Risk-managed, single-use, pre-calibrated, pre-sterilized sensors for use in bio-processing applications

摘要

Single-use, pre-sterilized, and pre-calibrated, pre-validated sensors are provided. These sensors are designed to store sensor-specific information, such as calibration and production information, in a non-volatile memory chip on the sensor or in a barcode printed on the sensor. These sensors may be utilized with in-line systems, closed fluid circuits, bioprocessing systems, or systems which require an aseptic environment while avoiding or reducing cleaning procedures and quality assurance variances. The sensors exhibit both their primary sensing function such as conductivity, pH level, dissolved oxygen, pressure or temperature, as well as at least one secondary sensing function of risk management or risk mitigation.

主权项

1. A single-use bio-solution processing sensor, comprising:
a fluid conduit through which a biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; a usage counter associated with the sensor; said usage counter includes a motion detector, the motion detector detects vibration corresponding to solution flow through the fluid conduit, and the memory device analyzes the vibration and designates the vibration as a counted sensor use event, whereupon the counted sensor use event is stored on the memory device and accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained; and the motion detector is an accelerometer that operates as a flow meter, whereby when a relatively non-compressible fluid flows through the fluid conduit a first accelerometer output is generated, and when a compressible fluid flows through the fluid conduit a second accelerometer output is generated, resulting in a differential between the first and second accelerometer outputs, thereby indicating an end to a cycle of a manifold within which the sensor is included.