SAMPLE PREPARATION CONTAINER

Abstract

A sample preparation container, preferably for use in sterility testing, comprising a housing (1) having a housing wall (2) defining an inside space (3), a support on which a membrane filter is placed or is to be placed so as to get in contact with a sampling fluid to be introduced into the inside space (3), and at least one inlet opening (4) to the inside space (3) and at least one outlet opening from the inside space (3). A sampling port (5) is provided for allowing access from the outside to the inside space (3), wherein said sampling port (5) is closed by a septum (6) and the septum (6) is separated from the inside space (3) by a barrier wall (7) which is preferably piercable or breakable on application of an external force, preferably applied through a sampling instrument like a needle (8).

Claims

1. A sample preparation container, preferably for use in sterility testing, comprising a housing (1) having a housing wall (2) defining an inside space (3), a support on which a membrane filter is placed or is to be placed so as to get in contact with a sampling fluid to be introduced into the inside space (3), at least one inlet opening (4) to the inside space (3) and at least one outlet opening from the inside space (3), and a sampling port (5) for allowing access from the outside to the inside space (3), wherein said sampling port (5) is closed by a septum (6;10) and the septum (6;10) is separated from the inside space (3) by a barrier wall (7).

2. The sample preparation container according to claim 1, wherein the barrier wall (7) is continuous/seamless with a part of the housing wall (2).

3. The sample preparation container according to claim 1, wherein the barrier wall (7) is integrally formed with a part of the housing wall (2).

4. The sample preparation container according to claim 3, wherein the barrier wall (7) is formed as a thinned part of the housing wall (2).

5. The sample preparation container according to claim 1, wherein the barrier wall (7) is piercable or breakable on application of an external force, preferably applied through a sampling instrument like a needle (8).

6. The sample preparation container according to claim 5, wherein the barrier wall (7) has a preformed piercing location and/or tear line, preferably formed on the side facing the septum (6;10).

7. The sample preparation container according to claim 1, wherein at least the part of the container wall (2) in the vicinity of and, optionally, including the barrier wall (7) is rigid or flexible.

8. The sample preparation container according to claim 1, wherein the septum (6) is located in a holding space (9) adjacent to the barrier wall (7).

9. The sample preparation container according to claim 8, wherein the holding space (9) is integrally formed with the housing wall (2) or is formed in an insert that also includes the barrier wall (7).

10. The sample preparation container according to claim 8, wherein the septum (6) is in the form of a block of piercable material and is held in the space (9) by a form-locking protrusion (12).

11. The sample preparation container according to claim 1, wherein the septum (6) is arranged adjacent to the barrier wall (7) substantially without any void volume located therebetween.

12. The sample preparation container according to claim 1, wherein the septum (10) is arranged on the sampling port (5), preferably in the form of a cap that surrounds at least part of the periphery of the sampling port (5).

13. The sample preparation container according to claim 12, wherein the septum (10) is arranged on the sampling port (5) such that a cavity (11) is formed between the septum (10) and the barrier wall (7).

14. The sample preparation container according to claim 1, wherein the septum (6) is in the form of a block of piercable material that has a self-sealing property.

15. The sample preparation container according to claim 1, wherein the septum (6) is protected from contact with the outside environment by means of a removable cap or seal.

Description

[0018] These and other aspects will become apparent from the description of preferred embodiments described below in connection with the attached drawing. In this drawing:

[0019] FIG. 1 is a perspective partial cross-sectional view of a sample preparation container according to an embodiment of the invention where a needle is partly inserted into a septum;

[0020] FIG. 2 is a perspective partial cross-sectional view of the sample preparation container of FIG. 1 where the needle is fully inserted into an inside space;

[0021] FIG. 3 is a perspective partial cross-sectional view of the sample preparation container according to an alternative design where the needle is inserted through the septum but not yet through the barrier wall; and

[0022] FIG. 4 is a perspective view of a known sample preparation container.

[0023] An example of a preferred embodiment of a sample preparation container of the invention is shown in FIGS. 1 and 2 at two stages of use in a sampling operation. The Figs. only show a part of the upper section of the container with details other than those related to the sampling port being omitted. The further features of the sampling container can be the same as or similar to those in the prior art of such containers, for example those described in connection with FIG. 4.

[0024] The housing 1 of the sample preparation container has a housing wall 2 defining an inside space 3. A support (not shown) on which a membrane filter is placed or is to be placed so as to get in contact with the sampling fluid to be introduced to the inside space 3 is formed inside the container (for example as shown and described in connection with the prior art of FIG. 4). The sample preparation container of the invention like the one shown in FIG. 4 has at least one inlet opening 4 to the inside space 3 and at least one outlet opening (not shown) from the inside space 3.

[0025] A sampling port 5 is provided for allowing access from the outside to the inside space 3. The sampling port 5 includes a septum 6, preferably in the form of a block of piercable material which has self-sealing properties and which is held in a space 9 defined by a cylindrical wall protuding from the housing wall, for example at an upper end of the housing 1. The cylindrical wall surrounds a barrier wall 7 which separates the septum 6 from the inside space 3 of the container. The barrier wall 7 is integrally formed with the housing wall 2 and, in this case, is formed as a thinned part of the housing wall 2. There are preferably no crevasses or cracks or other protrusions or recesses on the inside wall as the barrier wall 7 is continuous/seamless with the part of the housing wall were it is formed.

[0026] Due to the thin wall thickness the barrier wall is more easily piercable or breakable on application of an external force, preferably applied through a sampling instrument like a needle or syringe 8. In FIG. 1 the needle is shown partially inserted through the septum 6 but not yet through the barrier wall 7. In order to facilitate breaking/opening of the barrier wall with a defined force and with a defined retaining of fragments to the peripheral wall the barrier wall 7 is preferably formed with a preformed piercing location and/or tear line or lines, which are preferably formed on the side facing the septum in order to avoid crevasses or protrusions on the side facing the inside space.

[0027] The holding space 9 for the septum defined by the cylindrical protruding wall is located adjacent the barrier wall 7. The FIG. 2 shows a situation where the needle is fully inserted through the septum and through the barrier wall. As shown, the fragments of the barrier wall still adhere to the container at the periphery and preferably are in close contact to the outside of the needle due to their resiliency to maintain tight contact to reduce the risk of ingress of contaminants. Pulling out of the needle from the sampling port will at least partly restore the fragments of the barrier wall into their initial orientation but will of course not fully close the sampling port. The material properties and structure of the septum provide for the re-sealing of the sampling port.

[0028] The septum 6 is arranged adjacent and close to the barrier wall 7 substantially without any void volume located there between in order to reduce the potential retaining spaces or crevasses for a situation after the sampling port has once been opened.

[0029] The outside periphery of the cylindrical wall defining the holding space 9 is formed with a form-locking protrusion 12 protruding radially inside from the wall. This protrusion allows subsequent insertion of the septum after forming of the container and avoids that the septum is inadvertently withdrawn from the holding space 9 together with the sampling instrument. The dimensions of the block of the septum and the size of the space 9 can be adapted such that the septum, once inserted is maintained in an elastically deformed state such that it is constantly tightly pressed against the barrier wall in order to reduce any void volume. Other forms of protrusions are possible like plural inward-protruding teeth spaced about the periphery. A separate element, i.e. a flange, mechanically fixing the septum in the holding space can be provided instead of an integrated holding feature. The rounded or chamfered rim bordering the radial inner end of the protrusion 12 facilitates insertion of the septum.

[0030] FIG. 3 is a perspective partial cross-sectional view of a sample preparation container according to an alternative design where the septum 10 is arranged on the sampling port 5, preferably in the form of a cylindrical cap that surrounds at least part of the periphery of the sampling port 5. The port 5 in this case is a cylindrical wall or other form of protrusion formed on the upper wall of the container 1. Preferably the septum in this design surrounds and covers the entire outer periphery of the protrusion to maximize the sealing effect. The inner volume of the protrusion in the alternative design as shown is not filled with the septum 10 but is in the form of a cavity 11 that is formed between the septum 10 and the barrier wall 7. However, the septum in the form of a cylindrical cap can be provided with an inner stem or plug (not shown) that is at least partly inserted into the cavity.

[0031] The alternative design having the septum arranged on the sampling port, i.e. on the outside thereof, provides an advantage that a needle 8 or any other instrument used to pierce the septum and the barrier wall can be guided through the cavity 11, even if it is partly filled with septum material, and there is thus no risk that a force imparted on the septum though the needle, i.e. by friction or lateral movements causes the septum to dislocate from contact with the lateral side wall of its receptacle that could open an undesired path for ingress of contaminants from the outside. Thereby, the septum will even further contribute to maintaining the sterility of the container even after it has been pierced once. The other properties of the septum are the same as those described in connection with FIGS. 1, 2 and 4.

[0032] Although not shown the sampling port including the septum can be protected from contact with the outside environment of the container by means of a removable cap or seal that can be connected to the outer periphery of the wall defining the holding space 9 and/or to the top axial end surface of this wall and/or on the outer periphery of the septum in the case where this is already placed on the port as described above, i.e. by a threaded engagement, a frictional fit or a bonding connection.

[0033] Although the barrier wall 7 as well as the wall defining the holding space 9 for the septum 6 are shown to be integrally formed with the material of the container, these elements could be formed in the form of a separate insert that is either insert-molded with the material of the container at an appropriate location or is attached to an opening of the housing wall after the same has been formed. In this case the transition between the insert and the inner wall of the container should of course be sealed to avoid the crevasses or gaps that could retain antibiotics leading to potentially false testing results.

[0034] For the material of the container and for the septum any known materials used in the field can be used. The container can be made from a flexible material or from a rigid or semi-rigid material. The material and properties of the barrier wall and, if desired, of a certain periphery thereof can be different from those of the rest of the container. For example, while the container can be flexible in the form of a bag, the barrier wall and a part of its periphery can be relatively more rigid to withstand the forces when the sampling instrument is inserted to pierce the septum and rupture the barrier wall. The holding space for the septum can be formed with the more rigid barrier wall as well. Vice versa the barrier wall can be relatively more flexible as compared to a rigid container wherein this property could be achieved by sufficiently thinning out the barrier wall as compared to the thickness of the wall of the container.