S2E6: Marc and Mark: Airborne Particle Sampling Techniques

How Airflow Visualization Characterizes Pharmaceutical Sterility: Unlocking the Secrets

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.

Unlocking the Power of Single-Use Microbial Monitors: Validation and Expert Guidance

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.

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. 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.

S2E6: Marc and Mark: Airborne Particle Sampling Techniques

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.

BioCapt® Single-use Microbial Impactor: Reflections on a Decade of Success

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.