Abstract: A method for producing a sterilized container comprises: providing a preform having a hanger arranged on a bottom of the preform, heating the preform in a heating device, feeding the heated preform into a stretching and blowing apparatus, stretching and blowing the preform in the stretching and blowing apparatus such that the container for the infusion solution is formed from the preform, cleaning the formed container in a rinsing apparatus, and drying the cleaned container in a drying device, filling the cleaned and dried container at least with an infusion solution, via a filling opening present in the container, in a filling plant, closing the container by attaching a closure cap to the filling opening of the container, sterilizing the closed container in an autoclave, wherein the hanger of the preform is oriented and folded over by a bending apparatus prior to stretching and blowing in the stretching and blowing apparatus.

Abstract: A medicament delivery device and method of use thereof. The device includes a sensor module and an injector module. The injector module is adapted to (i) be coupled to the sensor module during injection of a cannula and a needle into subcutaneous tissue and during delivery of the medicament and (ii) be removed from the sensor module after the delivery of the medicament.

Abstract: A connection assembly configured to deliver a medical liquid to a container is described. The connection assembly includes a connecting member connected to the container, an attachment member, and a sealing element. The attachment member defines a lumen, a first end to be connected to a delivery device, and a second end connected to the connecting member. The sealing element is disposed in the lumen of the attachment member and includes a sealing head, a flange, and a foot portion. The sealing head seals the lumen of the attachment member, and the flange and the foot portion engage the connecting member.

Abstract: The present invention relates to a novel protein formulation. In particular, the invention relates to a liquid pharmaceutical composition of tocilizumab, a method of manufacturing the composition, a kit including the composition, a package including the composition and to methods of treatment using the composition and/or package.

Abstract: Enteral tube feed for patients in an intensive care unit comprising a lipid component, a carbohydrate component and at least 30 EN % of a protein component based on the total energy content of the enteral tube feed, wherein the protein component comprises a peptide fraction consisting of di-, tri- and oligopeptides with a molecular weight of at most 1 kD, wherein the peptide fraction provides at least 10 EN % of the total energy content of the enteral composition and wherein the carbohydrate component predominantly consists of carbohydrates having a GI of ?35 such as isomaltulose for use in treatment of ICU patients.

Abstract: The present invention relates to a method of maintaining cell viability at a level of at least 80% for up to 14 days in a fed-batch culture of cells producing a recombinant protein, the method comprising maintaining the cell culture medium at a pH of 6.5 to 7.0 and at a temperature of 31° C. to 35° C. for at least 5 consecutive days of the duration of the cell culture method.

Abstract: A connection assembly for conducting a medical liquid, comprising a connection piece, an attachment part attached to the connection piece; an opening into which the connection piece engages; and a seal element for sealing a passage between the connection piece and the attachment part. The seal element is held between the attachment part and the connection piece and has a sealing head, which closes the opening of the attachment part against the passage of liquid when the attachment part is attached to the connection piece, and a body, which adjoins the sealing head and which can be arranged in the opening at a radial distance to the attachment part.

Abstract: Described herein are pharmaceutical packaging systems which prevent oxidative degradation of oxygen-sensitive drugs, such systems including a primary packaging container with an oxygen permeable component, a secondary packaging with very low permeability to oxygen and an oxygen absorber.

Abstract: The invention relates to a pharmaceutical product or container closure system containing an overpouch with an intransparent first foil and a transparent second foil, a transparent primary container for holding a transparent liquid, e.g., a pharmaceutical formulation, wherein the transparent primary container is packed within the overpouch and labeled with at least one label and wherein the at least one label acts as a light absorbing segment having a reflection RL for light in the range of about 350 nm to about 800 nm and an inner surface of the intransparent first foil of the overpouch acts as a light reflecting background having a reflection RF for light in the direction of the primary container in the range of about 350 nm to about 800 nm with RF?RL. By the transparent second foil and the inventive reflection properties it is achieved that the at least one label on the primary container is visible and readable. Additionally, visual inspection of the content of the transparent primary container is possible.

Abstract: The present invention relates to a method of increasing biosimilarity of a TNF ? binding protein to a reference TNF ? binding protein by modifying the charge profile of the binding protein produced by cell culture in a cell culture medium, by making an adjustment to a cell culture condition The adjustment is an increase in the concentration of a metal ion in the cell culture medium and the adjustment occurs on one or more days during the cell culture method, whereby the adjustment in the cell culture condition results in the modification of the charge profile of the binding protein. The present invention also relates to a biosimilar protein obtainable by such a process.

Abstract: A container for blood or a blood component is provided, the container comprising one or more container walls defining an interior chamber, the container walls comprising one or more layers, the layers comprising or consisting of a composition comprising one or more polymeric materials and at least one extractable agent selected from the group consisting of a terephthalate ester, a cyclohexane dicarboxylic acid ester, a citrate ester, and a polyol ester, wherein the container further comprises one or more additional components, wherein the container comprises less than about 3% (w/w) of di-2-ethylhexyl phthalate (DEHP), preferably wherein the container comprises less than about 3% (w/w) of phthalates. Thereby, improved blood products are provided in which the DEHP or overall phthalate content is reduced.

Abstract: The invention relates to a valve unit for a system for producing parenteral nutrition, in which unit a three-way valve is used for each pair of connections to a source container. The valve unit is a component that can be mounted on die system and removed again after use. The valve unit is in particular provided as an interchangeable disposable component.

Abstract: The invention relates to a method and a system for synthesizing a medical preparation, a peristaltic pump being used for pumping liquid from a plurality of source containers. According to the invention, micro-amounts are extracted only in the linear region of the peristaltic pump.

Abstract: The invention relates to PUFA, vitamin E, vitamin D and the protein bound amino acids glycine, arginine and tryptophan as active ingredients for use in therapy of cancer patients, wherein an effective amount of said active ingredients is administered in the form of a nutritional composition comprising a) a lipid component providing 40-50 EN % based on the total energy of the nutritional composition, wherein 12-16 EN % based on the total energy of the nutritional composition is provided by PUFA, b) 4.0-8.0 mg/100 mL alpha-TE vitamin E, c) 5.0-12.0 ?g/100 mL vitamin D, d) 2.5-4.5 g/100 mL glycine, e) 0.5-1.5 g/100 mL arginine, and f) at least 0.02 g/100 mL tryptophan.

Abstract: A catheter device (1) for providing access to a body cavity of a patient comprises a tube (10) and an inserting shell (11) arranged on the tube (10) and constituted to be fastened to an insertion guide (3) for inserting the catheter device (1) into a body opening (C) of a patient (P). Herein, the inserting shell (11) comprises an opening (111) into which a thread (300) of the insertion guide (3) is insertable for fastening the catheter device (1) to the insertion guide (3). In this way, a catheter device is provided which, in an easy and efficient manner, allows for the fastening to an insertion guide.

Abstract: The invention relates to an installation for producing a medical preparation, in particular for producing a preparation for parenteral nutrition. Liquids are transferred by means of the installation from a plurality of source containers to a target container. The installation comprises a receptacle with drivers for a valve block, wherein the drivers of the valves are arranged offset from one another.

Abstract: Disclosed is a cover for a container for receiving enteral nutrition solutions, having a thread which can be brought into engagement with a mating thread of a container for receiving an enteral nutrition solution in order to cover an opening in the container for receiving the enteral nutrition solution, and having a connection piece for the connection of a hose line. An opening device having a first part connected to the cover in a form-fitting and/or force-fitting manner and having a second part which is permanently connected to the first part is arranged on an inner side of the cover. In a starting state of the opening device, the second part of the opening device is fixed to the first part of the opening device by a fixing element and, in an opening state of the device, is movable relative to the first part of the opening device.

Abstract: A sealing cap for a container for holding a medical liquid comprises a cap body and a connection device having a sealing element arranged on the cap body. The sealing element is arranged at the opening and is retained in the cap body in a clamped manner by a, preferably annular, flanged rim. The connection device has a break-off piece, which is firmly connected to the cap body and covers an outer face of the sealing element in the outward direction. The break-off piece is integral with the cap body, is connected to the cap body by a predetermined breaking point where the break-off piece can be detached from the cap body. The sealing element outer face is substantially flat and is accessible for wiping to provide a sealing cap having a sealing element arranged that can be simply and reliably disinfected.

Abstract: A syringe packaging system that includes a tube and a cap for enclosing a pre-filled syringe is disclosed. The tube includes a tube cut flange and the cap includes a cut skirt. With a syringe barrel contained within the tube, a syringe barrel cut flange is aligned with the tube cut flange. With the pre-filled syringe enclosed within the tube and the cap, the cut skirt of the cap surrounds the syringe barrel cut flange. In one embodiment, a film is securable to a portion of the tube and a portion of the cap to connect the tube and the cap with the pre-filled syringe enclosed within the cap and the tube.

Abstract: A container for a medical liquid, comprising a connection piece via which a medical liquid can be pumped into or out of the container, an attachment part which can be attached to the connection piece and connected to a pump device to pump a medical liquid or out of the container, and a sealing element for sealing a passage between the connection piece and the attachment part. The sealing element has a slot opening which is closed against a liquid flow when the pump device is not attached to the attachment part and which is open when the pump device is attached to the attachment part such that a medical liquid can be pumped through the slot opening. The attachment part has a connection portion with an opening into which the connection piece can be inserted along an insertion direction in order to connect to the attachment part.