Contamination Control in the Pharmaceutical Industry

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 i...

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...

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...

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 guidan...

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...

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 heat...

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 w...

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, i...

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 parti...

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.pmea...

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 (...

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 toda...

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 to...

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 advis...

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...

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 vari...

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 vacuu...

In Part 5 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 monitoring data that is generated by Facility Monitoring Systems and how to collect, evaluate, and use that data to make informed decisions. Their discussion includes how system-based data from...

In Part 4 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the path of nonviable/microbial particles inside a Pharmaceutical aseptic fill machine. Their discussion includes active air monitoring vs. settle plates in isolator environments, and best practices in sampling for co...

In Part 3 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the path of nonviable particles inside a fill machine/isolator and best practices in sampling for contamination control. Without measurement there is no control Do you have questions about today's topic? Our expert ad...

In this interview, Dwight Beal, Product Line Manager and Industry liquid contamination monitoring expert, talks about Particle Measuring Systems newly released Ultra DI 20 UPW particle counter, which measures particles in liquids down to 20 nm. 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...

In Part 2 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss pharmaceutical manufacturing contamination control strategy and risk assessment. Without measurement there is no control Do you have questions about today's topic? Our expert advisors are ready to help answer your que...