HK1237810A1 - Sterile sensor insertion - Google Patents

Description

Sterile sensor insertion

Technical Field

The present invention relates generally to bioprocessing systems and methods. In particular, the present invention relates to systems and methods for inserting sensors into bioreactor vessels and tubes (including flexible or semi-rigid bags or tubes).

Description of the Related Art

Various containers, devices, components and unit operations are known for performing biochemical and/or biological processes and/or manipulating liquids and other products of such processes. To avoid the time, expense and difficulty associated with sterilization of containers used in biopharmaceutical manufacturing processes, single-use or disposable bioreactor bags and single-use mixer bags are increasingly used as such containers. For example, biological materials (e.g., animal and plant cells) including, for example, mammalian, plant or insect cells and microbial cultures can be treated using disposable or single-use mixers and bioreactors.

The manufacture of complex biological products such as proteins (e.g., monoclonal antibodies, peptides, hormones, and vaccine immunogens) in many cases requires multiple processing steps from cell culture (bacteria, yeast, insects, fungi, etc.) and/or fermentation to primary recovery, purification, etc. Conventional bioreactor-based manufacturing of biological products generally uses batch or fed-batch processing through a series of unit operations with subsequent off-line laboratory analysis performed on representative samples collected from various points of the process to ensure quality.

In order to obtain information on the changing conditions within the bioreactor vessel in a timely manner during its operation, sensor technology has been applied. With respect to the use of disposable bioreactors, there are recognized difficulties in aseptically inserting sensors into flexible-walled bioreactors or flexible tubes that feed or discharge such vessels. Furthermore, for example, optical, electrical and pH sensors cannot withstand sterilization via gamma radiation, or are positioned within flexible bags or tubes and require attachment means that allow communication of clear signals to or from external analytical instruments.

An example of sterile insertion of the probe at the point of use is described in US7901934(Hyclone, Kunas et al). This patent describes a probe assembly that includes a flexible sleeve having a sterile interior within which a sterile probe is positioned. The sleeve includes one side of the sterile connector, the other side of which resides on the stirred-tank bioreactor system. The probe is attached by mating the two sides of the sterile connector, and then the test sensor tip is pushed into the bioreactor due to the flexible sleeve compression.

WO2010145747a1(Sartorious, Baumfalk et al) describes a sensor device comprising an optical sensor, a container and a compartmentalization means allowing the sensor to be held in a sterile calibrated position prior to insertion.

US20110201100A1(Millipore, Proulx, etc.) describes Millipore sensorReady for sterile insertion of a sensor into an external manifold aligned in a flow path rather than a bag^TMProvided is a system. This provides some flexibility in the construction with standard bags, but the sensor is not in direct contact with the bulk of the contents of the bioreactor.

US20110236962a1(Hamilton, Loebbert and Schoenfuss) describes the movement of a sensor through a sterile scale chamber prior to insertion into a bioreactor.

WO2013063550(Xcellerex, Damren, etc.) describes a probe assembly in which a sterile probe is held within the sterile interior of an at least partially rigid sheath. The sheath is connected to the bioreactor using a sterile face connector, and the probe is pushed into the bioreactor by an actuator.

There is a continuing need for improved sensor connectors and methods for inserting sensors into flexible disposable bioreactor bags or fluid circulation tubes. The improved apparatus and method for aseptically inserting non-disposable or disposable sensors into flexible bioreactor bags or tubes would also be advantageous for use in bioreactor-based manufacturing systems including on-line sensing to provide real-time data.

Because the sensors themselves can be expensive, there is also a continuing need for improved devices and methods for aseptically inserting the sensors into flexible bags or tubes, devices and methods that facilitate removal of the sensors from disposable bags or tubes without damaging the sensors. With such improved devices and methods, the bag or tube may be discarded with the sensor, or alternatively, the sensor may be removed, re-sterilized, and reused.

Summary of the invention

In accordance with the present invention, a system for inserting a pre-sterilized sensor probe into a sterile container is provided. The system of the present invention includes a body with a plunger positioned therein, wherein a pre-sterilized sensor probe is positioned within the plunger. The system includes a liquid-tight seal to maintain sterility of the probe during use. Suitable seals include configurations known to those skilled in the art, including but not limited to O-rings, overmolded seals, and the like. Once the system of the present invention has been connected to the container using the sterile connection system, the handle of the system that mates with the plunger guides the movement of the probe into the sterile container.

In one embodiment, the handle is rotated about a longitudinal axis of the system to guide movement of the plunger into the sterile container. In one embodiment, the movement of the plunger is linear.

The system of the present invention provides a reliable and straightforward way of inserting one or more sterile probes into a sterile container.

The invention also provides a sterile container comprising one or more of the systems of the invention. The sterile container may be a flexible or semi-rigid bag or tube of the type typically used for carrying out biochemical and/or biological processes and/or manipulating liquids and other products of such processes. Typically, single-use or disposable bioreactor bags and single-use mixer bags are used as such containers.

The present invention also provides a method for aseptically inserting an aseptic probe into an aseptic container, wherein the method utilizes the system of the present invention.

As previously described herein, it is known in the art to insert a reusable probe into a sterile container at the point of use. In contrast, the present invention provides a means to allow for the insertion of a single use probe, wherein the probe requires a means of sterilization in addition to ionizing gamma radiation or heating. The present invention uses a septum port and improved sterile connection, commercially available examples of which include Kleenpak from Pall^TMReadyMate from GE Healthcare^TMAnd AsputiQuik from Colder^TM. This provides a sterile barrier between the seal and the contents of the sterile container. By mating the connector septum port into the sterile container, advancement of the probe is actuated by rotation of the barrel (e.g., in fig. 7) or a rotating barrier (e.g., in fig. 1) that engages the threaded barrel. In certain embodiments, the locking tab prevents intentional or unintentional backout of the sensor probe engagement from the septum port once the probe is fully inserted.

Brief description of the drawings

The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular descriptions of exemplary embodiments of the invention as illustrated in the accompanying drawings wherein like reference numbers refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

FIG. 1 is a cross-sectional view of an exemplary system of the present invention connected to a bioreactor with an inserted probe.

Fig. 2 is a cross-sectional view of the second end of an exemplary plunger, which is in the form of a spike, advanced toward the sterile face connection, and then the septum is passed into the sterile container.

Fig. 3 shows an exemplary configuration of a plunger having a pointed configuration at its second end (a-C) and an example of a probe sheath suitable for use in the system of the present invention (D-E).

Fig. 4 is a cross-sectional view of an exemplary second end of a plunger having a flat configuration.

Fig. 5 shows a cross-sectional view of an exemplary second end of a plunger having a septum tip as its second end.

Fig. 6 is the plunger of fig. 5 after insertion through the septum and into the sterile container.

FIG. 7 illustrates a sensor probe and modified ReadyMate that may be used as exemplary body and plunger portions of the present invention^TMAnd (4) connecting the system. Also shown is a bioreactor with a sterile face connector, including a septum into which the probe can be inserted.

FIG. 8 illustrates an exemplary system of the present invention in which the probe is mounted on the sensor probe and the modified ReadyMate^TMWithin the insert of the connection system.

Description of The Preferred Embodiment

To more clearly and concisely describe and point out the subject matter of the claimed invention, the following definitions are provided for certain terms used throughout the specification and claims. Any examples of specific language herein should be considered as non-limiting examples.

Word "Aseptic probe"refers to a device useful in the measurement of one or more physical, chemical or biological properties of a substance, particularly where the substance is a solution, where the device has been sterilized. Word "Probe head"may be used interchangeably with the word" sensor ". The present invention is suitable for the insertion of any sterile probe into a sterile container, but is particularly suitable for the insertion of pre-sterilized probes, i.e., probes that require sterilization means other than ionizing gamma radiation or heating, e.g., sterilization using ethylene oxide.

“Sterile container"can be any container having a sterile interior. More specifically, the term sterile container is intended to cover any container used to contain a particular biological material without contamination by any other biological material. Such containers may also be referred to as "Raw material Article container", and non-limiting examples include bioreactors, intermediate reactor vessels, and bioprocessing equipment. In a particular example, the sterile container may be a flexible bag contained within a rigid holder (e.g., made of stainless steel).

Of the system of the invention "Body"is a substantially rigid and cylindrical member.

Term as used herein "Approximately"includes the embodiments in which a term used therewith is defined purely as well as in which a majority of the term may be defined as that particular term.

Term as used herein "Sterile face connection"refers to any device, or two opposing flat surfaces, that allows for sterile connection"Matching". Sterile face connection for general useIs a single-use sterile connection, a non-limiting example of which is Readymate^TMA connector is provided.

Term as used herein "Plunger piston"is used to denote a generally rigid and cylindrical member of the body as described above, but configured to movably fit within the body. Word "MoveableBy "is meant generally the property of being relatively easily movable by hand, applying a conventional level of force to allow the plunger to move in a direction along the central axis of the body. Words in this context "Diameter less than"may be more particularly understood to mean that the diameter is only slightly smaller, for example such that a liquid-tight seal is formed when the seal engages the outer surface of the plunger.

Term as used herein "Vias"is used to denote a generally tubular passage within which a component or substance can be accommodated.

Terms used herein to describe the relationship of the sterile probe to the internal passageway of the plunger "Is fixed in"is intended to mean fixed to the extent that the sterile probe moves with any conventional movement of the plunger. The means for securing the sterile probe within the plunger may include the use of an adhesive or connector applied between the sterile probe and the inner surface of the plunger, or by using a variety of other securing means known to those skilled in the art, provided that the means does not interfere with the normal operation of the probe.

Word "Electrical connection"refers to any known means of connecting a sterile probe to a power supply suitable for allowing the probe to function.

Word "Handle bar"refers to an accessory that allows movement by hand application. While a variety of configurations are possible, the handle should be strong enough to transmit the force required to move the plunger within the body, long enough so that it can be reliably grasped by a hand to apply force, and small enough so that the hand can wrap around it sufficiently to firmly grasp it as needed to apply force.

Word "Sterilization port"refers to an opening in the bodyWhich allows the penetration of a sterilizing gas, such as ethylene oxide or peroxide, into the sterile open pores (11). This is through a sterile porous barrier (a non-limiting example of which is Tyvek^TM) And (4) promoting.

In certain embodiments, the term used in connection with the plunger and handle "Screw thread"assigned threads, one on some portion of the outer surface of the plunger and one on the inner surface of the handle. These threads are well known in the mechanical arts to convert rotational forces into linear movement, as applied in certain embodiments of the present invention.

Word "Notch (S)"means a notch or cut in an edge or surface. In particular in the context of the present invention, the recess is configured to be received in a recess, for example to allow two elements to be associated or mated with each other.

Term as used herein "Cam wheel"refers to a rotating member for converting rotational motion to linear motion.

Term as used herein "Locking in"means rigidly fixed or immovable. In particular, the term is used to refer to a device in which the plunger is locked into a second position in which the probe is positioned within the sterile container. An example of a locking mechanism suitable for application to the present invention is described in US 7927316.

Word "Protective sleeve"refers to a tight fitting protective cover for the sensor end of the probe that allows liquid to flow and contact the sensor while protecting the sensor to allow it to function. Non-limiting examples of sheaths suitable for use with the present invention are shown in fig. 3D and 3E.

In a first aspect, the present invention provides a system (1) for inserting a sterile probe (30) into a sterile container (2), wherein the system comprises:

(i) a body (10) formed of plastic and having a sterile aperture (11) formed through at least a portion of an interior thereof, the body (10) having a first end (12) and a second end (13), the second end (13) including a body sterile face connection (14);

(ii) a plunger (20) formed of plastic and housed within a sterile bore (11) of a body (10), the plunger (20) having a shape generally corresponding to the shape of the sterile bore (11) and a diameter smaller than the sterile bore (11), the plunger (20) further having an internal passageway (21) leading to a first hole (11) on a first end (24) of the plunger (20) and a second hole (23) on a second end (25) of the plunger (20), wherein the first end (24) and second end (25) of the plunger (20) correspond to the first end (12) and second end (13) of the body (10), respectively, and wherein the plunger (20) is movable between a first position and a second position;

(iii) a sterile probe (30) secured within the internal passageway (21) of the plunger (20), wherein the sterile probe (30) includes an electrical connection end (31) generally aligned with the first end (24) of the plunger (20), a sensor end (32) generally aligned with the second end (25) of the plunger (20), and a sensor body (33) therebetween;

(iv) one or more seals (40, 41, 42) between the plunger (20) and the sterile aperture (11) to form a liquid-tight seal between respective portions of the plunger (20) and the sterile aperture (11); and the number of the first and second groups,

(v) a handle (50) cooperating with the plunger (20) to guide movement of the plunger (20) within the sterile aperture (11) between the first position and the second position.

In one embodiment of the system (1) of the present invention, the sterile probe (30) is selected from the group consisting of metabolic, biological and physical sensors. In another more specific embodiment, the sterile probe is a glucose sensor, a lactate sensor, a pH sensor, a temperature sensor, a conductivity sensor, or a cell mass and cell viability sensor.

In one embodiment of the system (1) of the present invention, each of the body (10) and the plunger (20) is independently formed from a plastic selected from the group consisting of Polyetherimide (PEI), Polyetheretherketone (PEEK), Polyetherketone (PEK), polysulfone, polyarylsulfone, polyalkoxysulfone, polyethersulfone, polyphenylene oxide, polyphenylene sulfide, polycarbonate, and mixtures thereof.

In one embodiment of the system (1) of the present invention shown in fig. 1, the body (10) further comprises a sterilization port (15).

In one embodiment, the system (1) of the present invention further comprises one or more seals (70, 71) between the sterile probe (30) and the internal passageway (21) of the plunger (20).

In one embodiment of the system (1) of the present invention, the handle (50) is rotated about a longitudinal axis of the system (1) to guide movement of the plunger (20) within the sterile aperture (11) between the first position and the second position. In a particular embodiment, the movement of the plunger is linear.

In one embodiment of the system (1) of the present invention, between the first end (24) and the one or more seals (40, 41, 42), the plunger (20) comprises a plunger thread (26) on an outer surface thereof, the handle (50) comprises a central opening (52) sized to accommodate a width of the plunger (20), and wherein the central opening (52) comprises a handle thread (51) that cooperates with the plunger thread (26) such that rotational movement of the handle (50) guides movement of the plunger (20) within the sterile aperture (11) between the first position and the second position. An example of this embodiment is shown in fig. 1.

In one embodiment of the system (1) of the present invention, the central opening (52) further comprises a recess (53) and the body (10) comprises a first notch (16) protruding outwardly from a surface thereof and positioned substantially at the first end (12) thereof, wherein the first notch (16) is received in the recess (53).

In one embodiment of the system (1) of the present invention, the body (10) further comprises a second recess (16a) protruding outwardly from a surface of the body (10), wherein the second recess (16a) provides mechanical support for the interaction of the first recess (16) and the recess (53).

In one embodiment and as shown in fig. 7 and 8, the system (1) of the present invention further comprises a cam (60) formed on an outer surface of the plunger (20) and received within a cam slot (61) defined by the body (10), wherein the cam (60) is movable between a first position within the cam slot (61) and a second position within the cam slot (61), and wherein the first position of the plunger (20) coincides with the first position of the cam (60) in the cam slot (61) and the second position of the plunger (20) coincides with the second position of the cam (60) in the cam slot (61).

In one embodiment of the system (1) of the present invention, said plunger (20) is locked into said second position.

In one embodiment of the system (1) of the present invention, the sensor end (32) of the sterile probe (30) comprises a sheath (32a, 32 b).

In a second aspect, the invention provides an aseptic container (2) comprising one or more systems (1) of the invention as defined above. Fig. 2 and 4 to 7 show examples of how the system (1) of the first aspect of the invention is connected to a sterile container (2).

Fig. 2 shows an exemplary configuration of the second end (13) of the body (10) and the corresponding second end (25) of the plunger (20) of the system (1) of the invention. In fig. 2, the body sterile face connection (14) and the container sterile face connection (14a) have been connected to form a sterile passageway (8), through which sterile passageway (8) the plunger (20) may pass before piercing the septum (7) to access the sterile container (2).

Fig. 4 also shows an example of how the second end (13) of the body (10) and the corresponding second end (25) of the plunger (20) may be positioned with respect to the sterile container (2) once the sterile face connectors (14, 14a) have been connected to form the sterile passage (8) between the system (1) and the sterile container (2) of the invention. The plunger (20) shown in fig. 4 has a flat second end (25).

Another exemplary plunger configuration is shown in fig. 5, in which the second end (25) of the plunger (20) is formed as a sharp point of narrower diameter compared to the body of the plunger (20). The aperture in the second end of the plunger allows a probe (30) (not visible in fig. 5) contained therein to come into contact with the liquid in the sterile container (2) once inserted through the septum (7). Fig. 6 shows the arrangement of fig. 5, but with the plunger (20) having pierced the septum (7) and its second end (25) within the sterile container (2).

Other tip configurations are selected and shown in fig. 3A-3C. Fig. 3A shows a tip with openings on the sides to allow fluid to flow into the sensor. Fig. 3B shows the spike at the second end of the plunger, with the sensor located non-axially away from the spike to protect the plunger as it pierces the septum. Alternatively, where the sensor can withstand penetration into the septum, a configuration such as that shown in fig. 3C may be considered in which the sensor is axially positioned in the plunger and protrudes from the second end of the plunger to serve as a point.

Fig. 3D and 3E show examples of probe sheaths that may be used to protect a precision sensor while also allowing fluid to contact the sensor. Such a probe sheath may also serve as a point of protrusion from the second end of the plunger to aid in piercing the septum.

The diaphragm is a membrane or seal that can be pierced by the plunger and probe arrangement. In one embodiment, after the plunger has pierced the septum, the septum forms a liquid-tight seal around the plunger so that no liquid from the sterile container enters the pathway between the system and the sterile container, i.e., no rearward leakage. Suitable diaphragms for use with the present invention are well known to those skilled in the art, for example, being made of an elastomeric material such as rubber or silicone.

In one embodiment, the sterile container (2) of the present invention is a biological container. In a more specific embodiment, the sterile container (2) is a bioreactor. In yet more specific embodiments, the sterile container (2) is a flexible bag supported within a rigid holder. An example of this latter configuration is shown in fig. 1, where the inside of the flexible bag is indicated by reference numeral (2), the wall of the bag is indicated by reference numeral (3) and the wall of the rigid holder is indicated by reference numeral (4). Fig. 1 also shows an example of a system (1) in cross-section, wherein the aseptic container comprises a wall (3) comprising a container aseptic surface connection (14a), and wherein the system (1) is connected to the aseptic container (2) by mating the body aseptic surface connection (14) of the body (10) with the container aseptic surface connection (14 a).

In one embodiment, the sterile container (2) of the invention comprises a wall (3) comprising a container sterile face connection (14a), and wherein the system (1) of the invention is connected to the sterile container (2) by mating the body sterile face connection (14) of the body (10) of the system (1) with the sterile container face connection (14 a). In one embodiment, the body aseptic surface connection (14) and the container aseptic surface connection (14a) are each single-use aseptic connections.

The system of the present invention allows for the placement of a sterile probe into a sterile container even when the sterile container is full. This is an advantage because it is preferable to insert expensive sensors after the integrity test of the sterile container. The presence of a septum on the side of the sterile container is helpful in this context as it acts to prevent a head pressure exerted on the sterile face connection by the liquid in the container, which can be relatively weak, at least in the case of certain sterile face connectors.

In one embodiment, the sterile container of the invention comprises more than one system of the invention. This may be particularly useful where the sterile container is relatively large. For example, when the sterile container is a 2000L bioreactor bag, a problem can be that it is very expensive to secure. Another situation where this would be useful is where the sterile container is used in a process that requires a relatively long time (i.e., beyond the life of only one probe). The facility to have a new probe simply added at another location on the sterile vessel wall overcomes any problems encountered due to the failure or lifetime of the probe configuration.

In a third aspect, the present invention provides a method for inserting a sterile probe (30) into a sterile container (2), wherein the sterile probe (30) is provided with the system (1) of the invention as defined herein and wherein the sterile container (2) comprises a container sterile face connection (14a), wherein the method comprises:

(a) mating the body sterile face connection (14) of the body (10) of the system (1) with the container sterile face connection (14 a);

(b) actuating a handle (50) of a plunger (20) of the system (1) to move the plunger (20) from the first position to the second position.

In one embodiment of the method of the invention, said actuating step comprises rotating said handle (50) around a longitudinal axis of said system (1).

All embodiments of the system (1) of the invention as described above are equally applicable to the sterile container (2) and the method of the invention.

Further features and advantages of the invention based on the above-described embodiments will be apparent to the person skilled in the art. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (21)

1. A system (1) for inserting a sterile probe (30) into a sterile container (2), wherein the system comprises:

(i) a body (10) formed of plastic and having a sterile aperture (11) formed through at least a portion of an interior thereof, the body (10) having a first end (12) and a second end (13), the second end (13) including a body sterile face connection (14);

(ii) a plunger (20) formed of plastic and housed within an aseptic aperture (11) of the body (10), the plunger (20) having a shape generally corresponding to the shape of the aseptic aperture (11) and a diameter smaller than the aseptic aperture (11), the plunger (20) further having an internal passageway (21) leading to a first hole (22) on a first end (24) of the plunger (20) and a second hole (23) on a second end (25) of the plunger (20), wherein the first and second ends (24, 25) of the plunger (20) correspond to the first and second ends (12, 13) of the body (10), respectively, and wherein the plunger (20) is movable between first and second positions;

(iii) a sterile probe (30) secured within the internal passageway (21) of the plunger (20), wherein the sterile probe (30) includes an electrical connection end (31) generally aligned with the first end (24) of the plunger (20), a sensor end (32) generally aligned with the second end (25) of the plunger (20), and a sensor body (33) therebetween;

(iv) one or more seals (40, 41, 42) between the plunger (20) and the sterile aperture (11) to form a liquid-tight seal between respective portions of the plunger (20) and the sterile aperture (11); and the number of the first and second groups,

(v) a handle (50) cooperating with the plunger (20) to guide movement of the plunger (20) within the sterile aperture (11) between the first position and the second position.

2. The system (1) according to claim 1, wherein the sterile probe (30) is selected from the group comprising metabolic, biological and physical sensors.

3. The system (1) according to claim 1 or claim 2, wherein the sterile probe is a glucose sensor, a lactate sensor, a pH sensor, a temperature sensor, a conductivity sensor, or a cell mass and cell viability sensor.

4. The system (1) according to any one of claims 1 to 3, wherein each of the body (10) and the plunger (20) is independently formed of a plastic selected from the group consisting of Polyetherimide (PEI), Polyetheretherketone (PEEK), Polyetherketone (PEK), polysulfone, polyarylsulfone, polyalkoxysulfone, polyethersulfone, polyphenylene oxide, polyphenylene sulfide, polycarbonate, and mixtures thereof.

5. The system (1) according to any one of claims 1 to 4, wherein the body (10) further comprises a sterilization port (15).

6. The system (1) according to any one of claims 1 to 5, wherein the system (1) further comprises one or more seals (70, 71) between the sterile probe (30) and the internal passage (21) of the plunger (20).

7. The system (1) according to any one of claims 1 to 6, wherein the handle (50) is rotated about a longitudinal axis of the system (1) to guide movement of the plunger (20) within the sterile aperture (11) between the first position and the second position.

8. The system (1) of any one of claims 1 to 7, wherein between the first end (24) and the one or more seals (40, 41, 42), the plunger (20) includes a plunger thread (26) on an outer surface thereof, the handle (50) includes a central opening (52) sized to accommodate a width of the plunger (20) and wherein the central opening (52) includes a handle thread (51) that mates with the plunger thread (26) such that rotational movement of the handle (50) guides movement of the plunger (20) within the sterile aperture (11) between the first position and the second position.

9. The system (1) of claim 8, wherein the central opening (52) further comprises a recess (53) and the body (10) comprises a first notch (16) projecting outwardly from a surface thereof and positioned generally at the first end (12) thereof, wherein the first notch (16) is received within the recess (53).

10. The system (1) of claim 9, wherein the body (10) further comprises a second notch (16a) protruding outwardly from a surface of the body (10), wherein the second notch (16a) provides mechanical support for the interaction of the first notch (16) and the recess (53).

11. The system (1) of any one of claims 1-10, wherein the system (1) further comprises a cam (60) formed on an outer surface of the plunger (20) and received within a cam slot (61) defined by the body (10), wherein the cam (60) is movable between a first position within the cam slot (61) and a second position within the cam slot (61), and wherein the first position of the plunger (20) coincides with the first position of the cam (60) in the cam slot (61) and the second position of the plunger (20) coincides with the second position of the cam (60) in the cam slot (61).

12. The system (1) according to any one of claims 1 to 11, wherein the plunger (20) is locked into the second position.

13. The system (1) according to any one of claims 1 to 12, wherein the sensor end (32) of the sterile probe (30) comprises a sheath (32a, 32 b).

14. An aseptic container (2) comprising one or more systems (1) according to any one of claims 1 to 13.

15. The sterile container (2) according to claim 14, wherein the sterile container (2) is a biological container.

16. The sterile container (2) according to claim 15, wherein the sterile container (2) is a bioreactor.

17. The sterile container (2) according to claim 16, wherein the sterile container (2) is a flexible bag supported within a rigid holder.

18. The aseptic container (2) according to any of claims 14 to 17, wherein the aseptic container (2) comprises a wall (3) comprising a container aseptic surface connection (14a), and wherein the system (1) is connected to the aseptic container (2) by mating the body aseptic surface connection (14) with the container aseptic surface connection (14a) of a body (10) of the system (1).

19. The aseptic container (2) according to claim 18, wherein the body aseptic surface connection portion (14) and the container aseptic surface connection portion (14a) are each a single-use aseptic connection portion.

20. A method for inserting a sterile probe (30) into a sterile container (2), wherein the sterile probe (30) is provided with a system (1) according to any one of claims 1 to 13, and wherein the sterile container (2) comprises a body sterile face connection (14a), wherein the method comprises:

(a) mating the body sterile face connection (14) of the body (10) of the system (1) with the container sterile face connection (14 a);

(b) actuating a handle (50) of a plunger (20) of the system (1) to move the plunger (20) from the first position to the second position.

21. The method according to claim 20, wherein said actuating step comprises rotating said handle (50) about a longitudinal axis of said system (1).