Abstract:
A sampling device including a closed sample container with a flexible wall and with an interior, a coupling member for releasable coupling to a sample outlet connector, a communicating passage between the coupling member and the interior of the sample container, at least the interior of the sample container being sterile, and a sterility protection device for ensuring the sterility of the interior of the sample container in the form of a three-way valve between the coupling member and the sample container, the three-way valve having a connection to the coupling member, a connection to the sample container and an outlet, and the three-way valve being, before use, in a closed position in which it bars access to the interior of the sample container.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a National Stage of International Application No. PCT/DK2010/050231 filed on Sep. 13, 2010 which claims priority from Denmark Patent Application No. PA 2009 70110 filed Sep. 11, 2009, the contents of all of which are incorporated herein by reference in their entirety. 
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to a sampling device. Such devices are used at, e.g., the sterile sampling through a sampling valve in a processing plant in the brewery industry, the pharmaceutical industry, the food industry, etc. 
     In the said industries and others, processing plants are used in which processes take place in liquids or gases, and from time to time sampling of the contents of, e.g., a container is required to monitor a process taking place in the container. In that connection, it is important that the sample is not contaminated, but that it is representative of the container contents. 
     Therefore, special sampling valves have been developed, see, e.g., WO9012972A and WO2005040671A. These valves are designed so that cleaning fluid, e.g., steam, may be passed through their valve housing and out through a sample outlet to clean and/or sterilize the path of a sample from the container and out through the valve. 
     At times, a simple cleaned, cup-shaped container is used to collect a sample which is passed out through the sampling valve when it is opened. In that way, however, there is a risk of airborne contamination of the sample so that, when analysed later, it is not representative of the contents of the container. 
     Therefore, a sampling device has been developed, which is marketed by Keofitt A/S under the designation: “Item 26000, Aseptic sampling system”. It is in the form of a glass bottle provided with a plug containing a pre-chamber, an inlet connector, a valve which opens and closes a passage to the interior of the bottle, and a valve which opens and closes a passage to the surroundings, and a vent opening arranged between the interior and the surroundings of the bottle and provided with a filter to prevent the ingress of airborne micro-organisms. The valve which opens and closes a passage to the surroundings allows the inlet connector of the sampling device to be connected to a sample outlet connector of a sampling valve by means of a tube, whereupon cleaning fluid, such as steam, is passed through the sampling valve, the tube and the pre-chamber in the plug so that the path of the sample is cleaned and/or sterilized all the way to the chamber in the plug before sampling. However, the use of a glass bottle for sampling may involve various disadvantages. Thus, sampling in some cases takes place in a processing environment rather than in a laboratory, and glass may be a potential danger to the product and the staff. Moreover, a glass bottle system requires prior maintenance, separation, cleaning, assembly and autoclaving as the products are costly and reusable. The preparations imply an implicit user-dependent risk as concerns the sterile interior of the sample container. 
     BRIEF SUMMARY OF THE INVENTION 
     The object of the invention is therefore to provide an alternative sampling device that may ensure sterile sampling without the use of a glass bottle. 
     According to the invention, this is obtained by means of a sampling device which is characterized in comprising a closed sample container with a flexible wall and with an interior, a coupling member, such as a socket, for coupling to a sample outlet connector, and a communicating passage between the coupling member and the interior of the sample container, at least the interior of the sample container being sterile, and in comprising a sterility protection for ensuring the sterility of the interior of the sample container in the form of a three-way valve between the coupling member and the sample container, that is, a valve with at least three ways into and/or out of the valve, the three-way valve having a connection to the coupling member, a connection to the sample container and an outlet, and the three-way valve being, before use, in a closed position in which it bars access to the interior of the sample container. In addition to obviating glass, the use of a sample container with a flexible wall obviates the need for a vent opening as the sample container can expand as it is being filled with a sample. The sterility protection ensures that the interior of the sample container is kept sterile until the sample is collected, when it will be necessary to break the sterility protection to allow the sample to enter the sample container. By barring access to the interior of the sample container, the three-way valve closes the sample container. The sterility protection comprises or is constituted by the three-way valve, which prevents the ingress of contamination, such as airborne micro-organisms, into the sample container in its closed position. The three-way valve allows sterilization of the connection between a sampling valve and the sampling device up to the three-way valve. 
     In a preferred embodiment, the sampling device is a single-use product, whereby sterility may be ensured already by the manufacturer of the product. 
     Preferably, the three-way valve is provided with a tamper-evident blocking device. The tamper-evident blocking device ensures that the valve is not opened until the sampling device is to be used or that a user is warned if the valve has been opened so that sterility has been compromised. 
     The sampling device preferably comprises a temperature indicator, whereby it may be ascertained when the sterilization temperature has been reached if, e.g., steam is used for sterilization. 
     The outlet of the three-way valve may be provided with an outlet connector. This makes it possible to mount a pressure valve which only opens for passage when a certain pressure is present in the three-way valve, whereby it is possible to obtain a higher temperature of steam used for sterilization of the sampling valve and the connection to the sampling device. 
     In that connection, it should be understood that the sampling device is preferably steam sterilizable as it is preferably made from materials, at least from the coupling member to the three-way valve, both included, which can tolerate steam sterilization at the pressures and temperatures used in the relevant processing plant, e.g., 1 bar(g), 121° C., cf. www.ehedg.org. 
     In a preferred embodiment, the three-way valve comprises a valve housing and a movable valve body with at least one through passage. This allows the valve to be designed with few components for the sake of the manufacturing costs. 
     The tamper-evident blocking device preferably comprises a tear-off member preventing the three-way valve from being set to any position other than the closed position. 
     In one embodiment, the tear-off member comprises a member, particularly a film member, which encapsulates the three-way valve at least partially. The film member may be a substantially non-stretchable shrink film. 
     In a preferred embodiment, the tear-off member comprises a portion of the valve housing, which portion blocks movement of the valve body. 
     In an alternative or supplementary embodiment, the sterility protection comprises a sterile packaging encapsulating the sample container, the coupling member and the communicating passage between them. 
     Preferably, the communicating passage between the coupling member and the interior of the sample container has an internal diameter of at least 4 mm. This allows sampling of viscous liquids or liquids with suspended particles. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The invention will now be described in more detail below by means of examples of embodiments and with reference to the schematic drawing, in which 
         FIG. 1  is a view of a sampling valve and a sampling device according to the invention, 
         FIG. 1 a    is a view of the sampling valve in its open position, 
         FIG. 2  is a close-up perspective view of a coupling member and a three-way valve of the sampling device of in  FIG. 1 , 
         FIG. 3  is a partially sectional view of the sampling device of  FIG. 1 , 
         FIG. 4  is a view of the sampling device in a packaging, 
         FIGS. 5-8  are sectional views of the three-way valve of  FIG. 2  in different positions, 
         FIG. 9  is a view of a sampling device with a second embodiment of the three-way valve, and 
         FIGS. 10 and 11  are sectional views of the second embodiment of the three-way valve in different positions. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows a sampling valve  1  which is mounted on a wall of a container or contents container  2  to enable sampling of the contents of the contents container  2  through a sample inlet  3  in the sampling valve  1 . This further has a sample outlet connector  5 , a cleaning inlet  7 , a valve chamber  9  and a valve body  11 . The sampling valve shown otherwise substantially corresponds to the embodiment disclosed in WO9012972A. It should be understood that there is free passage through the valve chamber  9  from the cleaning inlet  7  to the sample outlet connector  5  around the valve body  11 , also when the valve body  11  closes the sample inlet  3 , as shown in  FIG. 1 . 
       FIG. 1  further shows a sampling device  13  comprising a sample container  15  with a flexible wall  17  made of a suitable plastics material. The wall  17  is divided into panels interconnected through welds and/or scoring lines  19  which facilitate the mutual movement of the relatively rigid panels between a flat (not shown) and an unfolded state of the sample container  15 . The sample container  15  is hermetically sealed apart from an opening  21  to which a tube section  23  has been fitted. A three-way valve  25  has been inserted into the tube section  23 , and at the end of the tube section  23  a coupling member in the form of a socket  27  has been provided for connection to the sample outlet connector  5  of the sampling valve  1 . In this way, a communicating passage has been provided through the socket  27 , the tube section  23 , the three-way valve  25  in its open position to be described in detail below, and the opening  21  to the interior of the sample container  15 . This communicating passage is designed so that it has an internal diameter of at least 4 mm, preferably 6 mm, throughout its course to allow the sampling of viscous liquids or liquids with suspended particles without any risk of blocking of the communicating passage. 
     In the embodiment shown in  FIGS. 1-8 , the three-way valve  23  comprises a cylindrical, tubular valve housing  29 , through which extends a cylindrical valve body  31 . The valve housing  29  has two opposite tube connections  33   a  and  33   b  opening into the interior of the valve housing  29 . At one end of the valve housing  29  a recess  35  is provided with a shallow part  35   a  and a deep part  35   b  which is partially filled by a tamper-evident blocking device in the form of a tear-off portion  37  with a tab  39 . The tear-off portion  37  is connected with the rest of the valve housing  29  through two weakened, linear areas  40 . 
     The valve body  31  has a handle  41  at one end and is provided at the other end with a connector  43  abutting the adjacent end of the valve housing  29 . The valve body  31  is tubular with an internal cavity interrupted at the middle of the length of the valve body by a transverse passage  45  which is closed against the cavity. Additionally, the valve body  31  has an opening  47  in its side through which opening  47  there is a passage out through the connector  43 . Moreover, the valve body has a projection  49  located at the shallow part  35   a  of the recess  35  in the valve housing  29  ( FIG. 2 ). Accordingly, the valve body  31  is in a closed position in which the passage to the interior of the sample container  15  is barred so that the sample container  15  is hermetically sealed. By contrast, at this position of the valve body  31  there is a passage in through the socket  27 , the tube section  23  connected thereto, the tube connection  33   a , the opening  47  in the side of the valve body  31  and out through the connector  43 . 
     In the embodiment shown, the socket  27  is designed as a snap coupling having an internal, slotted, cup-shaped part  51  with internal claws  53  for engagement with an annular groove in a connector, such as the sample outlet connector  5 , and having an outer, displaceable, cup-shaped part  55  for sliding forward over the internal cup-shaped part  51  in order to lock the claws into engagement with the connector. The bottom of the internal cup-shaped part  51  is adapted for close engagement with the connector when the claws are in engagement with the groove of the connector. In an alternative embodiment, the socket or the coupling member could be constituted by a suitably flexible, possibly widened tube end. 
     As shown in  FIG. 3  and explained above, the three-way valve  25  is in a position in which the sample container  15  is hermetically sealed. As the sample container  15  has been sterilized, e.g. by radiation sterilization, and as it cannot be opened due to the presence of the tear-off portion  37 , the sterility of the interior of the sample container  15  and the passage to the three-way valve  25  is ensured, and the tear-off portion  37  constitutes a sterility protection. 
       FIG. 4  shows a variant of the sampling device in which the three-way valve  25  lacks the tear-off portion  37  as compared with the embodiment of  FIGS. 2 and 3 . The three-way valve is in the closed position shown in  FIGS. 2 and 3 , but the sample container  15  with the tube section  23 , the three-way valve  25  and the socket  27  is encapsulated in a sealed, sterilized packaging  57  of a type known per se to ensure the sterility of the interior of the sample container  15 . In this case, the packaging  57  constitutes a sterility protection. It should be understood that, for the sake of illustration, the sample container  15  in  FIG. 4  is shown in its unfolded state. In reality, the sample container  15  will be in its flat state in the packaging  57 . 
     The sampling device is used in the following manner: 
     The sterilized packaging  57  is opened and removed if present. The socket  27  is connected with the sample outlet connector  5  of the sampling valve  1 . Then the sampling valve is cleaned and/or sterilized in the usual manner by cleaning fluid, such as steam, being passed through the cleaning inlet  7 . The cleaning fluid flows through the valve chamber  9  and out through the sample outlet connector  5 . As the socket  27  is connected with the sample outlet connector  5 , the cleaning fluid flows on through the tube section  23  between the socket  27  and the three-way valve  25 , which is in its closed position at this point as described above. Therefore, the cleaning fluid flows in through the tube connection  33   a , through the opening  47  in the cylindrical valve body  31  and out through the connector  43 . As the three-way valve  25  is in its closed position while any packaging is removed and the socket  27  is connected to the sample outlet connector  5 , the sample container  15  is prevented, due to elasticity, from unfolding and sucking in air from the surroundings, which might compromise the sterility of the interior of the sample container  15 . 
     The connector  43  may be connected to a device for collecting the outflowing cleaning fluid and/or a pressure valve which only opens for throughflow when a certain pressure has been obtained upstream of the pressure valve so that, e.g., a higher steam pressure and thereby a higher temperature can be obtained in the parts through which the cleaning fluid or the steam flows. 
     In this way, the sampling valve  1  and the passage from it to the three-way valve  25  has been cleaned and/or sterilized. In the embodiment shown, a temperature indicator  59  of a type known per se indicating when a specific temperature has been reached and sterility is ensured has been provided on the tube section  23  between the socket  27  and the three-way valve  25 . 
     The three-way valve  25  is now opened by initially removing the tear-off portion  37  if it is present. The three-way valve  25  is thus in the position shown in  FIG. 5 . 
     By means of the handle  41 , the cylindrical valve body  31  is turned 90° to the position shown in  FIG. 6 , whereby the passage from the tube connection  33   a  to the connector  43  is closed, and the projection  49  is brought from the shallow part  35   a  of the recess  35  to the deep part  35   b.    
     The cylindrical valve body  31  is now pressed down to the position shown in  FIG. 7 , the projection  49  being moved to the bottom of the deep part  35   b  of the recess  35 , and the transverse passage  45  being brought into alignment with the tube connections  33   a  and  33   b . There is now an open passage throughout the tube  23  and thereby from the sampling valve  1  to the interior of the sample container  15 . 
     The sampling valve  1  is opened in a manner known per se by the valve body  11  being moved away from the sample inlet  3  to the position shown in  FIG. 1 a   , and a desired quantity of the contents of the contents container  2  is collected into the sample container  15 , which expands by virtue of its flexibility as it is being filled, whereupon the valve body  11  is returned to the position shown in  FIG. 1 . 
     As the projection  49  slides into a groove  60  extending in the circumferential direction from the bottom of the deep end  35   b  of the recess  35 , the cylindrical valve body  31  is subsequently turned a further 90° to the position shown in  FIG. 8 , whereby all passages in the three-way valve  25  are closed. The socket  27  can now be disconnected from the sample outlet connector  5 , and the sample container  15  with sample can be taken to the laboratory for analysis of the sample without any risk of it being contaminated along the way. 
       FIGS. 9-11  illustrate a sampling device  13 ′ as the one shown in  FIGS. 1 and 3 , and therefore corresponding parts are provided with the same reference numerals, but with a different three-way valve  25 ′. This comprises an elongated valve housing  29 ′ with an axial direction and a chamber having a first coaxial, cylindrical section  61  and a second section  63  enlarged in relation thereto. An outlet opening  65  and a tube connection  33   b ′ are provided in an end wall of the valve housing  29 ′. A valve body  31 ′ is axially displaceable in the valve housing  29 ′ and has a coaxial tube connection  33   a ′ and a coaxial pocket hole  67  communicating with a transverse passage  69  in the valve body  31 ′. The valve body  31 ′ is sealed relative to the first coaxial, cylindrical section  61  of the chamber of the valve housing  29 ′, and it is axially movable between a closed position shown in  FIG. 10  and an open position shown in  FIG. 11 . 
     An outlet opening  71  flushing with the transverse passage  69  when the valve body  31 ′ is in the closed position is provided in the wall of the valve housing  29 ′. This makes it possible to clean and/or sterilize a passage through the socket  27  and the tube section  23  up to the three-way valve  25 ′ as described with reference to  FIGS. 1-8  and particularly  FIG. 5 . 
     The valve body  31 ′ has an annular collar  73  abutting a tamper-evident blocking device in the form of a tear-off portion  37 ′ with a tab  39 ′. The tear-off portion  37 ′ is connected with the rest of the valve housing  29 ′ through a weakened linear area  40 ′ and prevents the valve body  31 ′ from being moved away from the closed position, and it thereby ensures the sterility of the sample container  15  in the same way as the tear-off portion  37  in the embodiment described above. 
     When the tear-off portion  37 ′ has been removed, the valve body  31 ′ may pressed axially in a direction towards the outlet opening  65 , projections  75  in the enlarged section  63  of the valve chamber preventing the valve body from blocking the outlet opening  65 . Accordingly, the three-way valve  25 ′ is in an open position corresponding to the open position of the three-way valve  25  shown in  FIG. 7  as there is a passage from the tube connection  33   a ′ to the tube connection  33   b ′ through the pocket hole  67 , the transverse passage  69 , the enlarged section  63  of the chamber of the valve housing  29 ′, between the projections  75  and through the outlet opening  65 . 
     It should be noted generally that the sample container is provided with a second opening  81  which is closed with a screw plug  83 . This second opening  81  may possibly be used to drain off the contents of the sample container after sampling. The sample container may also be provided with a septum (not shown) for removal of part of its contents by means of a syringe. Moreover, the sample container is provided with an eye  85  which permits suspension of the sample container  15 . 
     It should be noted that features described in connection with one embodiment may be used in several cases as a supplement or an alternative in others of the embodiments described. A non-stretchable shrink film may be used as a tamper-evident blocking device at the three-way valves  25  and  25 ′.