Insights On Critical Environments

  1. Single cGMP Module: An Engineering Perspective 4/12/2024

    Follow along on a tour through a recent Standard cGMP Module project. Germfree cGMP Modular Cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications.

  2. Overcoming Facility Constraints Posed By Process Intensification 4/14/2025

    Discover how your facility's layout and process flow might limit its potential and learn about media requirements in USP and DSP to optimize your scheduling and footprint for efficient media management.

  3. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  4. Applying Appropriate Limits In Cleanroom Monitoring 6/18/2024

    Explore ISO 14644-1:2015 and EU GMP Annex 1 in-depth, and learn about cleanroom classification, how to apply monitoring limits in cleanroom environments, and more.

  5. Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging 5/21/2025

    The 2022 EU GMP Annex 1 revision marks a pivotal shift in sterile manufacturing, emphasizing contamination control, advanced technologies, and global harmonization—driving industry-wide adaptation and regulatory interpretation challenges.

  6. Confessions Of A Microbiologist: What I Wish I Had Known For Our Facility Shutdown 11/17/2025

    Facility shutdowns often compromise contamination control strategies. Transitioning from manual cleaning to automated bio-decontamination ensures a more effective facility restart, eliminating persistent mold risks.

  7. Effective Cleaning Strategies For Irregular Surfaces In Cleanrooms 8/6/2024

    Explore effective strategies and cleaning supplies to ensure irregular cleanroom surfaces, such as light switches, door handles, valves, and piping, maintain the same standards as more accessible areas.

  8. 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.

  9. 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.

  10. How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance 9/26/2025

    Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.