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Vial preparation method and system

A temperature control, environmental technology, used in chemical instruments and methods, transportation and packaging, containers for laboratory use, etc.

Active Publication Date: 2014-05-07
HOSPIRA AUSTRALIA PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some solutions are oxygen sensitive and formulations can suffer from stability issues due to the inability to remove sufficient oxygen from the headspace of the vial prior to closing the vial as well as dissolved oxygen in the solution

Method used

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  • Vial preparation method and system
  • Vial preparation method and system

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Experimental program
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Effect test

Embodiment

[0156] In order to examine the desired oxygen level in the headspace over the actual number of cycles of steps 320 to 330, some experiments have been performed, at Figure 4 (for 5mL vials) and Figure 5 The results of these experiments are shown in graphs (for 20 mL vials) whose data are presented in Tables 1 and 2, respectively, below. Using the same lyophilization apparatus, some experiments were performed on small laboratory-scale (i.e., approximately 10 vials) apparatuses, and some larger laboratory-scale experiments were performed on approximately ten vials for those small laboratory-scale. Perform on a multiple-fold scale (i.e., 100-150 vials). Experiments were also performed on a laboratory scale using 10 mL vials, the results of which are listed in Table 3 below. These 10 mL vials have a neck size (external) diameter of 20 mm.

[0157] Different temperature set points (applied during depressurization and at 900mbar) were used in experiments carried out according to...

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PUM

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Abstract

The invention relates to a vial preparation method and system. Some embodiments relate to use of an apparatus, such as a lyophilisation apparatus, to perform the methods. An illustrative vial preparation method comprises: housing a plurality of vials in a temperature-controlled environment, wherein the plurality of vials each have a volume of a substance therein and each defines an unfilled volume therein, each vial having a stopper partially inserted into an opening of the vial so that gas can transfer between the unfilled volume and an external volume; applying a vacuum to the environment to reduce pressure in the environment and in the unfilled volume of each vial to a first pressure level; venting an inert gas into the environment to raise the pressure in the environment and in the unfilled volume of each vial to a second pressure level; allowing the vials to rest in the environment at the second pressure level for a predetermined period; repeating the applying, venting and allowing at least once; and fully inserting the stopper into each opening to seal each vial after the repeating.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201180038386.X entitled "Preparation Method and System for Vials" filed on August 5, 2011. technical field [0002] The described embodiments generally relate to methods and systems for vial preparation. Some embodiments relate to the preparation of vials containing oxygen-sensitive substances in solution. Background technique [0003] Some pharmaceutical formulations are provided as lyophilized powders in sealed vials for mixing with liquids prior to administering the formulation to a patient. Mixing the lyophilized formulation with its carrier liquid involves injecting the liquid into the vial using a syringe with a needle that pierces the stopper sealing the opening of the vial. The mixed formulation is then aspirated and transferred to another carrier container, such as a ready-to-seal bag for delivering the liquid into the patient. [0004] Freeze-drying of formulations is usually ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B65B31/02
CPCB65D39/0023B65D81/2076B65B7/00B65B7/2821F26B5/06B65B3/003B65B31/027B01L3/5082B65B31/02B65D47/32
Inventor 埃玛·J·温斯利安德鲁·马尔科姆·尼尔约翰·弗雷德里克·辛德曼
Owner HOSPIRA AUSTRALIA PTY LTD