Cleanroom Editorial and News

  1. The Ex-Regulator's View On Small Surface Contamination Control 2/26/2025

    Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. ​Learn about the critical steps, techniques, and validation needed to ensure 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. Topic Sterility Assurance With Noelle Clifford 2/3/2025

    Sterility assurance requires robust programs from raw materials to facility design. Learn about best practices, misconceptions, and the importance of environmental monitoring and regulatory compliance.

  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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Benefits Of Isolator Technology In Fill-Finish 12/10/2025

    Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.