Insights On Critical Environments

31. How A Rigorous Approach Delivers Unparalleled Results 6/12/2025

    In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.

32. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

33. How Airflow Visualization Characterizes Pharmaceutical Sterility 2/22/2024

    Explore how airflow visualization studies influence contamination control and risk management in pharmaceutical environments.

34. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

    A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

35. Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2 6/16/2025

    Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

36. Viruses And Viral Vectors, Are They Different? 10/23/2024

    Learn how effective disinfection solutions can ensure safety in pharmaceutical manufacturing by managing viral contaminants and enhancing patient protection.

37. The Hidden Costs Of Equipment Storage: What You're Really Paying For 5/9/2025

    Don't let idle assets drain your resources. Uncover the often-overlooked expenses of equipment storage, from rental fees to lost opportunity costs, and learn how to reclaim value.

38. Prefabricated Viral Vector Modular BSL-2LS cGMP Facility In 13 Months 6/26/2024

    Learn about the modular BSL-2LS cGMP facility that was constructed to support 3 processing lines for German-based CDMO Vibalogics as the company sought to expand in the U.S. market for viral vectors.

39. From Open Cleanrooms To Closed Systems – What Is Driving The Change? 3/14/2025

    Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

40. Risked-based Cleaning Validation Process Checklist 6/19/2025

    Is your cleaning validation process truly aligned with current regulatory expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate your highest-risk areas.