Baxter International Inc.

Baxter Healthcare Sa

Anastasios Hristakos

Ying-Cheng Lo

Yuanpang Samuel Ding

Thomas Edward Dudar

Joseph V Ranalletta

Bernd Krause

Mark Edward Pasmore

Grant Anthony Bomgaars

Michael Joseph Sadowski

Mark Joseph Doty

William S Hurst

Jacob Daniel Rivett

Joseph Vincent Ranalletta

Steven C Jepson

Karl Hans Cazzini

Marc Steven Minkus

Christine L Rebbeck

Sydney Jean Cope

David Filiberto Schuck

William Spencer Hurst

Steven Clarence Jepson

A medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.

Medical product including pre-filled product bag

A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.

Terminal sterilization filtration closed lyophilization in a container

A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 &#x3bc;m to approximately 0.5 &#x3bc;m. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.

Dual container system for product reconstitution

A method of providing a plurality of filled product bags of sterile fluid includes positioning a bag assembly onto a filling machine. The bag assembly includes a tube, a filter assembly, bladders, and stems. A stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into the bladders. The method includes fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source, and filling the bag assembly with a fluid. Filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway, and into the bladder. The method includes sealing the fluid passageway at a location between the tube and the bladders. The method includes cutting the stem to form a partially filled product bag having the sealed passageway. The method includes performing an integrity test on the filter assembly.

Method and machine for producing sterile solution product bags

A syringe system includes a syringe and a filtration device connected to the syringe for sterilizing and introducing fluid into the syringe. The syringe includes a syringe barrel having a proximal end defining a barrel opening, a distal end defining a delivery opening, a bore extending between the proximal end and the distal end, and a stopper disposed in the bore of the syringe barrel. The filtration device has an inlet and an outlet coupled in fluid communication with the delivery opening at the distal end of the syringe barrel. The filtration device includes a stem and a filter membrane disposed in line with the stem. The filter membrane optionally has a plurality of pores each with a nominal pore size in a range of approximately 0.1 &#x3bc;m to approximately 0.5 &#x3bc;m such that a pharmaceutical fluid can be introduced as a sterilized pharmaceutical fluid into the bore of the syringe barrel by passing through the filtration device.

Medical syringe system with filtered filling port

A product bag includes a bladder and an elongated filtration device. The bladder includes opposing first and second film layers defining a product chamber. The first and second film layers are sealed together along a perimeter seal extending along at least a portion of a perimeter of the bladder. The elongated filtration device includes a housing, a filtration membrane disposed in the housing, an inlet adapted for receiving a fluid to be filtered, and an outlet in fluid communication with the product chamber. A majority of the elongated filtration device is embedded between the first and second film layers of the perimeter seal of the bladder to provide for a compact form factor.

Filtered product bag with compact form factor

A method of providing filled product bags of sterile and particulate-free fluid includes securing a product bag to one of a plurality of movable cradles, wherein the product bag has a bladder, a stem fluidly connected to an opening of the bladder, and a filter disposed in-line with the stem. After securing the bag, an inlet of the stem is connected to an outlet of a nozzle assembly and at least partially filling the product bag with a fluid through a nozzle of the nozzle assembly to create a filled product bag, wherein filling the product bag includes passing the fluid through the filter and into the bladder. After filling, the stem of the filled product bag is sealed at a location below the filter. The stem is cut at a location above the seal and below the filter. The method including performing an integrity test on the filter, removing the filled product bag from the cradle, and depositing the filled product bag into a first bin for rejected bags if the filter fails the integrity test and a second bin for accepted bags if filter passes the integrity test.

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Evanston, IL, United States of America

Anastasios Hristakos