Kay Scheffler

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Articles

07.11.24 -- System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks

Jul 11, 2024 | pharmaceuticalonline.com | Kate Lenton |Ronan C. O’Malley |Kay Scheffler |Claudia Müller

Connect science and compliance at the 19th annual PDA Pharmaceutical Microbiology Conference, 07-09 October in Washington, DC, and navigate the crucial nexus between scientific advancement and regulatory adherence! Don’t miss out on directly interacting with the experts, poster presentations, and the Exhibit Hall where leading companies will showcase the latest technologies, equipment, and applications. This conference sells out quickly! View the agenda and register today.
05.02.24 -- Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market

May 2, 2024 | bioprocessonline.com | Idbs Hq |Kay Scheffler |Claudia Müller |Fran Carmody

Webinar: Addressing The Options And Challenges In Subvisible Particulate Contamination Monitoring In Single UseJoin us for a webinar on May 16th with Entegris! Particulate contamination in pharmaceutical and biopharmaceutical products produced using single-use systems can create detrimental health risks that are required to be minimized by regulatory agencies. This contamination can be divided into visible and subvisible ranges, both ranges of particles are tested using different techniques.
Five Inverted-Microscope Advantages For Industrial Applications

Jan 4, 2024 | bioprocessonline.com | Kay Scheffler |Claudia Müller |James DeRose

Article | January 4, 2024 By Kay Scheffler, Dr., Claudia Muller, and James DeRose, Ph.D. Take a look at 5 of the advantages provided by using an inverted microscopes for industrial applications. With inverted microscopes, samples are observed from below, as the optics are placed under the stage. The optics of upright microscopes are placed above the stage.
Why improving the cleanliness analysis workflow is key for the pharma industry

Feb 21, 2023 | pharmaceuticalmanufacturer.media | Kay Scheffler

Kay Scheffler, product manager - applied microscopy at Leica Microsystems, explains how microscopy is key in identifying particle contamination and ensuring quality control in the pharma industry. Key insights: Particulate contamination in pharma products can come from different sources, such as the environment, packaging materials, cleanroom personnel, and formulation ingredients.