Contamination Control in the Pharmaceutical Industry
Contamination Control in the Pharmaceutical Industry
Particle Measuring Systems
Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
How Airflow Visualization Characterizes Pharmaceutical Sterility: Unlocking the Secrets
Unlock the secrets of cleanroom sterility with Luca Calisi, an expert in pharmaceutical microbiology, as he discusses the essential role of airflow visualization studies. Listen now to explore how these studies influence contamination control and risk management in pharmaceutical environments.
Dec 15, 2023
14 min
Unlocking the Power of Single-Use Microbial Monitors: Validation and Expert Guidance
In this podcast, Megan from Particle Measuring Systems engages in a discussion with Emad Albarouki, an expert in microbiology and sterility assurance, as they explore the innovative BioCapt® Single-Use technology for microbial air monitoring. They highlight its single-use convenience, continuous monitoring capabilities, and the comprehensive validation documentation offered by Particle Measuring Systems to support its implementation.
Dec 11, 2023
14 min
Single-use Solution and Benefits to meet Annex 1 Continuous Microbial Monitoring Requirements
Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices of using BioCapt® Single-Use (BCSU) in continuous microbial active air monitoring.
Dec 11, 2023
17 min
S2E6: Marc and Mark: Airborne Particle Sampling Techniques
In this podcast episode, Marc Machauer and Mark Hallworth, both with 25 years of experience in pharmaceutical clean and aseptic manufacturing, discuss the newly published ISO 14644-21 standard for pharmaceutical contamination monitoring. They discuss the misinterpretation of the standard, the difference between classification and monitoring, and the importance of ISO classification.
Dec 11, 2023
15 min
BioCapt® Single-use Microbial Impactor: Reflections on a Decade of Success
This podcast covers the celebration of 10 years since the launch of the Biocapt® Single-Use Impactor and its evolution and success; with a focus on its application in pharmaceutical manufacturing for microbial air sampling and sterility control.
Dec 5, 2023
9 min
S2E5: Marc and Mark: Data Management
In this podcast episode, experts Marc and Mark discuss the challenges of pharmaceutical contamination monitoring and data management in pharmaceutical facilities. They discuss a software solution called PharmaIntegrity, which combines automatic and manual data collection for a comprehensive view of environmental monitoring. Marc and Mark touch on the various benefits of PharmaIntegrity like early detection of contamination.
Nov 9, 2023
15 min
S2E4: Marc and Mark: Particle Monitoring in Heat Tunnels - Crucial Insights
Join environmental monitoring industry veterans and experts Marc Machauer and Mark Hallworth while they discuss topics around particle monitoring in heat tunnels.
Oct 2, 2023
20 min
S2E2: Marc and Mark: The New ISO 14644-21: 2023 Airborne Particle Sampling Techniques
Marc Machauer and Mark Hallworth discuss the new release of ISO 14644-21: 2023 Airborne Particle Sampling Technique with behind-the-scenes insights from Mark's involvement in the writing of the new standard.
Sep 8, 2023
15 min
Contamination Control Strategy
In this Podcast BLU and UGO, discuss the concept of contamination control strategy and its significance in various industries. The dialogue covers key elements of an effective contamination control strategy, how to ensure successful implementation within an organization and the impact of material and equipment choices. The conversation provides a concise overview of contamination control strategy, its components, and its relevance in maintaining product quality, worker safety, and process efficiency. It touches on the importance of risk assessment, cleanroom design, personnel training, environmental monitoring, material control, equipment maintenance, and cleaning procedures in a contamination control strategy.
Aug 18, 2023
7 min
The Continuous Monitoring Concept for Pharmaceutical Manufacturing
Microbiologically controlled environments are crucial in the pharmaceutical industry to prevent contamination during aseptic processing. To ensure product and patient safety, continuous monitoring of viable and non-viable particles is essential, following Good Manufacturing Practice (GMP) requirements. The recent New Annex 1 published in August 2022 recommends adopting a continuous monitoring approach throughout critical processes.
Jul 27, 2023
9 min
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