Abstract: Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.

Abstract: A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest includes a base and first and second covers and is configured to support one or more receptacles each supporting one or more substances within interior spaces of the lyophilization nest. The interior spaces may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through the first and second covers. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior spaces when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

Abstract: A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest is configured to support one or more receptacles each supporting one or more substances within an interior space of the lyophilization nest. The interior space may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through a surface of the lyophilization nest. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior space when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

Abstract: The invention relates to the use of a polysaccharide having at least four saccharide units, such as stachyose, as a glass-forming agent for the freeze-drying of a reaction mixture comprising an enzyme. In particular, the enzyme is a polymerase useful in a nucleic acid amplification reaction such as a Polymerase Chain Reaction. Compositions comprising such polysaccharides as well as methods for preparing them, kits containing them and methods for using them form further aspects of the invention.

Abstract: The present invention is directed to a process for drying a material comprising at least one polysaccharide, said process comprising a step wherein the material is submitted to microwave irradiations under conditions which do not degrade said polysaccharide.

Abstract: A data collector for use in monitoring a lyophilisation process of a product in a test product container in a lyophilisation chamber, said data collector comprising a battery, a measuring device including an electronics unit and a sensor configured for being arranged in said test product container, a first compartment in a first portion, a second compartment in a second portion, a first end surface configured for resting on the support surface, and a second end surface opposite to the first end surface, wherein said first and second portions are arranged side-by-side when seen in a plane defined by the first end surface, and wherein the battery is housed in the first compartment and the electronics unit of the measuring device is housed in the second compartment, such that the battery and the electronics unit are separate from each other.

Abstract: The present invention relates to the field of food dehydration and production of snacks. In particular, the invention relates to a method for drying vegetables using microwaves in order to produce an improved dried product. The invention also relates to said dried vegetables and to the use thereof in the agro-food industry.

Abstract: A freeze vacuum drying apparatus includes: a spraying unit; a pipe unit; a heating unit; and a collection unit. The spraying unit sprays a raw material liquid into a vacuum chamber. The pipe unit has a non-linear shape, includes a first opening end and a second opening end, and traps frozen particles via the first opening end, the frozen particles being formed by self-freezing of liquid droplets formed by spraying the raw material liquid into the vacuum chamber. The heating unit heats the frozen particles in the pipe unit for sublimation drying, the frozen particles moving in the pipe unit from the first opening end toward the second opening end by kinetic energy produced during spraying. The collection unit collects dried particles that are formed by sublimation drying of the frozen particles in the pipe unit and released from the second opening end of the pipe unit.

Abstract: Disclosed is a substrate treating method of performing drying treatment on a pattern-formed surface of a substrate, the substrate treating method comprising: a supplying step of supplying a substrate treating liquid containing a plastic crystalline material in a molten state to the pattern-formed surface of the substrate; a plastic crystalline layer forming step of bringing, on the pattern-formed surface, the plastic crystalline material into a state of a plastic crystal so as to form a plastic crystalline layer; and a removing step of changing the plastic crystalline material in the state of the plastic crystal into a gas state without an intermediate phase of liquid so as to remove the plastic crystalline material from the pattern-formed surface.

Abstract: A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest is configured to support one or more receptacles each supporting one or more substances within an interior space of the lyophilization nest. The interior space may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through a surface of the lyophilization nest. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior space when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

Abstract: A method for processing skin, the method comprising freezing of the skin before freeze-drying this, freeze-drying of the skin and application of an impregnation material into the freeze-dried skin.

Abstract: Disclosed herein are embodiments of an energy recovery system for a freeze-drying system. In some embodiments, the freeze-drying system includes a freeze dryer chamber having one or more shelves disposed therein; a refrigeration system comprising a refrigerant condenser; a heat exchanger; a first fluid line to thermally couple the refrigerant condenser to the heat exchanger; and a second fluid line to thermally couple the one or more shelves to the heat exchanger.

Abstract: Described are a device and a method for rapidly sterilizing liquid nitrogen in a container using ultraviolet radiation irradiated for a predetermined length of time based on the temperature measured by a sensor and on the minimum dose of radiation necessary to kill micro-organisms resistant to liquid nitrogen.

Abstract: A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest is configured to support one or more receptacles each supporting one or more substances within an interior space of the lyophilization nest. The interior space may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through a surface of the lyophilization nest. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior space when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

Abstract: The present invention discloses a method for freeze-drying drug liposomes powder assisted by a variable-frequency alternating-current electric field, which includes the following steps: (1) preparing a drug-liposome suspension sample; (2) dehydrating the sample under a 1-10 kHz, 3-10 kV high-voltage alternating current; (3) freezing and drying the sample treated in step (2) at ?20° C. to ?40° C., under a 10-25 kHz, 0.2-1 kV high-voltage alternating current, until completion of the freezing process; and (4) heating and drying the sample in a vacuum until completion of sublimation and desorption, and obtaining the drug liposomes freeze-dried powder. The present invention not only greatly shortens a freezing and drying time, but also controls a size of nuclei and ice crystals, further ensuring a quality of the freeze-dried powder.

Abstract: A vacuum system, such as the form of a plasma system, includes a vacuum chamber. The side walls of the vacuum chamber are configured in the form of a completely closed chamber extruded profile. A first end face of the chamber extruded profile is closed off with a plate. A second end face of the chamber extruded profile, which lies opposite the first end face, has a reversibly openable and closable door. The door is fastened by at least one hinge pivotably to the chamber extruded profile. The side walls, which are fully closed transversely to the longitudinal axis of the chamber extruded profile, enable a simple and cost-effective production of the vacuum chamber. The vacuum chamber may be accommodated at least partially in a housing, which may likewise be configured at least partially in the form of an extruded profile.

Abstract: An apparatus and method for dehydrating biological materials, such as vaccines and microorganism cultures, in which the materials are dehydrated in an evacuated container which is in a microwave waveguide that is open to the atmosphere. The apparatus comprises means for freezing the container of biological material, a microwave generator, a waveguide, means for introducing the container into the waveguide, means for applying a vacuum to the container and means for removing the dehydrated material from the waveguide. In the method of the invention, the container of biological material is put in a microwave waveguide open to the atmosphere, a vacuum is applied to the container, the material is frozen and is radiated to dehydrate it. The dehydrated material is then removed from the waveguide.

Abstract: Disclosed is a process for the treatment or processing of containers that serve for storing, or contain, substances for medical, pharmaceutical or cosmetic applications, wherein the containers are conveyed automatically, by a conveyor, past at least one processing station or pass it for the treatment or processing. In the process, a plurality of containers is conveyed by the conveyor while being held by a carrier in a regular arrangement. The containers held on the carrier are raised to a raised position for the treatment or processing at or in the respective processing station and are lowered after the treatment or processing, to be held again on the carrier in the regular arrangement. The carrier is configured such that the containers can be held on the carrier during the entire process. A negative pressure acts on the bottoms of the containers in order to lower them.

Abstract: Disclosed is a process for the treatment or processing of containers that serve for storing, or contain, substances for medical, pharmaceutical or cosmetic applications, wherein the containers are conveyed automatically, by a conveyor, past at least one processing station or pass it for the treatment or processing. In the process, a plurality of containers is conveyed by the conveyor while being held by a carrier in a regular arrangement. The containers held on the carrier are raised to a raised position for the treatment or processing at or in the respective processing station and are lowered after the treatment or processing, to be held again on the carrier in the regular arrangement. The carrier is configured such that the containers can be held on the carrier during the entire process. A negative pressure acts on the bottoms of the containers in order to lower them.

Abstract: A method to monitor a secondary drying phase of a freeze-drying process comprises initial steps in which is provided to perform pressure rise tests at different time and to calculate a respective value of experimental desorption rate of product (steps 1 to 3). Subsequently, the method provides to estimate initial conditions and kinetic constants of a kinetic model of the process (step 4) and to calculate at time t=t2 a respective residual moisture content and a respective desorption rate (step 5). The method can be performed in a freeze-dryer apparatus which includes a drying chamber that contains a product to be dried and can be isolated to perform pressure rise tests.

Abstract: A stable and lyophilized pharmaceutical agent containing nocathiacin, which is prepared by lyophilizing a liquid formulation of nocathiacin, a stabilizer, an excipient, a pH regulator and injectable water, wherein the stabilizer is selected from polyethylene glycol, polysorbate or a mixture thereof, and the pH value of the liquid formulation is 1.0-6.0 is provided.

Abstract: The present invention provides a foaming instant coffee composition comprising particles having a bulk density of from 0.16 to 0.45 g/cm3, said particles comprising a continuous phase comprising an instant coffee matrix and a non-continuous phase comprising particles of a foamable component containing a gas.

Abstract: A closure (1) for a container (9), or for an ampoule (9), in which a medicament is accommodated, having a closure cap (2) and a closure stopper (5) accommodated in the closure (2). Detent moldings (6) are formed on the closure cap (2) for latchingly holding the closure (1) on the ampoule (9), and a sliding part (3) is provided which is movable relative to the closure cap (2) in order to displace the closure stopper (5) into the closed position. In order to advantageously provide, with respect to carrying out a freeze-drying process, a closure for a container, or for an ampoule, in which a medicament is accommodated, the closure stopper (5) is displaceable relative to the cap (2) by means of the sliding part (3) in order to move the closure stopper into the closed position. There is also a method for carrying out a freeze-drying process for a medium, or for a medicament, which is accommodated in a container, or in an ampoule (9).

Abstract: This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously and at approximately the same rate. The as frozen solution can then provide a lyophilized cake of the solutes with large and uniform pores.

Abstract: Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.

Abstract: A freeze dryer processes bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen. The resultant powder is freeze dried in a vessel, and the vessel contents is agitated to maintain product contact with heated vessel wall and to prevent agglomeration.

Abstract: The invention provides a monitoring device (32) for a dryer (10) includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (10), for example at a vial (20). The sensing means comprises an optical sensing fiber (38) having at least one fiber Bragg grating (54). Moreover, the invention provides a dryer, in particular a freeze dryer (10), which is equipped with such monitoring device (32).

Abstract: In a process and apparatus for treating or processing containers (2) that are used for storing substances for medical, pharmaceutical or cosmetic applications or contain the same, cylindrical containers open at least at one end are automatically led past or pass through processing stations for treatment or processing by means of a conveying device, while said containers are jointly held by a carrier (25; 134) in a regular two-dimensional arrangement. The carrier comprises a plurality of openings or receptacles (32; 39; 87; 120), which determine the regular arrangement. According to the invention, the treatment or processing of the containers is performed on or in at least one of the processing stations while the containers are supported by the carrier. This opens up new possibilities for treating or processing the containers, for example when crimping metal lids or during freeze-drying.

Abstract: A porous body that contains cellulose nanofibers having very thin fiber diameters and high hydrophilicity, and has a large specific surface area, and to provide a method of producing the porous body simply with low cost. A method of producing a porous cellulose comprises a process of lyophilizing a mixed liquid containing cellulose nanofibers and a dispersion medium, wherein the dispersion medium is a mixed dispersion medium of water and an organic solvent dissolving in water, a concentration of the organic solvent in the mixed dispersion medium is 2 to 40 mass %, and a solid content concentration of the cellulose nanofibers in the mixed liquid is 0.001 to 5 mass %.

Abstract: Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.

Abstract: A stopper device including a stopper, cap and ring provided with tabs for locking onto a container neck and a body for handling the ring. The body includes a first mechanism for transmitting a thrust force to the ring and a second mechanism for activating the tabs. The ring and the handling body are respectively provided with first and second retainers that hold the handling body in a waiting position. The handling body is mobile parallel to the thrust force direction and in relation to the ring, between a first position activating the tabs of the ring and is mobile in translation only in the thrust force direction, and a second position that also activates the tabs and is immobilized in relation to the ring in axial translation. The tabs extend from a continuous edge of the ring and are each arranged in an opening with a closed contour.

Abstract: The present invention provides processes for the preparation of amorphous form of sitagliptin dihydrogen phosphate. It also provides a solid dispersion of sitagliptin dihydrogen phosphate, including in the amorphous form, and processes for its preparation.

Abstract: A method of monitoring and controlling a freeze drying process in a freeze drying apparatus having walls, shelves and a number of vials or trays positioned on different areas of the shelves and containing product to be freeze dried. One or more vials or trays are selected that are representative of the positions of all of the vials or trays in different areas of the shelves. One or more heat flux sensors are positioned between the selected vials or trays and adjacent portions of the walls and/or shelves. The heat transfer between the selected vials or trays and the adjacent wall or shelf portions is measured during the freezing and drying stages of the freeze drying process.

Abstract: An apparatus for delamination drying a substrate is provided. A chamber for receiving a substrate is provided. A chuck supports and clamps the substrate within the chamber. A temperature controller controls the temperature of the substrate and is able to cool the substrate. A vacuum pump is in fluid connection with the chamber. A tilting mechanism is able to tilt the chuck at least 90 degrees.

Abstract: The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Abstract: System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.

Abstract: Vacuum concentrator, comprising a vacuum chamber with a closure which may be sealed in an airtight manner, a centrifuge rotor arranged in the vacuum chamber with at least one receiver for at least one vessel for samples to be dried, a drive motor arranged outside the vacuum chamber for driving the centrifuge rotor, a vacuum pump connected to the vacuum chamber, a tempering device associated with the vacuum chamber for tempering the at least one sample in the vacuum chamber, a pressure sensor associated with the vacuum chamber for detecting the pressure inside the vacuum chamber and an electrical control and evaluating device which is connected to the drive motor, the vacuum pump, the tempering device and the pressure sensor, for detecting the end point of the vacuum concentration by means of the pressures detected by the pressure sensor in the vacuum chamber and terminating the vacuum concentration when the end point is determined.

Abstract: The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.

Abstract: A process line (300) for the production of freeze-dried particles under closed conditions comprising at least a spray chamber (302) for droplet generation and freeze congealing of the liquid droplets to form particles and a bulk freeze-dryer (304) for freeze drying the particles, the freeze-dryer (304) comprising a rotary drum for receiving the particles. Further, a transfer section (308) is provided for a product transfer from the spray chamber (302) to the freeze-dryer (304). For the production of the particles under end-to-end closed conditions each of the devices (302, 304) and of the transfer section (308) is separately adapted for operation preserving sterility of the product to be freeze-dried and/or containment.

Abstract: A freeze-drying apparatus (1) includes an arrangement of individual product platforms (19) that are supported vertically in a frame (20) in a drying chamber, in which each platform is able to be moved to a shift level, in which lateral guides (20, 21) designed to support a carriage (15) are arranged with a fixed height position, and which cooperate with the guides (16, 18) of a loading and unloading device. All product platforms (19) in the drying chamber can be loaded by repeating this operation cyclically. In order to unload the drying chamber, the arrangement of the product platforms (19) are moved to such a position above the shift level in which the carriage (15) can be moved as far as its rear limit position inside the drying chamber, travelling underneath each loaded product platform (19).

Abstract: A process line (300) for the production of freeze-dried particles under closed conditions is provided, the process line comprising at least the following separate devices: a spray chamber (302) for droplet generation and freeze congealing of the liquid droplets to form particles, and a bulk freeze-dryer (304) for freeze drying the particles, wherein a transfer section (308) is provided for a product transfer from the spray chamber (302) to the freeze-dryer (304), for the production of the particles under end-to-end closed conditions each of the devices (302, 304) and of the transfer section (308) is separately adapted for closed operation, and the spray chamber (302) is adapted for separation of the liquid droplets from any cooling circuit.

Abstract: The invention relates to a method of preparation of lamellar porous microstructures and nanostructures of various density based on controlled vacuum freeze-drying of a liquid dispersion of nanoparticles. The liquid dispersion of particles is rapidly freezed into solid state inside a tightly closed volume. In this form it is submitted to vacuum freeze-drying with required rate of sublimation of molecules of a liquid dispersion medium, until their total removal, accompanied by the creation of lamellar microstructures and nanostructures. The orientation of the normal vector of the dominant surface of sublimation interface can be set with regard to the required properties of the final sublimate structure from vertically upwards to vertically downwards. The sublimation rate is adjusted by combination of vacuum depth and external heating of the sublimation interface of the frozen material.

Abstract: A method for monitoring and/or controlling and a freeze drying process in a freeze dryer apparatus provided with a drying chamber having a temperature-controlled shelf supporting containers of a product to be dried, comprises during a primary drying phase of the freeze drying process the steps of: isolating the drying chamber closing an isolating valve thereof and sensing and collecting pressure values inside the drying chamber for a defined pressure collecting time and a shelf temperature of the temperature-controlled shelf (Step 1); calculating a product temperature of product and a plurality of process/product related parameters (Step 2); calculating a new shelf temperature and a sequence of shelf temperatures up to the end of the primary drying phase, that maximizes a sublimation rate of the product maintaining the product temperature below a maximum allowable product temperature.

Abstract: The invention relates to a method for freeze-drying injectable compositions, in particular pharmaceutical compositions, comprising: A) storing a quantity of a dispersion of an injectable composition in an aqueous dispersion medium in at least one ready-to-use vial, B) rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial, C) during rotating of the vial according to step B) cooling the vial to form ice crystals at the inner surface of the circumferential wall of the vial, and D) drying the cooled composition to sublime at least a portion of the ice crystals formed in the dispersion by substantially homogeneously heating the circumferential wall of the vial. The invention also relates to a freeze-dried composition obtained by the method according to the invention and a system for freeze-drying injectable compositions, in particular pharmaceutical compositions, in particular by making use of the method according to the invention.

Abstract: The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Abstract: This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously. The as frozen solution then provides a lyophilized cake of the solutes with large and uniform pores.

Abstract: A freeze dryer shelf with opposed, parallel first and second plates is disclosed. The plates have at least one flow channel located therebetween for conveying a diathermic fluid between the plates. One of the plates has a surface treated to inhibit the sticking to the shelf of a rubber stopper pressed against that surface during the application of pressure to the stopper to push the stopper into a container.

Abstract: An apparatus for delamination drying a substrate is provided. A chamber for receiving a substrate is provided. A chuck supports and clamps the substrate within the chamber. A temperature controller controls the temperature of the substrate and is able to cool the substrate. A vacuum pump is in fluid connection with the chamber. A tilting mechanism is able to tilt the chuck at least 90 degrees.

Abstract: Method for spray drying a high-viscosity fluid product using a spraying device, wherein the method comprises projecting the fluid product out of an outflow opening of the spraying device for obtaining droplets of the fluid product, wherein the spraying device is arranged to cause a pressure drop in the fluid product across the outflow opening which is larger than 15 bar and at least partially drying the droplets in a drying medium, such as air, to become particles.

Abstract: A device for large-scale lyophilization of pharmaceutical solutions in medical hollow bodies, includes a lyophilization device and at least one camera. Images of at least one pharmaceutical solution to be lyophilized are recorded by the at least one camera. The images may be used for controlling and/or monitoring the lyophilization process.