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.

The invention provides novel apparatus and methods for efficiently and accurately filling vials with gaseous materials such as a fluorinated gas, with or without concomitantly filling the vials with another liquid or solid material.

The invention provides a process for preparing an aqueous pharmaceutical solution of calcium gluconate. The process comprises the steps of: (i) mixing calcium gluconate, calcium saccharate and water at a mixing temperature of 60-100? C. to form a bulk solution; (ii) filling portions of the bulk solution into containers at a filling temperature of 60-100? C.; and (iii) sealing the containers with a closure. The invention also provides a batch of containers obtainable by this process.

The invention provides novel apparatus and methods for efficiently and accurately filling vials with gaseous materials such as a fluorinated gas, with or without concomitantly filling the vials with another liquid or solid material.

A supporting structure for supporting a plurality of sealed medical cartridges is disclosed, comprising a planar supporting plate having a plurality of receptacles for accommodating the sealed cartridges. Retaining protrusions are formed at the bottom ends of the receptacles protruding inward, which are mated with the shoulder portions of the sealed cartridges in such a manner that the shoulder portions of the sealed cartridges are supported on the retaining protrusions of the receptacles and that the upper ends of the sealed cartridges protrude from the upper ends of the receptacles at an upper side of the planar supporting plate, when the sealed cartridges are accommodated upside-down in the receptacles. The inventive nest will be suitable for any nested liquid filling machine without much changes in filling table and general settings.

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.

A purgeable fill needle for dispensing pharmaceutical fluid into a pharmaceutical container comprises a fill needle hub, a fill needle tubing extending through the fill needle hub; a fill needle dispensing tip; a fill needle sheath removably mated with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a terminal fluid ejector for removing fluid retained by the tip after halting dispensing of pharmaceutical fluid. The terminal fluid ejector may be based on automatic injection of an aseptic gas into the fill needle tubing, automated action of a gas bladder at the dispensing tip, or the automated operation of a compression actuator at the dispensing tip. The removal of terminal fluid retained at the tip after halting dispensing of the fluid may also be effected by automatically blowing attached droplets off the tip and automatically shaking the fill needle tubing.

A system is presented for monitoring and controlling in a sterilizable environment the peeling of a cover from a tub sealed by the cover. The system employs a platform having a fiducial source locating structure for holding the tub, a cover removal station disposed to engage with the cover and to peel the cover from the tub, a light source disposed to illuminate a portion of the platform proximate the cover removal station, a light sensor sensitive to light from the light source and disposed to preferentially collect and measure light diffusely reflected from the illuminated portion of the platform, and a controller with software to operate the system. An associated method for monitoring and controlling the peeling of the cover involves moving a peeled portion of the cover into a predetermined peeling monitor zone within the illuminated portion of the platform, and measuring an intensity of light from the light source diffusely reflected specifically from the peeling monitor zone. The positioning of the elements of the system and the peeling monitor zone allow measured light intensity to be employed as a control measure for the peeling process.

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.

An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.