A sterile solution product bag includes sterilization grade filter integrated directly into the product bag such that microbial and particulate matter filtration can be performed using the filter directly at the point of fill. The filter can include a hollow fiber filter membrane contained in a stem connected to a bladder of the product bag.

A vial adaptor can include a connector interface and/or a piercing member. The vial adaptor can include a regulator assembly. The regulator assembly can include a regulator base, a regulator nest coupled with the regulator base, and/or a storage chamber formed at least partially by one or both of the regulator base and regulator nest. The regulator assembly can include a cover connected to one or both of the regulator base and regulator nest and fitted around a radially outward portion of one or both of the regulator base and regulator nest. In some cases, the regular assembly includes a flexible enclosure connected to the regulator nest and configured to transition between a contracted configuration and an expanded configuration. In some cases, the flexible enclosure is inhibited from transitioning to the expanded configuration prior to removal or modification of the cover from the regulator assembly.

A vial adaptor can include a connector interface and/or a piercing member. The vial adaptor can include a regulator assembly. The regulator assembly can include a regulator base, a regulator nest coupled with the regulator base, and/or a storage chamber formed at least partially by one or both of the regulator base and regulator nest. The regulator assembly can include a cover connected to one or both of the regulator base and regulator nest and fitted around a radially outward portion of one or both of the regulator base and regulator nest. In some cases, the regular assembly includes a flexible enclosure connected to the regulator nest and configured to transition between a contracted configuration and an expanded configuration. In some cases, the flexible enclosure is inhibited from transitioning to the expanded configuration prior to removal or modification of the cover from the regulator assembly.

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.

A BAK removal device is constructed as a plug of microparticles of a hydrophilic polymeric gel that displays a hydraulic permeability greater than 0.01 Da. The polymer hydrophilic polymeric gel comprises poly(2-hydroxyethyl methacrylate) (pHEMA). The particles are 2 to 100 μm and the plug has a surface area of 30 mm.sup.2 to 2 mm.sup.2 and a length of 2 mm to 25 mm and wherein the microparticles of a hydrophilic polymeric gel has a pore radius of 3 to 60 μm.

Provided is an exposure-preventing cap of a novel and simple structure that, by being mounted on a vial, can more reliably inhibit leaking of drug solution to an outside when pulling out and collecting drug solution in a syringe from the vial. An exposure-preventing cap, which is mounted on a mouth of a vial sealed with a rubber stopper, wherein a puncturing hole is formed in a center part of a cap-shaped housing that is attached to a mouth of the vial, and a rubber membrane is arranged at the puncturing hole so as to form an internal space between facing surfaces of the rubber membrane and the rubber stopper. The rubber membrane has a dome shape that is convex facing the rubber stopper.

A dispenser actuator assembly (100) actuates a dispenser (10). The dispenser (10) is a plastic ampoule (10) having a container (48) having an outer wall (50) and membrane (52) collectively defining a first chamber (54) containing a flowable material (M). The membrane (52) has a weld seam (56). The actuator assembly (100) has a base member (102) configured to mount on the container (48). A fracturing mechanism (116) is operably connected to the base member (102). The fracturing mechanism (116) has a first extending member (132a) and a second extending member (132b), the first extending member (132a) and the second extending member (132b) positioned on the base member (102) in opposed relation. Each extending member (132a,132b) has a projection (150a,150b) positioned proximate the membrane (52). In response to deflection of the extending members (132a,132b) towards one another, the projections (150a,150b) are configured to deflect the outer wall (50) proximate the membrane (52) wherein the weld seam (56) fractures to create an opening through the membrane (56) to allow the flowable material (M) to pass therethrough.

A filter device includes a first component having an outer casing with a first accommodating cavity; a second component having a flow channel, an actuator for closing or opening the channel, an actuator head rotatably connected to the second component, an actuator rod inserted in the flow channel, and covered by a seal cover; a filter membrane sandwiched between the first and second components; and a flow path sequentially passing through the channel, the filter membrane, and the first accommodating cavity. A filtering infusion container includes an infusion container and the filter device connected thereto. One end of the flow path leads to the infusion container and the other end leads to the filter membrane. The filter membrane and an infusion fluid are always located in different closed spaces before usage, to maintain the best integrity of the filter membrane and there is no fluid leakage or actuator loosening.

A particulate plug for removing a preservative from a solution, suspension, or emulsion comprising a drug is presented. The plug comprises microparticles of oxidized polyolefin (OxPO). The microparticles are irregular-shaped rigid aggregates and are sized and packed to yield a hydraulic permeability greater than 0.01 Da. The OxPO have absorbed portions of a preservative to be removed and/or a drug for delivery in solution, as can the copolymer.

A particulate plug for removing a preservative from a solution, suspension, or emulsion comprising a drug is presented. The plug comprises microparticles of a hydrophobic polymer/fatty acid blend. The microparticles of hydrophobic polymer/fatty acid blend selectively absorb preservative allowing the drug to remain in solution for delivery.