Insights On Critical Environments

  1. Contamination Control Strategies: Comparing Cleanrooms, RABS, Isolators 10/20/2025

    Sterile manufacturing relies on three main contamination control strategies (CCSs): cleanrooms, RABS, and isolators. Understand how each system compares in sterility assurance, startup cost, and operational flexibility.

  2. Integration From Formulation Development To Manufacturing, Packaging 2/27/2025

    Adare Pharma Solutions' Pessano, Italy facility offers 220,000 sq. ft. of end-to-end services, including R&D, formulation development, clinical and commercial manufacturing, packaging, and advanced analytical capabilities.

  3. Cleanroom Classification Zone Creation For ISO 14644, Annex 1, China GMP 6/11/2024

    Discover a particle counter that automatically determines the number of sample locations needed based on the sampling size of the area, enabling the easy selection of classification for certification.

  4. 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.

  5. How To Choose The Right Bowie-Dick Test Pack For Your Steam Sterilizer 11/26/2025

    Bowie-Dick testing is essential for compliance, but the choice between disposable and reusable systems impacts cost, waste, and efficiency. Learn how to balance sustainability with sterility assurance.

  6. The Status Quo Of Oligonucleotides Is Not The Future 12/2/2024

    The oligonucleotide field is booming, but manufacturing challenges loom. Experts discuss optimizing production for these promising therapies with flexible, sustainable, and high-yield approaches.

  7. Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance 12/18/2024

    Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.

  8. PUPSIT Without The Pain: Practical Solutions For Implementation 5/6/2025

    Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.

  9. Cleanroom Data Analytics To Consider When Setting Up Environmental Monitoring 7/16/2024

    Learn about innovative software that addresses the need of pharmaceutical manufacturing plants to centralize and trend data from various sources important to environmental monitoring systems.

  10. Visually Clean May Not Be Enough 10/23/2024

    Explore how to enhance product quality and safety in cosmetics manufacturing by standardizing cleaning procedures and emphasizing strict adherence to protocols.