Abstract: A disposable material processing apparatus, useable as a bioreactor or fermenter, includes a hollow tank (101) and a mixing paddle (110) disposed within the interior of the tank and adapted to mix contents therein. The paddle may be isolated within a flexible sleeve (140). Various functional elements, such as a sparger, sensor, material extraction conduit, material addition conduit, and/or heat exchange element may be provided, and optionally arranged to travel with the paddle within the tank interior. Baffles may protrude into a mixing tank to enhance mixing. A tank and/or sleeve may comprise polymeric film materials.

Abstract: An apparatus for processing fluid includes a vessel provided with a sidewall including a passage and at least partially defining an interior compartment. A drain tube positioned in the interior compartment may drain fluid through the passage in the sidewall. The drain tube may be angled, and arranged such that the end in the interior compartment may be adapted for movement as the result of manipulation of a structure, such as a coupler, external to the interior compartment. Accordingly, the drain tube may be positioned along the sidewall at a reference point for movement between a first position for draining fluid above the reference point and a second position for draining fluid below the reference point. An indexing feature may also be provided for incrementally adjusting the position of the drain tube, along with an associated tool to facilitate the adjustment. Related methods are also disclosed.

Abstract: A mixing apparatus including a kinetic energy source, a mixing tank, a pivot guide, and transfer shaft is used to drive a mixing paddle through a circular path within a tank without substantial shaft rotation. Sleeved and sleeveless mixing paddles are provided in combination with sealable mixing tanks. A volumetric compensation system responsive to tank wall deflection is used to maintain the internal volume of a mixing tank within predetermined limits. One mixing apparatus includes multiple mixing shafts and paddles coupled to at least one kinetic energy source. Methods for fabricating sleeved paddle-containing mixing apparatuses are further provided.

Abstract: A system providing a sterile connection between a sensor probe and a fluid processing apparatus (e.g., a bioreactor) includes a first probe receiving element mountable to the fluid processing apparatus and a second probe receiving element having a gas-permeable contaminant barrier material and coupleable to the first probe receiving element. A sensor probe may be mounted to the second probe receiving element, with the combination being sterilized with a sterilant gas such as steam. Following such sterilization, connection between the first and second probe receiving elements is made through matable sterile couplings, and the probe is insertable through the coupled receiving elements to a position in fluid contact with the interior of the fluid processing apparatus.

Abstract: A selectively closeable drain connector includes a hollow body or plunger moveable relative to a bore-defining drain flange. A locking element may be arranged to maintain the hollow body relative to the drain flange in one or more desired positions. At least one sealed jacket may extend between exterior portions of the drain flange and the hollow body to provide a barrier arranged to inhibit passage of contaminants to sealing surfaces along which the hollow body travels relative to the drain flange. The drain connector may be joined to a container, such as a tank, bag, vessel, or other receptacle for material storage and/or processing.

Abstract: An apparatus for processing fluid includes a vessel provided with a sidewall including a passage and at least partially defining an interior compartment. A drain tube positioned in the interior compartment may drain fluid through the passage in the sidewall. The drain tube may be angled, and arranged such that the end in the interior compartment may be adapted for movement as the result of manipulation of a structure, such as a coupler, external to the interior compartment. Accordingly, the drain tube may be positioned along the sidewall at a reference point for movement between a first position for draining fluid above the reference point and a second position for draining fluid below the reference point. An indexing feature may also be provided for incrementally adjusting the position of the drain tube, along with an associated tool to facilitate the adjustment. Related methods are also disclosed.

Abstract: A mixing apparatus including a kinetic energy source, a mixing tank, a pivot guide, and transfer shaft is used to drive a mixing paddle through a circular path within a tank without substantial shaft rotation. Sleeved and sleeveless mixing paddles are provided in combination with sealable mixing tanks. A volumetric compensation system responsive to tank wall deflection is used to maintain the internal volume of a mixing tank within predetermined limits. One mixing apparatus includes multiple mixing shafts and paddles coupled to at least one kinetic energy source. Methods for fabricating sleeved paddle-containing mixing apparatuses are further provided.

Abstract: An apparatus for use in material processing takes the form of a vessel including a wall at least partially formed of a flexible film The film includes at least two layers having an anti-static agent and sandwiching an intermediate layer. Related methods are also disclosed.

Abstract: A system providing a sterile connection between a sensor probe and a fluid processing apparatus (e.g., a bioreactor) includes a first probe receiving element mountable to the fluid processing apparatus and a second probe receiving element having a gas-permeable contaminant barrier material and coupleable to the first probe receiving element. A sensor probe may be mounted to the second probe receiving element, with the combination being sterilized with a sterilant gas such as steam. Following such sterilization, connection between the first and second probe receiving elements is made through matable sterile couplings, and the probe is insertable through the coupled receiving elements to a position in fluid contact with the interior of the fluid processing apparatus.

Abstract: A sterilizable composite bag or pouch at a temperature of at least about 125° C. includes a first sheet comprising a gas-permeable but bacteria-impermeable polyolefin material, a second sheet comprising a first layer comprising a polyolefin with a density of less than 0.94 g/cm3 disposed between a second layer and a third layer comprising a high density polyolefin and having a density of at least 0.94 g/cm3, with the first sheet and the second sheet being locally thermally welded to one another to form a bag or pouch defining a cavity suitable for holding an article. A method includes thermally bonding such layers to form a plurality of bags and subjecting the plurality of bags to an autoclave steam sterilization process, wherein each second sheet thereafter remains pinhole-free and substantially impermeable to bacteria.

Abstract: A disposable material processing apparatus, useable as a bioreactor or fermenter, includes a hollow tank (101) and a mixing paddle (110) disposed within the interior of the tank and adapted to mix contents therein. The paddle may be isolated within a flexible sleeve (140). Various functional elements, such as a sparger, sensor, material extraction conduit, material addition conduit, and/or heat exchange element may be provided, and optionally arranged to travel with the paddle within the tank interior. Baffles may protrude into a mixing tank to enhance mixing. A tank and/or sleeve may comprise polymeric film materials.

Abstract: A mixing apparatus including a kinetic energy source, a mixing tank, a pivot guide, and transfer shaft is used to drive a mixing paddle through a circular path within a tank without substantial shaft rotation. Sleeved and sleeveless mixing paddles are provided in combination with sealable mixing tanks. A volumetric compensation system responsive to tank wall deflection is used to maintain the internal volume of a mixing tank within predetermined limits. One mixing apparatus includes multiple mixing shafts and paddles coupled to at least one kinetic energy source. Methods for fabricating sleeved paddle-containing mixing apparatuses are further provided.

Abstract: A packaging article comprises two sheets of material bonded to form a pouch, with one layer comprising a first sheet of a porous material, e.g., Tyvek® film, and a second nonporous sheet overlying and sealed to the first sheet. The second sheet is impermeable to passage of gas therethrough and includes a peelable film, e.g., of polyethylene, in contact with the first sheet of porous material to permit peeling removal of the second sheet from the first sheet. A method of integrity testing includes fabricating a packaging article, pressurizing same with a gas and monitoring pressure to determine package integrity, removing the peelable film, and exposing a packaging article to sterilant gas supplied through the porous first sheet.

Abstract: A packaging article comprises two sheets of material bonded to form a pouch, with one layer comprising a first sheet of a porous material, e.g., Tyvek® film, and a second nonporous sheet overlying and sealed to the first sheet. The second sheet is impermeable to passage of gas therethrough and includes a peelable film, e.g., of polyethylene, in contact with the first sheet of porous material to permit peeling removal of the second sheet from the first sheet. A method of integrity testing includes fabricating a packaging article, pressurizing same with a gas and monitoring pressure to determine package integrity, removing the peelable film, and exposing a packaging article to sterilant gas supplied through the porous first sheet.

Abstract: A multilayer web article, including a first layer of a porous material, e.g., Tyvek® film, and a second layer overlying and sealed to the first layer. The second layer is non-porous to passage of gas therethrough and includes a peelable film, e.g., of polyethylene, in contact with the first layer of porous material. The peelable film permits peeling removal of the second layer from the first layer to expose the first layer of porous material for passage of gas therethrough. In a specific construction, the web article constitutes one of opposedly facing panels of a lay-flat bag article, in which the facing panels are bonded to one another along superposed edges thereof. After pressurization integrity testing of the bag, the peelable film is peeled away to enable steam - and/or ETO-sterilization of the bag and its contents to be carried out.

Abstract: A multilayer web article, including a first layer of a porous material, e.g., Tyvek® film, and a second layer overlying and sealed to the first layer. The second layer is non-porous to passage of gas therethrough and includes a peelable film, e.g., of polyethylene, in contact with the first layer of porous material. The peelable film permits peeling removal of the second layer from the first layer to expose the first layer of porous material for passage of gas therethrough. In a specific construction, the web article constitutes one of opposedly facing panels of a lay-flat bag article, in which the facing panels are bonded to one another along superposed edges thereof. After pressurization integrity testing of the bag, the peelable film is peeled away to enable steam- and/or ETO-sterilization of the bag and its contents to be carried out.

Abstract: A sterilizable container (20) is described which includes a flexible bag (23), the flexible bag (23) having a hole in a flat portion thereof and a hollow connector port (22) fixed thereto, the connector port (22) including a collar portion (22A) and a flange portion (24) defining an internal bore (26) of the connector port (22), the inside surface of the flexible bag (23) being sealed to an outside surface of the flange portion (24) and the collar portion (22A) extending through the hole in the flexible bag (23). Also disclosed is an adapter (10) having an internal bore (12), the connector port (22) and the adapter (10) being sealably connectable by a clamping and sealing device (11, 13) so that the internal bores (12, 16) of the connector port (22) and the adapter (10) are in open communication. Preferably, the adapter (10) has a removable door (16) sealed to the end of the adapter (10) remote from the sealable connection to the connector port (22).

Abstract: The present invention provides a system and method for a seal for a sterilizable bag. This seal is made between a first polymeric sheet material (5) and a second polymeric sheet material (3). The first sheet material (5) should be sufficiently porous so as to allow or permit gas or steam sterilization but substantially impervious to bacteria. The second sheet material (3) includes an outer heat sealable layer. The seal (4) is fabricated from a first thermal surface weld (15) between the heat sealable layer of the second sheet material (3) and the first sheet material (5), and a second thermal melt weld (12) between at least the heat sealable layer of the second sheet material (3) and the first sheet material (5). The thermal melt weld (12) may be narrower than the first weld (11) and lying within the boundaries of the first weld (11). Furthermore, seal (4) may be sufficiently flat in order to allow a cross-heat seal using conventional equipment.