PHARMACEUTICAL & MEDICAL
Trace gas analysis and VOC process monitoring in an industrial, GMP (Good Manufacturing Practice) controlled environment becomes more and more a requirement in the pharmaceutical industry. Fast, real-time, accurate and high precision measurements provides valuable information for monitoring production efficiency & product stability, as well as for health & safety control.
The analysis of volatile organic compounds (VOC's) in exhaled breath has become a growing field in medical research. Applications of real-time breath analysis involve screening for biomarkers, monitoring pharmacokinetics and metabolic processes and exercise stress tests.
Vaporized hydrogen peroxide monitoring
Cleanrooms, restricted access barrier systems and isolators need to be decontaminated to create sterile production environments. Vaporized hydrogen peroxide (H2O2) has become a standard method for decontamination, however large molecule drugs, like biopharmaceuticals, are highly sensitive for oxidation and degradation by the exposure of H2O2. Therefore aeration is required to remove vaporized hydrogen peroxide down to 100 ppb or even around less than 30 ppb. Monitoring residual H2O2 levels with a high precision & sensitivity is of utmost importance to ensure drug stability, efficacy and safety.
On-line monitoring of bioprocesses
Modern biopharmaceutical drugs are produced in biotechnological fermentation processes. The monitoring of these processes is becoming increasingly relevant, especially in the manufacturing sector to promote cost-effective production. Real-time trace gas concentration measurements of volatile metabolites in the off-gas of bio-pharmaceutical fermentations can be used for on-line process monitoring and process control.
Real-time breath analysis
In real-time breath analysis, the exhaled breath is directly analyzed without sample preparation. In blood, gas exchange in the lungs alveoli, where carbon dioxide is released into and oxygen is taken up from the inhaled air. This exchange also applies to volatile metabolites (endogenous compounds) or VOC's, that have been consumed or have previously been inhaled (exogenous compounds). Breath analysis can be used for different applications:
- screening for biomarkers: breath-markers for smoking, disease (e.g. COVID-19, lung cancer), kidney function, etc.
- monitoring (a non-invasive window into the body): pharmacokinetics, metabolic processes, live function test, etc.