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​In December 2024, a critical incident emerged in central Mexico involving contaminated intravenous (IV) feeding bags, leading to the tragic deaths of 17 children, primarily underweight, premature infants, and a 14-year-old patient. The contamination was traced to a manufacturing plant...
The pharmaceutical industry relies on robust cleaning processes and validation to ensure product quality and patient safety. ASTM International, a global standards organization, provides essential guidance that supports this critical area. “Clean systems, cleaner outcomes—ASTM standards make it possible.” ASTM...
The cleanroom sector is undergoing transformative changes, driven by technological advancements and evolving regulatory standards. These trends are revolutionizing how cleanrooms operate, focusing on efficiency, contamination control, and sustainability. 1. Advanced Automation and Robotics Automation is playing an increasingly vital...
Cleaning validation is a vital process in the pharmaceutical industry to ensure the safety, quality, and efficacy of drug products. It involves validating that the cleaning processes applied to manufacturing equipment consistently remove product residues, contaminants, and cleaning agents to...