Insights On Critical Environments

  1. Considerations And Strategies For Oligonucleotide Manufacturing Scale-Up 8/2/2023

    To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this scale-up process brings challenges that must be addressed.

  2. An All-In-One Solution For Residual DNA Quantitation 5/22/2025

    Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.

  3. Getting More From Your Buffer Management Strategy 1/17/2025

    A drug manufacturer was facing challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space, increase efficiency, and become more sustainable.

  4. Mobile Advanced Therapies Facility 6/19/2024

    Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

  5. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  6. Breaking Barriers In Malaria Prevention With A Mobile Cleanroom 6/19/2024

    The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

  7. Viruses And Viral Vectors, Are They Different? 10/23/2024

    Learn how effective disinfection solutions can ensure safety in pharmaceutical manufacturing by managing viral contaminants and enhancing patient protection.

  8. 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.

  9. Optimizing Microbial Air Sampling To Reduce False Positives In Cleanrooms 10/18/2024

    Learn how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

  10. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.