Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: A depth filter design is disclosed which has little if any open void area upstream of the media. Preferably, it also has little if any open void area downstream of the media as well. A preferred embodiment uses layers of stacked, fibrous media with several of the layers being separated from the others by spacers which serve to compress the media and to prevent the bypass of fluid around the media adjacent the inner wall of the housing. Several designs for attaching the end caps which allow for the compression of the media are also disclosed.

Abstract: A sterile to sterile connection device comprising a connector and one or more coupling devices. The connector has body portion which has two openings sealed from the environment so as to form a sterile environment within the connector. At least one of the openings being sealed from the environment by a sterile barrier plug. The connector also has a port capable movement within the body of the connector to at least an open and a closed position. The coupling device is formed of a body having two openings and a stem having a bore through at least a portion of the stem. The stem is contained within the body and capable of moving at least linearly through the body between a first and second stem position. One of the openings of the stem is sealed from the environment by a sterile barrier plug and the other is sealed to a presterilized component. The coupling device opening containing the sterile barrier plug is attached to either the inlet or outlet of the connector.

Abstract: The present invention provides a fluid sampling device comprising a port insert, a plurality of flexible conduits, and a plurality of sample containers. The port insert comprises a body having a plurality of shafts therethrough and a rotatably displaceable member for individually opening and closing any of said shafts to enable the flow of fluid therethrough. Flexible conduits (e.g., flexible tubing) are equal in number to the shafts, with each flexible conduit connected to or otherwise in fluid communication with an individual shaft. Similarly, sample containers (e.g., flexible bags) are equal in number to the conduits, with each sample container connected to an individual conduit opposite the connection to the shaft. A specific configuration for the port insert, as well as kit containing sterilized components of the fluid sampling device, are also described.

Abstract: A method for over-molding a tubular filter element 16, at least at one end 16b thereof, with a thermoplastic end cap 12. The over-molding method can be used to manufacture easily and cost-effectively a filter cartridge, of good durability, from an unprecedented range of polymeric materials and components. The thermoplastic over-molding method does not require pre-lamination of said end 16b, and can be performed at temperatures and pressures that do not result in undesirable morphological changes in the tubular filtration medium. Exemplary filter cartridges made through the over-molding method comprise a tubular filtration medium interposed between thermoplastic end caps, the thermoplastic material of the end caps infiltrating the tubular filtration medium, thereby creating mechanical interlock zones at the ends thereof.

Abstract: The present invention relates to a sterile sample collection device for fluids and a method of using the same. It is comprised of a transfer device having a body with a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to tube which is then connected to a collection bag. The plunger has corresponding first and second ends. The first end of the plunger when in the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components.

Abstract: The present invention is a bioreactor or fermenter formed of a container having two or more walled. One or more inlets and one or more outlets are formed in one or more of the walls of the container. At least one of the one or more inlets is formed in the bottom wall of the container and used for the introduction of one or more gases. A gas distribution device is formed within the body of the container adjacent the bottom gas inlet and a hydrophobic filter is mounted to the bottom wall gas inlet, upstream of the gas inlet. The distribution device is formed such as by bonding the two facing wall surfaces of the container together at discrete and spaced apart locations to form a series of gas ports into the remainder of the container. The hydrophobic filter acts to purify the gas entering the container so as to prevent the introduction of contaminants such as microbes into the container.

Abstract: A single-use fluid dispenser cartridge, installable or installed into a host fluid dispensing apparatus, is described. The single-use fluid dispenser cartridge is provided with a fluid reservoir and a fill tube assembly with bladder means for controlling pressure within the cartridge by accommodating the movement of gas into and out of the fill tube assembly.

Abstract: The present invention relates to a filter element having a non-porous extrusion laminated strip formed on at least one edge and at least one side of a membrane. The strip is used to provide a means for ensuring a good bond between the filter element and the material into which it is potted. The strip is formed by the use of one or more extrusion heads that apply molten or softened polymer to one or both of the surfaces of the filter in a width and height desired. The strip is then subjected to pressure such as through a nip to at least partially embed the polymer strip into the filter pores so as to create a strong mechanical bond between the strip and the filter element. Additionally, it allows for the simultaneous formation of more than one membrane with the edge lamination at the same time.

Abstract: The present invention provides a fluid sampling device comprising a port insert, a plurality of flexible conduits, and a plurality of sample containers. The port insert comprises a body having a plurality of shafts therethrough and sample gating means for individually opening and closing any of said shafts to enable the flow of fluid therethrough. The flexible conduits (e.g., flexible tubing) are equal in number to the elongate member, with each flexible conduit connected to or otherwise in fluid communication with an individual shaft. Similarly, the sample containers (e.g., flexible bags) are equal in number to the conduits, with each sample container connected to an individual conduit opposite the connection to the shaft. A specific configuration for the port insert, as well as kit containing sterilized components of the fluid sampling device, are also described.

Abstract: A barrier filter useful for aseptically discharging both gaseous and liquid fluids from a chemical process system is disclosed The barrier filter comprises, within a common enclosure, one or several filter membranes having singularly or collectively a mixture or hydrophobic and hydrophilic regions. The common enclosure of the barrier filter is provided with a fluid inlet and a fluid outlet. All filter membranes are located within the fluid path between the fluid inlet and the fluid outlet. A variety of membrane-based systems, into which such barrier filter is installed, are also disclosed.

Abstract: A sterile to sterile connection device comprising a connector and one or more coupling devices. The connector has body portion which has two openings sealed from the environment so as to form a sterile environment within the connector. At least one of the openings being sealed from the environment by a sterile barrier plug. The connector also has a port capable movement within the body of the connector to at least an open and a closed position. The coupling device is formed of a body having two openings and a stem having a bore through at least a portion of the stem. The stem is contained within the body and capable of moving at least linearly through the body between a first and second stem position. One of the openings of the stem is sealed from the environment by a sterile barrier plug and the other is sealed to a presterilized component. The coupling device opening containing the sterile barrier plug is attached to either the inlet or outlet of the connector.

Abstract: A single-use fluid dispenser cartridge, installable or installed into a host fluid dispensing apparatus, is described. The single-use fluid dispenser cartridge is provided with a fluid reservoir, a fill tube assembly, and means for controlling pressure within the cartridge by gating gas into or out of the reservoir and/or the fill tube assembly. The gas gating mean enables, in certain embodiments, use of a fluid reservoir that is “substantially rigid”.

Abstract: The present invention relates to a sterile transfer device for fluids, be they liquids or gases. It is comprised of a body having a bore formed through at least a portion of its interior. Preferably, it is a central bore formed through the entire length of the body. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components.

Abstract: The present invention relates to a filter element having a non-porous extrusion laminated strip formed on at least one edge and at least one side of a membrane. The strip is used to provide a means for ensuring a good bond between the filter element and the material into which it is potted. The strip is formed by the use of one or more extrusion heads that apply molten or softened polymer to one or both of the surfaces of the filter in a width and height desired. The strip is then subjected to pressure such as through a nip to at least partially embed the polymer strip into the filter pores so as to create a strong mechanical bond between the strip and the filter element. Additionally, it allows for the simultaneous formation of more than one membrane with the edge lamination at the same time.

Abstract: The present invention is formed of a transfer bag that is capable of being sterilized by steam or gas and then sealed to form an integral sterile device. It is preferably attached to a closed collar designed to fit onto a transfer port. The bag is formed of two sections, a first steam penetrable, porous section and a second non-porous section. The items are loaded into the bag through an opening; it is sealed and exposed to a steam or sterilizing gas environment. Steam or gas enters the first section of the bag and moves throughout the interior of the bag sterilizing the bag and its contents. After sterilization, the bag is removed and the contents are moved so as to all be within the second section of the bag. The bag is then sealed adjacent to the interface between the first and second sections to ensure the sterility of the bag and its contents.

Abstract: The present invention provides filters comprising supports (55) that are relatively flat. They may have knife seals (54, 56) or convention edge seals and porous fibrous media (58) is positioned there between and methods of manufacturing filters. The media may also be relatively flat providing for a self supporting non-lenticular filtration structure.

Abstract: The present invention provides a device for the filtration of fluids using porous fibrous filtration media. The present invention comprises a central support layer, one or more layers of porous media mounted on each side of the central support layer and an elastomeric seal on the outer edge of the support/media that forms a liquid tight seal so that all fluid must flow through the media before reaching the central support layer.

Abstract: The present invention relates to a filter element having a non-porous extrusion laminated strip formed on at least one edge and at least one side of a membrane. The strip is used to provide a means for ensuring a good bond between the filter element and the material into which it is potted. The strip is formed by the use of one or more extrusion heads that apply molten or softened polymer to one or both of the surfaces of the filter in a width and height desired. The strip is then subjected to pressure such as through a nip to at least partially embed the polymer strip into the filter pores so as to create a strong mechanical bond between the strip and the filter element. Additionally, it allows for the simultaneous formation of more than one membrane with the edge lamination at the same time.

Abstract: A barrier filter useful for aseptically discharging both gaseous and liquid fluids from a chemical process system is disclosed The barrier filter comprises, within a common enclosure, one or several filter membranes having singularly or collectively a mixture or hydrophobic and hydrophilic regions. The common enclosure of the barrier filter is provided with a fluid inlet and a fluid outlet. All filter membranes are located within the fluid path between the fluid inlet and the fluid outlet. A variety of membrane-based systems, into which such barrier filter is installed, are also disclosed.