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Determination of Oxygen Ingress Through Syringe Packages by Using Laser Headspace Analysis
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- Veale James
- Lighthouse Instruments
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- Victor Ken G.
- Lighthouse Instruments
Bibliographic Information
- Other Title
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- ヘッドスペース分析を用いたシリンジパッケージを通じた酸素侵入の判定
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Description
Syringes and cartridges need to be a barrier to microbial ingress and in some cases (e.g. oxygen sensitive formulations) oxygen ingress. Container Closure Integrity (CCI) is the main measure of a packages ability to maintain stability and sterility over the intended shelf life.<br> We develop laser headspace analysis for assessing oxygen ingress rates into two types of syringe packages. We measure oxygen ingress to a Luer Tip and Staked Needle syringe package. The syringe packages were prepared in a way that allowed isolated study of different parts of each syringe so that oxygen ingress rates could be determined for each part of the syringe.<br>
Journal
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- PDA Journal of GMP and Validation in Japan
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PDA Journal of GMP and Validation in Japan 18 (2), 128-141, 2016
Parenteral Drug Association Japan Chapter
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Keywords
Details 詳細情報について
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- CRID
- 1390282679448248448
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- NII Article ID
- 130005251335
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- ISSN
- 18811728
- 13444891
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed