Featured Articles

1. Avoiding IT Outages With Continuous Cleanroom Monitoring Technology 8/13/2024

   Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.

2. EU GMP Guidelines For Environmental Monitoring: Questions and Answers 7/16/2024

   Here, PMS Senior GMP Scientist, Mark Hallworth answers questions that arose while presenting on EU GMP Guidelines for Environmental Monitoring. Explore his answers to gain insights into these guidelines.

3. 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.

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. Why Is 50% The Limit For Particle Counting Efficiency Sizing Thresholds In Cleanrooms? 6/18/2024

   Particle counting efficiency is vital, especially when using optical particle counters. Learn why 50% is the limit for counting efficiency sizing thresholds in optical particle counters.

6. 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.

7. 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.

8. Designing An Environmental Monitoring Solution For cGMP Manufacturing 3/13/2023

   Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.

9. Review Of Annex 1 2022: Environmental Monitoring Changes 9/13/2022

   We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.

10. Risk Assessment As A Process Quality Assurance Tool 8/12/2022

    Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.