Abstract: Movement of a slot door of a freeze dryer is driven by a rack and pinion actuator. The actuator is easily sanitized and includes internal elements that are accessible to sanitizing sprays. The pinions are driven by pinion shafts that pass through a seal separating an aseptic area from a non-aseptic area where the drive train is positioned. Only rotary motion is transferred across the aseptic barrier, reducing the need for a bellows or sliding covers, which are difficult to sanitize.

Abstract: [Object] To provide a calculation method and calculation device for an average sublimation interface temperature, bottom part temperature, and sublimation rate of the whole to-be-dried material introduced into a drying chamber of a freeze-drying device without contaminating or collapsing the to-be-dried material. [Solution] The present invention is applied to a freeze-drying device that includes a drying chamber DC, a cold trap CT, vacuum adjustment means for adjusting the degree of the vacuum in the drying chamber DC, and a control device CR for automatically controlling the operations of the above elements.

Abstract: A method and apparatus for the continuous sublimation of a substance includes cascading a material containing a substance capable of sublimation, such as water, between a plurality of trays vertically stacked within a processing zone provided within a processing chamber. A substantially atmospheric environment is maintained within the processing zone at a temperature whereby the substance sublimes forming a sublimate within the environment. The environment containing the sublimate is contacted with a drying agent such as a desiccant to maintain the environment whereby the substance sublimes at substantially atmospheric pressure and at the controlled temperature.

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: A multilayer plastic container for storing lyophilized products includes at least three layers consisting of inner and outer layers having a moisture vapor transmission rate of not more than 0.1 gm mil/100 sq. in.-day at 73° F. and 95% rh, and an intermediate layer of hygroscopic resin construction having a moisture content less than 1000 ppm. The hygroscopic intermediate layer preferably comprises at least 30% of the total thickness of the three layers. The inner and outer layers preferably are of cyclic olefin polymer or cyclic olefin copolymer construction, and the hygroscopic intermediate layer preferably is of amorphous nylon construction. The container preferably is empty and sealed within a secondary container, such as a metallized bag, that is impervious to moisture.

Abstract: A method for producing a fog of ice nuclei by introducing a cryogenic fluid and a humid gas stream into a freeze dryer. The cryogenic fluid and humid gas stream will form ice nuclei having a preferred size for introduction into vials contained in the freeze dryer.

Abstract: A method and apparatus for the continuous sublimation of a substance includes cascading a material containing a substance capable of sublimation, such as water, between a plurality of trays vertically stacked within a processing zone provided within a processing chamber. A substantially atmospheric environment is maintained within the processing zone at a temperature whereby the substance sublimes forming a sublimate within the environment. The environment containing the sublimate is contacted with a drying agent such as a desiccant to maintain the environment whereby the substance sublimes at substantially atmospheric pressure and at the controlled temperature.

Abstract: The present invention pertains to a method for lyophilizing particles comprising frozen liquid having a pharmaceutical compound contained therein, comprising providing a heat conducting container having a bottom and side walls, filling the container with a bed of the particles, the bed comprising multiple layers of the particles and having an aspect ratio of not less than 1, providing a heat source above a top layer of the particles, the heat source having a surface directed to a top layer of the bed, which surface has an emissivity coefficient of at least 0.4, subjecting the particles filled in the container to a reduced pressure, heating at least the bottom of the container and the said surface to provide heat to the particles to support sublimation of the frozen liquid at the reduced pressure, and after the frozen liquid is sublimated, stopping the provision of heat to the particles.

Abstract: A new structure made of collagen for improving promotion of nerve tissue regeneration, curing and regeneration of a defective part of a soft biological tissue and so on without using laminin or nerve growth factor (NGF), and a member for tissue regeneration including the same. The structure made of collagen has a thin film multilocular formation and is therefore a new structure different from a colloid form, a gel form, and a fiber form. When the new structure made of collagen is used as a member for tissue regeneration, surprisingly, promotion of regeneration, shortening of a treatment period, functional recovery, or the like of bodily tissue such as nerve tissue, subdermal tissue, submucosal tissue, membranous tissue, fat tissue, muscle tissue, skin tissue, and gingival tissue can be improved. When the structure is used in a patient having neuropathic pain, the member has an effect on the disappearance of the pain.

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: A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

Abstract: The disclosure provides a method of preparing an immunologically-active adjuvant-bound freeze dried vaccine composition. A specific embodiment provides a stable vaccine composition comprising an aluminum-salt adjuvant, a recombinant Clostridium botulinum neurotoxin protein and a glass-forming agent. These vaccine compositions are useful in the treatment of humans and other animals at risk of infection from Clostridium botulinum neurotoxin.

Abstract: A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied.

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 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: A method of controlling the primary drying stage in a freeze drying apparatus having a shelf and bulk product or a number of vials in different areas on the shelf which contain product to be freeze dried. Temperature sensors are positioned in selected locations or vials which are representative of the different bulk product areas or the positions of all of the vials in different areas of the shelf. The temperature sensors are monitored and compared to determine the selected location or vial having the highest temperature while the temperature sensor therein is still in ice. The shelf temperature is controlled based on the selected location or vial with the highest temperature so long as the temperature sensor therein is still in ice. When the temperature sensor in the highest temperature selected location or vial is no longer in ice, another selected location or vial with the highest temperature and a temperature sensor therein that is still in ice is then used to control the shelf temperature.

Abstract: In one aspect, the invention features a textured microthread that includes or is fashioned from a naturally occurring polymer and that has a surface comprising micron-scale ridges with intervening grooves.

Abstract: A device for supporting at least one vessel containing a target material to be lyophilized generally includes a support panel, a central region, a perimeter region, a thermal shield, and at least one shielding cavity. The support panel has a support surface. The central region is defined by the support panel for supporting the at least one vessel. The perimeter region is also defined by the support panel and surrounding the central region. The thermal shield is positioned about the perimeter region and extends transverse to the support surface of the support panel such that the thermal shield and the support panel define a storage space for accommodating the at least one vessel. The at least one shielding cavity is defined by the thermal shield and contains a shielding material during a lyophilization process. The shielding material is distinct from the target material.

Abstract: A device for controlling the dehydration operation during a freeze-drying treatment comprises a freeze-drying chamber (1) connected to a vacuum line, and a gas analyzer, for analyzing the gases contained in the chamber. The gas analyzer comprises a gas ionization system (8) comprising a plasma source (13) in contact with the gases, which plasma source is combined with a generator (15) capable of generating a plasma from said gases, and a system for analyzing the ionized gases, comprising a radiation sensor (17) located close to the plasma generation zone and connected to an apparatus (18) for analyzing the change in the radiative spectrum emitted by the plasma. According to the invention, the device includes a means (16) for repeatedly turning the plasma source (13) on and off. The device may further include an optical port (25) placed between the gas ionization system (8) and the freeze-drying chamber (1).

Abstract: Devices used in conjunction with detecting analytes and methods of their manufacture are disclosed. A pre-concentrator device includes a thermoelectric material and an aerogel which includes a nanostructured material disposed on, and in thermal communication with, the thermoelectric material. Such a pre-concentrator is part of a detection system including a sensor. The detection system is used in a method for detecting analytes.

Abstract: A method for producing a fog of ice nuclei by introducing a cryogenic fluid and a humid gas stream into a freeze dryer. The cryogenic fluid and humid gas stream will form ice nuclei having a preferred size for introduction into vials contained in the freeze dryer.

Abstract: A freeze-dryer and method of controlling the same is provided. The disclosed freeze-dryer includes a chamber adapted to hold material or product to be freeze-dried; one or more depressurization orifices; a gas pressurization circuit having a source of gas to pressurize the chamber to a prescribed pressure; a depressurization circuit coupled to the chamber via the one or more orifices and having a depressurizing control valve; and a control unit adapted to pressurize the chamber with the source of gas and actuate the depressurizing control valve to depressurize the chamber upon command. The ratio of total depressurization orifice area to the chamber volume is preferably between about 6×10?2 and about 4×10?4 m2/m3.

Abstract: The invention provides a method for devitalizing plant seed, the method comprising the steps of hydrating a viable whole plant seed and freezing the hydrated whole plant seed. The invention further provides a collection of devitalized whole plant seed wherein the integrity of genomic DNA and protein within the devitalized plant seed is preserved.

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: The present invention relates to a process for the preparation of carbapenem antibiotic compounds, which is useful for intravenous and intramuscular administration.

Abstract: Method for transfer of containers, such as vials (101), between a freeze dryer (1) that is located at a first location and a separate transport vehicle (30) that is mobile with respect to the freeze dryer, wherein the freeze dryer (1) comprises a freeze dryer housing (2) with an access opening (11) towards an inner freeze drying chamber (10) inside the freeze dryer housing (2), multiple shelves (21-24) that are arranged spaced apart above each other inside the freeze dryer chamber (10) and each provided with a horizontally extending first flat supporting surface (25) for supporting the containers, wherein the mobile transport vehicle (30) comprises a mobile undercarriage (31) supporting a storage housing (33) with an access opening (40) towards an inner storage chamber (39), a carrier provided with a second flat supporting surface (58) for supporting the containers inside the storage housing (33), and a container shifter (60) for pushing out containers away from the second flat supporting surface (58) in a pu

Abstract: An apparatus and method for microwave vacuum-drying of temperature-sensitive biological materials on a continuous flow-through basis, in which the materials are frozen, ground to frozen particles, dehydrated to a powder, and the powder collected. The apparatus (10) has a microwave generator (12) and waveguide (14), a freezing chamber (46) with a grinder (52), a rotatable dehydration chamber (18) in or adjacent to the waveguide, and a powder collector (82) to receive the powdered biological material. The apparatus operates under reduced pressure provided by a vacuum system (92) coupled to the powder collector (82).

Abstract: The present invention relates to the use of a glass container having a contact angle of more than about 10° for preventing glass fogging during freeze drying of a pharmaceutical composition. The pharmaceutical composition comprises a therapeutic agent and a surfactant. The respective glass container and a method for freeze drying the pharmaceutical composition are also disclosed.

Abstract: A suitable container for plasma lyophilization has been designed for lyophilization (lyo-bag), storage, reconstitution and administering of blood products. A rigid support frame for use with a lyo-bag with sidewalls was designed as an external removable supportive system, which provides the necessary stability for the flexible container during lyophilization. A removable bottom wall support sheet was designed for use with any flexible container for lyophilization.

Abstract: Movement of a slot door of a freeze dryer is driven by a rack and pinion actuator. The actuator is easily sanitized and includes internal elements that are accessible to sanitizing sprays. The pinions are driven by pinion shafts that pass through a seal separating an aseptic area from a non-aseptic area where the drive train is positioned. Only rotary motion is transferred across the aseptic barrier, reducing the need for a bellows or sliding covers, which are difficult to sanitize.

Abstract: The invention relates to a process for the production of alginate-containing porous or sponge-like moulded articles, and to the moulded articles obtainable thereby and their use.

Abstract: A method for distributing a cryogenic fluid inside a freeze drying chamber. The cryogenic fluid is fed into the freeze drying chamber through a venturi device. The cryogenic fluid will form an ice fog which will be rapidly and uniformly distributed throughout the freezing chamber and into the vials present in the freezing chamber.

Abstract: Methods of preparing ZC-423 (I) which result in varying enantiomeric ratios.

Abstract: A device for storing a material to be lyophilized includes a support panel, a sidewall, an opening, a cover, and at least one lifter device. The sidewall and the support panel define a storage space for accommodating a material. The opening is defined by a rim of the sidewall. The cover is removably disposed adjacent to the rim of the sidewall for closing the opening. The lifter device is disposed between the support panel and the cover and includes a reservoir and at least one movable wall. The reservoir defines a sealed cavity containing a fluid. The movable wall is in operable communication with the fluid in the sealed cavity and engaging the cover to displace the cover away from the rim when the lifter device is subject to an ambient pressure that is less than the pressure of the fluid in the sealed cavity.

Abstract: A device for supporting at least one vessel containing a target material to be lyophilized generally includes a support panel, a central region, a perimeter region, a thermal shield, and at least one shielding cavity. The support panel has a support surface. The central region is defined by the support panel for supporting the at least one vessel. The perimeter region is also defined by the support panel and surrounding the central region. The thermal shield is positioned about the perimeter region and extends transverse to the support surface of the support panel such that the thermal shield and the support panel define a storage space for accommodating the at least one vessel. The at least one shielding cavity is defined by the thermal shield and contains a shielding material during a lyophilization process. The shielding material is distinct from the target material.

Abstract: A method and apparatus for the continuous sublimation of a substance includes cascading a material containing a substance capable of sublimation, such as water, between a plurality of trays vertically stacked within a processing zone provided within a processing chamber. A substantially atmospheric environment is maintained within the processing zone at a temperature whereby the substance sublimes forming a sublimate within the environment. The environment containing the sublimate is contacted with a drying agent such as a desiccant to maintain the environment whereby the substance sublimes at substantially atmospheric pressure and at the controlled temperature.

Abstract: A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

Abstract: Provided are compositions of cladribine and cyclodextrin which are especially suited for the oral administration of cladribine.

Abstract: During the investigation of the mechanism that cellular water in woody plants growing in cold districts keeps liquid state at low temperature, the inventors have studied to identify the causative substances. As the results, the present inventors identified supercooling promoting agents in woody plants. The supercooling ability of identified flavonoid glycoside and synthesized flavonoid glycoside with similar structure was tested. It was found that the supercooling promoting agent comprising these flavonoid glycosides enables to stably supercool bulk water at low temperature for long-term. The aqueous solution containing the supercooling promoting agent of the present invention is useful to store biological materials at low temperature.

Abstract: A material to be dried is frozen and is efficiently freeze-dried in a short time, thereby increasing production efficiency. A freeze-drying apparatus includes a vertical tube (2) having an inner circumferential surface formed with a frozen surface (2a), a liquid-supply device (5) for supplying a liquid material to be dried (47) onto the frozen surface (2a), a freezing device (10) arranged around the vertical tube (2) and intended for cooling the frozen surface (2a), a pressure-reduction device (12) which puts an interior area of the vertical tube (2) into a state of vacuum, and an internal heating device (41) in the vertical tube (2). The internal heating device (41) is arranged in the vertical tube (2) along a center axis thereof, and has an outer surface formed with a vertically long circular-cylindrical radiation surface (43).

Abstract: The present invention pertains to a method for lyophilising particles comprising frozen liquid having a pharmaceutical compound contained therein, comprising providing a heat conducting container having a bottom and side walls, filling the container with a bed of the particles, the bed comprising multiple layers of the particles and having an aspect ratio of not less than 1, providing a heat source above a top layer of the particles, the heat source having a surface directed to a top layer of the bed, which surface has an emissivity coefficient of at least 0.4, subjecting the particles filled in the container to a reduced pressure, heating at least the bottom of the container and the said surface to provide heat to the particles to support sublimation of the frozen liquid at the reduced pressure, and after the frozen liquid is sublimated, stopping the provision of heat to the particles.

Abstract: A method of preparing a pharmaceutical composition is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles at about atmospheric pressure to produce a powder, wherein said drying is performed in the presence of vibration, internals, mechanical stirring, or a combination thereof. Another method is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles to produce a powder; wherein the atomized formulation comprises droplets having an average mean diameter of between about 35? and about 300?, and/or the powder comprises dried particles having an average mean diameter of between about 35? and about 300?. Compositions made by the above methods, and methods of using the compositions, are also described.

Abstract: Process for producing containers of a freeze-dried product wherein droplets of the product are frozen to form pellets, the pellets are freeze-dried, assayed and loaded into the containers.

Abstract: The present invention relates to a continuous-feed furnace assembly and processes for preparing and continuously thermally exfoliating graphite oxide to give a highly exfoliated graphite.

Abstract: A sleeve consisting of metal and having a planar base manufactured to low fabrication tolerances for holding a cartridge, or other container for pharmaceutical products, filled with a pharmaceutical product, prior to, and during, freeze-drying is proposed. The sleeve has a cylindrical receptacle, into which a cartridge may be inserted. The base of that receptacle may have openings. Since the base of the metallic sleeve is manufactured to low fabrication tolerances, heat transfer from the cooling plate on which the sleeve containing the cartridge stands to the sleeve will be improved. Heat transfer from the sleeve to the interior of the cartridge will also be improved, since the latter is surrounded by the sleeve over the full length of the sleeve, thereby forming an enlarged surface, along which radiative heat transfer takes place. The sleeve preferably extends up to the level of the liquid pharmaceutical product arranged in the cartridge.

Abstract: This invention is directed to freeze dryers used in the pharmaceutical industry, and in particular, to a barrier system for freeze dryers located in an isolator or clean room facilitate sterilization of the isolator.

Abstract: A freeze-drying device for the monitoring and control of water vapor in a freeze-drying process, comprising an optical spectrometer, and methods of using same to monitor and control the amount of water vapor in said process under sterile conditions.

Abstract: A freeze-drying apparatus comprises a vertical tube (2) and a spray device (4) for supplying liquid onto an inner surface of the vertical tube (2). Connected to the spray device (4) is a liquid-supply device (5) for supplying liquid material to be dried. The vertical tube (2) has a lower portion, to which a vertical guide cylinder (14) is connected. The guide cylinder (14) has a mid portion at which a roughly crushing device (15) and a first open-close valve (18) are arranged in order from above. The guide cylinder (14) has a portion above the first open-close valve (18), to which portion the liquid-supply device (5) is connected through a liquid-recovery passage (19) so as to recover excessive dried material to the liquid-supply device (5). The liquid-recovery passage (19) is additionally provided with a second open-close valve (20). A heating-freezing device (10) is disposed around the vertical tube (2) so as to control a temperature of the inner surface of the vertical tube (2).

Abstract: A method for monitoring and/or controlling a freeze drying process is characterized by the use of an estimator algorithm. A product to be dried is arranged in at least one container on a temperature-controlled shelf in the drying chamber of a freeze dryer apparatus. During a primary drying phase, the drying chamber is isolated by closing an isolating valve. Pressure values inside the drying chamber are measured and collected for a defined pressure collecting time and a temperature of the temperature-controlled shelf. A product temperature for the product is calculated together with a plurality of process/product related parameters. A new shelf temperature is calculated with a sequence of shelf temperatures up to the end of the primary drying phase that maximizes a sublimation rate of the product in order to maintain the product temperature below a maximum allowable product temperature.

Abstract: A process for the purification of a crude organic compound comprising dissolving said compound in carbonated water to form a solution and freeze drying said solution.