Solvent drying is a crucial step in the production of pharmaceuticals, particularly in the manufacturing of active pharmaceutical ingredients (APIs). It involves removing residual solvents from the final product, which are typically used during the manufacturing process as reaction solvents or cleaning agents.

The presence of residual solvents in pharmaceuticals can pose a significant risk to patient safety, as they may cause toxicity or other adverse effects. Therefore, it is essential to ensure that residual solvents are completely removed from the final product.

Wastewater from pharmaceutical manufacturing processes can contain various chemical and biological contaminants that can be harmful to the environment and public health. Therefore, it is crucial to monitor and treat wastewater to ensure compliance with environmental regulations and protect the ecosystem.  

Our LAR™ QuickTOCultra™ water analyzer is a specialized water analysis monitor that can be used to monitor wastewater in the pharmaceutical industry. The instrument uses a unique combination of UV oxidation and conductivity detection to provide accurate and reliable measurements of the total organic carbon (TOC) content of wastewater.

Ultra-pure water is a critical component in the pharmaceutical industry, where it is used in a variety of applications, including drug formulation, cleaning, and analytical testing. Ultra-pure water is water that has been treated to remove all impurities, including minerals, organic compounds, and microorganisms, and has a very high level of purity.

One of the primary uses of ultra-pure water in the pharmaceutical industry is in drug formulation. Ultra-pure water is used as a solvent to dissolve and dilute active pharmaceutical ingredients (APIs) and excipients. Because ultra-pure water is free of impurities, it ensures the quality and purity of the drug product.

Ultra-pure water is also used in the cleaning of pharmaceutical equipment and facilities. It is used to clean equipment used in drug manufacturing and packaging, as well as laboratory glassware and surfaces. The high purity of ultra-pure water ensures that there are no contaminants left behind after cleaning, which could otherwise compromise product quality.

Our LAR™  QuickTOCtrace™ water analysis monitor is a highly advanced instrument used in the pharmaceutical industry to monitor ultra-pure water quality. The system uses a patented high-temperature catalytic oxidation technique to provide highly accurate and reliable measurements of total organic carbon (TOC) in ultra-pure water.

Fermentation and cell culture are critical processes in the production of biologics, such as vaccines, antibodies, and recombinant proteins, in the pharmaceutical industry. These processes involve growing cells, typically microbial or mammalian cells, in large-scale bioreactors under controlled conditions. The goal of fermentation and cell culture is to produce high-quality products with consistent quality, yield, and purity.

Our MGA 1200CS™ Gas Analyzer uses a combination of advanced mass spectrometry technology and real-time data analysis to measure these parameters accurately. The system works by continuously monitoring the gas streams from the fermentation process and analyzing the composition of the gases in real-time.

The Oxygen Uptake Rate (OUR) is a measure of the amount of oxygen consumed by the cells in the fermentation process. This parameter is critical for monitoring cell growth and metabolic activity. The MGA 1200CS Gas Analyzer can accurately measure the oxygen uptake rate in real-time by monitoring the concentration of oxygen in the gas stream.

The Carbon dioxide Evolution Rate (CER) is a measure of the amount of carbon dioxide produced by the cells during fermentation. This parameter is critical for monitoring the metabolic activity of the cells and determining the fermentation endpoint. The MGA 1200CS™ Gas Analyzer can accurately measure the carbon dioxide evolution rate in real-time by monitoring the concentration of carbon dioxide in the gas stream.

The Respiratory Quotient (RQ) is the ratio of carbon dioxide produced to oxygen consumed by the cells during fermentation. This parameter provides insight into the metabolic activity of the cells and can be used to optimize the fermentation process. The MGA 1200CS Gas Analyzer can accurately measure the respiratory quotient in real-time by measuring the ratio of carbon dioxide to oxygen in the gas stream.

Real-time, in-situ monitoring of glove boxes, incubation chambers, and vessels is important in pharmaceutical matters for several reasons:

• Quality Assurance: Real-time monitoring allows for the continuous assessment of critical environmental and process parameters, such as temperature, humidity, pressure, and gas composition, to ensure that they remain within pre-defined limits. This is important for maintaining the quality and consistency of pharmaceutical products.
• Process Control: Real-time monitoring allows for the rapid identification and correction of any deviations from set parameters. This ensures that manufacturing processes remain on track, minimizing the risk of product failure or rework.
• Compliance: Regulatory bodies require that pharmaceutical manufacturers demonstrate that their manufacturing processes are controlled and validated. Real-time monitoring provides a record of environmental and process conditions, demonstrating compliance with regulatory requirements.
• Cost Savings: Real-time monitoring can identify problems early, reducing the risk of costly product failures or rework. Additionally, it can help optimize manufacturing processes, leading to more efficient use of resources and lower operating costs.
• Risk Reduction: Real-time monitoring can reduce the risk of contamination, ensuring that manufacturing processes are carried out in a controlled and safe manner.

Our TIGER OPTICS™ Spark™ CRDS analyzer uses laser-based technology to detect and quantify trace gases at the parts-per-billion (ppb) level. The instrument works by passing a laser beam through a highly-reflective optical cavity. Trace gases in the sample absorb the laser light, causing the light to decay in intensity over time. The decay rate of the light is measured and used to determine the concentration of the trace gas in the sample.

Evolved Gas Analysis (EGA) is a powerful analytical technique used in the pharmaceutical industry for the characterization and quality control of materials. The technique involves heating a sample and monitoring the gases that are released as a result of the thermal decomposition or reaction of the sample. The gases that are released provide information about the chemical composition and thermal stability of the sample.

Our EXTREL™ MAX300-EGA™ mass spectrometer is a state-of-the-art instrument that is specifically designed for Evolved Gas Analysis (EGA) in the pharmaceutical industry. The instrument is an ideal solution for analyzing the thermal stability and chemical composition of pharmaceutical materials.

The MAX300-EGA uses a combination of mass spectrometry and thermal analysis to monitor the gases that are released from the sample during heating. The instrument is capable of detecting a wide range of gases, including small molecules and large polymers, and can provide detailed information about the thermal stability and chemical composition of the sample.