Sealed system for handling, manipulating and formulating...

Chemical apparatus and process disinfecting – deodorizing – preser – Physical type apparatus – Apparatus for treating solid article or material with fluid...

Reexamination Certificate

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Details

C312S001000, C312S242000, C422S120000, C422S297000, C422S300000, C454S057000

Reexamination Certificate

active

06207119

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a sealed system for handling, manipulating and formulating materials in an isolated environment and, more particularly, to an isolation system or facility interfaced to an accessory by way of an interfacing assembly to form the sealed system.
BACKGROUND OF THE INVENTION
In many industrial areas including pharmaceuticals, electronics, chemicals, and others, a significant amount of experimentation, manufacturing, production, and the like must be performed in sterile, contaminant-free, germ-free, and/or particle-free work spaces, often referred to as clean rooms. Additionally, special work spaces are necessary in order to isolate potentially harmful environments due to the presence of dangerous chemicals and/or biological matter. However, the cost to build, maintain, and operate such work spaces is significant. For example, special air filtering equipment must be provided for the work space, persons entering and leaving the work space must be specially attired and must observe strict transmitting rules, and materials must be exchanged into and out of the work space without allowing contaminants to be exchanged. As may be understood, the cost of providing such a work space is considerable and is ultimately passed on from the industry to customers and consumers.
As may be recognized, the biggest source of contamination in connection with a work space is caused by people entering and leaving the work space. Accordingly, one way the aforementioned industries are attempting to reduce costs is to remove the people from the work space. Thus, in the handling, manipulating and formulating of hazardous, toxic or other materials in a clean environment, it is known to employ sealed enclosures, locally controlled environments, isolation systems, and the like to allow at least one operator to work on materials in the interior of the enclosure without physically exposing the operator and the interior to one another.
In order to allow an operator to perform tasks in the interior of the sealed enclosure, the operator may reach in through one or more glove ports positioned on the enclosure. In relatively large sealed enclosures, the operator may employ a protective upper torso suit. Such a facility for providing a sealed work area is described more thoroughly in U.S. Pat. No. 5,257,957, hereby incorporated by reference.
While such facilities, locally controlled environments, sealed enclosures, isolation systems, and the like have been known for some time, the cleaning and sterilization of materials in the interior of the sealed enclosure has been problematic. In a typical clean room, an autoclave or the like is normally provided as an instrument for cleaning and sterilizing materials within the clean room. Accordingly, a properly garbed operator in the clean room would clean and sterilize a part or instrument by inserting the part or instrument into the autoclave and then operating the autoclave. Thereafter, the cleaned and sterilized part or instrument would be removed from the autoclave and used in the clean room.
Typically, an autoclave is a relatively large, heavy instrument and can occupy up to about 150 cubic feet of space. Also, and as is well known, an autoclave employs high pressure steam to clean and sterilize instruments. Accordingly, the autoclave is preferably positioned in a cavity within a masonry wall such that the autoclave is properly supported and such that damage from a sudden release of pressure is minimized.
Referring now to a facility such as that disclosed in U.S. Pat. No. 5,257,957, it should be apparent that the use of an autoclave in connection with the facility such that the autoclave is accessible from the interior of the facility presents several problems. Although the autoclave could be placed in the interior of the facility, the space occupied by the autoclave and the weight of the autoclave would be excessive. Further, the facility would not typically provide the same shielding as if the autoclave were placed within a masonry wall. As will also be recognized, the maintenance, cleaning and repair of the autoclave is complicated when the autoclave is located in the interior of the facility. Therefore, a need has arisen for a means and a method for coupling an isolation system for handling, manipulating and formulating materials and an autoclave positioned exterior to the isolation system, while maintaining the controlled environment within the isolation system.
SUMMARY OF THE INVENTION
Briefly stated, the present invention comprises a sealed system for handling, manipulating and formulating materials in an isolated environment. The system includes an isolation system for performing at least a portion of handling, manipulating, and formulating the materials. The isolation system has an interior at least partially defined by a plurality of walls, an inlet port for allowing air to flow into the interior, an outlet port for allowing air to flow out of the interior, and a transfer port positioned on one of the walls for transferring items into and out of the isolation system. An accessory receives and provides the transferred items and performs a procedure on the items. The accessory is selectively coupled to the transfer port of the isolation system and has an interior for receiving the items. The interior is accessible through an opening. A generally outwardly extending trough of predetermined configuration surrounds one of the transfer port of the isolation system and the opening of the accessory. The trough has a sealing substance disposed therein. A generally outwardly extending blade of predetermined configuration surrounds the other of the transfer port of the isolation system and the opening of the accessory. The configuration of the blade corresponds to the configuration of the trough. The blade is aligned with and placed within the trough such that the blade sealingly engages the sealing substance within the trough to prevent external matter from passing into the interior of the isolation system and the interior of the accessory through the transfer port and the opening such that the interior of the coupled accessory is accessible from the interior of the isolation system through the transfer port of the isolation system and the opening of the accessory.
In another aspect, the present invention is directed to a sealed system for handling, manipulating and formulating materials in an isolated environment. The system includes an isolation system for performing at least a portion of the handling, manipulating, and formulating of the materials. The isolation system has an interior at least partially defined by a plurality of walls, an inlet port for allowing air to flow into the interior, an outlet port for allowing air to flow out of the interior, and a transfer port positioned on one of the walls for transferring items into and out of the isolation system. The isolation system is portable. An autoclave receives the items from the isolation system, sterilizes the items, and returns the items to the isolation system. The autoclave is selectively coupled to the transfer port of the isolation system and has an interior for accepting the items. The interior is accessible through an opening. The opening and transfer port are in registry when the autoclave is coupled with the isolation system. A sealing device interconnects the isolation system and the autoclave and sealingly engages the transfer port of the isolation system to the opening of the autoclave to prevent external matter from passing into the interior of the isolation system and the interior of the autoclave through the transfer port and the opening.
In another aspect, the present invention is directed to a method for sealingly coupling an isolation system for handling, manipulating and formulating materials and an accessory for receiving items transferred from and providing items transferred to the isolation system. The isolation system has an interior at least partially defined by a plurality of walls and a transfer port positioned on one of the walls

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