Cleanroom Editorial and News

  1. Minimizing Residue Build-Up In Cleanrooms 10/15/2024

    Residues from cleaning agents can pose significant risks to cleanroom operations. Learn about residue management, measurement techniques, and best practices to ensure compliance and product safety.

  2. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  3. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

    Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

  4. The New Annex 1 Regulations – Why Is It Important And How Can We Help? 10/21/2024

    The new Annex 1 regulations will significantly impact facilities and companies globally, requiring a comprehensive Contamination Control Strategy (CCS). Learn how to navigate these changes and ensure compliance.

  5. The Hidden Engineering Behind Successful Upstream Bioprocessing 2/25/2026

    In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

  6. Low-Bioburden Powders For Terminal Sterilisation 2/24/2026

    Low‑bioburden powders for reconstitution demand strict microbial control, advanced formulation, and specialised manufacturing, making CDMO expertise vital for modern biopharma.

  7. Minimizing Cleanroom Contamination Risks In Drug Manufacturing 7/2/2024

    Considering ergonomics is crucial for optimizing cleaning efficiency and minimizing contamination risks. Explore key ergonomic considerations in cleanroom cleaning, best practices, and more.

  8. Beyond Compliance: A Strategic Approach To Annex 1 5/12/2026

    To align with Annex 1 expectations, sponsors should focus on three key steps: understanding the guidelines, selecting the right partners, and futureproofing their manufacturing strategies.

  9. Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh 3/19/2026

    Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.

  10. Advancing Subvisible Particle Characterization With AI 1/14/2026

    An advanced approach leveraging artificial intelligence identifies the root causes of aggregation, streamlining formulation development and ensuring consistent product quality across every batch.