Featured Articles

  1. 5 Key Principles Of Cleanroom Particle Counting 6/24/2025

    Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

  2. ISO Cleanroom Standards 6/24/2025

    Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

  3. Cleanroom Data Analytics For Setting Up Environmental Monitoring 6/24/2025

    Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing

  4. What Is OPC Counting Efficiency? 6/24/2025

    Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

  5. How Particle Counting Efficiency Affects Distribution Data 6/24/2025

    Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.

  6. 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.

  7. 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.

  8. Contamination Control Strategies For Regulatory Compliance 4/24/2025

    Discover how a robust Contamination Control Strategy (CCS) can mitigate contamination risks and gain insights from Ugo Omeronye's detailed responses in our comprehensive reference guide.

  9. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  10. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.