The Pharmaceutical industry continues to be an essential element of healthcare systems worldwide. Todays manufacturers need to know about the latest Process Analytical Technologies (PAT). Implementing the most innovative, cutting-edge technologies gives pharmaceutical manufacturers the tools needed to gain position in the marketplace. Significant opportunities exist to improve product development and to better analyze and control the manufacturing processes. In addition, the pharmaceutical industry has the same basic needs as many other industries. Reducing production downtime and increasing productivity are the main goals.
For analysis and control, engineers rely on Quadrupole Mass Spectrometers. Extrels MAX300 Quadrupole Mass Spectrometers can be found in pharmaceutical plants around the world. These advanced systems provide an array of analyses which give engineers the ability to better control processes such as:
Some of the advantages of using the MAX300 include:
Extrel has been producing Quadrupole Mass Spectrometers for over 45 years. We work closely with our customers to understand their obstacles involving pharmaceutical and biotechnology applications. Our expertise in developing the specific products our customers need has established our reputation as the worlds leading supplier of Gas Analysis Systems, Mass Spectrometers and Components.
The Extrel MAX300-BIO Bioreactor Gas Analyzer has been installed in major manufacturing stages within pharmaceutical industries. One of the main applications is Fermentation process control.
In the fermentation process, the growth of bacteria and production of drugs takes place under very tight conditions. The aeration rate, temperature and dosage of nutrients are regulated very closely during several stages of the process. The Quadrupole Mass Spectrometer is used to provide full, fast and precise analysis of the incoming air and the off-gas from the Fermentor. The results are used to calculate the Respiratory Quotient (RQ), a major parameter in controlling growth and health of the bacteria. In different stages of a batch fermentation process, the RQ value changes, thus allowing for optimum and efficient drug production. The additional analysis of minor concentrations of by-products allow for rapid process adjustment to avoid undesired reactions.
One MAX300-BIO Bioreactor Gas Analyzer is capable of analyzing up to 80 samples with the use of a single FAST multi-port valve. This multi-stream capability makes the Extrel MAX300-BIO the economical alternative to infrared and oxygen analyzers installed on top of each Fermentor.
Pharmaceutical manufacturers are well aware of the industry statistics that at least 25% of time and energy can be saved by terminating the active pharmaceutical ingredient drying process at its true endpoint. However, actually determining the true endpoint has always been an obstacle. To avoid interrupting the process (traditional methods to determine the drying process involved sampling and analyzing the product in a lab) and possible contamination of an entire batch, many producers choose to overextend the drying process. Todays engineers can solve this problem by using the MAX300-IG Industrial Gas Analyzer or the MAX300-LG Laboratory Gas Analyzer. The MAX300 monitors the atmosphere composition above the drying material. Because the headspace is in close relationship with the concentration of solvents in the material, the true drying process end point can be determined by analyzing the headspace vapors. The Quadrupole Mass Spectrometer allows you the ability to view the concentration profiles of solvents over time, pinpointing the exact moment the drying is complete. In addition, each batch can be dried to the same specification, thus reducing rejection rate when the final product is tested after packaging.
Due to the large number of chemical solvents used in the drying process, Quadrupole Mass Spectrometry is the only viable and economical analytical technology for Solvent Recovery applications. To achieve the flexibility of analysis and parts per billion detection (ppb) limits, the Extrel MAX300-IG Industrial Gas Analyzer is the system of choice.
This online Quadrupole Mass Spectrometer system is capable of fast and flexible analysis of an unlimited number of compounds in a single analytical method. The selection and tuning of analysis masses is achieved through software, not hardware. Therefore, a pharmaceutical plants solvent recovery process can be streamlined with no idle time between batches. Additionally, this same system is capable of analyzing the final gas exhausted to the atmosphere to monitor plant compliance with environmental regulations.
Thermogravimetric analysis (TGA) is a powerful approach to the study of the thermal behavior of solid and liquid samples. The interface of a TGA with a quadrupole mass spectrometer allows researchers to characterize and quantify compounds in the off-gas in real-time along with each mass loss.
The MAX300-EGA comes equipped to import a Start-of-Heating signal from the TGA for easy data synchronization and features a chemically-inert transfer line specially designed to keep the sample hot and under vacuum all the way to the ionizer, to guard against condensation or chemical interaction.
Pharmaceutical Applications for TGA-MS: