Cleanroom Editorial and News

  1. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

    Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

  2. “Futureproofing” Cleanroom Facilities 1/10/2024

    Explore factors that can impact the flexibility of your biopharmaceutical facility and cleanrooms as new designs are "futureproofed" to allow for a rapid response to changes in market demands.

  3. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  4. Solutions For Safe, Efficient, And High-Purity Automation Applications 6/12/2025

    At this year’s Automatica trade fair, the Fraunhofer Institute for Manufacturing Engineering and Automation IPA will be showcasing numerous solutions that – thanks in part to artificial intelligence (AI) – greatly simplify and accelerate the planning, programming, and training of robots.

  5. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

    The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

  6. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

    The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

  7. Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings 2/14/2025

    Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

  8. From Research Stage To GMP Production 9/18/2025

    Discover how to effectively navigate the transition to GMP, ensuring your project meets stringent requirements while streamlining development and minimizing risk.

  9. Key Takeaways From PDA Ireland Microbiology Event On Innovation And Technology 4/14/2025

    Insights from a PDA Ireland event reveal how innovative technologies like VR and automation are transforming sterile manufacturing, improving efficiency and addressing contamination control strategies.

  10. Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing 7/29/2024

    In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.