Featured Articles

  1. Selecting The Most Suitable Particle Sample Point Locations In Your Cleanroom 5/14/2021

    When considering where to place sample points for particle monitoring, whether it will be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Here, we help to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.

  2. Managing The Expectations Of Auditors For Microbial Data Collection 5/4/2021

    Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry, otherwise known as Industry 4.0. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.

  3. Steps To Ensuring A Successful Audit: Effective Risk Assessment Design 4/29/2021

    When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination. The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented. There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.

  4. Microbial Control And Monitoring In Aseptic Processing Cleanrooms 4/27/2021

    Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.

  5. Considerations And Steps For Building A Contamination Control Strategy 4/22/2021

    Contamination control strategies (CCS) are designed to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources all the more important. Learn how to create an effective CCS.

  6. Techniques To Understand And Mitigate Variability In Aerosol Particle Measurement Applications 4/22/2021

    Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively.

  7. Viable And Non-Viable Environmental Monitoring To Meet USP 797 1/15/2021

    The USP 797 requires sterility of all Compounded Sterile Products (CSP). Environmental Monitoring is an essential component to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. Learn more about what viable and nonviable monitoring involves.

  8. A Guide to Annex 1 Requirements For Particle Monitoring 1/15/2021

    The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

  9. Classification, Qualification And Monitoring According To EU GMP Annex 1 Rev 12 1/15/2021

    The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The latest Annex 1 draft has some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.

  10. A Practical Guide To Aerosol Particle Counter Matching 1/15/2021

    This short application note provides a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.