Insights On Facility Design

  1. Single-Use Microbial Impactor On A Filling Line 3/6/2024

    Discover the advantages of a single-use microbial impactor through a demonstration of its ease of use in an isolator and an explanation of its ability to eliminate false positives.

  2. How Airflow Visualization Characterizes Pharmaceutical Sterility 2/22/2024

    Explore how airflow visualization studies influence contamination control and risk management in pharmaceutical environments.

  3. ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments 2/22/2024

    Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

  4. EMPQ And Validation Support Services 2/21/2024

    A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

  5. SAP S4HANA Implementation: Commissioning, Qualification, And Validation 2/20/2024

    Explore how CAI helped one company navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.

  6. How To Prove A Sterility Assurance Level Of 10⁻⁶ 2/13/2024

    Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process.

  7. 6 Reasons To Use Biological Indicators During Your Sterilization Cycle 2/13/2024

    Understand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.

  8. Consolidating The Supply Chain For mRNA 2/12/2024

    Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

  9. Mabion: Your Biologics CDMO 2/8/2024

    Learn about Mabion's capabilities as a CDMO, its commitment to quality and customer satisfaction, and the crucial role the company plays in the drug development and manufacturing space.

  10. Multimodal R&D Management With Incyte's Jim Lee, M.D., Ph.D. 1/18/2024

    Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies.