Cleanroom Whitepapers and Case Studies

  1. Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing 5/7/2024

    For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

  2. How To Avoid Sticking And Picking In The Tableting Industry 9/23/2024

    Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

  3. Inside A Collaboration To Design Cutting Edge Modular Cleanrooms 1/31/2025

    Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

  4. Cell Collection Basics For The Transplant And CGT Industries 6/3/2025

    Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.

  5. Compliance With Annex 1- Sterile Fill Finish 5/5/2025

    Eurofins ensures Annex 1 compliance through robotic isolators, PUPSIT, contamination control strategies, and rigorous training for aseptic sterile fill-finish of early-phase clinical products.

  6. Designing A Disinfectant Study For Your Cleanroom 5/14/2024

    Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.

  7. Designing An Environmental Monitoring Solution For cGMP Manufacturing 3/13/2023

    Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.

  8. Improving API Solubility 3/3/2025

    Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

  9. Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals 6/6/2024

    VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

  10. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.