Abstract: The invention relates to a device and a method for filling or packing contents, particularly beverages, food, medications, or the like, into containers. As the containers pass through the device from an inlet to an outlet side, the containers passing through the working chamber have a sterile fluid, particularly sterile air, applied thereto for preventing germ growth. In order to reduce the cleaning effort for lines for the sterile fluid, the invention proposes that a cleaning medium having an internal line is inserted into the line for applying the sterile fluid. The line no longer needs to be disassembled in order to load the sterile fluid. In order to distribute the sterile fluid uniformly throughout the containers in a working chamber, the sterile fluid is distributed in two stages, first by means of the pipe extending into the working chamber, as described above and then through a profile extending over the containers and below the pipe, having openings for passing the sterile fluid.

Abstract: Disclosed is a container sealant composition with improved tensile strength and reduced squeeze-out during seaming. The composition comprises a latex of a carboxylated styrene-butadiene rubber, a colloidal silica filler, wherein the colloidal silica is pretreated with an organosilane, and a tackifier. Also disclosed is a method of sealing a can with the aforedescribed container sealant composition.

Abstract: The present invention provides a slider valve assembly for connection to a spout of an aseptically-packaged flexible container for filling and dispensing flowable material. The slider valve assembly comprises a cap member, a valve member, and an outlet member. The cap member has a central opening and is adapted to be secured to the spout of the container. The valve member defines one or more side openings in communication with a central bore, is slidable within the central opening of the cap member and is lockable into a closed or open position. The outlet member is detachably engaged to the valve member and is used for actuating the valve member. The outlet member also defines a hollow interior portion which is in communication with the central bore of the valve member.

Abstract: The disclosure relates to a packaging machine for packaging products, in particular food, wherein the packaging machine comprises at least one packaging station for producing packagings that accommodate products, and at least one high-pressure treatment station for high-pressure treatment of the products contained in the packagings. The disclosure is characterized in that a central control system for the packaging station and the high-pressure treatment station are provided. The disclosure moreover also relates to a method for operating such a packaging machine.

Abstract: The invention provides a method for single-step terminal sterilization process for bio-active heparin coatings on materials and biomaterials containing heparin used in medical devices, such as catheters, tissue engineering scaffolds, or drug delivery carrier materials. This may include any medical device or implantable that could benefit from improved antithrombotic and biocompatible heparin surfaces. Other relevant device examples may include heparin or a heparin derivative coated stents to reduce clotting and restenosis, dental or ophthalmological implants. These materials may comprise additional polymeric compositions such as polyethyleneimine, dextran sulfate or their modified forms. These polymers together with heparin coatings may be applied to other substrate of medical devices such as metal, ceramics or biologically derived materials.

Abstract: The present invention relates to packaging material for contrast media and more specifically to packages comprising containers filled with contrast media and closed with a closure means. In particular, the invention relates to packaging material comprising closure means comprising Carbon Black. The invention further relates to methods for improving the stability of such contrast media during storage, and in particular the method includes filling the contrast media in a container and closing the container with a closure means comprising Carbon Black.

Abstract: A device for filling containers with liquid may include a first transport, which transports a plurality of containers through a filling chamber. The filling chamber may include a sterile space. A plurality of treatment members may be arranged in the filling chamber for treating the containers, with at least one of these treatment members being a filling member which fills the containers with the liquid. The first transport may be designed in such a way that it transports the containers through the filling chamber in a cyclic manner.

Abstract: The presently disclosed subject matter relates generally to methods of generating at least one disinfecting gas within a package through a photochemical reaction. More particularly, the disclosed methods include incorporating a composition capable of generating a gas upon exposure to light into the disclosed package. As set forth in detail herein below, the amount of moisture present in the disclosed composition is directly related to the production rate of the gas. Accordingly, the amount of gas generation can be controlled by varying the amount of moisture present in the composition.

Abstract: An apparatus for filling containers, has an entrance through which open containers can be introduced into the apparatus, including at least one transport device which conveys the containers along a predefined transport path, and an exit via which the containers can be discharged from the apparatus. The speed at which the transport device conveys the containers is variable, and the apparatus comprises at least one filling device which fills the containers at least partially with a liquid medium on the transport path between the entrance and the exit. The apparatus includes a housing, and arranged in the interior of the housing is at least one sterilization device in the form of a ?-radiation unit which sterilizes components of the apparatus.

Abstract: Silicone hydrogel contact lenses that have good dimensional stability, are ophthalmically-acceptable, and can be manufactured without the use of alcohol solvents are formed from the reaction product of a polymerizable composition comprising at least one mono-functional acrylate-containing siloxane monomer having a molecular weight of less than 2,000; at least one bi-functional acrylate-containing siloxane monomer having a molecular weight of at least 3,000; and at least one hydrophilic vinyl-containing monomer, wherein the polymerizable composition has a molar ratio of total amount of mono-functional acrylate-containing siloxane monomer to total amount of bi-functional acrylate-containing siloxane monomer of at least 30:1, respectively.

Abstract: An apparatus for treating containers may include a treatment chamber in which the containers are treated, and a conveyor unit which transports the containers within the treatment chamber. The treatment chamber can be isolated by means of at least one wall from an environment external of the treatment chamber in such a way that sterile conditions can be achieved in the treatment chamber, and by means of at least one treatment unit which treats the containers within the treatment chamber. At least one wall of the treatment chamber is arranged to be movable. A sealing assembly seals the treatment chamber in an area with regard to elements of the apparatus, which are movable relative to each other, against the environment external of the treatment chamber. The sealing assembly includes a surrounding channel, into which a liquid sealing agent can be introduced, as well as a secondary wall which is arranged within the channel at least in sections.

Abstract: A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient is provided. The oxidation susceptible active pharmaceutical ingredient is mixed with excipients and deoxygenated water to prepare a non-sterile drug solution. The non-sterile drug solution is filled into a moist heat sterilizable flexible infusion bag. The flexible infusion bag with the non-sterile drug solution is terminally moist heat sterilized at a preset air overpressure between about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The highest degradation product in the parenteral drug product is less than 0.5% by weight of a labeled amount of the oxidation susceptible active pharmaceutical ingredient in the parenteral drug product.

Abstract: An apparatus for transporting objects and in particular containers, having a first conveyor which transports the objects along a specified transport path (P), including a sterile room, within which the objects are transported, and including a second conveyor which follows on from the first conveyor. According to the invention, the first conveyor is positioned completely inside of the sterile room and the second conveyor is positioned completely outside of the sterile room, wherein both the first conveyor and the second conveyor are preferably positioned in a specified transitional area (B) along the transport path (P).

Abstract: Methods for making an using convenience kits for hazardous drug (liquid) transfer from vials to syringes and target IV connectors. The following methods for making and using are disclosed: (1) Using a conventional plastic bag as a vial and vial adapter enclosing shroud. (2) Using of a flange (i.e. latch arm) free vial adapter which may, therefore, be used for a large variety of vial sizes. (3) Providing a seal about an access hole through which a vial adapter dispensing portion provides a closed fluid dispensing pathway. (4) Using the shrouding bag and an associated elastic band to provide desired stability of a spiked vial. (5) Accessing, measuring and transferring vial contents directly from a vial to a target IV container via an elongated connecting tube.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol. The ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is capable of being stored in a modified flexible plastic container that may be heat-sterilized without deformation and/or without having the integrity of the closure system being compromised. A method for the manufacture of the ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition is also disclosed.

Abstract: A system relating to improved medical-connector contamination prevention. More particularly, this invention relates to a reduced-touch contamination system for small-bore fluid connectors, including male and female Luer-type connectors.

Abstract: A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol which capable of been stored in modified flexible plastic container, heat-sterilized without deformation and/or integrity of the closure system been compromised, as well as method for its manufacture, is disclosed.

Abstract: Refrigerant cartridges for cryotherapeutic neuromodulation and associated systems and methods are disclosed herein. In one embodiment, for example, a cryotherapeutic system includes a shaft having a proximal portion, a distal portion and a supply lumen along at least a portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site. The supply lumen can be configured to receive a refrigerant from a refrigerant cartridge. The refrigerant in the refrigerant cartridge can have a moisture concentration of at most 10 ppm. The system can further include a cooling assembly at the distal portion of the shaft that has an expansion chamber in fluid communication with the supply lumen.

Abstract: The manufacturing process for packing of injectables for medical use, comprises in temporal sequence the steps of: a) forming (1) of glass primary containers, b) forming by plastic injection (3) of complementary devices (4), c (assembling (5) of the empty primary containers with corresponding complementary devices to form assembled devices (6), d) washing (7) the assembled devices with water for injection, e) nesting (8) the assembled devices in a tray (9), f) inserting said tray housing said assembled devices into a secondary container and closing said secondary container, g) sterilising (10) the assembled devices in the closed secondary container, h) preparing the closed secondary container for transportation to a remote site.

Abstract: The present invention relates to a method and system for aseptically filling of flexible packages containing dry cloth. Such a method may include a first stage that is performed in a non-sterile environment. The first stage may include cutting a first substantially dry cloth to a predetermined size; inserting the first cloth into a flexible package; sealing a first end of the flexible package; and sterilizing the flexible package. The method may also include a second stage performed in a sterile environment. The second stage may include filling the flexible package with a medical solution such that the substantially dry cloth absorbs at least a portion of the medical solution; and sealing the an open end of the flexible package.

Abstract: An eyewash dispensing container to store and deliver an eyewash fluid that is particularly suitable for terminal sterilization. The container includes a base and a locking lid with a tamper indicator. The container is able to be opened quickly and deliver the eyewash fluid directly to an eye of a user.

Abstract: Disclosed and claimed herein are devices for the treatment of medical waste using high temperature and pressure steam. The devices are designed to be self-contained and are movable by one person of average strength and ability. The devices are self-contained and require no special installation, connections, plumbing or permanent or semi-permanent electrical connections. Disclosed and claimed herein are methods using the disclosed and claimed devices.

Abstract: An apparatus includes a housing, a needle, a first energy storage member and a second energy storage member. The needle is movably disposed within the housing and is configured to be to be placed in fluid communication with a medicament container. The needle is configured to move between a first position and a second position. In its first position, the needle is contained within the housing. In its second position, at least a portion of the needle extends from the housing. The first energy storage member is disposed within the housing, and is configured to produce a first force when actuated. The second energy storage member is disposed within the housing, and is configured to be actuated in response to the first force to produce a second force to move the needle from the first needle position to the second needle position.

Abstract: Silicone hydrogel contact lenses comprising an ionic component sustain release of beneficial cationic polymers.

Abstract: The present invention generally relates to a method for applying a coating of hydrophilic polymers onto silicone hydrogel contact lenses to improve hydrophilicity and lubricity. In particular, the present invention is directed to a method for forming a coating on a contact lens, preferably a silicone hydrogel contact lens, directly in the primary package and maintaining the coated contact lens within said primary package until insertion of the coated contact lens in the eye of the contact lens user. The resultant silicone hydrogel contact lens has a coating with good hydrophilicity, improved lubricity and good durability and also can be used directly from the lens package by a patient without washing and/or rising.

Abstract: Methods provide a non-eluting antioxidant doped UHMWPE in the form of an implant bearing component. The process includes the steps of: (a) providing a preform; (b) irradiating the preform with ?-irradiation to crosslink the UHMWPE; (c) doping the crosslinked preform by exposing it to an antioxidant composition at a temperature below the melting point of the UHMWPE; (d) removing the doped material from contact with the antioxidant composition; and then (e) annealing by heating the doped material at a temperature above 30° C. and below the melting point of the UHMWPE; followed by (f) making an implant bearing component from the doped material, wherein at least 1 mm but no more than about 15 mm of material are removed to make the component.

Abstract: The present invention relates to a standing bag type container and aims to increase a visibility of the residual liquid volume in accordance with the progress of infusion process. The standing bag type container includes a bag 10 made of soft resin films and forming at its one end a base member 20 and an outlet port 18 at the other end of the bag. A suspension of the bag 10 is done in a manner that the base member 20 is located at the top. Marks for indication of residual liquid volume are printed on the surface of the bag. An infusion liquid is charged to the bag while an air gap 109? is left, so that a residual liquid volume is verified from the liquid level. Under the suspended condition, the base member 20 has a value of width which is unchanged from the when the bag is under upright condition. The base member 20 is not collapsed and maintains its width even when the residual liquid volume is zero.

Abstract: Methods of fabricating a culture container include molding a single monolithic layer of polymeric material into a container body having a container shape; introducing a colorimetric sensor material and growth media into the container body; introducing a gas mixture into the container body to define a headspace gas in an upper portion of the container body; attaching a stopper to the neck of the container body with the sensor material; sealing the container body with the stopper closed to define a sealed container with the growth media and the headspace gas enclosed therein; then sterilizing the sealed container; then applying a gas barrier coating to an exterior of the sterilized container body so that the sealed container has an oxygen transmission rate (cubic centimeter/container/day/atm) that is between about 0.001 to about 0.01 to thereby define a culture container that is ready-to-use and shelf stable without autoclaving.

Abstract: A unit (10) for filling containers (14), includes an insulator (16) having a body (18) provided with an inlet (E) and an outlet (S), the structure (20) of the body (18) defining a space (V) forming an aseptic working region (22) and including insufflation elements (28) which are arranged in the upper part of the insulator (16) and are able to insufflate a sterile air flow for creating an overpressure inside the space (V). The insufflation elements (28) are arranged in the insulator (16) in such a way as to project a laminar-type flow (F) to lick the outer surface (44) of the containers (14), and the insulator (16) includes evacuation elements (48) which are separate from the inlet (E) and the outlet (S) and used to enable a controlled evacuation of the insufflated sterile air flow (F).

Abstract: The present invention relates to improved contact lens products which not only have initial insertion comfort but also are comfortable to wear for more than about 6 hours. The invention is achieved by packaging and storing a hydrogel lens with two or more leachable polymeric lubricants incorporated therein in a relatively viscous packaging solution including a relatively low molecular weight polyethylene glycol (PEG) and a viscosity-enhancing hydrophilic polymer. The present invention also provides methods for making contact lens products of the invention.

Abstract: The present invention relates to improved contact lens products which not only have initial insertion comfort. The contact lens product of the invention comprises a soft hydrogel contact lens immersed and autoclaved in a packaging solution including a low molecular weight polyethylene glycol (PEG) (or glycerin) and a homopolymer or copolymer of vinylpyrrolidone. The present invention also provides methods for making contact lens products of the invention.

Abstract: A method for filling dual-chamber systems in pre-sterilizable carrier systems includes providing at least one washed, siliconized and sterilized dual-chamber system in a magazine. The dual-chamber system includes respective separating elements separating the two chambers from each other. The magazine accommodates at least one dual-chamber system and is arranged in a container that is sealed with a closing element. The method additionally includes introducing the container into a clean room; opening the container and filling a first chamber of the at least one dual-chamber system; and closing the first chamber. The method further includes filling a second chamber of the at least one dual-chamber system; closing the second chamber; and removing the system from the clean room.

Abstract: The invention relates generally to sterile packaging kit of components to be used to clean an area of a patient's skin, and more particularly to a sterile kit for cleaning a patient's skin area in the surgical field, following a surgical procedure. The kit, in its most basic form, comprises an outer envelope containing at least one dry towel and at least one wetted towel in its own pouch, separated from the dry towel. The kit may further include a heating element which efficiently transfers heat to the wetted towel. The cleaning kit may also provide sterile bandages for use in covering closed surgical incisions, after postop cleaning of the skin the surgical field, using the wetted and dry towel of the kit.

Abstract: A method of making a wound dressing comprising the steps of: providing an apertured substrate layer; coating the substrate layer with a fluid silicone prepolymer composition; thermally partially curing said silicone prepolymer composition to form a partially cured silicone coating on the substrate; laminating the coated substrate layer to a base layer to form a laminate having said partially cured silicone coating in contact with a surface of the base layer; followed by exposing the laminate to ionizing radiation, to further cure the partially cured silicone coating and to bond the silicone coating to said surface of the base layer. The radiation cure results in strong bonding between the siliconized substrate and incompatible base layers such as polyurethane foams. Also provided are wound dressings obtainable by the process of the invention.

Abstract: The tissue grafting method relates to a tissue graft material, a method of preparing the material, and a method of using the material. The tissue graft material is made from the tunica serosa of the small intestine of a warm-blooded vertebrate, which has been delaminated from the tunica muscularis, tunica submucosa, and the tunica mucosa of the intestinal tissue. The tissue graft material may be perforated by discrete punctures. The tissue graft material is dehydrated by air drying or vacuum drying, sterilized with ethylene oxide, and stored in a hermetically sealed enclosure at room temperature until needed, having an indefinite storage life. When needed, the tissue graft material is rehydrated, cut to match the size of the wound, and applied to the wound. The graft may be overlaid with nylon mesh, or bandaged with an elastic tubular dressing.

Abstract: The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.

Abstract: A plastic package for hydrophilic articles, in particular for hydrophilically coated medical instruments, is intended to ensure the hydrophilic nature of the enclosed instrument over a long period of time. The package includes at least one receiving compartment with a medical instrument for insertion into body tissue and is characterized in that, after sterilization by radiation, it has a proportion of volatile constituents of ?0.1 ?g/cm2.

Abstract: Improved electron beam sterilization apparatus and shielding techniques for use in are provided. A controller modulates an electron beam when sterilizing an interior to an object to ensure that adequate dose is received. Sterilization carousels are configured with input/discharge feeds to reduce the possibility of humans being exposed to dangerous levels of radiation. The system reduces the amount of shielding required to thereby lower cost of installation.

Abstract: An orthopedic fixation system includes a sterile packaged implant kit and a sterile packaged instrument kit. The sterile packaged implant kit includes at least one surgical implant, an insertion device, and an implant package adapted to receive the at least one surgical implant and the insertion device therein. The implant package maintains the at least one surgical implant and the insertion device sterile after sterilization of the sterile packaged implant kit. The sterile packaged instrument kit includes one or more instruments necessary to use the sterile packaged implant kit and an instrument package adapted to receive the one or more instruments therein. The instrument package maintains the one or more instruments sterile after sterilization of the sterile packaged instrument kit.

Abstract: Packaging systems for storing ophthalmic devices such as contact lenses and to methods for packaging such ophthalmic devices with solutions to improve the comfort of the lenses during wear are disclosed. A packaging system includes an ophthalmic device stored in an aqueous packaging solution comprising a brush copolymer comprising (a) monomeric units derived from an ethylenically unsaturated monomer containing one or more boronic acid moieties; and (b) monomeric units derived from an ethylenically unsaturated-containing hydrophilic macromonomer.

Abstract: A system for sterilizing bottles with a gaseous sterilant. The system includes moving means for continuously moving bottles one after another along a path. An assembly is provided for distributing a predetermined amount of the gaseous sterilant from a source of gaseous sterilant to each of the bottles. The assembly includes a plurality of injectors that are movable with the bottles. One of the plurality of injectors is associated with each of the bottles. The injector is fluidly connected to the source of gaseous sterilant when the bottle associated with the injector is disposed along a first portion of the path. The injector is disposed above the bottle when the injector is in a first position. The injector is disposed within an interior of the bottle when the injector is in a second position such that the predetermined amount of the gaseous sterilant is conveyed into the interior of the bottle.

Abstract: A container adapted for holding shrink wrap in place without the use of adhesives. The shrink wrap is held in place by at least one protuberance on the sides or bottom of the container. The protuberance has a particular design in relationship to the sides or bottom of the container that prevents slippage of the shrink wrap. Also disclosed is a container system for consumable products, comprising the aforementioned container, at least one lid, and a shrink wrap.

Abstract: A multi-layer sheet designed for the sealing of a container (10) made of glass by heat sealing on the sealing ring (12) of the container treated by means of oxides and/or of metal salts comprises at least a support layer (21) and a lower layer (22) made of a polymeric heat-sealable material onto which is grafted an unsaturated carboxylic acid.

Abstract: A method is for handling a sterilized food product and includes securing an aseptic fitment to a filling port of an intermodal container including a rigid shell having an elongate shape with opposed closed ends, and at least one frame assembly supporting the rigid shell. The method also includes sterilizing the intermodal container, and aseptically filling the sterilized intermodal container with the sterilized food product through the aseptic fitment. The method may also include sealing the aseptic fitment after aseptic filling. A related intermodal container and filling station are also disclosed.

Abstract: A sterile enclosure contains a transfer module defining a window. A port covers the window to maintain the inside of the enclosure as a sealed and sterile environment. A sliding, heated cutting element mounted on the port serves to sterilize and sever a portion of a sterile transfer bag assembly attached to the port. Preferably, the excised portion of the sterile transfer bag assembly is affixed to the port when the port opens. The sliding cutting element remains extended and heated to prevent contamination when the port is open. Further, a heating element is mounted about the window in order to sterilize around the opening when the port is open.

Abstract: The invention relates to a method for sterilizing a cosmetic product, in which said product consists of a fluid circulating under regulated pressure in a sterilization circuit (1), according to the viscosity of said fluid. The invention also relates to the device for implementing such a method.

Abstract: Package for a catheter, with a catheter having catheter tube with a distal end and a proximal end, the proximal end being provided with a catheter connector. A main body is provided for holding the catheter, and a cap for closing off the main body. A gel container is positioned inside the main body, the gel container being provided with a cavity for holding an amount of gel-like lubricating agent. The gel container comprises a first opening at a distal end, and a second opening at a proximal end. The catheter tube is disposed through the first opening and second opening when stored in the package. The main body is made of a rigid material to allow easy and reliable storage.

Abstract: The present disclosure relates to the use of a split and single electrical cells in industrial applications, and particularly in aseptic packaging applications.

Abstract: An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase.

Abstract: A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration engages the personalized prosthesis with the treatment site. The mesh or membrane is personalized to match the treatment site in the expanded configuration, and has an outer surface that substantially matches the treatment site shape and size. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.