Abstract: The analysis of the headspace of ampoule (especially the analysis of residual oxygen) is related to the stability of the quality of powder injection, water injection, infusion bottle and oral liquid during the shelf life. The HGA-01 top air analyzer and its special sampler produced by Labthink (Jinan Languang Electromechanical Technology Co., Ltd.) can easily and efficiently solve the problem of residual oxygen detection in ampoule, making packaging of small volume ampoule and so on. The detection is well implemented. Our PP combined Break-Off Cap is mainly used for medical soft-bag infusion and plastic bottle infusion. Our products are produced in a clean plant which passes the GMP standard with Class 10000-1000000 grade.From input to output , the products go through a series of standard procedures such as injection molding,automatic machinery assembly, sorting, inner packing and outer packing . Before we pack the goods, we prefer to get some sample from the large cargo to have a special quality test to ensure our quality. We sincerely believe we will be your best choice if you contact us for more details. We are looking forward to your inquires . Break-Off Cap Break-Off Cap,Break Off Spout Cap,Break Off Ring Cap,Plastic Sachet With Break Off Cap SUZHOU CRH PHARMACEUTICAL TECHNOLOGY CO.,LTD , https://www.crh-health.com
Key words: ampoule, residual oxygen analysis, headspace analysis, powder injection, water injection, oral solution, HAG-01 headspace analyzer
First, why should we control the amount of residual oxygen in the air volume of the bottle?
Oxygen is the main factor affecting the shelf life of powder injections, water injections, oral liquids, etc. It has been found that by controlling the proportion of gas components in the package, the shelf life of the product can be effectively extended or the quality of preservation can be improved. The current packaging of powder injections, water injections, oral liquids, etc. is mainly in the form of ampoules. When the filling is completed, a small amount of air remains in the bottles, so the actual gas composition in the bottles will differ from the expected ones. This makes it difficult to analyze the quality of the product, the expected effectiveness of the shelf life, and the rationality of the packaging design. The HGA-01 Headspace Air Analyzer produced by Labthink can effectively solve the problem of gas composition analysis in ampoule. Now it has become an important means to check the quality of drug design and one of the important methods to verify the shelf life of the product.
Second, the ampoule bottle top air body analysis and testing difficulties
The residual oxygen content is the focus of the analysis and detection of the headspace gas, but the volume of the ampoule package commonly used in powder injection, water injection, oral liquid and other products is small, while the amount of gas in the headspace of the ampoule is less, and the general headspace analysis The equipment can not carry out the analysis test of the gas collection amount less than 0.5ml or even 0.2ml, which is also the difficulty in the analysis and detection of the small air volume of the ampoule.
Third, choose the appropriate HGA-01 top air body analyzer
Conventional headspace air analyzers currently on the market are basically unable to complete the analysis of residual oxygen in water injections, powder injections and the like. Labthink 's HGA-01 top air analyzer can solve the above difficulties through a dedicated sampler, enabling the analysis of the headspace of small packages. The HGA-01 Headspace Analyzer draws on the benefits of benchtop and portable devices and offers many unique advantages. First of all, the content of both oxygen and carbon dioxide gases can be detected simultaneously, and the range and accuracy reach the international* product level. Secondly, there are two injection methods, automatic injection and manual injection, and simultaneous detection of oxygen and carbon dioxide. Special needles, gaskets and filters are installed, and the pumping time and response time are also greatly improved, which ensures the true and effective test data. In addition, the instrument is equipped with the current international mainstream gas analysis sensor, which can meet the normal use of at least 6 years. In order to facilitate the use of the instrument to combine portable and portable functions, but also has the printing function not available in traditional portable devices, it can be conveniently used in various environments and for rapid detection of samples.
IV. Summary of analysis and detection of residual oxygen in ampoule
Through the analysis and detection of residual air in the ampoules, we can more easily, accurately and quickly control the changes of gas components in the packaging of powder injection, water injection, oral liquid, etc., in order to analyze product quality, shelf life validity, packaging. The important data support of design rationality is an indispensable means of detecting product quality control, and the practical and reliable HGA-01 top air body analyzer combined with special procurement sample equipment is the relevant pharmaceutical unit for residual oxygen analysis and control. basis.
For more information on the drug headspace analysis (residual oxygen analyzer), please call Login or blue light labthink Inquire.