Syringe needle holder, container provided with syringe needle holder and method of sampling / injecting substance from / into a container

Abstract

A syringe holder comprising a base 2, a tube guide 3 for releasably holding a routing a tube (T) in a defined position relative to the base 2. A syringe needle guide 4 for releasably holding a syringe

Description

The present application relates to a syringe needle holder, a container provided with the syringe needle holder and a method of sampling / injecting a substance from / into a container, particularly for use in the field of microbiological sterility testing. Background The invention in particular, but not limited, relates to the field of microbiological sterility testing in a phase of the process where containers filled with culture media are incubated for a certain period of time, for example 14 days, to finally determine the presence or absence of microorganisms in a fluid sample. in this period, intermediate readings of the containers, before the final reading, can be taken by simple visual inspection for the presence or absence of culture media turbidity, the presence of which may be indicative of the presence of microorganisms. If turbidity is observed, one needs to safely extract an aliquot of the sample fluid from the container, i.e. without contaminating the sample in the container and / or risking injury to the user. In some applications one may also want to inject a substance (fluid) into the container, again without contaminating the sample in the container and / or risking injury to the user. A typicai container for accommodating the sample fluid for sterility testing is a cylindrical vessel that is substantially dosed in use and has a port for allowing the sample liquid to be introduced into the container, and a vent allowing gas to escape in the filling stage. The port and the vent are typically formed at a top of the vessel, possibly in a lid of the container. A flexible tubing loop may connect or bridge the port and the vent during incubation. A current method to extract an aliquot of the sample fluid during incubation is to remove the tubing from the port, e.g. by cutting it off, to gain access to the interior of the container through the open port. However, removing the tubing entails the risk of injury or introducing contaminants as it is more difficult to close off the container to the environment thereafter. Alternatively, the tubing loop may be pierced with a syringe needle at a position suitable to enter the port via the lumen / hollow of the tubing and reach inside the container with the end of the needle. If required, the piercing position should be chosen to leave enough clearance for a clamp to be put between the piercing point and the port (1 to 2 cm depending on the needle length) to subsequently squeeze and block the flexible tubing. Both above mentioned current methods are not easy to perform as they are processes that require some experience and are not really safe for the user as they involve a risk of having the needle not properly reaching the hollow / lumen of the tubing, slipping off of the needle due to a rolling motion of the tubing, or coming out of the tubing again and injuring the user and / or spilling sample fluid or substance outside the container. The invention aims at providing a solution to manage, in an easy, safe and secured manner, the sampling or inoculation (injection) of a container, in particular a container for sterility testing, while also minimizing or at least reducing the risk of introducing contaminants into the container. Summary The present inventors have now surprisingly found that the above objects may be attained either individually or in any combination by the present syringe needle holder with the features of claim 1, the present container with the features of claim 12 provided with the syringe needle holder, and the present method of sampling / injecting a substance from / into a container with the features of claim 14. Preferred embodiments are defined in the respective dependent claims. The invention accordingly provides for a syringe needle holder comprising (i) a base, (ii) a tube guide for releasably holding and routing a tube in a defined position relative to the base, and (iii) a syringe needle guide for releasably holding a syringe needle in a defined position relative to the base such that the syringe needle, when placed in the syringe needle guide, is directed to a position on the tube when placed at the tube guide to puncture the tube to reach a hollow / lumen of the tube. Preferably, the base is formed to be attached, preferably removably, to an outside of a tube that is connected or is connectable with a port of a container in that the tube is placed in the tube guide. Preferabiy, the base Is formed on or is configured to be attached, preferably removably, to an outside of a container provided with a port that is connected or is connectable with a tube so as to allow placement of the tube in the tube guide when the syringe needle holder is attached to the container. Preferably, the base includes a mechanical interface for removable attachment to the container, wherein the mechanical interface is preferably configured to be mechanically attached to a top peripheral edge of the container. Preferably, the syringe needle guide is configured to guide a sliding motion of the syringe needle relative to the base, preferably by engagement with the syringe needle, towards and away from the position at which the tube is punctured, when the tube is placed at the tube guide. Preferably, the tube guide and the syringe needle guide are configured and positioned relative to each other such that the syringe needle after puncturing the tube and upon further sliding motion of the syringe needle relative to the base is guided inside and along the hollow / lumen of the tube. Preferably, the tube guide comprises a releasable lock for retaining the tube in the defined position. Preferably, the syringe needle holder further comprises a clamp configured to selectively squeeze and block the tube placed at the tube guide at a position that is located at or is spaced from the position where the syringe needle punctures the tube, preferably is spaced downstream in a direction in which the syringe needle advances inside the hollow / lumen of the tube and upstream from an end of the tube attached to or to be attached to a / the port of the container (i.e. between the point at which the syringe needle punctures the tube and the end of the tube attached to or be attached to a / the port of the container). Preferably, the damp is part of the tube guide. Preferably, the base, the tube guide, the syringe needle guide, and preferably, if provided, the clamp are fixed relative to each other to form a self-contained accessory device, preferably are integrally formed, preferably molded or formed by additive manufacturing. Preferably, the syringe needle holder further comprises a plug or cap for closing access to a piercing hole created at the piercing position in the tube by the syringe needle, the plug or cap preferably attachable to the syringe needle guide to close an insertion opening for the syringe needle. The invention also provides a container for accommodating culture media for sterility testing, the container provided with a port connected or connectable with a tube and comprising, at a top of the container, a syringe needle holder according to the invention to allow sampling or injection of a fluid from / into the container by means of a syringe needle, placed in the syringe needle holder, via the port through a hoilow / iumen of the tube. Preferably, the syringe needle holder is integrally formed with a part of the container or is removably attached to a part of the container and / or to a tube connected the port of the container. The invention also provides for a method of sampling / injecting a substance from / into a container provided with a port communicating with an interior of the container, the port connected or connectable with a tube and preferably provided in a top of the container, the method comprising: (a) providing the syringe needle holder as described herein; (b) attaching a syringe needle holder as described herein to the container or a / the tube and placing the a / the tube into the tube guide; (c) connecting an end of the tube with the port if unconnected; (d) inserting a syringe needle into the syringe needle guide and advancing the syringe needle to puncture the tube and slide through and alonga hollow / lumen of the tube towards the interior of the container via the port; (e) sampling / injecting the substance from / into the interior ofthecontainerthrough the syringe needle, if required by tilting the container to submerge a tip of the syringe needle; and (f) retracting the syringe needle from the container and optionally removing the syringe needle from the syringe needle holder. Preferably, the method further comprises, after the step of retracting the syringe needle from the container, a step of squeezing and blocking the tube at a position that is located at or is spaced from the point where the syringe needle punctures the tube, preferably is spaced downstream in a direction in which the syringe needle advances inside the hollow / lumen of the tube and upstream from the end of the tube attached to the port of the container. Brief descriptton of the drawings The present invention will in the following be described in further detail on the basis of preferred but non-limiting exemplary embodiments by reference to the foiiowing attached schematic exemplary drawings: Figure la to 1g show a perspective view of a first embodiment of a syringe needle holder and its application in typical steps of a sampling process performed in connection with a sample container for sterility testing (collectively referred to as Figure 1 below); Figure 2 shows a perspective view of the syringe needle holder according to the first embodiment; Figure 3 shows a perspective view of the syringe needle holder according to the first embodiment attached to a sample container for sterility testing before the needie is inserted into the syringe needle holder and tube; Figure 4 shows a perspective view of the syringe needle holder according to the first embodiment attached to a sample container for sterility testing after the needle is inserted into the syringe needle holder and tube. It is noted that for reasons of clarity the liquid and consequently the liquid level in the container as shown in the Figures has been omitted. Detailed description The syringe needle holder of the invention provides a possibility to sample or inoculate a substantially closed container by a syringe needle (preferably attached to a manually operable syringe) in a defined process without risk of injury / contamination for a user but also without risk of contamination for the sample aliquot extracted from the container and the sample retained in the container for prolonged incubation as it allows easy and safe sampling or inoculation and also maintains the container integrity after the sampling / inoculation step. As this solution of the syringe needle holder is an accessory or add-on device, either for repeated or for single use, in particular for use in the field of microbiological sterility testing of containers filled with culture media, it avoids advance or initial implementation on all the containers for holding the sample to be tested so that unnecessary cost and material consumption are avoided if the functionality is not needed. It is therefore an economical and also sustainable solution to enhance the specific functionality required for sterility testing. Though it is generally preferred for the present syringe needle holder to be a separate accessory of add-on device, it may also be integrally formed with a part of the container. The main features / functions of this accessory are: - Sterile access to the interior ofthe container and, if the integral damp described herein is provided, facilitated closure after sampling; - Reduction of the number of components to be handled in the sampling / inoculation process; - Intuitive and stable set-up on the container and / or the tube; - Secure and defined guiding and holding of the tube in an optimized position facilitating its piercing by the syringe needle; - Secure and defined guiding of the syringe needle to avoid any risk of having the needle injuring the user or failing to reach the inside of the container, i.e. by coming out of the tube or slipping away upon insertion. A syringe needle holder 1 according to a first embodiment of the invention comprises a base 2, a tube guide 3 for releasably but fixedly holding and routing a flexible tube or tubing T (in the following only "tube") in a defined position and orientation relative to the base 2, and a syringe needle guide 4 for releasably holding a syringe needle N in a defined position relative to the base 2 such that the syringe needle N, when placed in the syringe needle guide 4, is directed to a position on the tube T placed in the tube guide 3 to puncture the tube T to reach a hollow / lumen of the tube T in a predefined relative orientation of the two. In the first embodiment of the syringe needle holder 1 of Figures 1 to 4, the base 2 is designed to be preferably removably attached to a part of an outside of the container C that is provided with a port P that is connected or Is connectable with a tube T, but which may also be directly formed or fixedly attached to the outside of the container, e.g. glued, welded, screwed or otherwise mechanically attached. To this end the base 2 is formed so as to allow placement of the tube T that is attached to the port P in the tube guide 3 in a fixed or substantially fixed defined relative position when the syringe needle holder 1 is attached to the container C. The base 2 of the syringe needle holder 1 leaves space to surround the port P with the tube T remaining attached to the port P and such that the needle guide 4 described later is located with a distance above and aligned with the port P without the need to remove the tube T from the port P as the syringe needle guide 1 is attached to the container C, The base 2 and tube guide 3 may be an integral one-piece part with a certain limited elastic deformation capability to allow routing of the tube T through the tube guide. The elastic deformation and restoring capability is of course not such that the tube is compressed to block fluid flow through the tube and / or prevent insertion of the syringe needle as described further below. In a modification, that is not shown, the base 2 can be made from two mating parts that can be separated to provide access to the receptacle for the tube and combined with each other and fixedly connected to each other by a mechanical lock that is integrated or in the form of a separate fastener, with or without a hinge connecting the two parts, but, in any case, such that the tube is fixedly held in its position in the tube guide when the parts are combined without blocking the fluid flow and / or prevent insertion of the syringe needle. In the first embodiment as shown, the base 2 of the syringe needle holder 1 is designed to be mainly fixedly attached to the top of the container. The routing of the tube T through the tube guide will contribute to holding the syringe needle holder in place on the container in conjunction with the holding force applied by the base to the container which is helpful in rendering it less mobile and less likely to inadvertently move upon insertion of the syringe needle. This helps reducing the risk of injury to a user inserting the syringe needle. A second embodiment of the syringe needle holder 1 that is not shown in the Figures differs from the first embodiment in that its base is formed to be attached, preferably removabiy, primarily to an outside of the tube T that is connected or is connectable with a port P of a container C in that the tube T is placed in the tube guide. The base thus integrates the tube guide in that the base is provided with a receptacle shaped so as to fix and force the flexible tube into the defined position relative to the base, and with an opening through which the tube can be inserted into the receptacle. In this second embodiment the opening may be sized slightly smaller than the width of the tube such that the tube must be pushed into the receptacle by applying a certain force elastically deforming the tube and / or the base to a certain extent. In this case the base may be an integral one-piece part with a certain limited elastic deformation capability. In the second embodiment, the base of the syringe needle holder is designed to be only attached to the tube T but not to the container. In a slight modification where the base is configured to be attached to the tube at the position where the same is connected with the port, which port may be in the form of a small chimney protruding from the top of the container and reaching into the end of the tube for a certain distance, the pressure applied by the base to the tube can be relatively high as it will be borne by the port so that, in combination with the rigid attachment of the port to the container, the base will also be fixed in position relative to the container via its attachment to the port. In the syringe needle holder 1 according to the first embodiment the base 2 preferably includes a mechanical interface 5 for removable attachment to a part of a periphery of the container C, wherein the mechanical interface 5 is preferably configured to be stably mechanically attached to a top peripheral edge of the container C so that it straddles the upper end over the diameter and has two or more spaced apart attachment portions distributed about the periphery that may engage with a rim or edge of the container in a form-locking or frictional engagement supported by a certain elastic deformation of the interface 5. As shown, the outer peripheral surface of the interface 5 may be curled or ribbed to improve a manual grip. The use of several spaced apart and interrupted attachment portions reduces the material needed but the attachment portions may be continuous as well. The base 2 is shaped so as to allow access to any port and / or vent on the container when attached and has appropriate recesses. In the first and second embodiments of the syringe needle holder 1 the syringe needle guide 4 is configured to receive the syringe needle N at an Insertion opening 14 and guide a sliding motion of the syringe needle N relative to the base 2, preferably by engagement with the syringe needle N, towards and away, i.e. in the opposite directions, from the point where to puncture the tube T, when the tube T is placed in its fixed defined position in the receptacle at the tube guide 3. The inner diameter of the syringe needle guide is slightly larger than the outer diameter of the syringe needle to allow the sliding movement without substantial application of force but to still securely hold and guide the syringe needle within the needle guide. To this end the syringe needle guide 4 is formed as a materia! portion of the base 2 through which an elongated hole with an inner diameter essentially matching, preferably slightly larger as described above, the outer diameter of the needle is formed in a specific direction towards the receptacle of the tube, with the term "receptacle of the tube" denoting the portion of the syringe needle holder between the tube guide 3 and the port of the container. The hole is sufficiently long and dimensioned to avoid a significant tilting of the needle N to guide the needle into the port P of the container C via the tube T. The hole can be further dimensioned to preferably create a certain small friction and sealing state between the needle and the needle guide in order to maintain it in each sliding position. While not shown, the needle guide may be provided with a pierceable septum or seal that is either formed from the same unitary material as the base or is made from a separate material and is mounted, e.g, by insert molding, to the base or is attached to dose the insertion opening 14. The tube guide 3, i.e. the receptacle forcing the tube T into the defined position, and the syringe needle guide 4 are configured and positioned relative to each other such that the syringe needle N after puncturing the tube N and upon further sliding motion of the syringe needle N relative to the base 2 in the needle guide 4 is guided inside and along the hollow / lumen of the tube T and further through the port P without exiting the tube. Thus, the direction of the syringe needle guide 4 is aligned with and parallel to the orientation of the tube's longitudinal axis at least in the section of the tube downstream of the point where the needle punctures and enters the tube towards an end of the tube T attached to or to be attached to the port P of the container C. Thus, the needle N may enter the inside of the container C via the port P. The tube guide 3 comprises a releasable lock for retaining the tube T in the defined position. In the second embodiment the lock may be realized, as described above, by the complete or hinged separation / connection of the mating parts of the base or by the limited elastic deformation of the integral base to allow insertion of the tube through the opening 7. In the first embodiment the lock is provided by bending the elastic tube adjacent to the needle guide by about 90 degrees and routing it through a corresponding limited pathway through the receptacle in the base where it Is held in position by engaging portions integrally formed in the base 2. The bending angle of the tube is not mandatory and is determined by the function to align the downstream section of the tube from the puncture point to the port with the sliding direction of the needle as described above and the necessity to fixedly hold the tube in its position for the puncturing process. The bending angle of around 90 degrees is also preferable as it avoids that the needle tip hitting the curved section slides off from the tube and only scratches the tube material or pierces only a portion of the tube material forming the wall instead of entering the hollow / lumen. Although not shown, the pathway may comprise sections that can be elastically deformed and / or pivoted, e.g. by a so called "living hinge" and engaging protrusions or hooks, or that can be removed and re-attached via engaging protrusions or hooks to create open and closed positions for facilitated attachment and removal of the tube in its receptacle. The syringe needle holder 1 optionally further comprises a clamp 6 configured to selectively squeeze and block the tube T placed at the tube guide 3 at a position that is located at or is spaced from the point where the syringe needie N punctures the tube T, preferably is spaced downstream in a direction in which the syringe needle N advances inside the hollow / lumen of the tube T and upstream from an end of the tube T attached to or to be attached to the port P of the container C. Such clamp 6 may be a part of the tube guide 3. The clamp 6 in the second embodiment shown in Figures 2 to 4 is in the form of a lever 8 that is integrally connected at one end thereof with the base 2, preferably through a "living hinge" 13 (i.e. a thinned portion that allows a certain facilitated elastic deformation in a defined direction) and is formed, at the other, free end with a locking protrusion or hook 10 that may engage, in the locked state bridging the tube, with a mating locking protrusion or hook 11 on the base, in the vicinity of the free end of the lever 8 a pushing surface 9 may be formed to receive a pushing force (e.g. from a thumb or other finger of a user) towards and into the locked state. The pushing surface 9 may be ribbed or curled to increase friction and promote a defined engaging position, in the vicinity of the hinged end, the lever 8 is formed, on the side facing the tube T, with a squeezing protrusion 12 that has a pointed edge formed and arranged to squeeze and deform the elastic tube in its receptacle until the hollow / lumen is closed. Thus, spillage of fluid from the container via the port or external contamination in the opposite direction through the puncture of the tube created by the syringe needle can be prevented. According to the invention, the base 2, the tube guide 3, the syringe needle guide 4, and preferably, if provided, the ciamp 6 are combined and integrated into one device and are fixed relative to each other to form a self-contained accessory device, preferably are integrally formed, preferably molded or formed by additive manufacturing from plastic or metal materia! or compounds. Meta! material or certain heat resistant plastic materials could be useful if the device is to be re-used and sterilized, e.g. heat-sterilized, between repeated uses, if the material is too rigid to allow the bending needed to route the tube through the tube holder or to allow the functionality of a "living hinge", a movable joint or pivot axis may be provided as needed. Material dimensions are generally defined according to the forces encountered, in particular for holding the tube in its position, in particular when bent within the receptacle about a certain angle, or for blocking the tube by the clamp. In the first embodiment shown in Figure 1 the syringe needle holder 1 may optionally further comprise a plug or cap (not shown in the drawing) for closing access to a piercing hole created in the tube at the piercing position by the syringe needle N. The plug or cap is preferably attachable to the syringe needle guide 4 to close the insertion opening 14 for the syringe needle N. A similar plug or cap may also be provided for the second embodiment. The cap or plug may be a separate part from the syringe needle holder. It may, however, be an integral part of the base 2 and connected, again, through a living hinge (not shown) so as to be pivotable between a closed position sealing the insertion opening and an open position providing access for the needle to the needle guide but avoiding that the plug or cap gets lost. The syringe needle holder 1 of the invention can be provided as a stand-alone device or accessory or, in a finished product package as sold, can be combined with: - a mating container C for accommodating culture media for sterility testing (empty or pre-filled), the container C provided with a port P connected or connectable with a tube T and comprising, at a top of the container C, - one or more syringe needle(s) having a length and diameter suitable for use with the respective syringe needle holder 1 and / or intended container to allow sampling or injection of a fluid from / into the container C by means of the syringe needle N via the port P through a hollow / lumen of the tube T, - one or more syringes for use with the syringe needles, or - combinations of the aforementioned components. In such a container C the syringe needle holder 1 may be integraliy formed with a part of the container C or may be removably attached to a part of the container C or to the tube T connected with the port P of the container C. The invention also pertains to a method of sampling / injecting a substance from / into a container C provided with a port P communicating with an interior of the container C, the port P connected with or connectable with a tube T and preferably provided in a top of the container C. Such a method is in particular useful in the field of microbiological sterility testing in the phase of the process where several containers filled with culture media are incubated for a certain period of time and where, in this period, intermediate readings of the containers, before the final reading, should be done by looking for the presence or absence of culture media turbidity, the presence of which may be indicative for the presence of microorganisms in the sample, if turbidity is observed, one needs to safely extract a portion of the sample from the container, i.e. without contaminating the sample in the container and / or risking injury to the user, or one may want to inject a substance (fluid) into the container, again without contaminating the sample in the container and / or risking injury to the user. The method of the invention makes use of the syringe needle holder 1 according to the invention and comprises: (a) providing the syringe needle holder 1 as described herein (Figure la); (b) attaching the syringe needle holder 1 to the container C (by the mechanical interface 5) and / or to a / the tube T (by the base 2) and placing a / the tube T into the tube guide 3 (Figures lb and 1c); (c) connecting an end of the tube T with the port P if previously unconnected; (d) inserting a syringe needle N (alone or provided affixed to a syringe as shown in Figure Id) into the syringe needle guide 4 and advancing the syringe needle N to puncture the tube T and slide through and along a hollow / lumen of the tube T towards the interior of the container C via the port P (Figures le and If); (e) sampling / injecting the substance from / into the interior of the container C through the syringe needle N; and (f) retracting the syringe needle N from the container C and detaching the syringe from the syringe needle (but leaving the needle in the holder or optionally removing the syringe needle N from the syringe needle holder 1 together with the syringe S). If the tip end of the syringe does not reach below the liquid level of the sample fluid in the container, the container may be tilted so that the needle tip is submerged. The method may optionally further comprise, after the step of retracting the syringe needle N from the container C and at least from the hollow / lumen of the tube, a step of squeezing and blocking the tube T at a position that is located at or is spaced from the point where the syringe needle N punctures the tube T, preferably is spaced downstream in a direction in which the syringe needle N advances inside the hollow / lumen of the tube T and upstream from the end of the tube! attached to the port P of the container C (Figure 1g). This can be achieved by the integrated clamp 6, if provided on the syringe needle holder 1 as in the second embodiment, or by a separate external damp (not shown). Thereby, the sampling point on the tube is isolated from the external environment. While the device and the method of the invention are described with respect to its application in the field of microbiological sterility testing in the phase of the process where one or several containers filled with culture media are incubated for a certain period of time and are to be sampled / inoculated before the final readingof the presence or absence of microorganisms in a fluid sample, the device and method can be applied in other processes in the medical or pharmaceutical fields or in industrial product testing where aliquots of a sample fluid are to be extracted or substances added from / to a substantially closed container or vessel by means of a syringe needle.

Claims

1. A syringe needle holder (1) comprising(i) a base (2);(ii) a tube guide (3) for releasabiy holding and routing a tube (T) in a defined position relative to the base (2)- and(iii) a syringe needle guide (4) for releasabiy holding a syringe needle (N) in a defined position relative to the base (2) such that the syringe needle (N), when placed in the syringe needle guide (4), is directed to a position on the tube (T) when placed at the tube guide (3) to puncture the tube (T) to reach a hollow / lumen of the tube (T).

2. The syringe needle holder (1) according to claim 1, wherein the base (2) is formed to be attached, preferably removably, to an outside of a tube (T) that is connected or is connectable with a port (P) of a container (C) in that the tube (T) is placed in the tube guide (3).

3. The syringe needle holder (1) according to claim 1 or 2, wherein the base (2) is formed on or is configured to be attached, preferably removably, to an outside of a container (C) provided with a port (P) that Is connected or is connectable with a tube (T) so as to allow placement of the tube (T) in the tube guide (3) when the syringe needle holder (1) is attached to the container (C).

4. The syringe needle holder (1) according to claim 3, wherein the base (2) includes a mechanical interface (5) for removable attachment to the container (C), wherein the mechanical interface (5) is preferably configured to be mechanically attached to a top peripheral edge of the container (C),5. The syringe needle holder (1) according to any one of claims 1 to 4, wherein the syringe needle guide (4) is configured to guide a sliding motion of the syringe needle (N) relative to the base (2), preferably by engagement with the syringe needle (N), towards and away from the position to puncture the tube (T), when the tube (T) is placed at the tube guide (3).

6. The syringe needle holder (1) according to claim 5, wherein the tube guide (3) and the syringe needle guide (4) are configured and positioned relative to each other such that the syringe needle (N) after puncturing the tube (T) and upon furthersHding motion of the syringe needle (N) relative to the base (2) is guided inside and along the hollow / lumen of the tube (T).

7. The syringe needle holder (1) according to any one of claims 1 to 8, wherein the tube guide (3) comprises a releasable lock for retaining the tube (T) in the defined position,8. The syringe needle holder (1) according to any one of claims 1 to 7, further comprising a clamp (6) configured to selectively squeeze and block the tube (T) placed at the tube guide (3) at a position that is located at or is spaced from the position where the syringe needle (N) punctures the tube (T), preferably is spaced downstream in a direction in which the syringe needle (N) advances inside the hollow / lumen of the tube (T) and upstream from an end of the tube (T) attached to or to be attached to a / the port (P) of the container (C).

9. The syringe needle holder (1) according to claim 8, wherein the damp (6) is part of the tube guide (3).

10. The syringe needle holder (1) according to any one of claims 1 to 9, wherein the base (2), the tube guide (3), the syringe needle guide (4), and preferably, if provided, the clamp (6) are fixed relative to each other to form a self-contained accessory device, preferably are integrally formed, preferably molded or formed by additive manufacturing.

11. The syringe needle holder (1) according to any one of claims 1 to 10, further comprising a plug or cap for closing access to a piercing hole created at the piercing position in the tube (T) by the syringe needle (N), the plug or cap preferably attachable to the syringe needle guide (4) to close an insertion opening for the syringe needle (N).

12. A container (C) for accommodating culture media for sterility testing, the container (C) provided with a port (P) connected or connectable with a tube (T) and comprising, at a top of the container (C), a syringe needle holder (1) according to any one of claims 1 to 11 to allow sampling or injection of a fluid from / into the container (C) by means of a syringe needle (IM), placed in the syringe needle holder (1), via the port (P) through a hollow / lumen of the tube (T).

13. The container (C) according to claim 12, wherein the syringe needle holder (1) is integrally farmed with a part of the container (C) or is removably attached to a part of the container (C) and / or to a tube (T) connected the port (P) of the container (C).

14. A method of sampling / injecting a substance from / into a container (C) provided with a port (P) communicating with an interior of the container (C), the port (P) connected with or connectable with a tube (T) and preferably provided in a top of the container (C), the method comprising:(a) providing the syringe needle holder (1) of any one of claims 1 to 11;(b) attaching the syringe needle holder (1) to the container (Q or a / the tube (T) and placing the a / the tube (T) into the tube guide (3);(c) connecting an end of the tube (T) with the port (P) if unconnected;(d) inserting a syringe needle (N) into the syringe needle guide (4) and advancing the syringe needle (N) to puncture the tube (T) and slide through and along a hollow / lumen of the tube (T) towards the interior of the container (C) via the port (P);(e) sampling / injecting the substance from / into the interior of the container (C) through the syringe needle (N), if required by tilting the container (C) to submerge a tip of the syringe needle (N); and(f) retracting the syringe needle (N) from the container (C) and optionally removing the syringe needle (N) from the syringe needle holder (1).

15. The method of claim 14, further comprising, after the step of retracting the syringe needle (N) from the container (C), a step of squeezing and blocking the tube (T) at a position that is located at or is spaced from the point where the syringe needle (N) punctures the tube (T), preferably is spaced downstream in a direction in which the syringe needle (N) advances inside the hollow / lumen of the tube (T) and upstream from the end of the tube (T) attached to the port (P) of the container (C).

Images