Method for filtering a large volume of a medium with a pre-sterilisable, at least semi-automated one-way filtration device

Patent metadata

Field	Value
Publication number	US-11712659-B2
Application number	US-201816764440-A
Country	US
Kind code	B2
Filing date	Oct 11, 2018
Priority date	Nov 16, 2017
Publication date	Aug 1, 2023
Grant date	Aug 1, 2023

Abstract

A method of filtering a large volume of a medium using a pre-sterilizable, at least partially automated single-use filtration device which includes an unfiltrate inlet, a filtrate outlet, a main line running between the unfiltrate inlet and the filtrate outlet, filter elements arranged in the main line, a venting line and sensors for detecting specific process parameters and regulating means for adjusting specific process parameters, wherein the sensors and regulating means are connected to an external monitoring and control system which is adapted for evaluating and processing sensor data and for piloting the regulating means based on one or more control algorithms, comprises the following process steps: a) filling the single-use filtration device with medium with low flow; b) venting the single-use filtration device through the venting line; c) closing the venting line; d) rinsing the single-use filtration device, in particular the filter elements; e) filtering the medium by means of the filter elements; f) re-rinsing with high flow; and g) closing the main line; wherein the process steps f) and g) are optional.

First claim

The invention claimed is:

1. A method of filtering a large volume of a medium in a pre-sterilizable, at least partially automated single-use filtration device, comprising the following process steps:
a) filling the at least partially automated single-use filtration device with the medium using low flow, the at least partially automated single-use filtration device including an unfiltrate inlet, a filtrate outlet, a main line running between the unfiltrate inlet and the filtrate outlet, filter elements arranged in the main line, a venting line and sensors for detecting specific process parameters relevant to a filtration process and regulating means for adjusting the specific process parameters, wherein the sensors and the regulating means are connected to an external monitoring and control system which is adapted for evaluating and processing sensor data from the sensors and for controlling the regulating means based on one or more control algorithms;
b) venting the at least partially automated single-use filtration device through the venting line;
c) closing the venting line;
d) rinsing the at least partially automated single-use filtration device including the filter elements;
e) filtering the medium using the filter elements;
f) re-rinsing the at least partially automated single-use filtration device with high flow; and
g) closing the main line;
wherein the process steps f) and g) are optional,
wherein at least process steps d) and e) are controlled by the external monitoring and control system for evaluating and processing the sensor data from the sensors and for controlling the regulating means based on the one or more control algorithms,
wherein the sensors include a flow sensor provided at the unfiltrate inlet, an outlet liquid detector provided at the filtrate outlet, and an outlet pressure sensor provided at the filtrate outlet, and
wherein the regulating means include an inlet regulating valve provided at the unfiltrate inlet and an outlet regulating valve provided at the filtrate outlet.

2. The method according to claim 1 , characterized in that a presence of liquid at the filtrate outlet is determined from an inlet flow signal and a known system volume.

3. The method according to claim 1 , characterized in that at least in process step e), an inlet pressure detected by an inlet pressure sensor is used as a regulating variable.

4. The method according to claim 1 , characterized in that in process step e), a control of a flow occurring during the filtering of the medium using the filter elements is carried out via a characteristic curve of a feed pump, an inlet pressure sensor and a venting liquid detector.

5. The method according to claim 3 , characterized in that, depending on the detected inlet pressure, a shutting-off of the main line is carried out by a manual valve.

6. The method according to claim 1 , characterized in that process step g) is carried out by simply shutting off the main line using a shut-off valve either at the unfiltrate inlet or at the filtrate outlet.

7. The method according to claim 6 , characterized in that a control of the shut-off valve is carried out via a characteristic curve of a feed pump, an inlet pressure sensor and a venting liquid detector.

8. The method according to claim 1 , characterized in that a venting liquid detector on a housing of a sterile air filter or on a distributing or collecting pipe is used for draining supervision and/or for air accumulation supervision.

9. The method according to claim 1 , characterized in that the at least partially automated single-use filtration device further comprises an inlet pressure sensor, a venting liquid detector, a controlled or regulated feed pump and a manually operated simple venting valve, wherein the process steps a), b) and c) are carried out manually and at least one of the process steps d), e) and f) is regulated in an automated manner based on an inlet pressure detected by the inlet pressure sensor and/or controlled based on a characteristic curve of the controlled or regulated feed pump.

10. The method according to claim 1 , characterized in that the at least partially automated single-use filtration device further comprises an inlet pressure sensor, a flow sensor, a venting liquid detector, a controlled or regulated feed pump and a manually operated simple venting valve, wherein the process steps a), b) and c) are carried out manually and at least one of the process steps d), e) and f) is regulated in an automated manner based on a flow detected by the flow sensor and an inlet pressure detected by the inlet pressure sensor.

11. The method according to claim 1 , characterized in that the at least partially automated single-use filtration device further comprises an inlet pressure sensor, a flow sensor, a venting liquid detector, a controlled or regulated feed pump, an automated inlet regulating valve, and a manually operated simple venting valve, wherein the process steps a), b) and c) are carried out manually and at least one of the process steps d), e) and f) is regulated in an automated manner based on a flow detected by the flow sensor and an inlet pressure detected by the inlet pressure sensor, including starting and shut-downs ramps.

12. The method according to claim 1 , characterized in that the at least partially automated single-use filtration device further comprises an inlet pressure sensor, a controlled or a regulated feed pump and a manually operated simple venting valve, wherein the process steps a), b) and c) are carried out manually and at least one of the process steps d), e) and f) is regulated in an automated manner based on an inlet pressure detected by the inlet pressure sensor and/or is controlled based on a characteristic curve of the controlled or the regulated feed pump.

13. The method according to claim 1 , characterized in that the process step f) is carried out with pressure supervision.

14. The method according to claim 1 , characterized in that a pH sensor integrated in the at least partially automated single-use filtration device is used for an automated adjustment of a pH value during dosing of an acid or base.

15. The method according to claim 1 , characterized in that an automated actuator is used during one or more samplings at predetermined time and/or fraction intervals.

16. The method according to claim 1 , characterized in that an automated rinsing medium access is used during a pre-rinsing or wetting of the filter elements.

17. The method according to claim 1 , characterized in that an automated drainage output or an automated gas access is used during a discharge of rinsing or wetting medium or of a process run-up.

18. The method according to claim 1 , characterized in that at least one of the sensors integrated in the at least partially automated single-use filtration device is used during a process supervision and/or documentation or data archiving, the at least one of the sensors including:
a capacitive, inductive, ultrasonic, vibration or conductive sensor for level measurement and/or liquid detection;
a temperature sensor;
a pH sensor;
a conductivity sensor;
a TOC sensor; or
a sensor for turbidity measurement.

19. The method according to claim 1 , further comprising a process step, before process step a), of pre-sterilizing the at least partially automated single-use filtration device.

20. The method according to claim 1 , wherein the sensors further include a venting liquid detector between a venting outlet of the venting line and a sterile air filter.

Assignees

• Sartorius Stedim Biotech Gmbh

Inventors

• Loewe Thomas
• Diel Bernhard
• Sommer Maik

Classifications

• B01D2313/60

  Specific sensors or sensor arrangements · CPC title

• B01D2313/70

  Control means using a programmable logic controller [PLC] or a computer · CPC title

• B01D2313/701

  comprising a software program or a logic diagram · CPC title

• B01D61/22 Primary

  Controlling or regulating · CPC title

• B01D29/601

  by clearness or turbidity measuring · CPC title