EP2707694A1

EP2707694A1 - Disposable sensor head and disposable container

Info

Publication number: EP2707694A1
Application number: EP12719599.8A
Authority: EP
Inventors: Daniel Riechers; Christian Grimm
Original assignee: Sartorius Stedim Biotech GmbH
Current assignee: Sartorius Stedim Biotech GmbH
Priority date: 2011-05-10
Filing date: 2012-05-05
Publication date: 2014-03-19
Also published as: WO2012152423A1; DE102011101107B4; DE202012004503U1; DE102011101107A1; US20140054186A1; US9400243B2

Abstract

The invention relates to a disposable sensor head for an optical sensor, comprising a central body (12) with - an axial passage channel (20) closed by a transparent viewing pane (14) oriented transversely with respect to the longitudinal direction thereof, and - a circumferential fastening flange (22) which can be used to fasten it to a wall of a flexible container (62) with sealing in such a manner that the passage channel (20) passes through the wall. The invention is distinguished by the fact that the passage channel (20) forms, in one section, an open flow chamber (34) which is bounded by the viewing pane (14) and also by a reflector disc (16) arranged opposite the viewing pane (14).

Description

Disposable sensor head and disposable container Field of the invention

The invention relates to a disposable sensor head for an optical sensor, comprising a central body with an axial, through a transversely to its longitudinal direction aligned, transparent lens closed passageway and

a circumferential mounting flange, by means of which it is sealingly fastened to a wall of a flexible container so that the passage channel passes through the wall.

The invention further relates to a disposable container with a flexible wall and at least one disposable sensor head of an optical sensor, wherein the sensor head with a central body

an axial, closed by a transversely oriented to its longitudinal direction, transparent viewing window

Through-channel and

a circumferential mounting flange,

has and by means of the mounting flange sealingly attached to the flexible wall, that the passage channel passes through the wall.

State of the art

Such disposable sensor heads and disposable containers are known from DE 10 2006 001 610 B4.

In particular, in the pharmaceutical and biotechnological industry for the manufacture, storage and use of liquids and gases (hereinafter collectively referred to as fluids) disposable container with flexible Walls instead of the previously used more commonly used rigid tanks and bottles. Such disposable containers are intended to be shortened here as a bag. As with rigid containers, it is necessary to monitor a wide range of parameters of the fluids in the bags. For this purpose, it is known from the cited document to use the bag wall passing optical sensors. For reasons of cost and sterility, the sensor head, ie the part of the sensor forming the optical contact with the fluid to be monitored, is designed as a disposable element, which is firmly connected to the customer with the bag and delivered sterile and after use of the bag together with the latter is disposed of. It is endeavored to accommodate reusable, expensive and / or non-sterilizable components, such as light sources, electronic evaluation units, etc. in a couplable module and as possible to accommodate only robust, inexpensive, sterilizable and easily disposable elements in the disposable sensor head.

In one of the exemplary embodiments disclosed in DE 10 2006 001 610 B4, the central body clamped to the bag wall by means of a counterpart to its fastening flange has a central through-bore. This forms a passageway having an entrance located outside of the bag and an outlet located within the bag and thus passes through the bag wall. A volume flow through the passage is prevented by a viewing window, which closes the channel. The viewing window is transparent, which in the context of the present description is to be understood in each case with reference to the measurement to be carried out and a sufficient transmission of light means the wavelengths required for the respective measurements. In the known embodiment, this lens is attached to the outlet of the passage channel and closes this dome-shaped. It forms the optical interface between a fluid in the interior of the bag and a glass fiber which is arranged in the interior of the channel and dissipates illumination light or detection light. Such a sensor head is suitable for carrying out backscatter, fluorescence and phosphorescence measurements. Transflection measurements, as used in particular in the context of NIR spectroscopy (near-infrared spectroscopy) can not be performed with the known sensor head.

task

It is the object of the present invention to further develop the known disposable sensor head in such a way that transflection measurements, in particular NIR spectroscopy measurements, can be carried out with it.

It is a further object of the present invention to provide sensor-equipped pouches which permit a transflection study, in particular a NIR spectroscopic examination of the pouch contents.

Presentation of the invention

The first object is achieved in conjunction with the features of the preamble of claim 1, characterized in that the passageway in one section forms an open flow chamber, on the one hand by the Viewing window and on the other hand limited by one of the visor opposite arranged reflector disc.

The above second object is achieved in conjunction with the features of the preamble of claim 9, characterized in that the passageway in a positioned inside the container, open flow chamber of the sensor head forms the container towards the outside through the lens and the container interior through one of the lens opposite arranged reflector disk is limited.

Preferred embodiments and further developments of the invention are the subject of the dependent claims. It is the basic idea of the present invention to open the passageway into a transflection flow chamber contained in the central body of the sensor head, which can be regarded as an end portion of the passageway. Unlike the prior art known, the through-channel thus not only serves the supply and discharge of light, but has an outer bag in the final assembly state inlet and Abführabschnitt for light and in the final assembly state bag inside an interaction section for defined interaction between light and bag contents. For this purpose, the viewing channel closing the passage is returned from the channel exit, the channel exit itself is vorverlagert towards the bag interior and completed with a reflector disc and resulting between viewing and reflector disc chamber is opened to the bag interior, so that it can be traversed by the fluid of the bag contents. By the inlet and Abführabschnitt of the passageway thus becomes Light from a light source, radiating through the lens, interacts with the medium in the flow chamber, is reflected and / or scattered on the reflector disc depending on their specific design, interacts again with the medium in the flow chamber, re-radiates through the lens and is through the Inlet and outlet section of the passage channel for appropriate detection removed. In order for the fluid contained in the flow chamber is representative of the entire bag contents, a good flow through the flow chamber is required. For this purpose, it is preferably provided that the flow chamber has at least two lateral, arranged between the lens and the reflector disc openings. Conveniently, the openings are chosen as large as possible. Preferably, they occupy the predominant wall part of the through-channel between the viewing window and the reflector disk and are separated from each other only by narrow webs.

In a preferred embodiment of the invention, it is provided that the central body, on the side facing away from the reflector disc of the lens has a coupling device for the reversible coupling of an optoelectronic sensor module. An optoelectronic sensor module is here understood to mean a structural unit which has a light source, a detector unit and suitable light-conducting elements. The light-guiding elements may be fiber-optic, but preferably of a beam-optical nature. In particular in the field of NIR spectroscopic measurements, fiber-optic light-conducting elements can have problems with regard to transparency, Dispersion, aperture, loss of fiber bends, etc. raise. The optoelectronic sensor module therefore preferably comprises an NIR light source, a purely or at least predominantly beam-optical illumination beam path comprising mirrors and optionally lenses, a likewise purely or at least predominantly radiolucent detection beam path, and an NIR detector, in particular an NIR spectrometer whose spectrometer input is definitely fiber-optic elements may contain. Due to the optical radiation supply and discharge of light, a positionally stable coupling between the sensor head and the optoelectronic sensor module is required. This requirement is met by said development of the invention due to the direct coupling with the central body. Corresponding coupling standards are known to the person skilled in the art, for example from microscopy.

The central body does not necessarily have to be constructed in one piece. Rather, it is quite possible and often advantageous if the central body is constructed in several parts and has a main body and at least one other central body component. This can for example be realized so that the lens is sealingly supported between the main body and an end face of a clamping ring. The clamping ring can be fixed, for example, as a threaded ring, like a snap ring, by a latching or in a similar manner to the main body. Its object is to press the lens against a preferably provided with a seal projection of the passage channel to hold them on the one hand and on the other hand to seal. In a further development of this embodiment, it is provided that the clamping ring on its side facing away from the lens end face

Coupling device for reversible coupling of the optoelectronic sensor module has. The clamping ring is thus assigned a dual function, namely on the one hand for holding and sealing the lens, as described above, and on the other hand as an adapter for the optoelectronic sensor module.

A further realization of a multipart center body, which may alternatively or preferably be implemented in addition to the aforementioned, is that the reflector disk is fixed on an adjusting plate, which is fixed at an adjustable distance from the lens on the main body. This embodiment has the particular advantage that the optical path for the transflection measurement can be adjusted as required by the individual case. For example, the adjusting plate may be formed as a body with external thread, which can be screwed into an internal thread at the outlet of the through-channel. Under cost aspects favorable and in the majority of practice-relevant cases probably sufficient will be a variant in which the adjustment plate and the main body have corresponding locking grooves and bulges. For example, the adjusting plate may be provided with a circumferential detent groove or a peripheral detent bead which snaps into one of a plurality of mutually parallel, corresponding detent grooves or latching beads in the outlet-near inner wall of the through-channel. In this way, the sensor head geometry specifies several fixed positions for the adjustment plate, from which one can be chosen during assembly of the sensor head. Of course, this type of fixation of the adjusting plate is basically possible even with only one predetermined position.

As already mentioned, it is

Main field of application of the disposable

Sensor head in its use together with flexible walled disposable containers, i. with the initially described bags. Accordingly, bags with integrated disposable sensor head according to the invention are an independent part of the present application, wherein each of the previously explained embodiments and further developments of the sensor head according to the invention can be used.

The attachment of the disposable sensor head according to the invention on the bag to provide a disposable container according to the invention can be done in different ways. In particular, the mounting flange can be welded to the wall, glued and / or clamped by means of an additional counterpart.

Other features and advantages of the present invention will become apparent from the following specific description and drawings.

Brief description of the drawings

Show it:

Figure 1: a Schitt representation of the invention

Sensor head, FIG. 2 shows a top view of the sensor head according to the invention along the line of sight arrow II in FIG. 1,

Figure 3: an optoelectronic sensor module for

Coupling to the sensor head of Figures 1 and 2 and the reflector plate of the sensor head of Figures 1 and 2 for illustrating an exemplary beam path,

Figure 4: a disposable container according to the invention, comprising a bag, a novel

Sensor head and a coupled to this optoelectronic sensor module.

Detailed description of preferred embodiments

Identical reference signs in the figures indicate the same or analogous elements. 1 shows a sectional view through a sensor head 10 according to the invention. Functional components of the sensor head 10 are its central body 12, a viewing window 14 and a reflector disk 16. In the present exemplary embodiment, the central body 12 is formed in three parts and comprises in particular a main body 18 with a central through-passage 20 and a mounting flange 22, a clamping ring 24 with which the viewing window 14 is supported, and an adjusting plate 26 which carries the reflector disk 16. The preferred material for at least the main body is a weldable hard plastic. By means of the mounting flange 22, the main body 18 can be fixed to a wall of a container, in particular a flexible bag 62, as shown by way of example in Figure 4 to be explained in more detail below. In this case, the mounting flange 22 can be glued or welded to the container wall. Alternatively, it can also by means of one or more counterparts, for example by screwing,

Deadlock, locking etc. are set. The fastening flange 22 thus forms a section boundary between an inner region lying in the interior of the container in the final assembled state and an outer region of the sensor head lying outside the container in the final assembled state. The passage 20 passes through both areas.

In the embodiment shown, the passage 20 has approximately at the level of the mounting flange 22 has a projection 28 on which a seal 30, for example, a flat or liquid seal is applied. On the seal 30 rests the lens 14, which has a sufficient transparency for the required within the scope of each applicable optical measurement light. In the preferred variant of the NIR spectroscopic measurement, a viewing window made of quartz or sapphire has proved favorable. By means of the clamping ring 24, the lens 14 is clamped against the seal 30, wherein the inherent elasticity of the seal 30, the clamping force sustained permanently. In the embodiment shown, the clamping ring 24 has a circumferential latching bead 32 which engages in a corresponding latching groove 33 in the main body 18. This requires a corresponding elasticity of the clamping ring 24 and / or the main body 18 ahead, but given is, if one or both of said elements, as preferably provided, are formed from a corresponding plastic. Alternatively to the embodiment shown, the clamping ring could for example also be provided with an external thread which can be screwed into an internal thread of the main body.

At its end facing away from the lens 14, a coupling structure 25 is formed on the clamping ring 24, which corresponds to the tri-clamp standard known in the art in the embodiment shown. As described in more detail below in connection with FIG. 4, the coupling structure 25 serves to couple an optoelectronic sensor module 40.

In the embodiment shown, the lens 14 forms the boundary between an inner and an outer region of the through-channel 20.

The inner region of the through-channel 20 or the main body 18 can be subdivided into two subregions. The partial area next to the viewing window 14 is designed as a flow chamber 34. For this purpose, lateral, the main body 18 passing through openings 36 are provided which allow ontageendzustand a fluid exchange between the flow chamber 34 and the container interior. The flow chamber is closed by the reflector disc 14 opposite and substantially parallel to this reflector disc, which in turn is attached to an adjustment plate 26, for example, glued to this. The adjusting plate 26 has in the illustrated

Embodiment a circumferential locking bead 38 which in one of two corresponding with him locking grooves 39 in the inner wall of the passageway 20 formed by the main body 18 is engaged. The distance between the reflector disk 16 and the lens 14, denoted by "d" in FIG. 1, forms the height of the flow chamber 34, which can be increased by one step in the illustrated embodiment by locking the adjustment plate 26 into the second locking groove 39 shown Of course, embodiments with only one latching groove 39, with more than two latching grooves 39 and with other fastening means are possible, for example an external thread on the adjusting plate 26, which can be screwed into an internal thread of the main body 18. Of course, it is also possible for the reflector disk 16 permanently fixed to the main body 18 in a non-adjustable manner.

Figure 2 shows a plan view of the sensor head of Figure 1 according to the sighting arrow II, with reference to the above explained for explanation.

Figure 3 shows a highly schematic sectional view of an optoelectronic sensor module, which forms an optical sensor together with the sensor head of Figures 1 and 2. To illustrate a preferred beam path, the reflector disk 16 of the sensor head 10 is shown in addition to the optoelectronic sensor module 40. The optoelectronic sensor module 40 has a preferably dust and liquid-tight housing 42. In the wall of the housing 42, an optical window 44 is embedded, which has sufficient for the intended measurement transparency in the respective required spectral range. In particular, in the preferred used near Infrared Area (NIR) can be used in quartz or sapphire windows. The optical window 44 is surrounded by a coupling structure 45, which corresponds to the coupling structure 25 of the sensor head 10, that is executed in the present example according to the tri-clamp standard. Of course, any other type of coupling can be used, which ensures in particular a rigid coupling between the optoelectronic module 40 and the sensor head 10. Thread and bayonet couplings are mentioned as examples.

The rigid coupling is particularly important in the preferred cases of free jet supply and removal of light to and from the sensor head. Such a case is sketched in FIG. A light source 48 fed by an electrical supply unit 46, in particular with an emission spectrum in the NIR, generates an illumination light which, in the case represented by means of a deflection mirror 50, is directed towards the optical window 44 and irradiates it. The illumination light is incident on the reflector disc 16, which is preferably designed as a Lambertian lens, but can also be designed differently, for example as a mirror. The light reflected by the reflector disk 16 again passes through the optical window 44 (this time in the opposite direction) and is recorded at the solid angle 52 to the numerical aperture of the fiber optic input 54 of a spectrometer 56. This structure allows a transflection measurement of a medium which is located between the optical window 44 and the reflector disk 16. In the final assembled state is the Flow chamber 34 of the sensor head 10 at exactly this point.

In addition to the aforementioned components, a reflection flap 58 is provided in FIG. 3, which can be folded into the illumination beam path for calibration purposes, so that the light from the light source 48 is thrown onto the reflection flap via the mirror 50 and mirrored from there to the input 54 of the spectrometer 56 can be scattered. This direct measurement of the illumination light can be used to create a reference with which subsequently measured detection light of a transflection measurement can be compared.

FIG. 4 shows the final assembly state of a disposable container 60 according to the invention. The container consists of a flexible bag 62 which is filled with a fluid 64. In the embodiment shown, an agitator 66 projecting into the interior of the bag 64 is additionally provided, which maintains a permanent flow within the medium 64. In a breakthrough 68 through the wall of the bag 62, the sensor head is used in the manner already described above. In particular, in the embodiment shown, it is welded to the outside of its mounting flange 22 against the inner wall of the bag 62. The flow chamber 34 is flowed through its openings 36 by the fluid 64, wherein the agitator 66 conveys the flow of "fresh" fluid, so that a measurement made on the volume of the flow chamber 34 can be taken as representative of the total bag contents of the sensor head 10 is the optoelectronic sensor module 40 coupled with the tri-clamp coupling structures 25/45 are held together by a clamp 70 in a standard manner. In the preferred embodiment shown in FIG. 4, the coupling structures 25/45 are designed so that the optical window 44 is not parallel to the viewing window 14, but at a low angle, preferably between 1 degree and 3 degrees, particularly preferably 2 degrees lies, takes. As a result, errors are avoided, which can be caused by a reflection of the illumination light on the lens 14.

Of course, the embodiments discussed in the specific description and shown in the figures represent only illustrative embodiments of the present invention. Those skilled in the art will be offered a wide range of possible variations. In particular, the structure of the optoelectronic sensor module can be technically adapted to the respective intended measurement method.

LIST OF REFERENCE NUMBERS

10 sensor head

12 central body

14 viewing window

16 reflector disc

18 main body

20 passageway

22 mounting flange

24 clamping ring

25 coupling structure

26 adjustment plate

28 paragraph

30 seal

32 locking bead

33 locking groove

34 flow chamber

36 flow opening

38 Rastwulst

39 locking groove

40 optoelectronic sensor module 42 housing

44 optical window

45 coupling structure

46 electrical supply unit 48 light source

50 deflection mirror

52 lens

54 fiber optic spectrometer input

56 spectrometers

60 disposable containers

62 bags

64 fluid

66 agitator 68 Wall penetration 70 bracket

Claims

claims

Disposable sensor head for an optical sensor, comprising a central body (12) with

- An axial, by a transversely to its longitudinal direction aligned, transparent lens (14) sealed passageway (20) and

- A circumferential mounting flange (22) by means of which it is sealingly fastened to a wall of a flexible container (62) so that the passage channel (20) passes through the wall,

characterized,

in that the through-channel (20) forms in one section an open flow-through chamber (34) which is delimited on the one hand by the viewing window (14) and on the other hand by a reflector disc (16) arranged opposite the viewing window (14). 2. Sensor head according to claim 1,

characterized,

that the flow chamber (34) at least two

lateral, between the lens (14) and the

Reflector disc (16) arranged openings (36).

3. Sensor head according to one of the preceding claims,

characterized,

that the central body (12) on the

Reflector disc (16) facing away from the

Lens (14) a coupling device (25) for the reversible coupling of an optoelectronic

Sensor module (40).

4. Sensor head according to one of the preceding claims, characterized

in that the central body (12) is constructed in several parts and has a main body (18) and at least one other

Central body component (24, 26).

Sensor head according to claim 4,

characterized,

that the viewing window (14) sealing between the

Main body (18) and a front side of a Klemmrin (24) is held clamped.

Sensor head according to claim 5,

characterized,

in that the clamping ring (24) on its end face remote from the viewing window (14) is the coupling device

(25) for reversible coupling of the optoelectronic sensor module (40).

Sensor head according to one of claims 4 to 6,

characterized,

that the reflector disc (16) on an adjusting plate

(26) fixed at an adjustable distance from the lens (14) on the main body (18) is fixed.

Sensor head according to claim 7,

characterized,

the adjusting plate (26) and the main body (corresponding locking grooves (39) and -wulste (38).

9. Disposable container with flexible wall and at least one disposable sensor head (10) of an optical sensor, wherein the sensor head (10) has a central body (12)

a circumferential mounting flange (22),

has and by means of the mounting flange (22) sealingly attached to the flexible wall such that the passage channel (20) passes through the wall, characterized

in that the through-channel (20) discharges into an open flow chamber (34) of the sensor head (10) positioned inside the container, towards the outside of the container through the viewing window (14) and towards the interior of the container through a reflector disc arranged opposite the viewing window (14) (16) is limited.

10. disposable container according to claim 9,

characterized,

that the mounting flange (22) welded to the wall, glued, and / or by means of a

additional counterpart is jammed.