Every precaution has been taken to protect the quality and safety of the medicine you’re filling. The final step that delivers the drug into the vial or syringe isn’t the place to let down your guard. Attempts at rudimentary aseptic filling began centuries ago. Though modern technology is ready, why aren't more manufacturers adopting it? Dive into it with us in this e-book.
Aseptic drug manufacturing – looking back, innovating forward
What do 16 billion safe injections a year have in common with a 17th century experiment involving goose quills? The opening chapter of our e-book, Aseptic filling by design: shaping the future of drug manufacturing, takes you on a journey from the earliest and sometimes alarming attempts at drug delivery to the cutting-edge science that protects patients today.
Enter the hidden world of contamination risks, where even the most advanced cleanrooms and best-trained operators face challenges that could impact safety. Discover why, despite decades of innovation, the pharmaceutical industry still wrestles with the “human factor.” And learn about the new technologies that are poised to change everything.
Brent Lieffers, Senior Director of Innovation Advocacy, Aseptic Filling at Cytiva, sets the stage for bringing aseptic filling into the 21st century. If we know where the industry needs to go, what’s holding us back?
Mind the gaps: a holistic approach to contamination control
What happens after the GMP manufacturing process but before a medicine is injected? The next chapter uncovers the critical battle against contamination in injectable pharmaceuticals. The stakes are high: a single lapse in sterility can mean product recalls, patient harm, or even public health crises.
It’s critical to keep these disasters at bay. Niamh Hanrahan, Technical Solutions Manager, Aseptic Filling at Cytiva, explores the world of contamination control, revealing why both visible and invisible threats—from bacteria to dust—demand a comprehensive approach. Learn about the advanced technologies regulators are urging manufacturers to adopt, and how they can transform your filling process. And discover how the industry’s mindset is shifting from fixing issues to preventing them.
We’ll help you flip the switch from reactive to proactive. But first, you’ll need to know about the three pillars of a robust control strategy, and why it's not “set it and forget it.”
Designing for purpose: what airflow studies reveal about aseptic filling zones
One of the keys to safer medicines lies in the invisible currents near the critical filling zone. Bobby Lumia, Hardware Manager, Aseptic Filling at Cytiva, invites you into the world of airflow studies – where smoke, simulation, and science converge to secure every vial and syringe that’s filled and packaged.
Discover how airflow patterns can make or break the sterility of injectable drugs. (Hint: Tiny particles in air don't always behave as you'd expect.)
This chapter dives into the vital tools that can help manufacturers qualify their aseptic filling processes. Why isn’t everyone using them?
The great plate debate: Are plates holding back the future?
Waiting for bacteria to grow (or not) is slow going, and some types aren’t easy to culture. Niamh Hanrahan challenges long-standing traditions in environmental monitoring and asks whether the old ways are still good enough for today’s advanced therapies. Learn about the world of settle plates, contact plates, and active air sampling – methods that have shaped contamination control for decades. But as regulations tighten and become more complex, this chapter reveals how new technologies are stepping up, offering real-time insights and the potential to release batches earlier and cut batch loss.
It’s comfortable to do things the way we’ve always done them. Yet that’s not how progress is made. Will we cling to familiar routines, or will we embrace innovations to move us forward?
Aligning to regulatory guidance: one last step before pressing “go”
What does it take to bring an injectable drug from the manufacturer to the patient’s bedside? Gary Kozinski, James Hathcock, and Sandra Racordon-Pape, professionals in quality and regulatory affairs at Cytiva, lift the veil on the world of regulatory guidelines, revealing how global standards and evolving expectations shape every part of aseptic filling.
Enter the maze where manufacturers must navigate requirements from regulatory bodies such as the US FDA and European Medicines Agency (EMA). Discover why the latest updates to EU Annex 1: Manufacture of Sterile Medicinal Products are changing how we perform sterile drug production. This chapter explores how modern technologies aren’t just meeting regulations from the FDA and other agencies – they’re reducing risk and improving efficiency. Get the full story on how quality by design is driving both compliance and progress.
Innovation with impact: connecting people to new treatments
What does it take to turn innovation into real-world impact for patients waiting on the next breakthrough therapy? In the final chapter, Zach Hartman, General Manager, Aseptic Filling at Cytiva, and Áine Brennan, Senior Manager, Qualification and Regulatory Services, Aseptic Filling at Cytiva, reveal how the latest advances in aseptic filling are paving the way.
Learn from two CDMOs that are tackling the challenges of small-batch GMP production, rapid changeovers, and the strictest regulatory standards. And discover how modern technologies are helping agile companies bring new medications to the clinic and beyond with exceptional speed and reliability. Will your organization be ready for the future of personalized medicine?