This FAQ paper is a follow up to the webinar, “Assuring Data Integrity in an Environmental Monitoring System” and answers questions about data management, security and calibration of an EMS. Many thoughtful questions were asked about current and future trends of data management. Questions submitted during and after the webinar are answered below.
This FAQ paper is a follow up to the webinar Controlling Quality in Advanced Optics Manufacturing. During this webinar there were many good questions about monitoring contamination in clean optics manufacturing environments. Many of these questions were answered during the webinar and a few were submitted later. Please read below to see all the webinar questions, or submit your additional questions directly to us.
Sterility assurance in aseptic manufacturing is one of the impressive technological advances over the last decade, ensuring the sterility and quality of a myriad of new drug and biological products and medical devices. These advances bring new treatments, improve quality of life and extend life expectancy for millions of patients. This paper summarizes some of those new sterility assurance technologies and focuses on a few examples that clearly enhance sterility assurance in the manufacturing of pharmaceuticals.
Cleanroom Facility Monitoring Systems (FMS) gather data from a variety of sensors, including particle monitors, microbial / viable monitors and environmental sensors. Once all the data is gathered it must be correctly interpreted for actionable insights.