Featured Articles

  1. 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.

  2. 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.

  3. 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.

     

  4. 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.

  5. A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter 12/4/2021

    A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more. 

  6. Viable Monitoring Solutions To Prepare Your Contamination Control Strategy For Annex 1 FAQs 12/4/2021

    In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.

  7. Particle Counting In Injectable Solutions 12/2/2021

    In this paper, we review counting particle specifications based on the type of injectable solution as well as the apparatus and methodologies you can use to demonstrate compliance.

  8. Trend Analysis Of Total And Viable Particle Monitoring Data 10/26/2021

    Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess environmental control performance.

  9. EU GMP Annex 1: Non-Viable Environmental And Process Monitoring 10/26/2021

    This paper covers many of the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events and deviations.

  10. Alarm Rationale For Continuous Particle Counting Systems 10/26/2021

    Here we review the description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system installed within a facility.