Environmental Monitoring

  1. The Successful Implementation Of A New Aseptic Filling Line 10/10/2024

    Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.

  2. Customizable Solutions For Cleanroom Facility Monitoring 10/31/2021

    In pharmaceutical environments, “facility monitoring” or “environmental monitoring” refer to systems that help pharmaceutical​ manufacturers monitor and control the viable and non viable contamination in their cleanrooms​. This includes managing data from particle counters, microbial samplers, temperature/humidity sensors and more. In this conversation, Daniele Pandolfi and Blu Buquoy discuss Facility Pro products that are offered by Particle Measuring Systems. ​

  3. Leveraging Microbial Contamination Monitoring Data For Actionable Insights To Meet And Exceed The Auditor's Expectations 11/18/2021

    Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.

  4. Particle Measuring Systems' FMS Solution At Argonaut Manufacturing Services 10/31/2021

    When Argonaut Manufacturing was setting up their new state-of-the-art fill line (a VarioSys line by Bausch & Stroebel and SKAN), they wanted the best contamination monitoring solution to ensure proven product reliability for their customers. The problem was, they had a tight timeframe to get everything done.

  5. The Evolution Of Pharmaceutical Modular Cleanroom Technologies And Project Execution 10/22/2020

    AES Clean Technology is expediting the delivery of fully functioning cleanrooms. Modular technology allows for repeatable installations of proven systems. New facility projects are time consuming and have thousands of decision points. AES has simplified this process offering standardization. The three models AES offers have taken into consideration the trends seen with modern facilities offering built-in flexibility. AES is also capable of working collaboratively with clients to design–build high-quality customized cleanroom systems with guaranteed performance.

  6. Water Activity Is A Critical Parameter For Microbial Stability 10/26/2022

    Learn about USP <1112> Application of Water Activity Determination to Non-sterile Pharmaceutical Products and USP <922> Water Activity, and why water activity is a critical parameter for microbial stability.

  7. Annex 1 Ready Cleanroom Classification Testing

    Discover a portable particle counter that ensures your classification testing complies with the revised EU GMP Annex 1 with updated limits and the ability to define limits that are no longer specified.

  8. Considerations & Steps For Building A Contamination Control Strategy (CCS) 9/30/2021

    Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.

  9. Replacing Settle Plates With Active Air Sampling 9/30/2021

    Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.

  10. A Real-Time Viable Particle Counter To Identify Contamination Source 12/11/2018

    Here, we introduce a real-time viable particle monitor and how it can quickly identify the source of contamination in pharmaceutical cleanrooms.