Stem cell therapy sterility assurance is becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration (FDA) made several advancements towards the regulation of stem cell therapy,,,
Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.
This FAQ paper is a follow up to the webinar, Leveraging Microbial Contamination Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations. Questions submitted during and after the webinar are answered in this paper.
Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. These applications, such as aseptic packaging, purging, and filtration, are critical processes monitored for their efficacy. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.
