Claim OwnershipContamination Control in the Pharmaceutical Industry
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© 2023 Contamination Control for Aseptic Manufacturing with the Pharmaceutical Industry
Description
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).
36 Episodes
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Discover the critical role of airflow visualization in pharmaceutical sterility assurance in this enlightening discussion featuring Particle Measuring Systems expert Luca Calisi. Dive into the intricacies of airflow studies, that are crucial in the qualification phases of cleanrooms and clean air equipment. Luca is a seasoned professional in pharmaceutical microbiology and he shares his profound insights on different types of air visualization studies, emphasizing their impact on sterility assurance from the Annex 1 perspective. This engaging discussion not only covers the technical aspects of smoke studies but also covers practical applications in contamination control strategies, risk management, and the significance of these studies in designing effective environmental monitoring plans. Watch here to gain a comprehensive understanding of how airflow visualization is pivotal in ensuring pharmaceutical product safety.
Join Megan from Particle Measuring Systems in an engaging conversation with Emad Albarouki, a Microbiology and Sterility Assurance specialist with a PhD in Molecular Biology. In this informative podcast, they discuss the innovative BioCapt® Single-Use Microbial Monitoring technology that is revolutionizing microbial air monitoring. Emad explains how this patented device combines the convenience of single-use with the reliability of stainless steel for active air monitoring, eliminating the need for sterilization. Discover how BioCapt® Single-Use can be employed for continuous monitoring, with options catering to different flow rates. Furthermore, Emad sheds light on the critical validation documents offered by Particle Measuring Systems and how their expert PMS® Advisory Team can assist you in implementing this groundbreaking technology. Don't miss this insightful discussion that will enhance your understanding of microbiological quality control and environmental monitoring.
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. Emad explains that BCSU represents the next generation of microbial monitoring, surpassing traditional stainless steel heads with its single-use design, radial slits, and increased infection area. The device, sterilized by gamma radiation, eliminates the need for disinfection and sterilization common with stainless steel counterparts. Emad highlights its versatility, recommending different flow rate versions for specific purposes, and discusses why pharmaceutical companies should opt for BCSU over legacy settle plates. The video concludes with insights into implementing and validating BCSU.
Marc Machauer and Mark Hallworth, both with 25 years of experience in cleanrooms and 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. They also provide guidance on materials and valves in particle transport. The discussion includes practical examples and a decision tree for better understanding. They also touch on the importance of measuring losses in particle transport and discuss the worst-case scenario. The episode ends with the announcement of an upcoming white paper and webinar.
Join Particle Measuring Systems in celebrating the 10-year milestone of the Biocapt® Single Use Microbial Impactor! Listen as Giulia Artalli, Microbial Product Line Manager discusses its evolution and success, focusing on its application in pharmaceutical manufacturing microbial air sampling. Additionally, Giulia discusses regulatory compliance, ease of use, and cost-effectiveness. Discover how it compares to the BioCapt Stainless Steel impactor and learn about its recommended validation process.
Marc and Mark discuss the challenges of pharmaceutical contamination monitoring and data management in pharmaceutical facilities. They introduce a software solution called PharmaIntegrity, which combines automatic and manual data collection for a comprehensive view of environmental monitoring. Using a mold-contaminated facility as an example, they illustrate the software's ability to generate heatmaps and track contamination progression. They emphasize the importance of analyzing data from different times and areas for a complete picture, and highlight the potential for early detection of contamination.
Join environmental monitoring industry veterans and experts Marc Machauer and Mark Hallworth while they discuss topics around particle monitoring in heat tunnels. Learn: 1) Heat/depyrogenation tunnel basics, 2) Particle vs. microbial monitoring, 3) Skipping the preheating zone, 4) Focus on cooling zones, 5) Probe placement & tubing length tips, 6) Regulations. Listen here (or watch the video with descriptive presentation at: https://youtu.be/KFsSeiQ8SBQ) for essential insights!
In Season 2, Episode 2 of the Marc and Mark Contamination Control Podcast, Marc Machauer and Mark Hallworth, particle monitoring experts at Particle Measuring Systems, discuss the new release of ISO 14644-21: 2023 Airborne Particle Sampling Technique. Mark Hallworth served on the ISO task force to rewrite this standard. They discuss behind-the-scenes stories from the writing of the new standard, including topics such as tubing length, isokinetic sampling, and best practices.
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?
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.
Welcome to Season 2 of the Marc and Mark Podcast! 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. 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.
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.
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.
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.
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.
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.
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.
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