In the pharmaceutical industry, more and more drugs need to be filled with inert gas (N2) inside the packaging for protection, replacing oxygen from the packaging to prevent drug oxidation reactions and microbial growth, which can affect drug quality. Therefore, for nitrogen filled drug packaging, it is necessary to detect and analyze residual oxygen in the packaging container in order to achieve the effect of determining the nitrogen filling process offline; But in order to achieve the goal of nitrogen filling process control and optimization, it is necessary to only detect and analyze the residual oxygen in a single sample drug packaging container, and not use multiple samples for sampling and analysis (the measured data is the average value of multiple samples), otherwise it will affect the purpose of process optimization.

At present, the most commonly used methods for residual oxygen detection in drug packaging containers are electrochemical or zirconia based sampling analyzers (such as the handheld Oxybaby6.0 and portable PA7.0 gas analyzers from WITT in Germany), which require at least 2ml of gas sample for headspace gas sampling and analysis inside the packaging. This method is more suitable for packaging containers with larger specifications and headspace gas greater than 3ml. For some small packaging drug containers such as ampoules, penicillin bottles, or pre injection bottles, there is not enough headspace gas sample for sampling and analysis. And this type of equipment requires maintenance and has vulnerable parts, especially sensors based on electrochemical principles that need to be replaced every 2 years.

The OXYSENSE 325I micro headspace residual oxygen analyzer from the United States is a fluorescence decay method oxygen analyzer developed based on optical principles. When the fluorescence principle analyzer is applied to headspace residual oxygen analysis, there is no need to sample and analyze the sample gas. Only a sample gas of less than 0.1ml needs to be collected to meet the analysis requirements. It can be applied to almost all specifications of residual oxygen testing requirements, such as ampoules, penicillin bottles, pre injection bottles, etc., and the fluorescence method has higher testing accuracy, meeting the ASTM F2714-08 standard testing method.

German WITT Handheld Gas Analyzer Oxybaby6.0 Installation Training Site

Installation Training Site for WITT Portable Gas Analyzer PA7.0 in Germany

Installation training site for OXYSENSE 325I trace oxygen/dissolved oxygen analyzer in the United States

Runbo Technology's professional technical engineers provide on-site installation training (optional IQOQPQ on-site verification) services to customers, which have received high praise from users. For more research on the stability of nitrogen filled packaging production quality control or R&D departments for drugs (including analysis of residual/dissolved oxygen in the headspace of penicillin bottles, ampoules, infusion bottles/bags, and cartridge bottles, analysis of residual oxygen in the headspace of solution preparation tanks, etc.), non-destructive gas analysis of oxygen concentration in the headspace of sealed syringes/analysis of CO2 pressure in the headspace, please feel free to contact us for inquiries.