A sealed pharmaceutical container includes a shoulder, a neck extending from the shoulder, and a flange extending from the neck. The flange includes an inclined sealing surface defining an opening in the sealed pharmaceutical container. The sealed pharmaceutical container also includes a sealing assembly including a stopper extending over the sealing surface of the flange and a cap securing the stopper to the flange. The stopper has a glass transition temperature (T.sub.g) that is greater than or equal to 70 C. and less than or equal to 45 C. The sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container of less than or equal to 1.410.sup.6 cm.sup.3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to 45 C.

A method is provided for preparing spray dried powder containing vancomycin hydrochloride. The method comprises providing a vancomycin hydrochloride solution with a chromatographic purity of at least 95%, adding an excipient to the vancomycin hydrochloride solution to form a mixture solution of the vancomycin hydrochloride solution and the excipient, concentrating the mixed solution of the vancomycin hydrochloride solution and the excipient to form a 20% to 30% vancomycin concentrate, filtering the vancomycin concentrate to form a final filtrate and spray crying the final filtrate to form a spray dried vancomycin hydrochloride powder with EP impurity B level of not more than 1.5%.

A device for sealing sample tubes comprises a tool assembly configured to interface with a rack (10) holding a plurality of sample storage tubes (20), the tool assembly holding a plurality of punches (322) and a die plate (324) including a plurality of cutting holes, with each of the plurality of cutting holes accepting one of the plurality of punches (322). The tool assembly receives a foil sheet (131) between the punches (322) and the die plate (324). The device includes an actuator enabling linear movement of the tool assembly. Linear movement of the tool assembly towards the rack (10) engages the die plate (324) against the rack (10) and punches the punches (322) through the cutting holes of the die plate (324) to punch a plurality of sealing sections from the foil sheet (131) and to press and seal each of the sealing sections against a top end of each of the plurality of sample storage tubes (20) in the rack (10).

A method for filling and sealing containers such as bottles, cartridges, syringes and the like, wherein the containers are accommodated individually within respective seats of a first nest which in turn is contained in a first transport tub. The method includes the step of supplying the containers; extracting at least one individual container at a time from the first nest and transferring it to a filling station in order to fill the at least one container with a substance; transferring the at least one filled container to a crimp capping station, passing through a separating partition; crimp capping the at least one container at the crimp capping station; and inserting the at least one crimp capped-container in a respective seat of a second nest.

A filling and sealing system is provided for efficiently filling a series of individual vials with therapeutic liquids. In particular embodiments, the system includes a filling zone or station, a sealing zone or station, an unloading zone or station, and electronic controls.

In a method for closing a plurality of medical cartridges (5) a closure nest for supporting a plurality of closures is used, comprising a planar supporting plate having a plurality of receptacles having a plurality of tubular receptacles (61) and retaining structures for reliably accommodating the closures (200). In the method the plurality of medical cartridges (5) is supported in a corresponding cartridge nest. The closure nest is disposed above the cartridge nest so that the receptacles of the closure nest are precisely aligned with the receptacles of the cartridge nest. The closures (200) are then pushed downward out of the receptacles of the closure nest and into the cartridges (5), while the cartridges are supported by the cartridge nest. The closure nest can be directly fed on existing filling and stoppering machine set-ups for processing sealed prefillable syringe barrels, basically without the necessity of changing the set-up.

In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligned concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.

In one general aspect, a method is disclosed for processing a pharmaceutical substance in a pharmaceutical processing system that includes lyophilizing a plurality of containers provided in a nest. A first controlled environment enclosure in the pharmaceutical processing system is isolated against an external environment, and a controlled environmental condition is established in the first controlled environment enclosure. The pharmaceutical substance is deposited into at least a portion of the plurality of containers in the first container nest at a filling station within the first controlled environment enclosure. The deposited pharmaceutical substance is lyophilized in the first container nest.

A transport or packaging container accommodating a plurality of supporting structures for closures, for transporting or packaging closures for closing cartridges for use in pharmaceutical, medical or cosmetic applications, in which the transport or packaging container is box-shaped and includes a bottom, which is closed or sealed by a seal, upstanding lower side-walls extending essentially perpendicularly from the bottom, a circumferential supporting step extending horizontally from the upstanding lower side-walls, upper side-walls extending upward from said circumferential supporting step, and a circumferential flange formed at upper ends of the upper side-walls; and the plurality of supporting structures for closures is accommodated inside the transport or packaging container.

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.