Abstract: 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.

Abstract: A method of mixing a pharmaceutical solution including adding a gas into an interior compartment of a mix bag to form a headspace. The interior compartment of the mix bag includes a top portion and a bottom portion. The headspace adjacent to the top portion contains gas. The method includes adding a solvent into the mix bag, and establishing a bubble column in the interior compartment by activating a recirculation assembly. The recirculation assembly includes a connecting pathway operably coupled to a recirculation pump. A first end of the connecting pathway is coupled to a top gas recirculation port and a second end is coupled to a bottom gas recirculation port of the mix bag such that the recirculation pump draws the gas from the headspace and delivers the gas to the interior compartment via the bottom gas recirculation port. The method includes adding a solute into the mix bag.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method of mixing a pharmaceutical solution including adding a gas into an interior compartment of a mix bag to form a headspace. The interior compartment of the mix bag includes a top portion and a bottom portion. The headspace adjacent to the top portion contains gas. The method includes adding a solvent into the mix bag, and establishing a bubble column in the interior compartment by activating a recirculation assembly. The recirculation assembly includes a connecting pathway operably coupled to a recirculation pump. A first end of the connecting pathway is coupled to a top gas recirculation port and a second end is coupled to a bottom gas recirculation port of the mix bag such that the recirculation pump draws the gas from the headspace and delivers the gas to the interior compartment via the bottom gas recirculation port. The method includes adding a solute into the mix bag.