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US 10,001,454 B2Granted
Single-use sensors in bioreactors, biotech purification and bioprocessing
AssigneeParker-Hannifin Corporation
InventorsKarl G. Schick, David Uhen
Life of this patent
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Abstract
Presteralized manifolds having disposable multifunctional sensors are provided which are designed for sterile packaging and single-use approaches. These manifolds, which have disposable tubing and flexible-wall containers and are adapted to interact with other equipment which can be operated by a controller and a flow-imparting unit, provide automated and accurate delivery or purification of biotechnology fluid. The disposable sensor monitors pH, oxygen and electrical conductivity, alone or in combination, that interact with the controller or are connected to a separate user interface. Disposable sensor components and re-usable components can be dockable with each other.
Claims22
A manifold system for biotechnology uses, comprising:
- a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
- (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
- (b) at least one single-use container in fluid communication with said tubing,
- (c) at least one single-use sensor that senses parameter combinations that include a pH sensing function combined with at least one other sensing function selected from the group consisting of electrical conductivity, oxygen, temperature and combinations thereof,
- (d) at least one valve remotely operable to engage the length of tubing;
- (e) a single-use separation component selected from the group consisting of a separation unit, a purification unit, a sterilizing filter and a combination thereof positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet end portion;
- a controller which controls operation of said valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable valve responsive to the parameters sensed at the sensor;
- the single-use sensor has usage counter capabilities, has an on-sensor memory device and an associated time event feature;
- and
- the time event feature is initialized by achievement of a threshold event and is counted as sensor use after having been maintained for a pre-selected time interval, whereupon the counted sensor use is stored on and optionally retrievable from the memory device and accumulates with prior or subsequent uses, as needed until a maximum use total is attained.
7 more elements
A manifold system for biotechnology uses, comprising:
- a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
- (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
- (b) at least one single-use container in fluid communication with said tubing,
- (c) at least one single-use sensor that senses parameter combinations that include a pH sensing function combined with at least one other sensing function selected from the group consisting of electrical conductivity, oxygen, temperature and combinations thereof,
- (d) at least one valve remotely operable to engage the length of tubing;
- (e) a single-use separation component selected from the group consisting of a separation unit, a purification unit, a sterilizing filter and a combination thereof positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet end portion;
- a controller which controls operation of said valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable valve responsive to the parameters sensed at the sensor;
- the single-use sensor is for biopharmaceutical solution processing, has usage counter capabilities, an on-sensor memory device and an associated usage counter;
- and
- said usage counter utilizes motion detection to detect movement of a component of the system to thereby designate initializing of sensor usage and ceasing of motion detection to designate ceasing of sensor usage.
7 more elements
A manifold system for biotechnology uses, comprising:
- a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
- (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
- (b) at least one single-use container in fluid communication with said tubing,
- (c) at least one single-use sensor that senses parameter combinations that include a pH sensing function combined with at least one other sensing function selected from the group consisting of electrical conductivity, oxygen, temperature and combinations thereof,
- (d) at least one valve remotely operable to engage the length of tubing;
- (e) a single-use separation component selected from the group consisting of a separation unit, a purification unit, a sterilizing filter and a combination thereof positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet end portion;
- a controller which controls operation of said valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable valve responsive to the parameters sensed at the sensor;
- the single-use sensor has usage counter-capabilities, an on-sensor memory device and an associated time event feature;
- said time event feature is initialized by achievement of a threshold event and is counted as sensor use after having been maintained for a pre-selected time interval, whereupon the counted sensor use is stored on the memory device and accumulates with prior or subsequent uses, as needed until a maximum use total is attained;
- a usage counter utilizing motion detection to designate initializing of sensor usage and ceasing of motion detection to designate ceasing of sensor usage;
- and
- said time event feature and usage counter utilizing motion detection electronically interact to confirm total usage.
9 more elements
A manifold system for biotechnology uses, comprising:
- a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
- (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
- (b) at least one single-use container in fluid communication with said tubing,
- (c) at least one single-use sensor that senses parameter combinations that include a pH sensing function combined with at least one other sensing function selected from the group consisting of electrical conductivity, oxygen, temperature and combinations thereof,
- (d) at least one valve remotely operable to engage the length of tubing;
- (e) a single-use separation component selected from the group consisting of a separation unit, a purification unit, a sterilizing filter and a combination thereof positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet end portion;
- a controller which controls operation of said valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable valve responsive to the parameters sensed at the sensor;
- the single-use component is a biopharmaceutical solution processing device has gamma irradiation exposure reporting capabilities;
- an on-sensor memory device that maintains function under gamma irradiation;
- the on-sensor memory device has a stored pre-gamma irradiation threshold voltage and a stored post-gamma irradiation threshold voltage greater in magnitude than a pre-gamma threshold irradiation voltage;
- and
- the on-sensor memory device is readable, the pre-gamma irradiation threshold voltage correlates to a zero kGy gamma irradiation level, and the post-gamma irradiation threshold voltage correlates to a positive kGy gamma irradiation level substantially corresponding to a gamma irradiation exposure level for said sensor.
9 more elements
Dependencies are inferred from the claim text.