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Process for preparing a lyophilised material

A dry, controlled technology, applied in the field of process equipment

Inactive Publication Date: 2009-12-02
防腐技术公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Certain problems with known freeze-drying processes using the vials described above are that the mouth openings and vents of these known vials provide an opportunity for contamination to enter after the material dispersion has been introduced into the vial, for example after subsequent loading of the vial containing the dispersion. In the process to the stage where the freeze-drying unit is adapted and the vials are transferred to the shelves of the freeze-drying unit

Method used

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  • Process for preparing a lyophilised material
  • Process for preparing a lyophilised material
  • Process for preparing a lyophilised material

Examples

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Embodiment Construction

[0088] refer to figure 1 with figure 2 , shows a pharmaceutical vial 10 in longitudinal section, which is of the type disclosed in WO-A-04 / 018317. The vial 10 comprises a generally cylindrical body 11 made of transparent plastic material with an upper mouth 12 closed by an elastomeric plug closure 13 having an upper domed region 14 . The closure 13 is held in place on the vial body 11 by clamping parts 15 of plastics material which snap fit onto the flange 16 of the vial body 10 . The combination of vial body 10 and stopper closure 13 comprises an envelope as referred to in this application.

[0089] The vial 10 contains an aqueous solution 17 of vaccine material which is freeze-dried after subsequent freezing into a solid plug by lowering its temperature. The closure 13 has a piercing hole 18 extending completely through it. The solution 17 is released by sterilizing the interior of the vial 10 with radiation, passing a hollow perfusion needle (not shown) through the cl...

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PUM

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Abstract

A process for preparing freeze-dried material (111), providing a container (10) with a penetrable envelope and containing the material in a carrier liquid (17), whereby a penetrator ( 20) The permeable region (14) is penetrated and the carrier liquid is evaporated out of the container (10) via the conduit, after which the penetrator (20) is withdrawn. Apparatus suitable for performing the process are also disclosed.

Description

technical field [0001] The present invention relates to a process for providing freeze-dried material and a device for such a process. Background technique [0002] Freeze-drying is a well-known process in the pharmaceutical and vaccine industries in which a dispersion (such as a solution or suspension) of a material in a carrier liquid (usually water) is frozen and subsequently subjected to a reduced pressure to evaporate the liquid, e.g. by performing Sublimation transition from frozen to gaseous state. This process makes it possible to withdraw the water contained in the material to make it more stable at ambient temperature and thus facilitate its preservation. A typical freeze-drying process is disclosed in EP-A-0 048194. [0003] Typically, the dispersion is contained in a container, usually a vial, which is subjected to a reduced pressure such that liquid can evaporate through an opening in the container, for example through the open mouth of the vial. Vial closure...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): F26B5/06B65D51/24
Inventor J·蒂利C·范德卡西里
Owner 防腐技术公司
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