Multi-use sterile access/GMP diaphragm valve housing

Details Multi-use sterile access/GMP diaphragm valve housing Multi-use sterile access/GMP diaphragm valve housing

2001-11-13

2004-01-06

Mancene, Gene (Department: 3754)

Valves and valve actuation

Reciprocating valve

Diaphragm

C137S015210, C137S861000

Reexamination Certificate

active

06672566

ABSTRACT:

CROSS-REFERENCE TO RELATED APPLICATIONS
(Not Applicable)
STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
(Not Applicable)
BACKGROUND OF THE INVENTION
The present invention relates generally to fluid valves, and more particularly to a diaphragm type valve housing usable in sterile access and GMP orientations.
A diaphragm type main flow valve includes a valve housing body. The valve housing body has an inlet port which connects with an upstream passage which extends into the valve housing body. The valve housing body further has a downstream passage which is aligned with the upstream passage. The downstream passage extends to an outlet port. A main flow valve mounting surface is formed upon the valve housing body. A main flow valve weir is formed in the valve housing body adjacent the main flow valve mounting surface, and separates the upstream and downstream passages. A diaphragm type valve housing may be mounted upon the main flow valve mounting surface, with a diaphragm being configured to engage the main flow valve weir. Actuation of the diaphragm against the main flow valve weir prevents fluid flow between the upstream and downstream passages thereby closing the valve. As such, with the diaphragm in a closed position, fluid flow from the upstream passage is prevented from entering into the downstream passage. With the diaphragm in an open position, the downstream passage is in fluid communication with the upstream passage for passage of fluid flow from the upstream passage. In this regard, the main flow valve is intended to control fluid flow in a product distribution loop to which it is attached.
For a variety of reasons, it is often desirable to fluidly communicate directly with the main flow valve. An access port may be formed in the main flow valve housing body to gain fluid communication with either the upstream or downstream passages. In this regard, with the diaphragm of the main flow valve in the closed position, fluid flow is allowed to pass into the upstream passage an through such an access port. Alternatively, with the diaphragm of the main flow valve in the open position, fluid flow is allowed to pass into the downstream passage and through such an access port. Connecting to the access for may be a sampling valve for obtaining product samples from the distribution loop for example. A branch connection may be attached to the access port to divert flow from a main flow line in which the main flow valve is disposed. In another common arrangement, a purge valve may be attached to the access port for purging the main flow valve.
These valve arrangements have application in a wide range of fluid handling systems, such as those for pharmaceutical, biotech processing, food and beverage, and cosmetic and consumer products applications. Such applications are typically subject to strict governmental regulations and industry practices and procedures. Of interest is the cleanliness and sterility of the downstream passage of the main flow valve housing body and any attached structures at the access port (e.g., tubing to a sampling valve or purge valve, or branch connection tubing). In this regard, efficient gravitational drainage of the downstream passage and any such attached structures at the access port is of particular concern.
The interior drainage design characteristics of the downstream passage is dependent upon the orientation of the overall main flow valve and attached structure that is to be installed. Those valve arrangements which are designed to be utilized with the upstream and downstream passages of the main flow valve housing body arranged horizontally are referred to as sterile access valves. Those valve arrangements which are designed to be utilized with the upstream and downstream passages of the main flow valve housing body arranged vertically are referred to as GMP (good manufacturing practices) valves.
Those responsible for maintaining fluid product handling systems must typically carry dedicated inventories of both sterile access and GMP valves. This is because sterile access valves and GMP valves are not interchangeable due to their particular configurations associated with desired drainage when utilized in their intended orientations. As such valves generally perform the same function, however, utilization of two different valve housing designs is inefficient. Accordingly, there is a need in the art for an improved main flow valve housing design in comparison to the prior art.
BRIEF SUMMARY OF THE INVENTION
In accordance with an embodiment of the present invention, there is provided a multi-use sterile access/GMP diaphragm valve housing. The housing has a valve housing block having a main flow axis. The housing further has a main flow valve mounting surface formed upon the valve housing block parallel to the main flow axis. The housing further has a first port and an opposing second port each respectively formed in the valve housing block aligned along the main flow axis. The housing further has a first passage extending from the first port to the main flow valve mounting surface. The housing further has a second passage extending from the main flow valve mounting surface to the second port. The housing further has a main flow weir disposed adjacent the main flow valve mounting surface between the first and second passages for controlling flow between the first and second passages. The housing further has first and second planar lands formed upon the valve housing block adjacent the first passage for forming a third passage through a respective one of the lands in fluid communication with the first passage. The first and second planar lands is disposed orthogonal to each other and parallel to the main flow axis. In practice, the first passage may be an upstream passage which may be attached to a product distribution loop. As such, the second passage would be a downstream passage. In this regard, such third passage could be used to divert fluid flow to a sampling valve.
In an embodiment of the housing, the main flow valve mounting surface is disposed between about 45 degrees to about 10 degrees with respect to the first and second planar lands. Further, the first and second planar lands abut each other, and the first and second planar lands extend along the valve housing block adjacent the first and second passages.
According to another aspect of the present invention, there is provided a method of use of a multi-use sterile access/GMP diaphragm valve housing in a sterile access orientation. The method begins with providing a diaphragm valve housing as generally described above. A third passage is formed through a respective one of the lands extending to a lowestmost portion of the first passage. Tubing is attached to the third passage adjacent the respective one of the lands. The housing is aligned in a sterile access orientation with the main flow axis disposed horizontally. Further, the third passage may be formed tangentially with the first passage and the housing may be aligned with the tubing being horizontal. Alternately, the housing may be aligned with the tubing being vertical.
According to another aspect of the present invention, there is provided a method of use of a multi-use sterile access/GMP diaphragm valve housing in a GMP orientation. The method begins with providing a diaphragm valve housing as generally described above. A third passage is formed through a respective one of the lands extending to a lowestmost portion of the first passage. Tubing is attached to the third passage adjacent the respective one of the lands. The housing is aligned in a GMP orientation with the main flow axis disposed vertically. Further, the third passage may be formed tangentially with the main flow weir. The housing may be aligned with the tubing being horizontal. The first and second planar lands may abut each other at an abutting edge, and the third passage may be formed through the abutting edge. A v-cut may be formed in an end of the tubing, and the end of the tubing may be attached with the v-cut at the abutting edge.
As such, based on the f

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