Processes for the preparation of a batch of an active...

B - Operations – Transporting – 01 – J

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B01J 2/02 (2006.01) A61J 1/00 (2006.01) A61K 9/16 (2006.01) A61K 39/36 (2006.01) F16K 17/00 (2006.01)

Patent

CA 2548249

The present invention relates to processes for the preparation of a batch of an active pharmaceutical ingredient, e.g. an allergen product. The invention also relates to a container comprising cryogranules of a liquid composition of an allergen product, and to a cryogranule of an allergen product. The processes feature formation of cryogranules using a container having therein a cryogenic medium (e.g. liquid nitrogen) and storage of the cryogranules in the same container. The cryogranules obtained can be stored and handled without prior freeze-drying.

L'invention porte sur un procédé de préparation de lots d'ingrédients pharmaceutiques actifs tels que par exemple un produit allergène, et sur un récipient rempli de cryogranules d'une composition liquide d'un produit allergène, et sur les cryogranules ainsi obtenus. Ledit procédé de formation de cryogranules recourt à un récipient contenant un milieu cryogène (par exemple de l'azote liquide) et pouvant stocker les cryogranules. Les cryogranules peuvent ainsi être stockés et manipulés sans lyophilisation préalable.

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