Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.

A drug delivery system for injecting a medicament includes a housing defining a cavity, a container received within the cavity and configured to receive a medicament, the container comprising a stopper configured to move within the container and a closure, a drive assembly received within the cavity and configured to drive the stopper within the container, a needle actuator assembly received within the cavity and comprising a needle configured to be placed in fluid communication with the container, the needle moveable from a first position and a second position spaced from the first position, and a sterilizer received within the cavity and configured to sterilize at least one of the container, the drive assembly, and the needle actuator assembly upon activation of the drug delivery system.

A wipe kit includes a pouch having a first compartment with a one-way valve coupled to an end thereof, a second compartment, and a frangible seal between the first and second compartments. The first compartment receives a liquid through the one-way valve and the second compartment contains a dry wipe. The frangible seal can be broken to permit liquid to flow from the first compartment onto the wipe in the second compartment. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.

A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Systems and methods for performing Direct Sodium Removal (DSR) therapy are provided in which an implantable device includes a pump coupled to an inlet catheter designed for placement in a patient's peritoneal cavity, an outlet catheter designed to be coupled to the patient's bladder, and is operably coupled to an analyte sensor, the pump programmed to transfer and/or cease transfer of fluid from the patient's peritoneal cavity to the patient's bladder for voiding responsive to a level of analyte detected by the analyte sensor. In addition, the system may include a processor that computes an amount of analyte transferred per pumping session.

The disclosure describes a method of reducing or preventing the growth of microbes on the surface of an object, wherein the object is of such material that it can act as a working electrode. The method comprises the steps of providing a counter electrode, and a reference electrode. The object is used as the working electrode. A first electrical current is passed through the working and counter electrodes. The first current through the counter electrode is varied such that a first electric potential of the working electrode is constant relative to the electric potential of the reference electrode. In some embodiments, a second electrical current is passed through the counter electrode such that a second electric potential of the working electrode is constant relative to the electric potential of the reference electrode.

A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

The present invention concerns packaging for preserving a sterile pharmaceutical composition, comprising at least an inner layer of polypropylene having a thickness of between 200 and 800 μm and an outer layer made from polyethylene, the outer layer being in contact with the environment and having a thickness of between 300 and 1000 μm. The invention also concerns a method for the sterile preservation of a pharmaceutical composition using such packaging.

A modular production system including a plurality of production modules connected in a linear series to form a production tunnel, and collectively defining a production channel, and wherein at least one fluid inlet port defined along the production tunnel, said inlet port is in fluid communication with a pressurized fluid source, whereby influx of fluid from said fluid source through said fluid inlet port acts to maintain the fluid pressure within the production channel at a higher pressure than the atmospheric pressure outside of the production tunnel; and wherein one of said production modules positioned between said proximal-most and distal-most production modules comprises a depyrogenator and/or sterilization module, comprising a transparent tubular body, and an irradiation source positioned external to said transparent tubular body, said irradiation source capable of heating the internal environment of the depyrogenation and/or sterilization module to a temperature sufficient to depyrogenate or sterilize articles passing therethrough.

Products, compositions, systems, and methods for modifying a target structure which mediates or is associated with a biological activity, including treatment of conditions, disorders, or diseases mediated by or associated with a target structure, such as a virus, cell, subcellular structure or extracellular structure. The methods may be performed in situ in a non-invasive manner by placing a nanoparticle having a metallic shell on at least a fraction of a surface in a vicinity of a target structure in a subject and applying an initiation energy to a subject thus producing an effect on or change to the target structure directly or via a modulation agent. The nanoparticle is configured, upon exposure to a first wavelength λ.sub.1, to generate a second wavelength λ.sub.2 of radiation having a higher energy than the first wavelength λ.sub.1. The methods may further be performed by application of an initiation energy to a subject in situ to activate a pharmaceutical agent directly or via an energy modulation agent, optionally in the presence of one or more plasmonics active agents, thus producing an effect on or change to the target structure. Kits containing products or compositions formulated or configured and systems for use in practicing these methods.