METHOD FOR MEASURING A PLURALITY OF STATUS PARAMETERS OF A FLUID CONTAINED IN A CONTAINER

Abstract

A method is provided for measuring status parameters of a fluid contained in a container (10). The container (10) is configured for single use and has a wall on which a sensor-carrier plate is fixed in a fluid-tight manner. The plate carries sensors (S1-S5) that are in operative contact with the internal chamber of the container (10) and connected for data exchange (14) with an external control unit (16) that receives and processes the measurement data from the sensors (S1-S5). The sensor plate also carries a temporarily inactive duplicate (D1-D5) of at least one of the sensors (S1-S5) that is activated if measurement data of the sensor (S1-S5) is classified as atypical in the context of an integrity or plausibility test carried out by the external control unit (16).

Claims

1. A method for measuring a plurality of status parameters of a fluid contained in a container (10), wherein the container (10), configured for a single use, has a wall, on which a sensor carrier plate is fixed in a fluid-tight manner, said plate carrying a plurality of sensors (S1-S5) that are in operative contact with the internal space of the container (10) and are connected for data exchange (14) with an external control unit (16) that receives and processes the measurement data from the sensors (S1-S5), the sensor carrier plate of at least one of sensors (S1-S5) further carries a temporarily inactive duplicate (D1-D5), the method comprising: operating the external control unit (16) to carry out an integrity or plausibility test using measurement data of the sensor (S1-S5); and activating the duplicate (D1-D5) if measurement data of the sensor (S1-S5) are classified as atypical in the context of the integrity or plausibility test carried out by the external control unit (16).

2. The method of claim 1, further comprising: operating the control unit (16) to temporarily processes both the measurement data received from the sensor (S1-S5) and the measurement data received from the duplicate (D1-D5).

3. The method of claim 2, further comprising: deactivating the duplicate (D1-D5) if the processing of the measurement data received from the sensor (S1-S5) and from the duplicate (D1-D5) provides the same results within a predetermined tolerance.

4. The method of claim 3, further comprising: deactivating the sensor (S1-S5) if the processing of the measurement data received from the sensor (S1-S5) and from the duplicate (D1-D5) provides different results in consideration of the predetermined tolerance.

5. The method of claim 1 further comprising: using the control unit (16) to process the measurement data received from the duplicate (D1-D5) instead of the measurement data received from the sensor (S1-S5).

6. The method of claim 5, further comprising: reactivating the sensor (S1-S5) and deactivating the duplicate (D1-D5) if the processing of the measurement data received from the duplicate (D1-D5) and of the measurement data received, prior to activation of the duplicate (D1-D5), from sensor (S1-S5) provide the same results within a predetermined tolerance.

7. The method of claim 5, further comprising: deactivating the sensor (S1-S5) and activating the duplicate (D1-D5) if the processing of the measurement data received from the duplicate (D1-D5) and of the measurement data received, prior to activation of the duplicate (D1-D5), from sensor (S1-S5) provide the same results within a predetermined tolerance.

8. The method of claim 1, further comprising: calculating a parameter value by the external control unit, based on measurement data of a plurality of different sensors for a status parameter that cannot be directly measured by any of the sensors.

9. The method of of claim 1, wherein the container is a disposable bioreactor or a disposable mixing container.

10. The method of claim 9, wherein the disposable bioreactor or the disposable mixing container are provided as bags with a wall that has flexible segments, or as a plastic container, with a wall that has rigid segments.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 shows a schematic representation of a container, which is connected to an external control unit.

[0017] FIG. 2 shows a flow chart illustrating an embodiment of the inventive method.

DETAILED DESCRIPTION

[0018] FIG. 1 is a schematic representation of a container, such as a disposable bioreactor bag or a disposable mixing container 10 that carries a sensor region 12. The sensor region 12 comprises a carrier plate, not shown that is connected in a fluid-tight manner to the wall of the container 10, and that is welded to the bag wall. In other embodiments of the invention, the connection may also be a force-fit connection or a form-fit connection; it is only important that the connection provides the tightness to fluids. Sensors S1-S5 are arranged on the carrier plate and operatively contacts a sensor head, not shown, in the inner space of the bag, in particular a fluid provided inside the bag. Each sensor S1-S5 also is connected via a communication path that is indicated generally by communication arrow 14 to an external control unit 16. Data and control commands may thus be exchanged through the communication path 14 between the external control unit 16 and sensors S1-S5. The communication path 14 may be cabled, such as an electrical cable and/or an optical fiber cable. Alternatively, or additionally, at least one of sensors S1-S5 may be connected wirelessly, in particular over a radio or IR link, to the external control unit 16. The sensors S1-S5 have different measurement tasks, the type of which is not important for the present invention. Their different form is however shown in FIG. 1 by a different shaping of sensors S1-S5.

[0019] Moreover, the sensor region 12 comprises duplicates D1-D5 that are constructively identical to sensors S1-S5 that are associated respectively to one of sensors S1-S5 (indicated by the same shape in FIG. 1). The duplicates D1-D5 also are connected through the communication path 14 to the external control unit 16.

[0020] FIG. 2 shows a greatly simplified flow chart of a preferred embodiment of the inventive method. For the sake of clarity, FIG. 2 shows only the method pertaining to one of sensors S1-S5. However, one skilled in the art will recognize that the same method or a similar method may be used for each one of sensors S1-S5.

[0021] After the usual and required initialization routines have been performed and a process in the container 10 (for example a disposable bioreactor bag or a disposable mixing container) is steadily proceeding, at step 102 of method a certain status parameter of the fluid in the container 10 is measured by means of an associated sensor. The corresponding measured value is subject in step 104 to an integrity test, wherein reference values 20 stored to this end and/or measurement data 22 from a reference process run in parallel are used as comparison values. If the current measured values in step 104 pass the integrity test, i.e., they lie within a predetermined tolerance around the nominal values to be reached, the method 100 branches at decision step 106 back to the measurement step 102.

[0022] If, on the contrary, the current measurement data do not pass the integrity test at step 104, the sensor that has provided the atypical measurement data is switched off at step 108 and the respective duplicate is activated. In other words, at step 108, the switch over from the sensor to its duplicate takes place. Then, at step 110, the measurement is repeated by means of the duplicate. Alternatively, both the sensor and its duplicate may provide measurement results in parallel, i.e., the sensor is not deactivated, but the measurement results provided by the sensor are not subject to further processing, while only the results provided by the duplicate are processed.

[0023] The measurement result provided by the duplicate at step 110 is compared at step 112 with the result provided by sensor at step 102. If both measurement results are identical or within a predetermined tolerance, then the method 100 branches at decision step 114 to step 116, where a back-switching from the duplicate to the original sensor occurs. In fact, the equivalence of the measurement results from the comparison at step 112 means that the atypical measurement values are not due to a sensor defect, but much more probably to a process deviation. Thus, there is no reason to perform future measurements without the original sensor. The back-switching to the original sensor could obviously also be omitted, while the duplicate remains active, since the comparison at step 112 also proves the correct operation of duplicate. Due to reasons of data consistency it is however more advantageous to essentially use the same sensor for the whole process.

[0024] However, in this case, the atypical measured values hint at a very probable process deviation, so that at step 118, simultaneously, a process alarm is issued to initiate the introduction of repairing routines or the intervention by an operator. The precise measures to be taken following the process alarm at step 118 depend from the process configuration, the type and value of the deviation of the status parameter and the technical conditions of the particular plant. This is indicated in FIG. 2 by the continuation points at step 118.

[0025] If, however, the comparison at step 112 indicates that the measurement values of sensor and its duplicate differ from each other beyond the predetermined allowed tolerance, then method 100 branches at decision step 114 to step 120, where the data generated by the duplicate are subject to a plausibility test. In fact, a double sensor defect could be hypothesized, i.e., a defect of the sensor and of its duplicate, wherein due to probability considerations, it may be substantially excluded, that both defective sensors provide identical values. It is thus sufficient to perform a plausibility test at step 120. It is also possible to interpose a similar plausibility test between the decision step 114 and the back-switching step 116. The plausibility test at step 120, as well as the integrity test at step 104, may use the reference values 20, 22 and/or further process-depending measurement and setup-data.

[0026] If the measurement data generated by the duplicate pass the plausibility test at step 120, i.e., if they lie within the expected values, the method 100 branches at decision step 122 to method step 124, where the production process is continued without further interventions, wherein in the following only the duplicate is used instead of the sensor, which has been recognized to be defective. At the same time, however, according to step 118 a process alarm is issued and is only used for indicating that the duplicate is used instead of the sensor. Such a process occurrence usually is indicated in the process protocol.

[0027] If the plausibility test at step 120 shows, on the contrary, that the measurement values provided by the duplicate are also either incorrect or, although correct, demonstrate a process deviation, the process 100 branches out, at decisional step 122, without delay, to process alarm according to step 118. In this case, important measures have to be introduced. In particular it is then necessary to verify, if the atypical measurement values of the duplicate are the result of a duplicate error or the result of an actual process deviation. In case of a process deviation, corrective measures may be introduced. In case of a defect of the duplicate, the entire process normally has to be stopped, since after the failure of a sensor and of its duplicate, the corresponding status parameter cannot be measured anymore. One skilled in the art will understand, based on this context, that it is fundamentally also possible to provide more than one duplicate for each sensor, so that before the interruption of the process, in a similar way to the above description, the switch over to a further duplicate may take place.

[0028] The embodiments discussed in the specific description and shown in the figures are obviously only illustrative examples of embodiments of the present invention. One skilled in the art is provided with a wide spectrum of possible variations, based on the present disclosure.

REFERENCE LIST

[0029] 10 container [0030] 12 sensor region [0031] S1-S5 sensor at 12 [0032] D1-D5 duplicate of S1-S5 [0033] 14 communication path [0034] 16 external control unit [0035] 20 reference data [0036] 22 reference measurement values [0037] 100 method [0038] 102 step [0039] 104 step [0040] 106 decision step [0041] 108 step [0042] 110 step [0043] 112 step [0044] 114 decision step [0045] 116 step [0046] 118 step [0047] 120 step [0048] 122 decision step [0049] 124 step