Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. A New Challenge For Quality Experts – The Data Quality Concept 4/20/2022

    Quality experts are facing the challenge of rethinking their roles and redesigning the quality systems of their pharmaceutical companies to be based on the concepts of data quality.

  8. USP <1788> Methods For Determination Of Subvisible Particulate Matter Revision Overview FAQs 2/26/2022

    Thoughtful questions regarding how the USP <1788> revision expands the scope of testing requirements to include newly viable technologies such as flow imaging and new therapeutic protein solutions.

  9. Study Of Single Use Device Media Dehydration And Biological Recovery Efficiency 2/26/2022

    In this study, we review the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use under unidirectional airflow, at 22 °C with 48% relative humidity.

     

  10. An Analysis Of Acceptable Particle Losses In Tubing 2/1/2022

    This paper addresses the various forces, the losses, and what are the acceptable results to allow for a better understanding what is acceptable particle loss in tubing.