The present invention is directed to an improved lyophilization process wherein a plurality of vials is not in contact with the shelf of the lyophilization device. The present invention is further directed to lyophilization cake and intermediate cake obtainable according to the process of the invention.

[Object] To freeze droplets of a raw material liquid in a shorter drop distance while maintaining a cooling velocity, which is a super high speed, without deteriorating a solute or dispersoid.

[Solving Means] A vacuum freeze-drying method according to an embodiment of the present invention is a vacuum freeze-drying method that includes steps of injecting a raw material liquid from an injection nozzle inside a vacuum chamber, generating frozen particles by self-freezing of the raw material liquid, and drying the generated frozen particles to thereby produce a dry powder, including: injecting the raw material liquid from the injection nozzle in a state in which the vacuum chamber is maintained at water vapor partial pressure corresponding to a self-freezing temperature of the raw material liquid, such that an injection initial velocity of the raw material liquid from the injection nozzle is 6 m/s or more and 33 m/s or less; and adjusting, when the maximum diameter of the generated frozen particle exceeds a predetermined value or droplets of the raw material liquid are unfrozen, an injection flow rate of the raw material liquid from the injection nozzle or properties of the injection nozzle such that frozen particles having a maximum diameter equal to or smaller than the predetermined value are generated.

A container of the present invention is for producing or housing a freeze-dried material. The container includes a bottom wall, a side wall, a support part for supporting a fluid to be freeze-dried in such a way that the fluid does not contact the bottom wall; and at least one vent disposed in the bottom wall or in at least a portion of the side wall located below the top of the support part.

A container of the present invention is for producing or housing a freeze-dried material. The container includes a bottom wall, a side wall, a support part for supporting a fluid to be freeze-dried in such a way that the fluid does not contact the bottom wall; and at least one vent disposed in the bottom wall or in at least a portion of the side wall located below the top of the support part.

A transport device having a plate; a conveyor to transport articles; a pusher to push and move a row of articles on the conveyor onto the plate; and a stopper to prevent the articles from being moved by the conveyor and to define the start of a row of articles being moved onto the plate by the pusher. The conveyor causes the positions of rows of articles stopped by the stopper to move alternately so that the positions of rows of articles moved onto the plate are shifted alternately.

A syringe for mixing and ejecting an active pharmaceutical ingredient is disclosed. The syringe is designed in such a manner that it is ensured that substantially all of the mixed drug is ejected, and in such a manner that an active pharmaceutical ingredient can be lyophilized directly into the syringe. The syringe comprises a syringe body, a first plunger arranged movably inside the syringe body and a second plunger arranged movably inside the first plunger. In one aspect the second plunger comprises a first plunger part and a second plunger part, and the first and second plunger parts are adapted to cooperate to collapse the cavity of the first plunger. In a second aspect the cavity of the first plunger has a first diameter at a distal end and a second diameter at a proximal end, the first diameter being smaller than the second diameter.

A syringe for mixing and ejecting an active pharmaceutical ingredient is disclosed. The syringe is designed in such a manner that it is ensured that substantially all of the mixed drug is ejected, and in such a manner that an active pharmaceutical ingredient can be lyophilized directly into the syringe. The syringe comprises a syringe body, a first plunger arranged movably inside the syringe body and a second plunger arranged movably inside the first plunger. In one aspect the second plunger comprises a first plunger part and a second plunger part, and the first and second plunger parts are adapted to cooperate to collapse the cavity of the first plunger. In a second aspect the cavity of the first plunger has a first diameter at a distal end and a second diameter at a proximal end, the first diameter being smaller than the second diameter.

Feed system provided with feed means located inside a lyophilization chamber and able at least to supply electric energy to a slider, autonomously mobile at least inside the lyophilization chamber, and to the possible other internal components which need the energy present in or associated to the slider. The feed means are positioned along the travel of the slider and cooperate with energy receiver means associated to the slider, being static at least during the loading and unloading steps of at least a loading plane.

Feed system provided with feed means located inside a lyophilization chamber and able at least to supply electric energy to a slider, autonomously mobile at least inside the lyophilization chamber, and to the possible other internal components which need the energy present in or associated to the slider. The feed means are positioned along the travel of the slider and cooperate with energy receiver means associated to the slider, being static at least during the loading and unloading steps of at least a loading plane.

A continuous microwave vacuum-drying method includes loading, onto a conveyor belt, a lower half of an integrated container, filing, by a frozen-drug dispenser, a first chamber of a lower half of an integrated container with a frozen compound, exposing, by microwave emitters within a vacuum chamber, the frozen compound of the first chamber of the lower half of the integrated container to microwave radiation to lyophilize the frozen compound into a lyophilized compound, filing, by a reconstitution solution dispenser, a second chamber of the lower half of the integrated container with a reconstitution solution, removing, by the conveyor belt, the lower half of the integrated container out of the vacuum chamber, and sealing, by a container sealer, an upper half of the integrated container onto the lower half of the integrated container to create a prefilled integrated package.