Abstract: A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.

Abstract: A method of drying (sublimation or desorption) a frozen product stored in a container, comprising: a) capturing a thermal IR image of the container wall using a thermal IR camera; b) processing the thermal IR image by calculating temperature values of points located on the outer surface of the container wall; c) calculating a maximum temperature of the product in the container using a mathematical model that models heat flow and that models progress of the drying process; d) controlling an amount of power supplied to the container based on the calculated maximum product temperature and on a temperature safety_margin. A freeze drying apparatus for performing said method. A container having a specific shape for use in such a process.

Abstract: Methods of preparing dried powders of biologically active compositions are disclosed. They are designed to provide dried material that maintains biological activity at low economic cost. Compositions made by the above methods are also described.

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 cooling gas discharge nozzle 7 is arranged above an initial position P(Rin) distant from a rotation center P(0) of a substrate W toward the outer edge of the substrate W and supplies a cooling gas to the initial position P(0) of the rotating substrate W to solidify DIW adhering to an initial region including the initial position P(Rin) and the rotation center P(0). Following formation of an initial solidified region FR0, a range to be solidified is spread toward the outer edge of the substrate W and all the DIW (liquid to be solidified) adhering to a substrate surface Wf is solidified to entirely freeze a liquid film LF.

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: Parameters of a freeze drying process are monitored by measuring trace materials in the vacuum pump exhaust. The measurements are made using techniques such as acousto-optic spectrometry, multipass cavity-enhanced absorption spectrometry (CEAS) and cavity ring-down spectrometry (CRDS). The technique may be used to diagnose problems such as leakage in the freeze drying shelves, leakage in the condensation coils, leaks from atmosphere in the chambers and the presence of residual cleaning materials. The technique may also be used to monitor the presence of water vapor in the exhaust of a secondary drying process.

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: 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 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: This invention provides methods and compositions to preserve bioactive materials in a dried foam matrix. Methods provide non-boiling foam generation and penetration of preservative agents at temperatures near the phase transition temperature of the membranes.

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 drying rack for the stationary drying of articles to be dried, which can be installed in the drum of a clothes dryer. The articles can be knitwear or shoes that must not be moved when dried even when the drum turns. For articles, especially, wool articles, to dry faster, the drying rack has at least two spaced-apart surfaces disposed one on top of the other on which the articles to be dried can be spread, thereby substantially enlarging the surface of the articles to be dried. As such, the drying air current can better remove the moisture and larger individual wool articles can be dried in the clothes dryer.

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

Abstract: Methods and systems are provided for microscale lyophilization or microscale drying of agents of interest, such as pharmaceutical agents or other molecules that are unstable or easily degraded in solution. The drying method includes (a) providing a liquid comprising an agent of interest dissolved or dispersed in a volatile liquid medium; (b) depositing a microquantity (between 1 nL and 10 &mgr;L) of the liquid onto a preselected site of a substrate; and then (c) drying the microquantity by volatilizing the volatile liquid medium to produce a dry, solid form of the agent of interest. The lyophilization method includes freezing the microquantity of liquid after step (b) and before step (c). By processing the agent of interest in microquantities in controlled contact with a substrate surface, improved heat and mass transfer is provided, yielding better process control over drying of the agent of interest compared to conventional bulk drying or lyophilization.

Abstract: A cake resistance measuring system and method are used to measure the cake resistance of a freeze dried sample during or after processing, with the results of the measurement being used to improve that processing and/or subsequent freeze drying processes or formulations.

Abstract: In a method for controlling a freeze drying process, a frozen product is arranged on temperature controlled surfaces (12) in an air-evacuated chamber (1) and undergoes a main drying and after-drying phase. During the main drying phase, the temperature of the ice surrounding said product is continuously measured. The pressure in the chamber and/or the temperature of the surfaces are modified during transition from the main drying phase to the after-drying phase. In order to avoid longer idle periods between the chamber (1) and the evacuation device (3, 4, 14) and to determine transition from the main drying phase to the after-drying phase, the pressure and/or the temperature of the surfaces during said transition are modified according to changes int he temperature of the ice.

Abstract: The present invention relates to a lyophilization process involving the use of a cap intended for vials or use therewith for containers that are subjected to lyophilization conditions where the cap, which may be resiliently helped in place or screwed on, includes a plug member movable within a fluid passageway in the cap, the plug member while positioned in the fluid passageway is movable between a first upwardly extending venting position and second downwardly engaging, sealing position whereby fluid from the vial or container is precluded from flowing through the fluid passageway in the cap.