which is arranged on an opening of the container and fastened on a wall of the container, having a tubular portion which is in flow connection with the interior of the container and extends away from the container wall.
  • the apparatus further includes a separate tube having a first end sealed to the interior of the container and a closed second end guided to close the mouth of the container or tubular portion.
  • the hose is removable in a separating position.
  • the invention is based on the recognition that a multiple aseptic sampling from a container without processing or damage to the container by means of a multiple detachable tube is possible, which is preferably formed from a thin, tear-resistant thermoplastic material.
  • this tube section can be filled with medium from the container without detours - in particular without sterile filters, ie with cells present in the medium.
  • the withdrawn and filled tube section can then be separated. If at or after the Separating the newly formed second end of the tube is closed, can be removed in the same way further samples until the tube supply is used up.
  • the deduction to the separation position does not mean that it is pulled off in a certain direction. Rather, it should be understood that only a certain hose length (in any direction) is deducted, which can then be brought into a suitable position for separation from the rest of the hose.
  • the container and the neck of the device according to the invention are made of a sterilizable material, so that the container and the already attached to the container neck can be sterilized as a unit, for. B. by gamma rays.
  • the unit of container and nozzle can be sterilized either immediately before use or before packaging or - in the case of suitable packaging material - in the packaged state together with the packaging.
  • all components of the device according to the invention ie in particular also the tube, are made of a sterilizable material.
  • the entire device including tube can be attached to the container and sterilized together with the container.
  • the nozzle preferably has a flange. This can be stably fastened to the wall of the container, in particular by welding, thanks to its flat all-round support.
  • the first end of the hose is fixedly attached to the neck.
  • a section of the tube is arranged in a sealed receiving space, wherein the second end of the tube is guided out of the receiving space.
  • the tube reserve located in the receiving space does not come into contact with the medium in the container still with the external environment.
  • the guided out of the receiving space second end of the tube is only with its inside in contact with the medium, so that only this side must have been sterile before sampling, while the outside of the second end does not necessarily have to be kept sterile.
  • such a vote of the seal on the hose is advantageous in which the static friction resistance of the hose is so large that a force exerted by the static pressure of a medium in the container on the second end of the hose force is insufficient to withdraw the hose from the receiving space ,
  • the hose can therefore only be deducted by a correspondingly large force, if this is actually desired. Uncontrolled removal is excluded.
  • a sufficient holding force can be achieved for example by a seal with two sealing rings, between which the second end of the hose is clamped.
  • the receiving space is formed in a housing portion of the nozzle.
  • the housing portion extends into the interior of the container.
  • the housing section is arranged outside the container.
  • This variant has the advantage that the housing section does not influence the flow behavior of the medium in the container. This is particularly important for containers that are equipped with a stirrer.
  • the receiving space is not provided in a specially provided housing portion of the nozzle, but it is formed between the tubular portion of the nozzle and a sleeve surrounding the tubular portion.
  • a particular development of the device according to the invention provides a piston that can be displaced back and forth in the longitudinal direction of the tubular section which engages the second end of the hose.
  • the tube By means of the piston, the tube can be pushed from a parking position towards the interior of the container in a reservoir position.
  • a specific hose length is automatically subtracted, in which the sample to be taken is taken.
  • pushing in the second end of the hose, if necessary into the container ensures that no "stagnant" but actually representative medium is withdrawn.
  • an automated displacement device for controlled displacement of the piston wherein the displacement device preferably comprises an electronic control for the individual adjustment of a displacement distance.
  • the displacement device preferably comprises an electronic control for the individual adjustment of a displacement distance.
  • the piston for displacing the second end of the hose can, in addition to pulling off the hose and avoiding the removal of non-representative medium from a dead volume, take on another function.
  • the front of the piston provides a support surface for the second end of the hose ready.
  • the second end of the tube is exposed to the static pressure of the medium in the container. Thanks to the relief provided by the support surface, the hose material does not necessarily have to be as tear-resistant as the container wall.
  • the piston gripping means for holding the second end of the hose. Unintentional release of the second end of the hose from the piston is thus avoided.
  • the guidance of the piston is favored by a design in which the inner diameter of the tubular portion and the diameter of the space surrounded by the annular housing portion are substantially equal.
  • the piston can then be easily slid back and forth between the tubular portion and the clearance bounded by the annular housing portion.
  • the piston can also be used to move the second end of the hose away from the container to the separation position.
  • the withdrawn and filled with medium hose section is separated from the rest of the hose. This is preferably not done manually, but by a preferably automated separator.
  • the T renn is preferably designed so that when separating the withdrawn tube section both the separated tube section and the remaining tube section are automatically sealed at the separation point. This ensures, on the one hand with regard to aseptic sampling, that the container still has an intact sterile barrier. There is thus no risk that the entire contents of the container will be contaminated during the sampling.
  • the automatic closing ensures that the entire system (container and sampling device) is permanently closed and that no fluid can escape from the container or out of the tube.
  • This measure also has the advantage that no valuable fluid is lost from the container, and it also saves cleaning work and ensures the safety of personnel present, especially in the case of a toxic fluid.
  • the automatic closing can be achieved in particular by means of a suitable thermal welding device.
  • the separating device itself can, for example, have two clamping sections, between which a part of the withdrawn tube section can be clamped. Similar to the sausage production of the trapped part of the withdrawn tube section is severed while closed at the same time.
  • the device according to the invention can be supplemented by a downstream automated labeling device for labeling the separated tube section and / or an automated freezing device for freezing the separated and filled with medium tube section. The entire process from sampling to (intermediate) storage can thus be carried out largely without personnel.
  • the separated tube section with the sample can also be conveyed immediately after removal (possibly after labeling) by means of an automated feeding device to an analysis device in which the sample is preferably made accessible and analyzed in an at least partially automated process.
  • a filter element can be introduced between the interior of the flexible container and the hose. This achieves automatic filtering of the sample before it is removed.
  • Such filtering is z. B. useful if a cell-free sample to be examined. With a correspondingly small pore size, a purification during the sampling is possible (sterile filtration).
  • this comprises a system for the automatic provision of the hose.
  • the tube has at least one of the following functional elements: septum in the tube wall; Valve; Port; Identification information, in particular in the form of a QR code or in the memory of a hose-mounted RFID tag; printed electronics; temperature-sensitive field; self-healing material.
  • Several identical functional elements may be provided, in particular spaced apart in the longitudinal direction of the tube, as well as any combinations of different functional elements.
  • the invention also provides a method for taking a sample from a container, in particular from a disposable container, by means of a device according to the invention, the method comprising the following steps:
  • the hose is provided at the location of the device and placed around the connecting piece.
  • the hose is formed from a film web by folding and subsequent joining, in particular by welding, gluing or sealing.
  • the tube can also be formed by a 3D printer or by a pultrusion process.
  • FIG. 1 shows a first embodiment of the device according to the invention for taking a sample from a container in a side sectional view in a parking position
  • Figure 1 a is a detail view of Figure 1;
  • Figure 2 shows the device of Figure 1 in a reservoir position
  • Figure 2a is a detail view of Figure 2;
  • FIG. 3 shows the device from FIG. 1 in an alternative reservoir position
  • Figure 3a is a detail view of Figure 3;
  • Figure 4 shows the device of Figure 1 in a Abtrennposition
  • Figure 4a is a detail view of Figure 4.
  • FIG. 5 shows a second embodiment of the device according to the invention for taking a sample from a container in a side sectional view in a parking position
  • FIG. 5a is a detail view of Figure 5;
  • FIG. 6a shows a third embodiment of the device according to the invention for taking a sample from a container in a perspective view;
  • FIG. 6b shows a first lateral sectional view of the device from FIG. 6a without a piston
  • FIG. 6c shows a second lateral sectional view, rotated by 90 °, of the device from FIG. 6a without a piston;
  • FIG. 7 shows an embodiment of the device according to the invention with a filter element in a side sectional view
  • FIG. 8a is a perspective view of part of a system for producing the hose intended for sampling at the location of the device according to the invention
  • Figure 8b is a plan view of the part of the system of Figure 8a;
  • FIG. 8c shows a sectional view along the line AA from FIG. 8b; and FIG. 8d shows an enlargement of the detail X from FIG. 8c.
  • FIGS. 1 and 1 a show a first embodiment of a device 10 for taking a sample from a disposable container filled with a biotechnological fluid.
  • the device 10 comprises a connecting piece 12, which is arranged at an opening of a flexible disposable container 14 (bag) (shown only in FIG. 1).
  • the nozzle 12 is fixed by means of a flange 16 on the outside of the outer wall of the flexible container 14, for. B. by welding.
  • annular housing portion 18 extends into the interior of the flexible container 14. Based on the central axis of the annular housing portion 18 between an inner wall 20 and an outer wall 22 of the housing portion 18, a receiving space 24 is formed on the in the flexible container 14th protruding end face is closed by a bottom 26. On the opposite end of the receiving space 24 is limited by an outer sealing ring 28 and an inner sealing ring 30 which press against each other.
  • a recessed portion 34 of a flexible tube 32 is received.
  • the tube 32 is formed from a thin, tear-resistant thermoplastic material or other flexible and weldable material that meets the sterility requirements of biopharmaceutical processes.
  • the first end 36 of the tube 32 is welded to the housing portion 18 in the region of the bottom 26 or otherwise secured there.
  • the opposite second end 38 of the tube 32 is out between the two sealing rings 28, 30 out of the housing portion 18 in the direction of a tubular portion 40 of the nozzle 12 (see detail view in Figure 1 a).
  • the tube 32 is located mostly inside the flexible container 14, only the second tube end 38 guided out of the receiving space 24 comes into contact with the medium with which the flexible container 14 is filled, since the receiving space 24 in the housing section 18, which is here essentially formed by the inner wall 20, the outer wall 22 and the bottom 26, is sealed by the sealing rings 28, 30.
  • the tubular portion 40 extends from the outside of the flange 16 away from the flexible container 14.
  • a piston 42 is mounted, which is along the central axis (longitudinal extent) of the tubular portion 40 back and forth displaceable.
  • an automated displacement device can be provided with a drive.
  • the piston 42 can be moved by hand.
  • a gripping device 44 is provided at the flexible container 14 facing the front end of the piston 42. The gripping device 44 clamps the second end 38 of the hose 32 (see detail view in Figure 1 a) and can take this with a movement of the piston 42.
  • the front of the piston 42 also forms around the gripping device 44 a support surface 46 for the second hose end 38.
  • the device 10 is shown in the so-called park position, in which the front of the piston 42 is positioned approximately at the level of the flange 16 with respect to the central axis of the tubular portion 40.
  • the second end 38 of the tube 32 is firmly clamped in the gripping device 44.
  • the pinched portion and adjoining portion of the tube 32 close the opening of the medium filled flexible container 14. Since the second end 38 of the tube 32 is welded or otherwise closed and the two sealing rings 28,30 are applied to the intermediate portion of the tube Press, no medium from the flexible container 14 in the tubular portion 40 and in the receiving space 24 of the nozzle 12 penetrate.
  • the support surface 46 of the piston 42 relieves the second end 38 of the hose 32 of the static pressure that the medium exerts on the second end 38 of the hose 32.
  • the static friction resistance of the tube 32 clamped between the two sealing rings 28, 30 is so great that the static pressure of the medium in the flexible container 14 - even in the absence of the piston 42 - is insufficient to the second end 38 of the tube 32 in the tubular Press Section 40.
  • the piston 42 is first displaced into the so-called reservoir position shown in FIG. 2, so that "fresh” medium reaches the second tube end 38. It pulls the piston 42 a of the displacement distance corresponding length of the shirred in the receiving space 24 hose section 34 from. The tube 32 is withdrawn from the receiving space 24 against the resistance of the two sealing rings 28, 30, while the sealing effect is further ensured (see also the detail view in Figure 2a).
  • the front of the piston 42 is located approximately at the level of the bottom 26 of the housing portion 18. If a larger amount of sample is to be removed or even better mixing of the medium to take place before sampling, the piston 42 If required, they are displaced even further into the flexible container 14, ie beyond the bottom 26 of the housing section 18, as shown in FIGS. 3 and 3a.
  • the piston 42 After pushing the piston 42 into the reservoir position, the piston 42 is displaced in the opposite direction into a so-called separating position. This movement is carried out without much resistance and usually requires no drive, since the previously withdrawn tube section 48 is automatically pushed by the static pressure of the medium in the flexible container 14 through the tubular portion 40 through to the outside. As soon as the withdrawn tube section 48 is completely filled with medium, this section 48 does not move further outward, since the two sealing rings 28, 30 prevent further removal of the tube.
  • the withdrawn tube section 48 now projects clearly beyond the tubular section 40 to the outside and can be separated by means of a - preferably automated - separating device 50.
  • the separating device 50 is shown during the separation of the withdrawn tube section 48.
  • Two mutually movable clamping portions 52, 54 of the separator have compressed the withdrawn tube portion 48 just behind the tubular portion 40 of the nozzle 12.
  • the separator 50 may thermally (by welding) or otherwise (mechanically) separating the withdrawn tube portion 48 so that both the severed tube portion 48 with the sample removed and the tube portion remaining on the apparatus 10 are sealed.
  • the piston 42 After disconnecting the withdrawn tube section 48, the piston 42, more precisely its gripping device 44, can grip the newly formed second end 38 of the tube 32 and be displaced back into the parking position with it. In this way, multiple sampling can be performed until the gathered in the receiving space 24 shirred tube section 34 is consumed.
  • FIGS. 5 and 5a show a second embodiment of the device 10 for taking a sample from a disposable container.
  • the second embodiment differs from the first embodiment in that the housing portion 18 of the nozzle 12 does not extend inwardly into the flexible container 14 but outwardly from the flange 16. To the housing portion 18 then joins the tubular portion 40 of the nozzle 12.
  • the housing portion 18 with the shirred tube section 34 does not protrude into the flexible container 14 and thus does not constitute a flow obstacle.
  • the tube 32 is protected in the receiving space 24 both from the medium in the flexible container 14 and from external influences.
  • the position of the piston 42 shown in FIGS. 5 and 5a, with its front side positioned approximately at the level of the flange 16, corresponds here to the parking position. Starting from this parking position, the piston 42 against the resistance of the sealing rings 28, 30 can be moved inwardly into the interior of the flexible container 14 in the reservoir position and then through the housing portion 18 and the tubular portion 40 to the outside in the separation position in which the Separator 50 then separates the filled with medium withdrawn hose section 48.
  • FIG. 6a, 6b and 6c A third embodiment of the device 10 for taking a sample from a disposable container is shown in Figures 6a, 6b and 6c.
  • the receiving space 24 for the shirred tube portion 34 and the tubular portion 40 of the nozzle 12 are disposed outside of the flexible container 14.
  • the tubular portion 40 extends here over a greater length than in the previously described embodiments, although this is not absolutely necessary.
  • the cross section of the tubular portion 40 may change at its end facing away from the container 14, in particular in one plane expand (see Figure 6b) and constrict in a plane perpendicular thereto (see Figure 6c), although this also for the basic function is not mandatory.
  • Other variations are of course possible.
  • the tubular portion 40 simultaneously defines the receiving space 24 for the gathered tube portion 34.
  • the tube 32 is at its first end 36 in between the tubular portion 40 and the Sleeve 56 formed receiving space 24 attached and led out between the two sealing rings 28, 30 out of the receiving space 24, which in turn are arranged between the tubular portion 40 and the sleeve 56 at its end facing away from the flexible container 14.
  • the tube 32 in the receiving space 24 is protected by the tubular portion 40 and the sealing rings 28, 30 on the one hand from the medium in the flexible container 14 and on the other hand by the sleeve 56 and the sealing rings 28, 30 from external influences.
  • no displaceable piston 42 is provided, although this would be possible in principle.
  • the tube 32 is pulled by hand or by means of a gripping device 44 equal to the separation position.
  • a gripping device is to be understood here as meaning any automated transport device (such as, for example, a roller pair).
  • the withdrawn tube section 48 fills automatically with medium. In the separation position then the withdrawn tube section 48 can be separated automatically or manually.
  • a first separated first sample may be discarded and instead a second sample taken immediately thereafter may be used for the intended purpose (analysis) to remove a "stale" amount of Medium from the dead volume of the tubular portion 40 outside the actual wall of the flexible container 14 to avoid.
  • a filter element 58 may be incorporated in the flow connection between the interior of the flexible container 14 and the tube 32, as shown by way of example in Figure 7 for the second embodiment.
  • the filter element 58 is supported on the inside of the flexible container 14 facing side of the bottom 26 of the housing portion 18 and covers the entire opening of the flexible container 14, which opens into the nozzle 12.
  • the pore size and the other properties of the filter element 58 which may also be formed as a grid or the like, are matched to what is to be retained with the filter element 58. For example, it may be provided to retain cells and cell debris during the sampling in order to achieve a cell-free sampling.
  • the filter element 58 can also be designed for a very fine filtration, in particular a sterile filtration, which retains more than just particles and cells and allows a purification during the sampling.
  • the "separation" of the filled and withdrawn tube section 48 does not necessarily mean a physical separation of the tube section 48 from the remaining tube 32.
  • a number of sample compartments can be produced which are physically connected to one another via the closure regions (in particular welding seams) but are not in fluid communication with one another.
  • the intended for sampling hose 32 does not have to be pre-installed in the device 10, but can also be provided directly on site.
  • the provision of the tube 32 can be done by means of a suitable system. With the system, the hose 32 can be formed at the location of the device 10 from a film web by appropriate shaping and subsequent welding, gluing, sealing or the like, wherein it is automatically placed around the connecting piece 12.
  • FIG. 8a to 8d a part of such a system for providing the tube 32 is shown by way of example.
  • a previously folded film web 60 is withdrawn from a conveyor (not shown) and laid around a tube 62, one end of which merges into the tubular portion 40 of the nozzle 12 as the film web 60 is drawn towards that tube end.
  • the free longitudinal edges of the film 62 placed around the tube 62 are brought together and assembled by a welding device 64, so that the tube 32 is closed all around.
  • the tube 32 can be made by a 3D printer or by a pultrusion process (pultrusion) directly on site.
  • the tube 32 Before the transition to the tubular portion 40, the tube 32 passes through sealing elements 64, for example in the form of O-rings, and is thereby sealed from the interior of the container 14.
  • sealing elements 64 for example in the form of O-rings
  • An advantage of providing the hose 32 in the field is that no receiving space 24 is needed and consequently the length of the hose 32 is not limited by the size of the receiving space 24.
  • the device 10 is not limited to the specific embodiments described. In particular, individual features of the embodiments can be combined with each other in a meaningful way.
  • the device 10 may include further, the separator 50 downstream devices. These downstream devices may be supplied with a single tubing section 48 remote from the tubing or a series of multiple spaced compartments removed from the tubing. In principle, it is of course also possible to supply a severed hose section 48 or a series of samples without prior removal from the hose directly to a downstream device. Hereinafter, for the sake of simplicity, it is always assumed that a single severed hose section 48 has been used.
  • the medium-filled withdrawn tube section 48 can be replaced by an automated labeling device with a label in the form of a printed sticker, RFID tags or the like or directly by printing, laser marking or the like, to enable identification prior to storage, transportation and / or further processing (analysis).
  • a label in the form of a printed sticker, RFID tags or the like or directly by printing, laser marking or the like, to enable identification prior to storage, transportation and / or further processing (analysis).
  • the labeling can also be done manually.
  • a freezer can also be connected to the separating device 50 and the optional labeling device in order to freeze the removed sample directly (also automated) if the further processing is to take place only at a later point in time.
  • the separated tube portion 48 with the sample may also be conveyed to an analyzer by an automated feeder for immediate analysis of the sample.
  • the sample z. B. be made accessible by piercing a syringe or cannula in the separated tube section 48.
  • the tube 32 can already be equipped with functional elements before sampling.
  • septa as described, for. B. are common in ampoules. Such a septum can be punctured with a cannula, the puncture hole being automatically closed again when the cannula is withdrawn. For each septum of the tube 32, a small area with such a functional material is introduced into the tube wall. This functional material does not have to have all the special properties of the tube wall due to the limited use, such as high flexibility, weldability, etc.
  • the septa may be provided at certain intervals in the longitudinal direction of the tube 32 so that each severed tube section 48 has at least one septum. Thus, from each separated tube section 48 later part samples taken with a cannula and z. B. an analyzer.
  • valves for (partial) removal or for coupling the hose sections 48 may be introduced to an analyzer.
  • Hose sections 48 z. B. can be coupled to hose lines (eg self-tapping Luer-lock connector).
  • the functional elements described above facilitate the later (partial) removal of the samples from the resulting tube sections 48.
  • the functional elements described below serve primarily for sample identification, optimization / support of the sampling itself and / or tracking of the storage conditions of the sample.
  • the tube 32 may include RFID tags, the z. B. for the identification of the samples based on the assignment to a tube section 48 are read by a reader.
  • the tube 32 is already printed with appropriate information, z. B. in the form of QR codes. This information can be used for later sample identification.
  • assemblies and circuits may be applied, which were manufactured entirely or partially by means of printing processes (printed electronics, printed electronics). These elements make it possible to carry out measuring tasks such as temperature measurement (eg by resistance measurement) or fill level indication (by capacitive measurement) during sampling or later sample handling of the tube sections 48.
  • measuring tasks such as temperature measurement (eg by resistance measurement) or fill level indication (by capacitive measurement) during sampling or later sample handling of the tube sections 48.
  • the tube 32 may be equipped with (printed) electronics and / or temperature-sensitive fields of applied temperature-sensitive materials / dyes to detect a later exceeding or falling below a permissible transport or storage temperature of the tube sections 48.
  • the tube 32 may also be made of a self-healing material, for. B. based on a thermoplastic elastomer (TPE), so that partial samples can be removed from the tube sections 48 with a syringe or cannula without destroying the respective tube section 48.
  • TPE thermoplastic elastomer
  • the flexible container 14 together with the Stub 12 and the tube 32 are sterilized, in particular by gamma radiation.
  • the piston 42 for removing the tube 32 and the separator 50 and any other devices need not necessarily be sterile because they do not come into direct contact with the medium or the inside of the tube 32.
  • the hose 32 is provided directly on site, its sterility, in particular that of the inner wall of the hose 32, can also be ensured separately.
  • the device 10 has been described in detail only in connection with a disposable container 14, the device 10 is basically also suitable for reusable containers.
  • a plurality of samples can be taken at predetermined times from the same disposable container 14, so that v. a. the temporal evolution of a process in the container 14 can be studied.
  • sampling from the flexible container 14 may also be the final filling of a product, eg. As a drug represent.
  • the medium can be filled directly into portions in separate sections of hose 48 (tube compartments), which correspond to the final sales volume and only have to be packaged accordingly.
  • the tubing compartments may have the septa described above. The drug may then be withdrawn directly with the cannula of a syringe and administered to a patient. Bezuas Schweizer Liste

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  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
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Abstract

L'invention concerne un dispositif (10) destiné à prélever un échantillon à partir d'un récipient (14), en particulier à partir d'un récipient jetable, comprenant une tubulure de raccordement (12) agencée au niveau d'une ouverture du récipient (14), fixée sur une paroi du récipient (14), ayant une partie tubulaire (40) qui est en communication fluidique avec l'intérieur du récipient (14) et qui s'étend à distance de la paroi de récipient. Le dispositif (10) comprend en outre un tube séparé (32) ayant une première extrémité (36) qui est rendue étanche par rapport à l'intérieur de récipient et une seconde extrémité fermée (38) qui est guidée de manière à fermer l'ouverture du récipient (14) ou la partie tubulaire (40). Le tube (32) peut être retiré dans une position de séparation. L'invention concerne également un procédé destiné à prélever un échantillon à partir d'un récipient (14), en particulier à partir d'un récipient jetable, au moyen d'un tel dispositif, comprenant les étapes suivantes : le retrait, dans une position de séparation, du tube séparé (32) qui, avec sa première extrémité (36), est rendu étanche par rapport à l'intérieur de récipient et qui, avec sa seconde extrémité fermée (38), est guidé de manière à ce que la seconde extrémité (38) ferme l'ouverture du récipient (14) ou la partie tubulaire (40) de la tubulure de raccordement (12) agencée au niveau de l'ouverture, fixée sur une paroi du récipient (14) et en communication fluidique avec l'intérieur du récipient (14) ; et la séparation de la partie de tube retirée (48).
PCT/EP2018/081544 2017-11-16 2018-11-16 Dispositif et procédé de prélèvement d'un échantillon à partir d'un récipient Ceased WO2019096987A1 (fr)

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DE102017127015.9A DE102017127015B4 (de) 2017-11-16 2017-11-16 Vorrichtung zur Entnahme einer Probe aus einem Behälter
DE102017127015.9 2017-11-16

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US12239127B2 (en) 2021-07-28 2025-03-04 Sartorius Stedim North America Inc. Thermal capacitors, systems, and methods for rapid freezing or heating of biological materials

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DE19631812A1 (de) * 1996-08-07 1998-02-12 Basf Lacke & Farben Entnahmevorrichtung für Stoffproben
DE19943606C1 (de) * 1999-09-11 2001-02-08 Karlsruhe Forschzent Verfahren zur Beprobung von Gewässern
US6530871B1 (en) * 1998-10-09 2003-03-11 Westfalia Separator Ag Centrifuge having a bag arrangement and a method for operating the centrifuge
DE102005008144A1 (de) * 2005-02-21 2006-09-07 Infors Ag Beutel mit darin gezüchteter Kultur sowie Probeentnahmeverfahren
DE102005039427A1 (de) * 2005-08-18 2007-02-22 Bürkle, Veit Flexibler Probennehmer
EP1637584B1 (fr) 2004-09-20 2007-07-11 Infors AG Sac de culture et procédé de prélèvement d'echantillon

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DE102007017816A1 (de) * 2007-04-16 2008-10-30 Hecht Anlagenbau Gmbh Adaptervorrichtung für Behälter zur kontaminationsfreien Entnahme deren Inhalts
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DE19631812A1 (de) * 1996-08-07 1998-02-12 Basf Lacke & Farben Entnahmevorrichtung für Stoffproben
US6530871B1 (en) * 1998-10-09 2003-03-11 Westfalia Separator Ag Centrifuge having a bag arrangement and a method for operating the centrifuge
DE19943606C1 (de) * 1999-09-11 2001-02-08 Karlsruhe Forschzent Verfahren zur Beprobung von Gewässern
EP1637584B1 (fr) 2004-09-20 2007-07-11 Infors AG Sac de culture et procédé de prélèvement d'echantillon
DE102005008144A1 (de) * 2005-02-21 2006-09-07 Infors Ag Beutel mit darin gezüchteter Kultur sowie Probeentnahmeverfahren
DE102005039427A1 (de) * 2005-08-18 2007-02-22 Bürkle, Veit Flexibler Probennehmer

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119242424A (zh) * 2024-10-09 2025-01-03 临邑安康医疗器械有限公司 一种干细胞取样装置及其取样方法

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DE102017127015B4 (de) 2019-09-19

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