Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
  • B01D63/08—Flat membrane modules
  • B01D63/087—Single membrane modules
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/56—Labware specially adapted for transferring fluids
  • B01L3/563—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors
  • B01L3/5635—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors connecting two containers face to face, e.g. comprising a filter
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
  • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
  • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
  • C12Q1/04—Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
  • G01N1/40—Concentrating samples
  • G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2311/00—Details relating to membrane separation process operations and control
  • B01D2311/08—Specific process operations in the concentrate stream
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2311/00—Details relating to membrane separation process operations and control
  • B01D2311/26—Further operations combined with membrane separation processes
  • B01D2311/2688—Biological processes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2313/00—Details relating to membrane modules or apparatus
  • B01D2313/13—Specific connectors
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2313/00—Details relating to membrane modules or apparatus
  • B01D2313/18—Specific valves
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2313/00—Details relating to membrane modules or apparatus
  • B01D2313/60—Specific sensors or sensor arrangements
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2315/00—Details relating to the membrane module operation
  • B01D2315/08—Fully permeating type; Dead-end filtration
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/06—Auxiliary integrated devices, integrated components
  • B01L2300/0672—Integrated piercing tool
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/06—Auxiliary integrated devices, integrated components
  • B01L2300/0681—Filter
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/06—Valves, specific forms thereof
  • B01L2400/0633—Valves, specific forms thereof with moving parts
  • B01L2400/065—Valves, specific forms thereof with moving parts sliding valves
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
  • G01N1/40—Concentrating samples
  • G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
  • G01N2001/4088—Concentrating samples by other techniques involving separation of suspended solids filtration

Definitions

• the invention relates to a filter module comprising a housing which, through a membrane filter in an inlet chamber, with a rigid on the housing
• the invention further relates to a method for detecting microorganisms in a test liquid using such a filter module.
• test liquid The liquid to be tested, designated here as test liquid, is replaced by a test liquid
• the microorganisms which may have been enriched on the filter surface, increase to a degree in which they can be detected with suitable detection means.
• the above-mentioned, generic document proposes the double use of the filter module both as a filter holder and as Incubationsgefäß.
• the housing of the known filter module In the region of its inlet chamber, the housing of the known filter module has an inlet nozzle for liquid as well as a venting pipe provided with a sterile filter.
• the outlet chamber on the other side of the housing dividing membrane filter is a as a
• Test fluid via a hose connection through the inlet port in the
• Outlet nozzle pumped into a collecting vessel. Then, i. Following or after one or more optionally interposed cleaning and / or rinsing steps, the outlet is closed.
• the tubing connection to the inlet port is removed and replaced with a tubing connection to a nutrient medium bottle.
• a vacuum pump is connected. With this then suture medium is sucked from the nutrient medium bottle into the inlet chamber, so that the membrane filter is wetted with nutrient medium.
• Microorganism-matched nutrient medium is available. The on the
• test liquid to be tested for microorganisms is injected through a septum stopper into the culture medium bottle, which is then referred to as
• Incubation container is used.
• the activity of the microorganisms leads to a change of an externally detectable property of the integrated sensor, for example to a color change.
• this method sets one
• Terminal and a second terminal which, by means of a built-in inlet port 3-way valve comprising a first input connected to the first port, a second port connected to the second input and an outlet connected to the inlet chamber, optionally with the inlet chamber are fluidically connectable, wherein the first port is formed as an adapter for outwardly dense, a gravitationally driven fluid exchange with the first input of the 3-way valve allowing coupling a nutrient medium bottle.
• the object is further achieved by a method for detecting microorganisms in a test fluid, comprising the steps:
• the invention uses the principle known idea of the double use of
• Nutrient media reservoir on the other hand by providing an integrated in the filter module, in particular in the inlet pipe, valve unit.
• a manual Umstöpseln hose connections is unnecessary and replaced by an easily automatable switching of a 3-way valve, the connection of the Inlet chamber with the test fluid reservoir (via the second port) to a connection of the inlet chamber with the nutrient medium bottle (via the first port) switches.
• the term of the 3-way valve is to be understood here broadly and only states that it has at least 3 ports (first input, second input, output). These must be connectable to one another in at least the above-mentioned two positions, ie, so that the connections can be fluidly connected at least individually to the inlet chamber.
• a 3/2-way valve with exactly three ports and exactly two switch positions is used.
• a more complex valve results, for example because test liquid is to be used from multiple sources, this is of course also possible within the scope of the invention.
• Ports are additionally in common, fluidly connectable via different flow paths with the inlet chamber.
• an additional switching position is realized in which the first connection is connected to the inlet chamber via a first flow path and in which the second connection is connected to the inlet chamber via a second flow path different from the first flow path.
• the valve as a slide valve, such a switching position
• valve piston be formed for example as an additional sliding position of the valve piston.
• valve piston Alternatively, a special rotational position of the valve piston may be provided.
• step bb the following step may also be provided: cc) Pumping of nutrient medium from the coupled culture medium bottle into a waste reservoir connected to the second connection.
• waste reservoirs are to be interpreted broadly. In particular, there is no need for a separate vessel devoted exclusively to the purpose of waste disposal. It is sufficient to accept a small amount of from the second
• Connection hose can be used.
• Microorganism activity sensor can thereby still improve. Just before the final switching of the valve into its exclusively the first port, i. the nutrient medium bottle, position connecting to the inlet chamber, introduces a small amount of nutrient medium through the inlet chamber (and through the first port) into the inlet chamber
• Membrane filter ago regrowing microorganisms thereby facilitating the way through the valve in the nutrient medium bottle and the microorganism activity sensor.
• Another advantage of this additional valve position is the possibility to make a pressure equalization between the connected Nährmedienflasche and represented by the test liquid reservoir environment.
• Commercially available culture media bottles with microorganism activity sensor are usually under negative pressure. This results from their typical use in blood collection.
• a pressure difference from the environment is rather disadvantageous.
• the temporary short between the nutrient medium bottle and the environment - be it an additional nutrient medium or a waste reservoir - can overcome this disadvantage.
• the negative pressure in the Nutrient media bottle can even be used to advantage as a drive for pumping nutrient medium from the external nutrient medium reservoir into the nutrient medium bottle.
• Another special feature of the invention lies in the special design of the first connection of the device intended for coupling to the nutrient medium bottle
• Bottle neck of a nutrient medium bottle designed. After coupling via the adapter, the inlet nozzle and the nutrient medium bottle form a rigid unit that can be oriented as required.
• this rigid coupling makes it possible to tilt the nutrient medium bottle and the filter module coupled to it in such a way that the nutrient medium flows out of the bottle mouth to the 3-way valve and from there, if this is switched correctly, further into the inlet chamber of the filter module and continue to the membrane filter. Due to the direct coupling, the path is so short that, possibly supported by a continuous pivoting movement, the
• Microorganism activity sensor are continuously wetted and in fluid-exchanging contact with each other. However, this is only possible if, as provided according to the invention, the adapter has a sufficiently large connection between the
• Nutrient medium bottle and the first input of the 3-way valve creates, so that the nutrient medium gravitationally driven, i. without the application of an external positive or negative pressure (for example by means of a pump), it is possible to flow back and forth between the microorganism activity sensor and the membrane filter.
• Such a filter module configured in accordance with the invention allows the detection method, which is known and proven in principle, to be carried out with a few, simple steps which exclude virtually any errors and which are also easy to automate.
• the steps to be performed are above in the context of the invention
• the step of attaching the nutrient medium bottle (step b) at any time before the switching of the 3-way valve (step e) can take place.
• the adapter has a central cannula and a collar which surrounds the latter coaxially. The inner diameter of the collar has of course to be matched to the outer diameter of the bottle neck or the bottle mouth of Nährmedienflasche.
• the cannula serves for the fluid-exchanging coupling between the nutrient medium bottle and the inlet chamber of the filter module. As explained above, it has an inner diameter that is purely gravitationally driven
• Fluid exchange allows. It will be easy for a person skilled in the art to choose a suitable cannula diameter, taking into account the cannula length and the viscosity of the nutrient medium.
• the cannula diameter is preferably between 1 mm and 5 mm.
• the design of the fluid connection as a cannula is particularly favorable in view of the usual configuration of the closures of culture media bottles as septum closure.
• the collar is divided into at least two mutually circumferentially adjacent collar segments which are elastically pivotable relative to each other about a tangential pivot axis.
• the collar has radially inwardly projecting latching projections, in particular at its collar edge, on. This results in a locking mechanism, which is particularly suitable for coupling Nährmedienflasche with respect to the bottleneck thickened bottle mouth.
• the collar segments When pushed onto the nutrient medium bottle, the collar segments are spread apart relative to one another.
• the latching projections are pushed over the bottle mouth, they snap, driven by the elasticity of the collar segments, radially inward and engage behind the edge of the thickened bottle mouth.
• Said embodiment of a segmented collar has particular advantages in terms of facilitated demolding in an injection molding tool to his
• latching projections or the latching edge have a trailing edge bevel
• a permanent axial force can be generated in conjunction with an elastic gasket resting against the edge of the bottle, with which the filter module and nutrient medium bottle are drawn towards one another.
• this can compensate for manufacturing tolerances and make the overall system backlash.
• the collar has an internal thread.
• Such an adapter is particularly suitable for coupling Nährmedienflaschen with corresponding external thread.
• Nutrient media bottle two positions, namely an active and a passive position are provided. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet. In the passive position, the adapter and the nutrient medium bottle are already mechanically but not fluidically connected yet.
• adapter and nutrient medium bottle are also fluidically connected in the active position.
• a movably mounted cannula can be provided, which is folded and / or axially displaced during the transition from the passive to the active position in such a way that it pierces a septum closure of the nutrient medium bottle.
• this movement of the cannula is coupled to the switching of the 3-way valve.
• the cannula can be used as a blocking element.
• the 3-way valve can be designed in any desired manner; It is particularly preferred, as already mentioned above, designed as a slide valve.
• a gate valve builds much flatter, so that the distance between the inlet chamber of the filter module and the
• the 3-way valve irreversibly connects its switching position (at least also) connecting the second connection to the inlet chamber into its (exclusively) the first connection to the inlet chamber
• Switching position is switchable.
• this can be realized, for example, by unidirectional locking means which engage the valve piston on the valve housing as soon as it reaches the second switching position mentioned above. This can be reliably prevented that the user accidentally switches back after a proper switching of the valve and thereby causes unsterilities in the incubation or an interruption of the connection between culture media bottle and membrane filter.
• a movably mounted cannula can also be used to block the valve piston.
• the displaceably mounted valve piston of the slide valve can with a
• Abkoppelmechanik be provided for the second port, which at the same time throws off the hose connection at the second connection when switching the valve.
• the first port of the inlet nozzle is perpendicular to the
• the filter module can be regarded as an extension of the nutrient medium bottle. This embodiment facilitates the classical, horizontal positioning of the nutrient medium bottle in the incubation cabinet and / or on a rocking table, so that the above-mentioned wetting of membrane filter and microorganism activity sensor is ensured.
• FIG. 1 shows a sectional view of a filter module according to the invention in a first valve position
• FIG. 2 shows a sectional view of a filter module according to the invention in a second valve position
• Figure 3 the filter module of Figures 1 and 2 in the coupling position with a
• Figure 4 the arrangement of Figure 3 after switching the valve position.
• FIG. 5 shows the arrangement of FIG. 4 during the incubation step
• FIG. 6 is a sectional view of an alternative embodiment of the invention.
• FIG. 7 is a sectional view of the filter module of FIG. 6 in a second embodiment
• FIG. 8 a sectional view of the filter module of FIG. 6 in a third
• FIG. 1 shows a filter module 10 according to the invention in a first valve position.
• the filter module 10 comprises a housing 12, which by one between two
• Housing halves 12 a, 12 b liquid-tight clamped (and / or glued,
• membrane filter 14 is divided into two chambers. Between the membrane filter 14 and the lower housing half 12 a extends the
• Inlet chamber 16 Between the membrane filter 14 and the upper half of the housing 12 b extends the outlet chamber 18, which opens into a serving as Filtratauslass, central outlet 20.
• the inlet chamber 16 opens into a central inlet port 22, which has an integrated slide valve 24, via which it splits into two ports, namely a first port 26 and a second port 28.
• the slide valve 24 is designed as a 3/2-way valve, by means of which the inlet chamber 16 - depending on
• valve position - either with the first port 26 of the inlet port 22 ( Figure 1) or with the second port 28 of the inlet port 22 ( Figure 2) is connectable.
• the slide valve 24 comprises a parallel to the plane of extension of the membrane filter 14 extended valve housing 241 in which a valve piston 242 is slidably mounted.
• the valve piston 242 is penetrated by a first valve channel 243 extending transversely through it and by a second valve channel 244 adjacent thereto, the latter being angled and bends from an orientation transverse to the sliding direction into an orientation parallel to the sliding direction.
• the inputs and outputs of the channels 243, 244 are sealed with seals 245 which are fixed to the valve piston 242.
• the first port 26 of the inlet nozzle 22 is formed in the illustrated embodiment as a cap 261 and a collar 262 constructed cap, the collar is divided into individual collar segments 262 a, 262 b, 262 c, which is elastic about their respective line of connection to the lid 261 are pivotable.
• the lid 261 is formed in the region of its central opening as a pointed cannula 264 and carries in the annular area around the cannula 264 a gasket 265. This may, for reasons of cost, preferably of the same material in the context of a
• a metal cannula which may be ground at its free end.
• FIG. 2 shows the same filter module 10 as FIG. 1, but in a second valve position of the slide valve 24, in which the second connection 28 is connected to the inlet chamber 16.
• FIG. 3 shows the filter module 10 of FIGS. 1 and 2 in a coupling position in a sewing media bottle 30.
• the nutrient medium bottle 30 In the region of its neck, the nutrient medium bottle 30 has a mouth thickening 32. The mouth itself is closed in the uncoupled state with a septum not visible in Figure 3.
• Nutrient media bottle 30 to the first port 26 pierces the cannula 264 the septum and so connects to the slide valve 24 ago.
• Collar segments 262a, b, c over their front chamfers through the
• Locking projections 263 then behind the mouth thickening 32 and form a
• the culture medium bottle 30 is partially filled with a medium 34. At its bottom, it has a microorganism activity sensor 36. This can happen for example, to act an element which undergoes a color change in contact with (generated by microorganisms) carbon dioxide in the nutrient solution. Of course, other types of microorganism activity sensors can also be used. Of importance for the practice is the monitorability or readability of the sensor 36 from outside of the culture medium bottle 30, for example, in an optical manner by their
• any microorganisms present in the test liquid accumulate on the membrane filter 14 on the input chamber side.
• test liquid reservoir and the collecting container are uncoupled.
• the outlet nozzle 20 is preferably closed by a closure cap 44.
• Inlet neck 22 is not required. Rather, this connection is through
• tilting of the entire arrangement causes the sewing medium to flow into the inlet port 22 through the first port 26 of the inlet port 22
• Inlet chamber 16 flows and wets the membrane filter 14.
• the microorganism activity sensor 36 remains wetted by the nutrient medium 34.
• a periodic rocking, as indicated in Figure 5, and / or a rotation of the arrangement about their Central axis, is preferred because the liquid exchange is fast and permanent wetting of membrane filter 14 and microorganism activity sensor 36 is ensured.
• the incubation is preferably carried out in an incubation cabinet which ensures a suitable temperature for growth of the microorganisms on the membrane filter 14.
• the microorganism activity sensor 36 is read out continuously, regularly or sporadically, as indicated by the monitoring symbol 46 in FIG.
• FIGS. 6 to 8 show an alternative embodiment of a filter module 10 according to the invention, the slide valve 24 allows three different positions.
• the valve 24 has three valve channels 243, 244, 246. The shown in Figure 6
• Valve position corresponds functionally to the valve position of Figure 2 or of Figure 3, i. it is only the second port 28 connected to the inlet chamber 16. As explained in the context of Figure 3, the filtration step is performed with this valve position.
• the valve position shown in Figure 8 corresponds functionally to the valve position of Figure 1 and of Figure 4, i. it is only the first port 26 connected to the inlet chamber 16. As explained in the context of Figure 4, the
• Figure 7 shows an additional valve position by the additional, third
• Valve channel 246 is enabled. In this position, both the first port 26 and the second port 28 - although via different flow paths - connected to the inlet chamber 16. Consequently, nutrient medium from an unillustrated, external culture medium reservoir via the inlet chamber into the
• Nutrient medium bottle 30 are pumped. If this step is carried out after the filtration step and before the incubation step, it can be used to rinse off microorganisms attached to the membrane filter 14 and into the
• valve piston 242 in particular its actuator 247, relative to the valve housing 241 so
• valve piston actuator 247 in the incubation position ( Figure 8) can lock with the valve housing 241, so that the transfer of the valve 24 is irreversible in its incubation.
• a plurality of filter modules according to the invention can be used in parallel and optionally with different culture media bottles, e.g. for aerobic and anaerobic microorganisms.
• different culture media bottles e.g. for aerobic and anaerobic microorganisms.
• mercantile units both sterile filter modules can be isolated and already with one
• Unpowered connections can each come with a removable, sterile cap, with a removable one
• Sterile paper or a tearable shrink wrapping be closed.
• pre-coupled units especially in embodiments with two
• Coupling point can be nestled a sterile shrink film, which seals the coupling point against the environment.
• Other known and still unknown measures for preserving the sterility of the respective mercantile unit are of course equally applicable. LIST OF REFERENCE NUMBERS

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• 2017
  • 2017-11-06 DE DE102017125881.7A patent/DE102017125881B4/de active Active
• 2018
  • 2018-10-22 WO PCT/EP2018/078905 patent/WO2019086286A1/de unknown
  • 2018-10-22 EP EP18793631.5A patent/EP3706888A1/de active Pending
  • 2018-10-22 CN CN201880070621.3A patent/CN111278540B/zh active Active
  • 2018-10-22 KR KR1020207015601A patent/KR102393041B1/ko active IP Right Grant
  • 2018-10-22 JP JP2020524858A patent/JP7032527B2/ja active Active
• 2020
  • 2020-05-06 US US16/867,725 patent/US11541357B2/en active Active

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