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Contamination Control in the Pharmaceutical Industry
Contamination Control in the Pharmaceutical Industry episodes
- Validation and Qualification in Pharmaceutical Environments
Serena Steidl, Advisory expert at Particle Measuring Systems, discusses Validation and Qualification topics with Blu Buquoy.
Listen to this podcast to learn about:
* What is cleanroom validation and qualification, with examples?
* What is needed to perform these activities in a limited timeframe?
* Annex 1 revision impact on lyophilization and smoke studies.
* How to qualify an online viable particle counter.
* How often should requalification be performed?
12 min - S2E3: Marc and Mark: Data Quality and Interpretation in Pharma Manufacturing
What is quality data from contamination contol sources and how do you interpret it within the pharmaceutical manufacturing environmental monitoring? Long-term industry experts Marc Machauer and Mark Hallworth discuss the importance of collecting the right contamination control data and understanding what it means. PMS offers risk analysis through its advisory team. Learn more here https://www.pmeasuring.com/advisory-services/
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.19 min - S2E1: Marc and Mark: Performing a Contamination Control Risk Assessment on a Manual Fill Line
Welcome to Season 2 of the Marc and Mark Podcast!
Without measurement there is no control
Hosted by Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business Manager, and Mark Hallworth, Senior Global GMP Scientist.
In Season 2 Episode 1 of this podcast, Marc and Mark discuss the topic of performing a contamination control Risk Assessment, as required by Annex 1: 2022, on fill lines with manual (vs. solely mechanical or robotic) processes. These manual processes are frequently found in ATMP manufacturing, and pharmaceutical compounding; and are often performed in laminar flow hoods with limited space.
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.16 min - S1E10: Marc and Mark: Retroactive Contamination Control Risk Assessments on Aseptic Fill Lines
In Part 10 of this Limited Series from Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the topic of performing a retroactive Risk Assessment on existing fill lines as required by the release of EU GMP Annex 1 in August 2022.
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.23 min - Sustainability Progress with Rebecca Dunn
Particle Measuring Systems, a Spectris company, has a goal of Net Zero (2030 for Scope 1 and 2; 2040 for Scope 3). The plan has been validated by the Science Based Targets Initiative. In this interview, Rebecca Dunn (Head of Sustainability for Spectris) talks about the progress and the reality of hitting our goals
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.8 min - S1E9: Marc and Mark - Environmental Monitoring During Toxic Product Manufacturing
In Part 9 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the unique environmental monitoring issues encountered when manufacturing products with high toxicity profiles.
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.13 min - S1E8: Marc and Mark - Support Areas Surrounding Aseptic Fill Lines
In Part 8 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the environmental classification, management, and effective monitoring of Grade B & C areas surrounding Isolator and RABS systems.
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.17 min - S1E7: Marc and Mark - Particle Counter Sample Tubing Concerns in Aseptic Manufacturing
In Part 7 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss nonviable particle counter sample tubing concerns raised by the most recent EU GMP Annex 1 release. Their conversation includes how particles act in tubing, optimum tubing length, acceptable risk, and other variables contributing to obtaining effective and actionable particle counts in aseptic manufacturing.
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.16 min - 7 min
- S1E6: Marc and Mark - Environmental Monitoring System Installation on Aseptic Fill Lines
In Part 6 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss environmental monitoring systems on aseptic fill lines and best practices for their installation to ensure accurate viable and nonviable particle monitoring. Their discussion includes considerations around vacuum systems, sample tubing, and ensuring monitoring flexibility.
Without measurement there is no control
Do you have questions about today's topic?
Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.21 min
About Contamination Control in the Pharmaceutical Industry
From the publisher's feed
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).