A method and apparatus for pharmacy fulfillment and verification of non-sterile compounding. A system includes an entry node, the entry node including at least a processor, a memory and an input/output device, the memory including at least an operating system and an order entry process, and a pharmacy fulfillment and verification of non-sterile compounding system, the entry node communicatively linked to the pharmacy fulfillment and verification of non-sterile compounding system, the pharmacy fulfillment and verification of non-sterile compounding system including a set of components, the set of components including at least a formulating component, a fabrication component and a dispensing component.

Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

A fluid dispenser device including a body; a reservoir containing one or two doses of a fluid, the reservoir including a stopper that closes the reservoir in leaktight manner before actuation; a dispenser head that is provided with a dispenser orifice; and dispenser mechanism for dispensing at least a portion of the fluid through the dispenser orifice during actuation. The device further includes a needle having a tip that is adapted to pierce the stopper during actuation, the reservoir being filled with the fluid and being closed with the stopper under a vacuum, so that the residual volume of air present in the reservoir between the fluid and the stopper is substantially zero.

In a method embodiment, an example method for simultaneously filling balloons with water, using an apparatus sufficiently compact to be operated while being held by hand, is disclosed. The method includes attaching the apparatus to a water supply. The apparatus includes a fitting comprising an inlet configured to connect to the water supply and a bulkhead joining the at least three branch assemblies. Each branch assembly includes a tube and an automatically-sealing balloon with a neck disposed around and removably attached to the tube. The method further includes simultaneously providing water from the attached water supply to each balloon of the balloon-filling apparatus. The method further includes detaching one or more of the balloons from the balloon-filling apparatus using a force comprising gravity each detached balloon and the water contained therein. Each detached balloon automatically seals upon detachment.

A method of providing a plurality of filled product bags of sterile fluid includes positioning a bag assembly onto a filling machine. The bag assembly includes a tube, a filter assembly, bladders, and stems. A stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into the bladders. The method includes fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source, and filling the bag assembly with a fluid. Filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway, and into the bladder. The method includes sealing the fluid passageway at a location between the tube and the bladders. The method includes cutting the stem to form a partially filled product bag having the sealed passageway. The method includes performing an integrity test on the filter assembly.

The purpose of the present invention is to provide a detection device that detects the occurrence of an event (so-called “double capping”) in which two caps are disposed on one container. To that end, the detection device (10, 10A) of the present invention has two types of sensors provided on a production line (100) for a commercial product in which an opening (1A) of a container (1) is sealed with a cap (2), said sensors being a proximity sensor (3) along a path where the container (1) moves and a sensor (4: for example, a transmission sensor) equipped with a transmitter (4A), which is inside the same path, and a receiver (4B). An area detected by the sensors (3, 4) is an area where the cap (2) is not present in a normal state (a state in which double capping has not occurred), but where a subsequent cap (2-1) is present if two caps (2) in a row have been attached to one container (1).

Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

The present invention provides a medical device containing a cake composition comprising aripiprazole as an active ingredient and capable of suppressing agglomeration of aripiprazole in a suspension obtained by resuspending a freeze-dried substance; and a cake composition comprising aripiprazole as an active ingredient. The present invention relates to a medical device containing, in a storage container whose inner wall is treated with silicone, a freeze-dried cake composition comprising separately prepared aripiprazole as an active ingredient, wherein there is a space between the inner wall and the cake composition; and a cake composition comprising aripiprazole as an active ingredient and having a strength of 5 to 100 N.

The present invention provides a medical device containing a cake composition comprising aripiprazole as an active ingredient and capable of suppressing agglomeration of aripiprazole in a suspension obtained by resuspending a freeze-dried substance; and a cake composition comprising aripiprazole as an active ingredient. The present invention relates to a medical device containing, in a storage container whose inner wall is treated with silicone, a freeze-dried cake composition comprising separately prepared aripiprazole as an active ingredient, wherein there is a space between the inner wall and the cake composition; and a cake composition comprising aripiprazole as an active ingredient and having a strength of 5 to 100 N.