Aseptic filling by design: shaping the future of drug manufacturing

Though we didn’t know it in the 17th century when a dog was injected using goose quills, we know it now: Bacteria and other contaminants can make patients very ill. That’s why the final aseptic filling step is so critical for making injectable drugs. How can we get better at protecting drug quality and patient safety? This e-book takes you on a journey to answer that question and others. Each chapter gives you practical insights: Dive into the “human factor” and why it continues to confound us. Discover why we need to go far beyond monitoring to keep contaminants at bay. Learn why regulators encourage the use of modern barrier technologies, such as gloveless isolators. Explore why airflow studies and computational fluid dynamics are key tools for qualifying aseptic filling processes. Learn how real-time tools for environmental monitoring can save batches and protect patients. Finally, get strategies for navigating complex regulations and see how innovation is helping companies deliver new therapies quickly and safely.