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Contamination Control in the Pharmaceutical Industry
Particle Measuring Systems
33 episodes
8 months ago
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).
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Education
Business,
Science
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All content for Contamination Control in the Pharmaceutical Industry is the property of Particle Measuring Systems and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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).
Show more...
Education
Business,
Science
Episodes (20/33)
Contamination Control in the Pharmaceutical Industry
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.
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1 year ago
14 minutes 39 seconds

Contamination Control in the Pharmaceutical Industry
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.
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1 year ago
14 minutes 23 seconds

Contamination Control in the Pharmaceutical Industry
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.
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1 year ago
17 minutes 54 seconds

Contamination Control in the Pharmaceutical Industry
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.
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1 year ago
15 minutes 41 seconds

Contamination Control in the Pharmaceutical Industry
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.
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1 year ago
9 minutes 5 seconds

Contamination Control in the Pharmaceutical Industry
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.
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2 years ago
15 minutes 24 seconds

Contamination Control in the Pharmaceutical Industry
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.
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2 years ago
20 minutes 45 seconds

Contamination Control in the Pharmaceutical Industry
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.
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2 years ago
15 minutes 41 seconds

Contamination Control in the Pharmaceutical Industry
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.
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2 years ago
7 minutes 17 seconds

Contamination Control in the Pharmaceutical Industry
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.
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2 years ago
9 minutes 51 seconds

Contamination Control in the Pharmaceutical Industry
Validation and Qualification in Pharmaceutical Environments
2 years ago
11 minutes 4 seconds

Contamination Control in the Pharmaceutical Industry
S2E3: Marc and Mark: Data Quality and Interpretation in Pharma Manufacturing
2 years ago
18 minutes 2 seconds

Contamination Control in the Pharmaceutical Industry
Data Quality Limited Series Part 5: What Your Future Holds After Employing a Thoughtful Data Quality Program
2 years ago
8 minutes 36 seconds

Contamination Control in the Pharmaceutical Industry
Data Quality Limited Series Part 4: How and Where to Collect Data for Better Analytics
2 years ago
5 minutes 29 seconds

Contamination Control in the Pharmaceutical Industry
Data Quality Limited Series Part 3: Data Quality's Role in Action and Alert Limits
2 years ago
5 minutes 20 seconds

Contamination Control in the Pharmaceutical Industry
Data Quality Limited Series Part 2: Data Quality Considerations in an Environmental Monitoring Plan
2 years ago
6 minutes 32 seconds

Contamination Control in the Pharmaceutical Industry
Data Quality Limited Series Part 1: The Data Quality Journey in Pharma Manufacturing
2 years ago
3 minutes 7 seconds

Contamination Control in the Pharmaceutical Industry
S2E1: Marc and Mark: Performing a Contamination Control Risk Assessment on a Manual Fill Line
2 years ago
15 minutes 30 seconds

Contamination Control in the Pharmaceutical Industry
S1E10: Marc and Mark: Retroactive Contamination Control Risk Assessments on Aseptic Fill Lines
2 years ago
23 minutes

Contamination Control in the Pharmaceutical Industry
Sustainability Progress with Rebecca Dunn
2 years ago
7 minutes 51 seconds

Contamination Control in the Pharmaceutical Industry
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).