Single-use manifold for automated, aseptic transfer of solutions in bioprocessing applications

A manifold system for biotechnology uses, wherein said system is for automated preparative chromatography, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port,
• (c) aseptic connector means for operatively connecting said length of tubing with said single-use bag,
• (d) said tubing is in at least two sections including a chromatography feed section and a chromatographed fluid section,
• (e) said chromatography feed section has an outlet and a plurality of serially arranged inlet passageways having one of said aseptic connector means for operable connection with said single-use bag, and
• (f) said chromatographed fluid section has an inlet, and said outlet end portion of the tubing is on the chromatographed fluid section and has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag;
• and
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve, wherein said pinch valves control passage of the biotechnology fluid from said single-use bags to the chromatography feed section, and wherein another said pinch valve controls passage of the biotechnology fluid from the tubing chromatographed fluid section to the single-use bag of the chromatographed fluid section.

A manifold system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port, one said single-use bag is a process solution bag and another said single-use bag is a permeate collection bag,
• (c) said tubing is in at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution bag, said filtered fluid section includes said permeate collection bag,
• (d) an aseptic connector for operatively connecting said length of tubing with said single-use bag, and
• (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution bag is filtered through said disposable filter and is collected in said permeate collection bag;
• and
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve.

A manifold and pump system for biotechnology uses, wherein said system is for automated preparative chromatography, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port,
• (c) aseptic connector means for operatively connecting said length of tubing with said single-use bag access port,
• (d) said tubing is in at least two sections including a chromatography feed section and a chromatographed fluid section,
• (e) said chromatography feed section has an outlet and a plurality of serially arranged inlet passageways having one of said aseptic connector means for operable connection with said single-use bag access port, and
• (f) said chromatographed fluid section has an inlet, and the chromatographed fluid section has and said outlet end portion of the tubing which has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag;
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve, wherein said pinch valves control passage of the biotechnology fluid from said single-use bags to the chromatography feed section, and wherein another said pinch valve controls passage of the biotechnology fluid from the tubing chromatographed fluid section to the single-use bag of the chromatographed fluid section;
• a chromatography column between said chromatography feed section and said chromatographed fluid section;
• and
• a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said chromatography column.

A manifold and pump system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port, one said single-use bag is a process solution bag and another said single-use bag is a permeate collection bag,
• (c) said tubing is in at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution bag, said filtered fluid section includes said permeate collection bag,
• (d) an aseptic connector means for operatively connecting said length of tubing with said single-use bag, and
• (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution bag is filtered through said disposable filter and is collected in said permeate collection bag;
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve;
• and
• a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said disposable filter.

An automated manifold and pump system for biotechnology uses, wherein said system is for automated preparative chromatography, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port,
• (c) aseptic connector means for operatively connecting said length of tubing with said single-use bag,
• (d) said tubing is in at least two sections including a chromatography feed section and a chromatographed fluid section,
• (e) said chromatography feed section has an outlet and a plurality of serially arranged inlet passageways having one of said aseptic connector means for operable connection with said single-use bag, and
• (f) said chromatographed fluid section has an inlet and said outlet end portion of the tubing which has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag;
• a plurality of pinch valves, at least one of which is remotely operable, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve, wherein said pinch valves control passage of the biotechnology fluid from said single-use bags to the chromatography feed section, and wherein another said pinch valve controls passage of the biotechnology fluid from the tubing chromatographed fluid section to the single-use bag of the chromatographed fluid section;
• a chromatography column between said chromatography feed section and said chromatographed fluid section;
• a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said chromatography column;
• and
• a controller which controls operation of said pump unit and of said pinch valve, said controller having control logic which dictates opening and closing of said remotely operable pinch valve.

An automated manifold and pump system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) a plurality of single-use bags, each having an access port, one said single-use bag is a process solution bag and another said single-use bag is a permeate collection bag,
• (c) said tubing is in at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution bag, said filtered fluid section includes said permeate collection bag,
• (d) an aseptic connector means for operatively connecting said length of tubing with said single-use bag, and
• (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution bag is filtered through said disposable filter and is collected in said permeate collection bag;
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong;
• a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said disposable filter;
• and
• a controller which controls operation of said pump unit and of said pinch valve, said controller having control logic which dictates opening and closing of said remotely operable pinch valve.

A manifold system for biotechnology uses, comprising:

• a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including:
• (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,
• (b) at least one single-use bag having a primary access port, and
• (c) an aseptic connector means for operatively connecting said length of tubing with said primary access port of the single-use bag;
• and
• a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve;
• and
• wherein said system is for tangential flow filtration, wherein one said single-use bag is a process solution bag and another said single-use bag is a permeate collection bag, wherein said tubing is in at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution bag, said filtered fluid section includes said permeate collection bag, and further including a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution bag is filtered through said disposable filter and is collected in said permeate collection bag.