Disposable Alternating Tangential Flow Filtration Units

Patent metadata

Field	Value
Publication number	US-2018238317-A1
Application number	US-201615772761-A
Country	US
Kind code	A1
Filing date	Aug 26, 2016
Priority date	Nov 10, 2015
Publication date	Aug 23, 2018
Grant date	—

Abstract

Disclosed herein are robust disposable alternating tangential flow (ATF) housing and diaphragm pump units and associated methods of manufacturing, testing, wetting, and using the same.

First claim

1 . A disposable alternating tangential flow (ATF) housing and diaphragm pump unit comprising:
a hollow tube of a sterilizable, non-toxic, rigid plastic; a first pump hemisphere secured to an end of the hollow tube, wherein the first pump hemisphere comprises a first circumferential flange; and wherein an opening in the first pump hemisphere enables fluid to flow between the first pump hemisphere and the hollow tube; a second pump hemisphere comprising a second circumferential flange configured to mate with the first circumferential flange, wherein either the first circumferential flange or the second circumferential flange comprises an external threading; a flexible diaphragm configured to be arranged between the first and second circumferential flanges; and a clamp ring having an internal surface comprising an internal threading, wherein the clamp ring is configured to be placed over the pump hemisphere without a threaded circumferential flange and to be secured to the threaded circumferential flange.

2 . The disposable ATF unit of claim 1 , wherein the clamp ring comprises one or more of acrylonitrile-butadiene-styrene, polyethylene, polyethylene, polycarbonate and polysulfone plastic.

3 . The disposable ATF unit of claim 1 , wherein the clamp ring comprises a lower portion comprising the internal threads and an upper portion comprising an internal surface configured to accommodate a curved or angled outer surface of the first pump hemisphere.

4 . The disposable ATF unit of claim 1 , further comprising one or more ports used to attach any one or more of an air reservoir, a permeate flush bag, and a fluid supply bag through sterile connections to achieve a closed system capable of being operated as an ATF and wet the filter membrane.

5 . The disposable ATF unit of claim 1 , wherein the ATF unit has a structure that can withstand a pressure of up to 450 psi without rupturing or leaking.

6 . The disposable ATF unit of claim 1 , wherein the first and second flanges have a groove configured to mate with a protrusion on the flexible diaphragm.

7 . The disposable ATF unit of claim 1 , wherein the clamp ring is configured to compress the flexible diaphragm between the first and second flanges.

8 . The disposable ATF unit of claim 7 , wherein a level of compression can be changed by applying a torque specification that correlates to sufficient compression of the diaphragm to contain pressure at several orders of safety in the design.

9 . The disposable ATF unit of claim 8 , wherein the torque specification is approximately 10 to approximately 100 lbft.

10 . The disposable ATF unit of claim 9 , wherein the torque specification is approximately 30 to approximately 70 lbft.

11 . (canceled)

12 . The disposable ATF unit of claim 1 , further comprising sealing features between the first and second hemispheres to aid in sealing across the diaphragm.

13 . The disposable ATF unit of claim 12 , wherein the sealing features comprise energy directors or raised surfaces.

14 . A method of preparing a fully wetted disposable filtration device, the method comprising:
connecting retentate and permeate fluid bags to top ports of a disposable alternating tangential flow (ATF) unit of claim 1 using sterile connections; attaching a media or other fluid containing bag to a pump inlet port; and operating the disposable ATF unit to achieve flux of media or other fluid across a filter membrane within the hollow tube of the disposable ATF unit.

15 . The method of claim 14 , further comprising draining retentate fluid from the disposable ATF unit through the pump inlet port after operating the disposable ATF unit to achieve fluid flux to permeate a chamber within the hollow tube of the disposable ATF unit.

16 . A method of using a disposable filtration device, the method comprising:
obtaining a disposable alternating tangential flow (ATF) unit of claim 1 ; disposing the ATF unit into a fluid circuit by connecting fluid bags to top ports of the ATF unit using sterile connections, and attaching a fluid container to a pump inlet port such that the ATF unit can achieve flux of media or other fluid to be filtered across a filter membrane within the hollow tube of the disposable ATF unit; and when the filtration is complete, disposing of the ATF unit.

17 . A method of performing an integrity test of a disposable filtration device, the method comprising:
draining media used to flush a disposable filtration device into a wetting fluid bag with an air pressure source open to raise a diaphragm inside the filtration device; closing an air pressure source valve to release any pressure on the diaphragm; closing a valve located between the wetting fluid bag and a port on the filtration device and a valve connected to a retentate port of the filtration device; pressurizing one side of a filter using the air pressure source; closing a valve between the filter and the air pressure source; measuring the pressure decay versus time; and correlating the measured pressure decay to air flow.

18 . The method of claim 17 , wherein the media is drained by gravity.

19 . The method of claim 17 , wherein the media is drained by pumping the media from the device.

20 . The method of claim 17 , wherein the air pressure source provides air at a pressure of about 1-2 psi.

21 . A method of performing an integrity test of a disposable filtration device, the method comprising:
draining media used to flush a disposable filtration device into a wetting fluid bag with an air pressure source open to raise a diaphragm inside the filtration device; closing an air pressure source valve to release any pressure on the diaphragm; closing a valve located between the wetting fluid bag and a port on the filtration device and a valve connected to a retentate port of the filtration device; pressurizing one side of a filter using the air pressure source; measuring pressure inside the device versus time; measuring flow between the air pressure source and the device using a flow meter; and correlating the measured pressure to the measured air flow.

Assignees

• Repligen Corp

Inventors

• Ward Travis R
• Pearl Steven R
• Malone Adam
• Erlandson Tim

Classifications

• F04F99/00

  Subject matter not provided for in other groups of this subclass · CPC title

• F15C1/16

  Vortex devices, i.e. devices in which use is made of the pressure drop associated with vortex motion in a fluid {(vortex chambers F15D1/0015; vortex chambers as resistances F15C1/02; vortex chambers associated with amplifiers for improving the switching time by interaction F15C1/14)} · CPC title

• C12M29/16

  Hollow fibers (hollow fiber modules in general B01D63/02) · CPC title

• B01D27/08

  Construction of the casing · CPC title

• F04B43/073 Primary

  the actuating fluid being controlled by at least one valve · CPC title