Validation, Commissioning & Design White Papers & Case Studies

  1. Quality By Design: The Importance Of Reference Standards In Drug Development 8/1/2024

    Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.

  2. What Changes When Your CPV Goes Digital 7/10/2024

    Explore the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.

  3. Bypassing The Challenges Of Paper-Based Validation 7/10/2024

    Gain insight into why a biotechnology startup and CDMO views investment in a digitized validation lifecycle management system as crucial for accelerating innovation and reducing time to market.

  4. Best Practices In Commissioning And Qualification 7/5/2024

    An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.

  5. Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine 6/19/2024

    Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

  6. Mobile Sterile Compounding Pharmacy USP 797/800 6/19/2024

    Learn how Germfree's 53-foot mobile cleanroom trailer ensured uninterrupted sterile drug compounding during a facility renovation.

  7. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  8. Understanding Biosafety Levels 5/20/2024

    Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

  9. 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.

  10. Transforming Quality Processes And Collaboration 4/16/2024

    Learn how a global CDMO improved efficiency, visibility, and collaboration by standardizing quality procedures and expanding them to external partners.