Cleanroom Editorial and News

  1. ISO Cleanroom Standards 6/24/2025

    Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

  2. What To Expect From A Sterile Injectables CDMO 1/20/2026

    Sterile injectable manufacturing demands built‑in contamination control, rigorous monitoring, skilled personnel, and robust quality systems, far beyond sterility testing, to ensure safety, compliance, and reliable CDMO performance.

  3. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  4. Designing For cGMP Compliance: Facility Requirements And Best Practices 6/26/2026

    Integrating process flows, HVAC controls, and cleanability during initial cleanroom planning ensures cGMP compliance and mitigates long-term contamination risks.

  5. How Cleanroom Testing Protects Sensitive Optics And Lasers   10/7/2025

    Engineers know that a pristine optical path is critical, but keeping it that way requires rigorous cleanroom testing, precise handling, and an understanding of how contaminants interact with light at both the particulate and molecular levels. 

  6. Cleanroom Door Considerations: A Comprehensive Guide (Part 1) 4/9/2024

    Explore the importance of cleanroom doors in maintaining a sterile environment in industries such as pharmaceutical manufacturing and scientific research labs.

  7. A Driving Force For Advanced Cleanroom Standards 2/18/2025

    Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

  8. EU Annex 1: Building Modern CDMO Sterile Fill/Finish Facilities 2/13/2026

    A CDMO guide to implementing EU Annex 1 for modern sterile fill/finish facilities, covering cleanroom design, contamination control, utilities, personnel, monitoring, and audit essentials.

  9. Optimizing Microbial Air Sampling To Reduce False Positives In Cleanrooms 10/18/2024

    Learn how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

  10. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.