Optical Sensors for Monitoring Biopharmaceutical Solutions in Single-Use Containers

Abstract

Disposable, pre-sterilized, and pre-calibrated, pre-validated sensor components are provided. The sensor components interact with a sensor system having disposable fluid conduit or bioreactor bag and a reusable sensor assembly. The components can include an optical bench or inset optical component or module designed to be integrated within the disposable fluid conduit or bioreactor bag, which provides an optical light path through the conduit or bag. The sensors systems are designed to store sensor-specific information, such as calibration and production information, in a non-volatile memory chip on the disposable fluid conduit or bag and on the reusable sensor assembly. Methods for calibrating the sensor and for determining a target property of an unknown fluid are also disclosed. The devices, systems and methods relating to the sensor are suitable for and can be outfitted for turbidity sensing.

1 . A sensor for measuring one or more properties of a fluid, the sensor comprising:
 (a) a source of electromagnetic radiation, and a detector for measuring electromagnetic radiation;   (b) a conduit or container having an interior, an exterior, and an optical inset component; 
 i) said optical inset component includes at least one reflective surface and at least one optically clear portion; 
 (1) said optically clear portion is located between the interior and the exterior of said conduit or container, and 
 (2) said reflective surface is located in the interior of said conduit or container, whereby electromagnetic from the electromagnetic radiation source reflects off said reflective surface, then reflects off one or more particulates when located in the interior of said conduit or container, and thereafter passes through said optically clear portion and to said electromagnetic radiation detector. 
 
   
     
     
         2 . The sensor of  claim 1 , wherein said optical inset component is included in a disposable flowcell, and said source of and said detector of electromagnetic radiation are included in a reusable sensor assembly comprising a housing, said housing supporting said electromagnetic radiation source for generating a path of electromagnetic radiation. 
     
     
         3 . A system for measuring turbidity of fluid, the system comprising:
 (a) a housing component, said housing component enclosing at least one source of electromagnetic radiation for generating electromagnetic radiation and at least one reference detector for measuring electromagnetic radiation, said housing component having a portion which permits the transmission of electromagnetic radiation;   (b) a conduit or container having an interior, an exterior, and an optical inset component including at least one reflective surface and at least one optically clear portion, said optically clear portion being positioned between the interior and the exterior, whereby electromagnetic radiation from the source of electromagnetic radiation reflects off said reflective surface and reflects off one or more particulates located in the interior of said conduit or container, and thereafter passes through said optically clear portion; and   (c) said exterior portion of the conduit or container is optically aligned with said optical inset component when said housing component is attached to said conduit or container.   
     
     
         4 . A method of measuring turbidity of fluid, the method comprising:
 (a) providing a disposable conduit or container, the conduit or container having an interior cavity for a fluid, the conduit or container having connected thereto a docking port receiving an inset optical component, the inset optical component having one reflective surface, the reflective surface extending toward the interior of the conduit or container, the inset optical component having a bench docking port;   (b) providing a reusable sensor assembly having an electromagnetic radiation source and detector supported by a housing having a housing docking port;   (c) docking the disposable conduit or container to the sensor assembly housing by engaging together the inset optical component docking port and the housing docking port;   (d) delivering a fluid into the interior cavity, the fluid having particulates;   (e) reflecting electromagnetic radiation off the reflective surface of the inset optical component, whereby the electromagnetic radiation is directed through the fluid while the fluid is within the conduit or container;   (f) measuring the electromagnetic radiation reflected by the particulates in the fluid; and   (g) calculating the turbidity of the fluid.   
     
     
         5 . The method of  claim 4 , further comprising retrieving a calibration value from a memory device associated with the disposable conduit or container. 
     
     
         6 . A method of calibrating a turbidity sensor, the method comprising:
 (a) providing a disposable conduit or container, the conduit or container having an interior cavity for a fluid, an inlet to said cavity and an inset optical component, the inset optical component having a reflective surface and a docking port, the reflective surface extending toward the interior cavity;   (b) providing a reusable sensor assembly having an electromagnetic radiation source and detector supported by a housing having a housing docking port;   (c) docking the disposable conduit or container to the sensor assembly housing by engaging together the inset optical component docking port and the housing docking port;   (d) delivering a fluid with a known concentration of particulates to the interior cavity through the inlet;   (e) reflecting electromagnetic radiation off the reflective surface of the inset optical component, whereby the electromagnetic radiation is directed through the fluid while the fluid is within the cavity;   (f) measuring the electromagnetic radiation reflected by the particulates in the fluid; and   (g) calculating one or more calibration values based on the result of measuring of the electromagnetic radiation reflected off the particulates in the fluid.   
     
     
         7 . The method of  claim 6 , further including storing one or more calibration values in a memory device associated with the disposable conduit or container. 
     
     
         8 . The sensor of  claim 1 , wherein the sensor further comprises a turbidity sensor. 
     
     
         9 . The sensor of  claim 2 , wherein the disposable flowcell is suitable for single use. 
     
     
         10 . The method of  claim 4 , further comprising retrieving a calibration value from a memory device associated with the disposable conduit or container. 
     
     
         11 . The system of  claim 3 , wherein the housing is part of a reusable sensor assembly that supports the electromagnetic radiation source and detector of electromagnetic radiation, and the optical inset component is included in a disposable flowcell.