Disposable bioreactor interface for disposable probe

Abstract

An optical interface having a housing (e.g., a bioreactor bag) and a bioreactor bag having an optical interface. In some embodiments, the optical principles of Raman technology are used to provide a plurality of embedded disposable optical interfaces in the housing, if necessary, related Raman probe modifications. In some embodiments, the optical interface includes a disposable cap to reduce ambient light intensity that may affect Raman signals. Devices according to embodiments disclosed herein can avoid sterile disruption, which typically occurs due to the insertion of an invasive reusable sensor into a housing through a sterile connection.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 347,683, filed on June 1, 2022, the entire contents of which are incorporated herein by reference. Background Art

[0003] Disposable bioreactors are often the preferred containers for biomolecule processing. Bags are often used as disposable containers for receiving and storing fluids (e.g., biological fluids). The bag may include a single-layer wall or a multi-layer flexible wall formed from a polymer composite material, such as polyethylene, including ultra-high molecular weight polyethylene (UHMWPE), ultra-low density polyethylene (ULDPE), linear low density polyethylene (LLDPE), low density polyethylene (LDPE) and medium density polyethylene (MDPE); polypropylene (PP); ethylene vinyl alcohol (EVOH); polyvinyl chloride (PVC); polyvinyl acetate (PVA); ethylene-vinyl acetate copolymer (EVA copolymer); thermoplastic elastomer (TPE) and / or blends or alloys of any of the above materials and various other thermoplastic materials and additives known in the art. The bag should be able to support a biologically active environment (e.g., an environment capable of growing cells in a cell culture context). The bag can be a two-dimensional (2D) or "pillow" bag, or a three-dimensional (3D) bag. The bag may include one or more inlets, one or more outlets, and optionally, other features (e.g., sterile gas outlets, sparges, and ports) for sensing the fluid within the container to obtain parameters known to those skilled in the art (e.g., conductivity, pH, temperature, dissolved gases (e.g., oxygen and carbon dioxide), etc.).

[0004] Conventional monitoring strategies for mammalian cell cultures lack real-time measurements and rely on daily or other periodic manual sampling and feeding, which increases the risk of contamination and batch failure. Raman analyzers (such as the Bio4C TM ProCellics PAT Raman Software TM Raman analyzers) can have the ability to monitor, evaluate and / or measure various parameters of bioreactor cultures online in real time. These parameters may include one or more key process parameters (e.g., concentrations of glucose, lactate and ammonium) as well as key performance indicators (e.g., total cell density and viable cell density). However, the sensing device (which may or may not be disposable or disposable) must not harmfully interfere with or compromise the integrity of the disposable device. In addition, the communication method of the sensing device with the contents of the bioreactor may be problematic at multiple levels (including sterility, component compatibility, attachment and removal methods, etc.).

[0005] Raman analyzers and instruments are mainly multi-purpose and require sterilization such as autoclave processes before being integrated into the bioreactor bag. This also requires specific sterile interfaces in order to insert the probe into the bag.

[0006] To improve upon existing systems, it would be desirable to provide a disposable analyzer optical interface with a bioreactor bag.

[0007] To further understand the nature of these and other objects of the present disclosure, reference should be made to the following description considered in conjunction with the accompanying drawings. Summary of the invention

[0008] The problems of the prior art have been solved by the embodiments disclosed herein, which relate to optical interfaces that interface with containers or housings (e.g., disposable bioreactors and / or mixer disposable bags). In some embodiments, the optical principles of Raman technology are used to set up multiple embedded disposable optical interfaces in the bioreactor bag, and relevant Raman probe modifications are made when necessary. Preferably, the interface is gamma sterilizable. In some embodiments, the optical interface includes a disposable cap to reduce the intensity of ambient light that may affect the Raman signal. The device according to the embodiments disclosed herein can avoid sterile damage, which is usually caused by inserting an invasive reusable sensor into a bioreactor through a sterile connection.

[0009] In some embodiments, the optical interface may include a disposable cap to reduce the intensity of ambient light that may affect the Raman signal.

[0010] In some embodiments, the optical interface includes a sleeve configured to receive a probe (e.g., a sampling immersion tube of a Raman probe) having a dimmer such that external light that may interfere with Raman signal generation is reduced or eliminated. In some embodiments, the sleeve cooperates with a barb that interfaces with the bioreactor and a clamp that secures the sleeve to the barb, etc. In some embodiments, the interface is leakproof even in the absence of a probe because the interface can be sterilized and the container or housing (e.g., bag) can remain closed even in the absence of the probe.

[0011] In some embodiments, the sleeve includes an optical window, such as a sapphire or quartz window. Thus, the probe itself may not have such a window.

[0012] Thus, an interface assembly for inserting a probe into a bioreactor is disclosed, the interface assembly comprising: an elongated sleeve having a channel configured to receive the probe, the sleeve comprising a window; and a fixture for fastening the sleeve to an accessory positionable in a port of the bioreactor. In some embodiments, the channel has a generally cylindrical cross-section. In some embodiments, the sleeve has a proximal end into which the probe is inserted and a distal end spaced apart from the proximal end, wherein a cap is disposed at the distal end. The cap may extend longitudinally from the window and may include one or more radial openings. In some embodiments, the interface further comprises: a barbed fitting having a barbed rod fixed to a fixture; and a flange configured to be disposed in the internal volume of the bioreactor. In some embodiments, the window is a sapphire or quartz window.

[0013] In some embodiments, a bioreactor having an internal volume is disclosed, the bioreactor comprising: a port providing access to the internal volume from an area outside the bioreactor; and a fitting attached to the port, the fitting being configured to receive an interface assembly for receiving a probe through the port into the bioreactor volume, the interface assembly comprising an elongated sleeve having a channel configured to receive the probe, the sleeve comprising a window, such as a sapphire or quartz window. The interface assembly may also include a clamp for securing the sleeve to the fitting, and the fitting may be a barbed fitting or a fitting threaded to the port.

[0014] Thus, an interface assembly configured for inserting a probe into a housing (e.g., a bioreactor or bioreactor bag) is disclosed, the interface assembly comprising: an elongated sleeve having a channel configured to receive the probe, the sleeve containing an optical window; and a fixture for fastening the sleeve to a fitting positionable in a port of the housing. The sleeve may have a proximal end in which the probe is inserted and a distal end spaced apart from the proximal end, wherein a cap is provided at the distal end. The cap may extend longitudinally from the window and may have one or more radial openings. The probe may include an optical lens positioned by a window adjacent to the sleeve when in an assembled state. The interface assembly may also include: a barbed fitting having a barbed rod fixed to the fixture; and a flange configured to be disposed in an internal volume of the housing. The housing may have a threaded port so that the interface assembly is threadedly connected to the threaded port. The elongated sleeve may be a disposable sleeve. The optical window may include sapphire.

[0015] Also disclosed is a housing having an internal volume, the housing comprising: a port providing access to the internal volume from an area outside the housing; and a fitting attached to the port, the fitting being configured to receive an interface assembly, the interface assembly being configured to insert a probe into the volume through the port, the interface assembly comprising an elongated sleeve having a channel configured to receive the probe, the sleeve containing an optical window. The interface assembly may also include a clamp for securing the sleeve to the fitting, the fitting may be a barbed fitting and may be threadedly connected to the port. The optical window may include sapphire. The housing may be a bioreactor or a bioreactor bag. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a perspective view of an optical interface according to some embodiments of the present disclosure;

[0017] Figure 2A is a perspective view of an optical interface inserted into a barb fitting according to some embodiments of the present disclosure;

[0018] Figure 2B is a cross-sectional view of an optical interface inserted into a barb fitting according to some embodiments of the present disclosure;

[0019] Figure 3 is a cross-sectional view of an optical interface according to some embodiments of the present disclosure, wherein a probe tube is inserted into the optical interface;

[0020] Figure 4 is a perspective view of an optical interface according to some embodiments of the present disclosure, wherein a probe tube is inserted into the optical interface;

[0021] Figure 5A is a perspective view of a probe and an optical interface before the probe is inserted into the optical interface according to some embodiments of the present disclosure;

[0022] Figure 5B is a perspective view of a probe and an optical interface after the probe is inserted into the optical interface according to some embodiments of the present disclosure;

[0023] Fig. 6A is a perspective view of an alternative embodiment of a probe and an optical interface prior to inserting the probe into the optical interface according to some embodiments of the present disclosure;

[0024] Figure 6B is a perspective view of an alternative embodiment of a probe and an optical interface after the probe is inserted into the optical interface according to some embodiments of the present disclosure;

[0025] Fig. 7A is a probe according to some embodiments of the present disclosure and Fig. 6AA cross-sectional view of an alternative embodiment of an optical interface;

[0026] Figure 7B is a probe according to some embodiments of the present disclosure and Fig. 7A A perspective view of an alternative embodiment of an optical interface;

[0027] Figure 8 is a perspective view of yet another embodiment of an optical interface according to some embodiments of the present disclosure;

[0028] Fig. 9A is a perspective view of yet another embodiment of an optical interface according to some embodiments of the present disclosure;

[0029] Fig. 9B yes Fig. 9A A perspective view of an embodiment of comprising a probe just prior to insertion into an optical interface according to some embodiments of the present disclosure;

[0030] Fig. 9C yes Fig. 9A A perspective view of an embodiment of , including a probe shown inserted into an optical interface according to some embodiments of the present disclosure;

[0031] Fig.9D According to some embodiments of the present disclosure Fig. 9A A cross-sectional view of an optical interface;

[0032] Fig.10 is a perspective view of an additional embodiment of an optical interface shown engaged with a probe according to some embodiments of the present disclosure;

[0033] Fig.11 is a perspective view of a bioreactor according to some embodiments of the present disclosure including an exploded view of an optical interface prior to being inserted into a barbed fitting on a port of the bioreactor;

[0034] Fig.12 According to some embodiments of the present disclosure Fig.11 A perspective view of a bioreactor of , wherein the bioreactor is shown with an optical interface inserted into a barbed fitting on a port of the bioreactor;

[0035] Fig.13 is a perspective view of a bioreactor according to some embodiments of the present disclosure including an exploded view of an optical interface prior to insertion into a threaded port of the bioreactor; and

[0036] Fig.14 According to some embodiments of the present disclosure Fig.13A perspective view of a bioreactor shown having an optical interface inserted into a threaded fitting on a port of the bioreactor. DETAILED DESCRIPTION

[0037] By referring to the accompanying drawings, the components, processes and devices disclosed herein can be more fully understood. These figures are merely schematic diagrams based on the convenience and ease of use of demonstrating the present disclosure, and therefore, are not intended to indicate the relative size and dimensions of devices or components and / or to define or limit the scope of exemplary embodiments.

[0038] Although specific terms are used in the following description for the sake of clarity, these terms refer only to the specific structures of the embodiments selected for illustration in the accompanying drawings, and are not intended to define or limit the scope of the present disclosure. In the accompanying drawings and the following description, it should be understood that the same number designations refer to components with the same functions.

[0039] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0040] As used in this patent specification, various devices and components may be described as "including" other components. The terms "including", "comprising", "having", "having", "can", "containing" and their variations used herein are intended to be open transitional phrases, terms or words that do not exclude the possibility of the presence of additional components.

[0041] All ranges disclosed herein are inclusive of the endpoints and are independently combinable (eg, a range "from 2 inches to 10 inches" includes the endpoint, 2 inches and 10 inches and all intermediate values).

[0042] As used herein, approximating language can be used to modify any quantitative representation that can be changed without causing a change in the underlying function to which it is associated. Thus, in some cases, a value modified by one or more terms (e.g., "about" and "substantially") may not be limited to the exact value specified. The modifier "about" should also be considered to disclose a range defined by the absolute values ​​of the two endpoints. For example, the expression "from about 2 to about 4" also discloses a range "from 2 to 4".

[0043] It should be noted that many of the terms used herein are relative terms. For example, the terms "upper" and "lower" are relative to each other in position, i.e., the upper component is located at a higher height than the lower component, and should not be interpreted as requiring a specific orientation or position of the structure. As another example, the terms "interior," "exterior," "inwardly," and "outwardly" are relative to the center and should not be interpreted as requiring a specific orientation or position of the structure.

[0044] The terms "top" and "bottom" are relative to an absolute reference, ie the surface of the Earth. In other words, a top position is always located at a higher altitude than a bottom position (towards the surface of the Earth).

[0045] The terms "horizontal" and "vertical" are used to indicate directions relative to an absolute reference, ie, the ground. However, these terms should not be interpreted as requiring that structures be absolutely parallel or absolutely perpendicular to each other.

[0046] In the present disclosure, the terms "bioreactor", "bag" and "container" are generally used interchangeably. The terms bioreactor, bag and container used herein refer to any manufacturing or engineering device or system that supports a biologically active environment, including mixing bags (e.g., bags for cell culture medium preparation, antibody-drug conjugate (ADC) reactions) or other downstream processing steps that are performed or can be performed in batches. In some cases, a bioreactor is a container with an internal volume in which a cell culture process is performed, which involves an organism or a biochemically active substance derived from such an organism. A flexible bioreactor, bag or container means a flexible container that can be folded, contracted and expanded, etc., which can accommodate, for example, a biological fluid. A disposable bioreactor, bag or container, which is also generally flexible, is a container that is used once and is discarded. In some embodiments, the bag, bioreactor or container can be a two-dimensional (2D) or "pillow" bag, or alternatively, a three-dimensional (3D) bag. The specific geometry of the container or bioreactor is not limited in any embodiment disclosed herein. In some embodiments, the container can include a rigid base that provides access points such as ports or vents. Any of the containers described herein can include one or more inlets, one or more outlets, and optionally, other features (e.g., sterile gas vents, sparger and ports) for sensing parameters of the fluid within the container (e.g., conductivity, pH, temperature, dissolved gases (e.g., oxygen and carbon dioxide), etc.), as known to those skilled in the art. The size of the container is sufficient to accommodate mixed fluids (e.g., cells and culture medium) ranging from pilot scale (e.g., 50 L) to small or large production capacity containers (e.g., 500 L to 3000 L or larger bioreactors).

[0047] The bioreactor may include a flexible, collapsible bag having an inner surface and an outer surface. The inner surface defines a compartment or space into which liquid may be added. The bag may include side walls having a generally circular or polygonal cross-section extending between a first end and an opposite second end when the bag is unfolded. The first end terminates at a top end wall and the second end terminates at a bottom end wall. The bag may be composed of a flexible, impermeable material, such as a polyethylene or other polymer sheet, having a thickness in the range of about 0.1 mm to about 5 mm, more commonly about 0.2 mm to about 2 mm. Other thicknesses may also be used. The material may be composed of a single layer of material or of two or more layers, which are either sealed together or separated to form a double-walled container. In the case where the layers are sealed together, the material may include a laminated or extruded material. A laminated material includes two or more separately formed layers, which are subsequently secured together by an adhesive. The bag material comprises a single integral sheet comprising two or more layers of different materials separated by a contact layer, the materials either being laminated together or being coextruded all at once. In one embodiment, the material is approved for direct contact with living cells and capable of maintaining the sterility of the solution. In such an embodiment, the material can also be sterilized, for example, by ionizing radiation. Other examples of usable materials are disclosed in U.S. Patent No. 6,083,587 issued on July 4, 2000 and U.S. Patent Application No. 10 / 044,636 filed on October 19, 2001, which are hereby incorporated by specific reference.

[0048] The terms "sterility" and "sterilization" are defined as the condition of being free from contaminants, particularly in the bioprocessing industry, free from pathogens (e.g., undesirable viruses, bacteria, germs, and other microorganisms). Relatedly, the terms "bioburden reduction" and "bioburden reduction" (e.g., by non-sterile doses of gamma or X-ray radiation <25 kGy) may be substituted for certain embodiments where a sterility statement is not required.

[0049] In certain embodiments, a bioreactor system is disclosed that includes a bioreactor volume or chamber for containing a bioreactor culture and a probe capable of providing a Raman spectrum of the bioreactor culture in the bioreactor volume or chamber. In some embodiments, the probe interfaces with the bioreactor chamber via an optical interface as described herein.

[0050] In certain embodiments, a computer including a processor or processing unit that performs computer-readable instructions can be provided in a bioreactor system. The processor or processing unit can be a general-purpose computing device (e.g., a microprocessor). Alternatively, it can be a dedicated processing device (e.g., a programmable logic controller (PLC)). A storage element can also be provided, which is used to store instructions and provide temporary storage for the use of the processor. The storage element can utilize any storage technology, such as RAM, ROM, EEPROM, flash ROM, NVRAM or any other applicable technology. An input device (e.g., a touch screen, a keyboard or other applicable device) can be provided.

[0051] In some embodiments, Raman spectroscopy can be performed in the visible, near infrared, infrared, near ultraviolet, or ultraviolet (UV) range. In some embodiments, surface enhanced Raman spectroscopy (SERS) can be used. In some embodiments, resonance Raman spectroscopy, tip enhanced Raman spectroscopy, polarized Raman spectroscopy, stimulated Raman spectroscopy, transmission Raman spectroscopy, spatially offset Raman spectroscopy, differential Raman spectroscopy, Fourier transform (FT) Raman spectroscopy, or hyper Raman spectroscopy can be used.

[0052] Now go to Figure 1 , Figure 2A and Figure 2B , an optical interface assembly 10 according to certain embodiments is shown. In some embodiments, the optical interface assembly 10 includes a sleeve 12 and a fixture 14. The sleeve 12 can have a generally cylindrical configuration and an internal bore or channel that is configured (e.g., shaped and sized) to receive a probe (e.g., a Raman probe). In the illustrated embodiment, the sleeve 12 includes an optional cap 15 located at the distal end of the sleeve 12, which can be integral with the sleeve 12. The cap 15 has one or more radial openings or through-holes 19 that terminate before the distal-most end of the cap 15. When in an assembled state, the one or more radial openings can provide access to the contents of the bioreactor or expose an optical window to the contents of the bioreactor. The cap 15 helps manage stray light (e.g., reducing the intensity of ambient light that may interfere with the Raman signal) and helps protect the user from laser light that may otherwise escape from the sleeve 12. As shown, the optical window 16 can be located at or near the end of the channel, such as an overmolded sapphire window (as known to those skilled in the art), overmolding is the process of adding additional layers of material to an already existing workpiece or part. Typically, a first material (sometimes referred to as a substrate) is partially or completely covered by a subsequent material (the overmolding material) during the manufacturing process. Those skilled in the art will understand that any material suitable for the application can be used for the optical window (e.g., sapphire or quartz).

[0053] Preferably, the sleeve 12 is disposable, i.e., disposable; designed to be discarded after a single use. Preferably, it is made of a material that is easily sterilized by gamma rays, such as plastic or stainless steel, including plastic materials with low-intensity Raman features, such as plastics with CxHy components, such as polyethylene (PE), polypropylene (PP), polystyrene (PS), polystyrene sulfonate (PSS), polycarbonate (PC), polyamide PA6 / PA12, etc.

[0054] The outer diameter of the sleeve 12 is configured to receive a standard hose barb 17, such as a 1" (inch) barb. The barb 17 is configured to mate with a hose such as Fig.11 and Fig.12 The bioreactor bag 300 shown in FIG. 1 is mated, docked, coupled or otherwise integrated (usually mechanically) (e.g., with a port of the bag as is conventional) and includes a barbed stem fixed to the clamp 14. Thus, the barb 17 has a first region 17A, such as a flange that is located in the bioreactor chamber or volume in use; that is, located inside it, and a second region 17B, such as a stem with one or more radial ridges or serrations, and located outside the bag; for example, the probe insertion side. The flange surrounds the stem and protrudes radially outward from the stem. The barb 17 may include threads (e.g., internal threads) to fix or retain the probe in the sleeve 12. Fig.13 and Fig.14 Another embodiment is shown in , where the PG13.5 or other threads on the bag 300 are used and the disposable sleeve 12 is threaded thereon. Fig.14 Insertion of the tube in this embodiment and connection of the probe to the bag 300 is shown. The threaded member coupled to the bioreactor port may include a sapphire window and may also include an optical lens.

[0055] In some embodiments, the sleeve 12 is oriented to be inserted into the barb 17, such as Figure 2B As shown, and fixed to the barb member 17 ( Figure 2A , Figure 2B). In some embodiments, the fixture 14 includes a distal annular radially inwardly protruding ridge 14A and a proximal annular radially inwardly protruding ridge 14B, the distal annular radially outwardly protruding ridge 14A abuts against the barb radial ridge 17C on the rod and locks the barb in place, and the proximal annular radially inwardly protruding ridge 14B abuts against the annular ring 11 on the sleeve 12. The annular ring 11 serves as a stopper, thereby correctly positioning or arranging the fixture 14 on the sleeve 12. An O-ring seal 18 or the like may be positioned on the sleeve 12 to ensure a liquid-tight connection between the barb 17 and the sleeve 12. Although a reusable invasive sensor is inserted, the configuration of the assembly avoids aseptic damage. In some embodiments, the probe or tube that can be introduced into the sleeve 12 can be threaded (e.g., with PG13.5 or other thread configurations), or can be mechanically fastened to the sleeve 12.

[0056] Figure 3 , Figure 4 , Figure 5A and Figure 5B One embodiment of a probe 20 is shown that is insertable or inserted into the sleeve 12. In the illustrated embodiment, the probe 20 includes a terminal optical lens 29 that is disposed proximate to the optical window 16 of the sleeve 12 when in an assembled state.

[0057] Fig. 6A , Figure 6B , Fig. 7A , Figure 7B and Figure 8 An embodiment is shown in which the barb-like fitting 17' is integrated with the sleeve 12' (i.e., formed as a single integral piece). Thus, in certain embodiments, the sleeve 12' having an optical window 16' (e.g., sapphire) overmolded on the sleeve 12' and optionally one or more optical lenses includes a barb-like structure 17' overmolded on the sleeve 12'. Like the barb 17, the barb-like structure 17' includes: a first region 17A', such as a flange that is located in the bioreactor chamber or volume (i.e., located inside thereof) during use; and a second region 17B', such as a rod having one or more radial ridges or serrations and located outside the bag (e.g., the probe insertion side). The flange surrounds the rod and protrudes radially outward from the rod. The sleeve 12' has a generally cylindrical configuration and an internal bore or channel that is configured (e.g., shaped and sized) to receive a probe (e.g., a Raman probe). An optional end cap 15' can be used for stray light management (eg, to reduce the intensity of ambient light that may affect the Raman signal) and laser safety, and can be integrated into the sleeve 12'. Figure 1 As with the embodiments described above, the flange serves as an interface to the bioreactor bag (eg, via a port in the bioreactor).

[0058] In some embodiments, the probe 20, which may include an internal stainless steel tube, may be coupled to the sleeve (e.g., using external threads 21 that mate with internal threads in the sleeve) once in its operable position. One or more internal optical lenses 22 may be mounted on the inner tube (e.g., via an applicable lens holder). Alternatively, one or more optical lenses may be mounted in the sleeve 12', and the probe body 20 may be mounted directly on the sleeve 12' without an inner tube.

[0059] Fig. 9A , Fig. 9B , Fig. 9C and Fig.9D Another embodiment is shown in which the proximal end of a disposable sleeve 12" having an optical window 16" includes external threads 122 (e.g., PG13.5 / M18 type threads) that mate with threads on a port of a bioreactor, thereby eliminating barb fittings. A probe 20" having an inner tube 200 with an optical lens can be inserted into the internal bore or channel of the sleeve 12" ( Fig. 9C In some embodiments, the inner tube 200 may be omitted and the probe 20" may be mounted directly on the disposable sleeve 12" ( Fig.10 ).

Claims

1. An interface assembly, the interface assembly being configured to be used for inserting a probe into a housing, the interface assembly comprising: an elongated sleeve having a passage configured to receive the probe, the sleeve containing an optical window; as well as A clamp is provided for securing the sleeve to a fitting positionable in a port of the housing.

2. The interface assembly of claim 1, wherein: The sleeve has a proximal end in which the probe is inserted and a distal end spaced apart from the proximal end, and a cap is provided at the distal end.

3. The interface assembly of claim 2, wherein: The cap extends longitudinally from the window.

4. The interface assembly of claim 1, wherein: The cap has one or more radial openings.

5. The interface assembly of claim 1, wherein: The probe comprises an optical lens positioned adjacent to the window of the sleeve 12 in the assembled state.

6. The interface assembly of claim 1, wherein: The interface component also includes: a barbed fitting having a barbed stem secured to the clamp; and A flange is configured to be positioned within the interior volume of the housing.

7. The interface assembly of claim 1, wherein: The housing has a threaded port, and the interface assembly is threadably connected to the threaded port.

8. The interface assembly of claim 1, wherein: The elongated sleeve is disposable.

9. The interface assembly of claim 1, wherein: The optical window comprises sapphire.

10. The interface assembly of claim 1, wherein: The housing is a bioreactor.

11. The interface assembly of claim 1, wherein: The housing is a bioreactor bag.

12. A housing having an internal volume, the housing comprising: providing a port leading from an area exterior to the housing to the interior volume; and An accessory is attached to the port, the accessory being configured to receive an interface assembly for inserting a probe through the port into the volume, the interface assembly comprising an elongated sleeve having a channel configured to receive the probe, the sleeve containing an optical window.

13. The housing according to claim 12, wherein: The interface assembly also includes a clamp for securing the sleeve to the fitting.

14. The housing according to claim 12, wherein: The fitting is a fitting with a barb.

15. The housing of claim 12, wherein: The fitting is threadably connected to the port.

16. The housing of claim 12, wherein: The optical window comprises sapphire.

17. The housing of claim 12, wherein: The housing is a bioreactor.

18. The housing of claim 12, wherein: The housing is a bioreactor bag.

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