Industrial Microbiology Webinars

Mar. | 2017

• Presenters:
  
  • Tommaso Ronconi, Global Product Manager, In-Process Testing, Merck KGaA, Darmstadt, Germany
  • Moderator: Sarah Thomas, Editorial Team, SelectScience
• Abstract

  You would be surprised by how much a liquid sample can tell you about its microbiological content! Over the years, membrane filtration has become a standard for microbial enumeration of colonies in the pharmaceutical and beverage industries.
  
  It is time to unveil some of its secrets. How are membranes made? Which one should I select for my application? One membrane looks just like another, but what about performance? We decided to investigate these products to help make the invisible visible, and evaluate the latest bioburden testing products from Merck KGaA, Darmstadt, Germany, against a variety of other membranes and sterile funnels.
  
  Key Learning Objectives:

  • Introduction to membrane manufacturing
  • Choosing the appropriate filter for all laboratory applications
  • Dealing with hard to filter matrices and antibiotics
  • Evaluating filter performance: comparison study example

  Who Should Attend:
  
  QA/QC technicians, managers and scientists, students, and anyone interested in microbiology who is, or could be, working in a laboratory.

Feb. | 2017

• Presenters:
  
  • Barbara Gerten, Senior Scientist Traditional Microbiology, Merck KGaA, Darmstadt, Germany
  • Dr. Andreas Bubert, Senior Product Manager Merck KGaA, Darmstadt, Germany
• Abstract

  How can you stay ISO certified in the current environment of an ever-increasing, but necessary regulation? The ISO food microbiology standards are changing for ISO 11290, ISO 21528, and ISO 22964. All food products and ingredients intended for human consumption and the feeding of animals are implicated, along with environmental samples in food production and handling areas. Our food microbiology expert, member of the German ISO delegation, will guide you through the most recent changes for handling the testing of Listeria (ISO 11290), Enterobacteriaceae (ISO 21528), and Cronobacter (ISO 22964) to help you remain compliant.

Jan. | 2017

• Presenters:
  
  • Gary Oishi, R&D Chemist,Merck KGaA, Darmstadt, Germany
• Abstract

  Air volume sampled is currently determined by calibrating the desired flow rate across the sampling media. The calibrated flow rate and time are used to establish total sampled air volume. Mathematically, the larger the total sample volume, the lesser of an impact that an error in the actual volume would have on a result. Most importantly, we want to know with confidence that a measured value will allows us to make a decision based on the most accurate and reliable data available. A new innovation in pumped air sampling that incorporates a patented mass air flow meter in a personal sampling pump will bring us closer to what is needed. This combination can provide an accurate real air volume sampled by continuously measuring flow rate over the entire sampling period.

Dec. | 2016

• Presenters:
  
  • Carine Muckensturm, Global Product Manager, BioMonitoring Services, Merck KGaA, Darmstadt, Germany
  • Tony Ancrum, Associate Director, Environmental Monitoring, Merck KGaA, Darmstadt, Germany
• Abstract

  Choosing and implementing your environmental monitoring instruments is critical for a safe production and continued compliance. Ensure optimum performance from your microbial environmental monitoring in aseptic manufacturing processes in cleanrooms and isolators. Merck can support the quick implementation of specifically designed and validated products along with the reliable tests to be fully compliant with current regulations. We provide a high level of expertise and good practices on both applications and equipment used within quality control laboratories. We have gained the regulatory and technological know-how to offer you a comprehensive range of best-in-class equipment and professional services.

Sept. | 2016

• Presenters:
  
  • Anne-Grit Klees, Biomonitoring Marketing and Product Management, Merck KGaA, Darmstadt, Germany
  • Tony Ancrum, Associate Director, Global Product Manager Environmental Monitoring, Merck KGaA, Darmstadt, Germany
• Abstract

  We will introduce you to the microbial environmental monitoring in production isolators. You will learn how to be compliant and ease your workflow.
  
  Microbial environmental monitoring in aseptic manufacturing processes in isolators and RAB systems needs specifically designed and validated products. Air samplers and products, such as the MAS-100 Iso NT®, MAS-100 Iso MH® and IsoBag™ are designed for this purpose. These microbial air samplers are able to communicate with your isolator and are validated according to ISO 14698 in combiation with ICR culture media. ICR culture media is now available in IsoBag™ which allows the use of plates without any need for decontamination in order to increase productivity and save space in your isolator.

Sept. | 2015

• Presenter:
  Tim Sandle, Ph.D., Head of Microbiology, Bio Products Laboratory
• Abstract

  Our guest speaker Tim Sandle gives an overview on biocontamination and how to set-up an ISO 14698 compliant environmental monitoring program in pharmaceutical production. He explains how the use of agar plate active microbial air samplers that are validated to ISO 14698 support environmental monitoring programs and help to stay compliant.

April | 2015

• Presenter: Volker Lanz, Global Product Manager Core Products, BioMonitoring Business Field, Life Sciences, Merck
• Abstract

  Soybean Casein Digest Medium (SCDM) or Tryptic Soy Broth (TSB) is the only medium for aerobic media fill which is mentioned with formulation in international Pharmacopeias. Yet, the risk of contaminations with Transmissible Spongiform Encephalopathies and the documentation effort involved have caused the use of media with alternative, vegetable peptones to become more and more popular in recent years. These Vegetable Peptone Broths require a validation to prove equivalence with standard TSB. A comprehensive comparison study provided by culture media manufacturers can help to reduce the effort for internal validation. An example of such a study will be discussed.
  
  One of the most frequent issues related to the use of dehydrated culture media for aseptic filling process simulations is filterability, especially challenging with Vegetable Peptone Broth. A recently conducted comparison study of the most relevant dehydrated media fill broths commercially available reveals considerable differences between both the media and the filter types commonly used for this application.

April | 2015

• Presenter: Thomas Hartung, MD PhD, is Professor of Toxicology, Pharmacology, Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and University of Konstanz, Germany; he also is Director of their Centers for Alternatives to Animal Testing (CAAT)
• Abstract

  In this webinar you will learn:

  Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies endotoxins, while the rabbit pyrogen test (RPT) endangers animals. Fortunately, the MAT (Monocyte-Activation Tests) alternative covers a much broader range of pyrogens and is completely animal-free. In our insightful webinar you will get a closer look at the whole blood assay, non-endotoxin pyrogens detection, and pyrogen testing in medical devices.

Nov. | 2014

• Presenter: Shari Spector, Field Marketing Manager, Merck
• Abstract

  In this webinar you will learn:

  • How a deeper understanding of membrane filtration can help with method development for bioburden and sterility testing
  • How to optimize membrane filtration for different samples
  • Tips and tricks for membrane filtration method development

Nov. | 2014

• Presenter: Barbara Gerten, Application Training Scientist at Merck Millipore and a member of the ISO committee for microbiological standards regarding food and water testing.
• Abstract

  International Organization for Standardization recently published the revised EN ISO 11133, which is now a full standard and as such mandatory for all accredited laboratories that perform microbiological testing of food, animal feed or water using culture media. It has been completely restructured, clarifying procedures and drawing a clear line between the responsibilities of the laboratories and the manufacturers of culture media regarding media preparation, production, storage and performance testing.

Oct. | 2014

• Presenters: Tim Sandle, Ph.D., Head of Microbiology, Bio Products Laboratory and Anne Connors, Regional Marketing Manager, Merck
• Abstract

  This webinar pieced together the essential components and best practices for successful implementation of an environmental monitoring program.
  
  Key learning points for this webinar:
  
  

  • Understand the essentials of a robust risk based Environmental Monitoring program.
  • Learn about the importance of ISO 14698 when selecting air sampling instrumentation
  • Discover the value in using products designed to work together to ensure optimal recovery with results you can trust

July | 2014

• Presenter: Scott Sutton, Ph.D., Principal of Microbiology, Network, Inc
• Abstract

  This webinar will be a focused review of sterility testing requirements as described in USP <797> and the parameters of the test as described in USP <71> with emphasis on the required number of units and volume per unit as well as the need for demonstration of method suitability.