Environmental Monitoring
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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.
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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.
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AES Clean Technology Career Opportunities
2/19/2020
AES Clean Technology provides industry-leading modular clean room facilities with career opportunities in design, manufacturing, installation and sales. Hear how our current employees came on board to AES and what they enjoy about their careers.
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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.
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Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance
12/18/2024
Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.
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Viable Monitoring Solutions: Prepare Your Contamination Control Strategy (CCS) For EU GMP ANNEX 1
10/31/2021
The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects.
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Understanding ISO 21501-4 – Particle Counter Calibration
3/3/2022
In this webinar we review how to be compliant with the most recent particle counter calibration requirements, particle counter terminology, and how a particle counter works in theory.
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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.
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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.
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USP<1788>2022 Revision Summary
3/3/2022
Review the latest revisions to the USP<1788>, which has expanded to support a holistic view of finished product contaminants, how they should be investigated, and added flow imaging technologies.