Abstract: the oxygen residual quantity inside medical packages has close links with the shelf life period of medical products. However, the small packaging volume has led to difficulties in gas collection for headspace gas analysis, especially for oxygen residual analysis. Labthink HGA-01 Headspace Analyzer, with the special samplers, has effectively resolved the problem of headspace analysis and gas residual analysis of medical packages. The product is efficient, precise and long-life with favorable responses from the industry.

1.      Significance of Oxygen Residual Analysis for Medical packages

Oxygen is the main factor affecting shelf life of medical products; it is effective to prolong the shelf life and improve the quality of storage by controlling the gas composition of packages. However, there is a little quantity of air left inside the package during filling-packing process. Such gaseous ingredients can not be eliminated after been sealed. As time goes by, the ingredients will have further changes. Thus, no matter what forms of packaging is chosen, we cannot fully command the gaseous ingredients inside packages, which would lead to difficulties for the analysis of product quality, shelf life design and package design. Yet, with the help of LabthinK HGA-01 Headspace Analyzer, the problem can be effectively resolved.

2.       Introduction to the Usage of Medical Package Oxygen Residual Analyzer

Oxygen and carbon dioxide are the key testing items for the analysis of oxygen residual inside packages. Oxygen would not only affect the medical ingredients negatively, such as oxidization and unfavorable aroma, but would generate toxic substances. At the same time, oxygen is the environment for bacteria growth. When the oxygen content is controlled under 2% and carbon dioxide above 7%, the product and bacteria would become hibernate, so that the shelf-life period can be effectively prolonged. Many medicine, such as molysite, iodide, nitrite and other organic medicines which contains unsaturated iron, can oxidize slowly and lead to color transform, foreign odor, decomposition, deterioration and invalidation, even toxicity. For instance, the infusion liquid will become yellow in color or produce suspended substances inside the packages.

Carbon dioxide is another important gaseous ingredient inside medical packages and medical MAP packages. The content and its change have close relationship with the shelf life of products. Meanwhile, the content of oxygen dioxide inside packages directly links to the quality of medical products: for some medicines can combine with the CO2 in the air, and lead to deterioration and invalidation, such as some hydroxide, oxide and calcium salt medicine, which can absorb carbon dioxide and generate carbonate.

With the help of headspace gas analyzer, we can analyze the oxygen residual and carbon dioxide content.

3.       How to Select Proper Headspace Gas Analyzer/Oxygen Residual Analyzer

Labthink HGA-01 Headspace Analyzer can analyze headspace of most medical packages. Moreover, with the special sampler, the headspace analysis of small packages can be achieved. Labthink HGA-01 Headspace Analyzer combines the advantages of desktop and portable instruments, and has many innovative advantages. Firstly, the gas quantities of oxygen and carbon dioxide can be determined simultaneously, with the world advanced testing scope and precision. Secondly, the instrument has two sample feeding modes: auto and manual, which can both detect oxygen and carbon dioxide content. With the professional probe, sealing mat and filter, the sorption time and response time have been great improved to guarantee effective testing data. Moreover, reliable gas analysis sensor guarantees more than 6 years’ excellent performance. HGA-01 is portable and equipped with built-in mini-printer, a convenient and easy tool for operators in varied situations.

4.       Conclusions for Oxygen Residual Analysis of Medical Packages

Oxygen residual analysis of infusion bottles and infusion bags offers an efficient and accurate way for the command of gas ingredient changes inside the package, so as to provide important data support for analysis of product quality, quality guarantee period estimation and package design. Thus, it’s a necessary testing means for product quality control. Labthink HGA-01 Headspace Gas Analyzer, together with its special sampler, helps establish the foundation for oxygen residual analysis in pharmaceutical manufacturers.

To lean more about headspace analysis of infusion packages and oxygen residual analyzer, please write to: trade2@labthink.cn, or visit Labthink official website: www.labthink.cn.