Abstract: The disclosure concerns methods for executing PBV protocols to preserve biopharmaceuticals using a conventional lyophilizer. Also described are steps for maintaining isolation of a biopharmaceuticals for achieving aseptic drying using the conventional lyophilizer. As a collateral benefit, the invention provides good manufacturing practice (GMP) compliant methods for achieving aseptic drying of biopharmaceutical compositions using a conventional lyophilizer disposed outside of a clean-room area. Finally, methods and formulations str disclosed for preserving biopharmaceuticals suitable for mucosal or transdermal delivery to a patient.

Abstract: A process for producing nanoparticles of a substance, including in a first chamber, forming a dispersion of a substance in a fluid and bringing the fluid into a supercritical state; passing the dispersion from the first chamber through a cooling device or into a cooling zone in a second chamber, wherein the cooling device or cooling zone configured to reduce temperature of the dispersion below a temperature at which the fluid forms solid particles such that nanoparticles of the substance are formed, wherein the second chamber comprises a surface configured to receive the solid particles of the fluid and the nanoparticles of the substance; allowing pressure to decrease and/or temperature to increase in the second chamber to transform the solid particles into a gaseous state, removing the fluid in the gaseous state and with the nanoparticles remaining on the surface; and collecting the nanoparticles from the surface.

Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and a volatile organic solvent, yet the carbohydrate-glass particles are insoluble in the volatile organic solvent.

Abstract: Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma.

Abstract: A continuous cycle bottling line (1) for containers of thermoplastic material, comprises: a parison (4) moulding unit (3), a thermal conditioning unit (6) for the parisons (4); a blow-moulding unit (10); a filling unit (12) configured to receive the blow-moulded containers (11) from the blow-moulding unit (10) and to fill them with liquid or semi-liquid food products; a moulding unit (13) for making caps (14) of plastic material; a capping unit (15); a storage system (2) which is configured to contain the parisons (4) and the caps (14), which is interconnected with the units making up the line, and which defines inside it a controlled-atmosphere environment; the line defines an integrated system where the connections of the different units with each other and with the storage system (2) are located in a controlled-atmosphere environment.

Abstract: The disclosure concerns compositions containing inactivated but therapeutically active biopharmaceuticals, and methods for formulation thereof. Biopharmaceuticals are encapsulated and immobilized in dry amorphous carbohydrate-glass and irradiated for inactivation while in the dry state. The resulting compositions provide ambient-temperature stable, therapeutically active but inactivated biopharmaceuticals for use in vaccines and other applications.

Abstract: The invention relates to a freeze-drying device comprising: —an evaporation chamber (5) comprising heating means (15, 16), —a condensing chamber (10) communicating with the said evaporation chamber, —the said evaporation chamber (5) and the said condensing chamber (10) being mounted secured to one another about an axle (30) capable of rotating, characterized in that the device further comprises: —a products inlet and outlet (1, 8) which are connected to the said evaporation chamber (5) by flexible connectors, the products inlet and outlet (1, 8) being mounted fixedly with respect to the evaporation chamber, and —a motor (12) driving the said axle (30) on itself with the following back-and-forth movement: —a first movement driving the said axle (30) in a first direction of rotation with an angle of rotation (?1) of between 5° and 90°, and —a second movement driving the said axle (30) in a second direction of rotation, opposite to the first angle of rotation, with an angle of rotation (?2) of between ?5° and ?9

Abstract: The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: 1-100 wt. % of particles consisting of: 0.01-10 wt. % of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof; 5-70 wt. % of buffering agent; 20-94 wt. % of branched glucan; 0-70 wt. % of other pharmaceutically acceptable ingredients; 0-95 wt. % of one or more pharmaceutically acceptable excipients; the solid dosage unit comprising at least 5 ?g of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.

Abstract: A method for the production of freeze-dried pellets comprising factor VIII comprises the steps of: a) freezing droplets of a solution comprising factor VIII to form pellets; b) freeze-drying the pellets; wherein in step a) the droplets are formed by means of droplet formation of the solution comprising factor VIII into a cooling tower which has a temperature-controllable inner wall surface and an interior temperature below the freezing temperature of the solution and wherein in step b) the pellets are freeze-dried in a rotating receptacle which is housed inside a vacuum chamber.

Abstract: An extraction apparatus and a processes for preparing extracts of natural products, such as plant material, and for preparing purified extracts from crude extracts of natural products by extraction with a non-polar solvent hot gas.

Abstract: Microfluidic cryopreservation technology is provided and particularly, but not exclusively, devices, systems, and methods for cryopreservation of biological materials such as oocytes, zygotes, and embryos. The present microfluidic devices and related systems and methods are configured to maintain biological material in a housing chamber when subjected to a constant volumetric flow of fluid of changing fluid density.

Abstract: A composition and method for generating reagents and the composition of these reagents for the stabilization and preservation of viability of cancer tissue which has been surgically excised and the suspension and/or termination of apoptosis (cell death) by significant modulation of cell metabolism by low molar concentrations of synergistic chemistries and hormonal growth enhancers while maintaining normal gene expression patterns of the surgically excised tissue.

Abstract: The present invention discloses dry formulations of room temperature stable vaccines that comprise a live attenuated virus, a sugar stabilizer, and an amino acid stabilizer. The present invention also discloses the manufacture of such vaccines and methods of protecting an animal by administration of such vaccines.

Abstract: A microwave filter for use with a microwave brazing system having a brazing chamber, a vacuum line, and a pressure gauge located proximate the vacuum line. The microwave filter includes a baffle plate configured to be mounted in an opening between the brazing chamber and the pressure gauge, and a plurality of hollow pipes configured to substantially prevent the transmission of microwaves from the brazing chamber to the pressure gauge, and further configured to allow gas to flow between the brazing chamber and the vacuum line.

Abstract: An bearing cooling system is connected to and actuated by the vibration of a vibratory device to pump lubricant to lubricate internal components of the vibratory device. The bearing cooling system has a bottom end cap with an inlet in fluid communication with the vibratory device, a top end cap with an outlet for delivering the lubricant to lubricate components of the vibratory device, a tube disposed between and sealingly engaging the bottom end cap and the top end cap, and a piston having a lubricant passageway. The piston is slidably disposed within the tube downstream of the bottom end cap and upstream of the top end cap. Vibration of the vibration device causes the piston to oscillate within the tube to draw lubricant from the vibration device which passes through the lubricant passageway in the piston, and delivers lubricant to lubricate internal components of the vibration device.

Abstract: An aqueous or powder composition includes anti-gram-negative antibiotic or salt thereof being present at an amount ranging from about 100 mg/ml to about 200 mg/ml. Another aqueous or powder composition includes anti-gram-positive antibiotic or salt thereof being present at a concentration ranging from about 0.6 to about 0.9 of the water solubility limit, at 25° C. and 1.0 atmosphere, of the anti-gram-positive antibiotic or salt thereof. Other embodiments include unit doses, kits, and methods.

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: A process for lyophilizing a solution of an active agent in a container is provided. Solution of active agent is deposited into a container, the container is covered with a covering plate and placed inside a lyophilizing apparatus. Lyophilization can be conducted to dryness by radiation, convection or both. Also provided is a device made by this process, an active agent-plastic administration device (e.g., a syringe), containing an active agent in the form of lyophilized cake, and an array of such administration devices.

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: 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: A rotary drum (302) for use within a vacuum chamber (212) in a vacuum freeze-dryer (204) for the bulkware production of freeze-dried particles is provided. The drum (302) is in open communication with the vacuum chamber (212) and comprises a main section (304) terminated by a front plate (306) and a rear plate (308), the rear plate (308) is adapted for connection with a rotary supporting shaft (312) for rotary support of the drum (302), and the rear plate (308) is permeable for sublimation vapor from freeze-drying the particles.

Abstract: A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer (100) for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer (100) comprising a rotary drum (104, 302) for receiving the frozen particles, and a stationary vacuum chamber (102) housing the rotary drum (104, 302), wherein for the production of the particles under closed conditions the vacuum chamber (102) is adapted for closed operation during processing of the particles.

Abstract: A hair care appliance for application of vapor to dry hair to provide humidity to the hair, including a housing defining an inner cavity, a vapor-generating system positioned at least partially within the cavity, and a spacer including a cap, a plurality of spacer elements projecting outwardly from the cap, and an aperture through the cap. The spacer elements partially define therebetween a work area in which the hair is gathered. The vapor-generating system discharges vapor through the aperture to the work area for application to the hair.

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: 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: 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: 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.

Abstract: This work is in simplifying the freezing and heating process required for a typical lyophilization process. From a liquid nitrogen supply tank called LIN tank, calculated quantity of vaporized nitrogen is transported the use point where a heater that uses heating media heats up nitrogen to a desired temperature and pass into the annular space of the steel plate where lyophilized solvent such as water of solvent is deposited on the outer surface of the plate. The heated nitrogen temperature will dictate the rate at which the solvent or water will be thawed. This unique process offer simplicity, safety and ease operation allowing the user to avoid heating oil as heating media, a common practice in the industry.

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: 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: 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: 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: A vacuum freeze-drying apparatus capable of rapid drying is provided. A cold trap for drying, which is arranged inside a drying chamber, is set to a low temperature of ?70 degrees Celsius or below, and heat is supplied to frozen particles on a conveyor belt to a degree such that the frozen particles do not melt. The amount of the liquid component evaporating from the frozen particles increases, and the amount of the liquid component entering the frozen particles decreases so that the time for drying the frozen particles is shortened.

Abstract: A method of manufacturing heat-sensitive pharmaceutical powder is disclosed. The original pharmaceutical substances are dissolved in a solution or suspended in a suspension, which is sprayed through an atomizing nozzle and frozen in a cold gas phase or liquid nitrogen atomized directly in the spray-freeze chamber or gas jacket at the same time (for cooling purposes). The particles are freeze-dried at roughly atmospheric pressure in a down-stream fluid flow with exit filter thereby to remove moisture entrapped on or inside the frozen particles. The system has applicability for forming other powders.

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: 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: Device and method for lyophilizing a substance within the device and storing therein the lyophilized substance. The device defines a chamber for receiving therein the substance to be lyophilized, a penetrable and resealable portion of the device is penetrable or pierceable by a needle for filling the device with the substance, and a resulting hole therein is resealable by transmitting radiation from a radiation source thereon. A filter is connectable in fluid communication between an interior and exterior of the chamber for permitting fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and for substantially preventing contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.

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: This technology relates to a process and associated apparatus for use in spray freeze drying a fluid substance such as fruit juice, pharmaceuticals, nutraceuticals, tea and coffee. The method includes the steps of: holding a chamber at a temperature and pressure below the triple-point of the liquid substance; injecting and/or atomizing the liquid substance into the chamber through at least one injection port to generate a frozen liquid substance portion having a predetermined particle size and a first evaporated liquid substance portion; collecting the FLS portion as a layer on a conveying surface; and exposing the collected layer of FLS portion to a heating means thereby inducing sublimation and generation of a second evaporated liquid substance portion and a product, wherein the conveying surface conveys the collected FLS portion at a rate which achieves substantially a monolayer thickness of the FLS portion to accumulate on the conveying surface.

Abstract: [Object] To provide a freeze-drying apparatus and a freeze-drying method, which are capable of increasing a drying efficiency of frozen particles. [Solving Means] The freeze-drying apparatus 100 includes a freezing chamber 10 into which a raw material fluid F is injected. During the injection of the raw material fluid F, after the injection of the raw material fluid F, or for a time period covering the start to the termination of the injection of the raw material fluid F, a shelf 16 is vibrated in a horizontal direction due to an actuation of vibration generators 31. With this, the frozen particles deposited on the shelf 16 are evenly diffused on the shelf 16 in such a manner that a deposition thickness thereof becomes smaller or a single layer thereof is formed. With this, a freezing efficiency and the drying efficiency of individual particles are promoted.

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: 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: [Object] To provide a freeze-drying apparatus and a freeze-drying method, which are capable of increasing a collection rate of a raw material without a need for providing a member such as a baffle plate or the like. [Solving Means] The freeze-drying apparatus 100 includes: a container 4 to store a raw material fluid F; a freezing chamber 10 being a vacuum chamber; a vacuum pump 1 to exhaust the freezing chamber 10; and an injection mechanism 25 to inject the raw material fluid F stored in the container 4 into the freezing chamber 10. The cold trap 20 is arranged within the freezing chamber 10, and hence a phenomenon that the raw material is discharged to the outside of the vacuum chamber together with a vapor as in the past can be prevented. With this, the collection rate of the raw material can be increased. Further, it becomes unnecessary to provide the baffle plate or the like for preventing the phenomenon in vicinity of an exhaust port of the vacuum chamber.

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.

Abstract: A method for treatment of organic matter, and inorganic matter that has been biologically contaminated, such as human cadavers, animal carcasses and clinical waste, to prepare the matter for burial or other disposal is disclosed. The method involves freeze-drying the size-reduced organic matter whilst subjecting the partially-dehydrated remains to a series of vacuum-pressure cycles. Process conditions are chosen so as to favour microbial inactivation.

Abstract: The invention relates to a spray freeze dryer apparatus and method of using same for use in drying or concentrating a raw material which at ambient conditions has a solid and an aqueous portion. The dryer includes a chamber and a chamber pressure reduction device; an inlet nozzle or nozzles through which the raw material is injected into the chamber; and a collection surface or surfaces which collect a frozen portion of the raw material. The chamber is kept at a pressure below the triple-point pressure of the aqueous portion of the raw material. Several additional features are described to control the thickness of the layer on the collection surface.

Abstract: The present invention relates to dry particles and methods of preparing the same, in particular to methods of producing dry particles comprising a thermally labile component such as a colloidal system or a thermally labile biopharmaceutical compound, to the use of such dry particles, and to pharmaceutical compositions comprising the same.