Disposable alternating tangential flow filtration units

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, wherein:
• the diaphragm is arranged between respective circumferential flanges of first and second hemispheres by a clamp ring,
• an opening in the first hemisphere enables fluid to How between the first hemisphere and a hollow tube of a sterilizable, non-toxic, rigid plastic secured thereto,
• the respective circumferential flanges of the first and second hemispheres are configured to mate with each other,
• one of the circumferential flanges comprises an external threading, and
• the clamp ring is configured to fit over the hemisphere without a threaded circumferential flange and to couple with the threaded circumferential flange, an upper inner surface of the clamp ring is shaped to correspond to a curved or angled outer surface of the hemisphere without a threaded circumferential flange;
• 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.

A disposable alternating tangential flow (ATF) housing and diaphragm pump unit comprising:

• a hollow tube of a sterilizable, non-toxic, rigid plastic;
• a pump chamber comprising first and second half chambers, wherein the first half chamber is secured to an end of the hollow tube, and wherein an opening in the first half chamber enables fluid flow between the first half chamber and the hollow tube;
• a clamp ring;
• and
• a flexible diaphragm compressed between the first and second half chambers, wherein the first and second half chambers are secured at respective circumferential flanges by the clamp ring, wherein one of the respective circumferential flanges comprises an external threading to be secured to a threaded internal surface of the clamp rings;
• and
• an upper inner surface of the clamp ring is shaped to correspond to a curved or angled outer surface of the pump hemisphere without a threaded circumferential flange.