Cleanroom Editorial and News

  1. 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.

  2. Key Cleanroom Design Considerations For Drug Manufacturing 4/18/2023

    Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.

  3. Designing Facility Monitoring Systems For Cleanrooms 12/4/2023

    Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

  4. Safety Cabinets' Essential Role In EU GMP Annex 1 10/25/2024

    A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.

  5. The Critical Role Of Training In Cleanroom Cleaning And Disinfection 5/21/2024

    Learn why proper training is vital in cleanroom cleaning and disinfection and how to develop and maintain a successful training initiative.

  6. The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing 6/10/2024

    This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.

  7. Balance cGMP And BSL-3 Regulatory Requirements 6/12/2023

    Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.

  8. Navigating EU GMP Annex 1 Revisions In Drug Manufacturing 11/27/2023

    Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.

  9. Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities 6/12/2023

    How do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities?

  10. Prioritize Particulate Control For Safer Therapy Development 8/10/2023

    As particulate control continues to be a top concern for advanced therapy manufacturers, SUT suppliers must regularly assess every element of the single-use component supply chain.