Insights On Critical Environments

  1. EU ANNEX-1 And The Impact Of Contamination Control Strategy On Cleaning & Disinfection 10/21/2024

    New EU rules tighten grip on contamination control for sterile drugs. Learn how to ensure your cleaning and disinfection meet the stricter standards.

  2. 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.

  3. 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.

  4. Data Management Considerations For Environmental Monitoring 6/18/2024

    Learn what data management factors to take into consideration when setting up an environmental monitoring system in a pharmaceutical manufacturing facility.

  5. Thermo Fisher Scientific Large Volume Liquid Expansion 5/2/2024

    Take an insightful look into the expansion of the large volume liquids manufacturing site at the Grand Island facility, highlighting the various stages of the manufacturing process and the capabilities it offers to support the bioprocessing industry.

  6. 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.

  7. Normalized Data In Microbial Continuous Monitoring 7/24/2025

    Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

  8. The Benefits Of Low Endotoxin Products 6/16/2025

    Minimizing endotoxin contamination is vital in pharmaceutical manufacturing to protect patients from harmful reactions. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.

  9. Reducing Risks In Your SIP Validation Cycles 8/6/2024

    Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles.

  10. Key Topics And Trends In Aseptic Filling 1/9/2026

    Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.