Method and apparatus for eliminating oxygen in the filling of a flexible bag with a beverage utilizing sources of inert gas, vacuum, and beverage. A filling head regulates the injection of inert gas and applies a vacuum to the flexible bag the bag spout. The bag spout is separately rinsed of oxygen prior to recapping the same on the flexible bag.

The invention relates to a device for vacuum stoppering a medical container. The device includes a main body defining an internal volume that has a variable pressure chamber configured to be connected to a vacuum pump. A stopper holder system is arranged in communication with the variable pressure chamber and is configured to receive and hold a stopper aligned with the direction of travel of a piston rod. A piston rod is moveable inside the internal volume of the main body along a longitudinal axis between a proximal rest position and a distal operative position wherein the piston rod pushes the stopper into the medical container. A container holder system provided in the main body, is arranged distally relative to the stopper holder system and in communication with the variable pressure chamber.

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.

A self retaining bottle stopper fixture assembly configured to seal and opening of a bottle and to preserve an oxygen sensitive substance under pressure therein and/or for sealing the bottle for transport or horizontal storage. The assembly generally includes an anchor member for inserting onto a neck of a bottle or other container, and a retainer member for covering the stopper and coupling to the anchor member to secure the stopper to the bottle.

A disposable isolator including a bottom, a flexible peripheral wall defining a clean and sterile inner volume, a first pair of joining parts forming a first tight junction at the bottom, this first pair including an inner part placed inside the inner volume and suitable for positioning containers, and an outer part placed outside the inner volume and suitable for cooperating by shape matching with a positioning cavity provided on a support table, and a second pair of joining parts forming a second tight junction at the peripheral wall and including an outer part suitable for being connected to a robot, and an inner part suitable for being connected to a manipulating tool, the first and second pairs being designed so that the robot applies the manipulating tool on the containers positioned on the support table.

The invention relates to chemical and pharmaceutical industry, in particular to technologies of obtaining sterile drugs, drug substances and cosmetic products used in the form of solutions or emulsions, and comprising poloxamer. The thermal method for sterilizing aqueous poloxamer solutions is provided, the method including: dissolving a poloxamer in water for injection; performing the sterilizing filtration of the aqueous poloxamer solution simultaneously with filling sterile containers with the filtered poloxamer solution; sealing the containers containing the poloxamer solution; applying a thermal sterilization with steam under pressure to the containers containing the poloxamer solution, and cooling them, wherein the thermal sterilization of the containers containing the poloxamer solution with steam under pressure is performed under the pressure between 82.4 and 107.8 kPa.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Edaravone, in the United States, is approved in the form of ready-to-use intravenous solution for infusion, RADICAVA. RADICAVA injection is supplied in a polypropylene bag overwrapped with polyvinyl alcohol (PVA) secondary packaging. Edaravone is susceptible to oxidation and the overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Various efforts have been put in the art for packaging edaravone drug solution in different types of packaging materials, for example, plastic containers and glass bottles to prevent edaravone from oxidation and other degradation. The present invention involves use of simple and economic container-closure system for packaging edaravone drug solution while maintaining its stability during storage, transportation and use which includes glass bottles or vials and closures made of elastic polymer or rubber (for example elastomer, isoprene rubber or butyl rubber and the like).