Sanofi Pasteur Sa

Bayer Pharma Aktiengesellschaft

Matthias Plitzko

Bernhard Luy

Manfred Struschka

Thomas Gebhard

Roland Kaiser

Christian Zerillo

Carsten Olbrich

Stefan Christian Schneid

A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer comprising a rotary drum for receiving the frozen particles, and a stationary vacuum chamber housing the rotary drum, wherein for the production of the particles under closed conditions the vacuum chamber is adapted for closed operation during processing of the particles; the drum is in open communication with the vacuum chamber; and at least one transfer section is provided for a product transfer between a separate device of the process line and the freeze-dryer, the freeze-dryer and the transfer section being separately adapted for closed operation, wherein the transfer section comprises a temperature-controllable inner wall surface.

Process line for the production of freeze-dried particles

A heating device () for heating particles to be freeze-dried in a rotary drum () of a freeze-dryer () is provided, the device comprising at least one radiation emitter () for applying radiation heat to the particles, and a tube-shaped separator () for separating the particles from the at least one emitter (), The separator () being integrally closed at one end and separating an emitter volume () encompassing the at least one emitter () from a drum process volume () inside the drum (), wherein the heating device () protrudes into the drum process volume () such that said integrally closed end of the separator () is arranged inside the drum () as a free end.

Heating device for rotary drum freeze-dryer

The present invention provides, inter alia, for a liquid feeding device for the generation of droplets, in particular for the use in a process line for the production of freeze-dried particles, with a droplet ejection section for ejecting liquid droplets in an ejection direction, the droplet ejection section comprising at least one inlet port for receiving a liquid to be ejected, a liquid chamber for retaining the liquid, and a nozzle for ejecting the liquid from the liquid chamber to form droplets, wherein the liquid chamber is restricted by a membrane on one side thereof, the membrane being vibratable by an excitation unit, wherein the longitudinal axis of the liquid chamber is tilted relative to the longitudinal axis of the nozzle, and/or the liquid feeding device further comprises a deflection section for separating the droplets from each other by means of at least one gas jet, wherein the deflection section gas jet intersects perpendicular with an ejection path of the liquid ejected from the liquid chamber.

Liquid feeding device for the generation of droplets

A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer () for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer () comprising a rotary drum () for receiving the frozen particles, and a stationary vacuum chamber () housing the rotary drum (), wherein for the production of the particles under closed conditions the vacuum chamber () is adapted for closed operation during processing of the particles. The drum () is in open communication with the vacuum chamber () and at least one transfer section () is provided for a product transfer between a separate device of the process line and the freeze-dryer (), the freeze-dryer () and the transfer section () being separately adapted for closed operation, wherein the transfer section () comprises a temperature-controllable inner wall surface.

A heating device () for heating particles to be freeze-dried in a rotary drum () of a freeze-dryer () is provided, the device comprising at least one radiation emitter () for applying radiation heat to the particles, and a tube-shaped separator () for separating the particles from the at least one emitter (). The separator () being integrally closed at one end and separating an emitter volume () encompassing the at least one emitter () from a drum process volume () inside the drum (), wherein the heating device () protrudes into the drum process volume () such that said integrally closed end of the separator () is arranged inside the drum () as a free end.

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.

Method for the production of freeze-dried pellets comprising factor VIII

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

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

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

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Neuenburg, Germany

Matthias Plitzko