Webinar - From Manual to Automated QC: Key Considerations, Challenges and Solutions

The increasing pressure on biopharmaceutical quality control (QC) labs to deliver faster, more reliable results is driving demand in rapid and automated technologies. However, transitioning comes with its own set of challenges—from resource limitations and data management complexities to regulatory considerations and integration into existing workflows.

When: Tuesday, June 23, 2026

Time: 4:00 PM Central European Summer Time

Running time: 1 hour

How to join? Go to Merck Webinar

In this webinar, our experts will outline what to consider when evaluating and implementing automated solutions. Through case studies we will demonstrate how present-day QC challenges—such as staffing constraints and increasing production volumes—can be effectively overcome. The webinar will also highlight how to select the right solution and partner, what level of support is required for successful implementation, and why now is the right time to invest in automation.

In this webinar, you will learn about:

• Implementing rapid sterility/bioburden/environmental monitoring methods
• Return on investment (ROI) of rapid methods
• Overcoming regulatory & technology challenges
• The benefits and challenges in day-to-day use

Speakers:

Anne Weeks

Automation & Robotics Specialist, MilliporeSigma (The Life Science business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada)

Johannes Oberdörfer

Senior Manager Field Applications, Rapid Micro Biosystems

Tim Cser

Senior Technology Specialist, Commercial Applications, MilliporeSigma (The Life Science business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada)

Sign up here.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Pharmaceutical Resources

 See what Merck has to offer in terms of knowledge and resources, here.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Webinar: Getting Equipped for the Future with the New MAS-100 Sirius® Microbial Air Sampler

 

The environment for pharmaceutical production has changed massively over the last few years. A clear trend towards digitalization and automation is observable. New regulatory requirements have been set for GMP-compliant aseptic manufacturing to minimize contamination risks in cleanrooms. In this webinar we will give an introduction to the portable new MAS-100 Sirius® Microbial Air Sampler, which meets the new challenges. We will demonstrate how it supports regulatory compliance in a digital environment, minimizes handling errors and makes active air monitoring easier to perform. Another key focus will be the validation process – highlighting what GAMP 5-based development is all about and how validation on customer side is supported.

Details: 

Thursday, July 10, 2025

9:00 AM Central European Summer Time

1 hour

To register see Air-sampling. 

In this webinar, you will learn:

• How the MAS-100 Sirius® supports regulatory compliance in a digital environment.
• Strategies to minimize handling errors and enhance active air monitoring
• Insights into the validation process for effective implementation

To register. 

Speakers:

Corina Keller

Product Manager, MBV AG

Corina Keller holds a master’s degree in biochemistry from the University of Zurich and an MBA from the Lucerne University of Applied Sciences and Arts. She has been working in product management for over seven years, focusing on translating customer needs into well-aligned product portfolio strategies. She is responsible for the portfolio of portable microbial air samplers and works closely with interdisciplinary teams to develop effective solutions for microbial air monitoring in pharmaceutical cleanrooms.

Dr. Anne-Grit Klees

Global Product Manager, Merck KGaA, Darmstadt, Germany

Dr. Anne-Grit Klees is responsible for Innovation & Product Life Cycle Management with regard to microbial air samplers and media for aseptic process simulation for pharma cleanrooms and isolators. With a professional background in microbiology, she has been working in product and marketing management within the health industry for 30 years.

Register here. 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

In 1975, the Steritest™ system made the sterility test reliable. Read the story of its invention

 Fernand Burghard, Millipore’s European Manufacturing Director until 2000, was part of the Steritest™ adventure from the beginning. In an interview, he tells us about how this breakthrough sterility testing system came into being.


When and why was there an idea to develop something like the Steritest™ system?

In the early 70s, large pharmaceutical companies were struggling with the sterility testing needed to release a pharmaceutical to the market. Sterility tests were performed openly under a laminar flow hood. Many false positives, often more than 30%, were observed, leading to additional tests and controls, discarded production lots, and manufacturing delays. The financial consequences were huge and drug access for patients impaired. Millipore found out about these sterility testing and end-user issues from customers in the United States.


In 1972, Jack Buch, Millipore founder and Chairman, settled in Molsheim (France) and had some clear user requirement specifications for a new product in mind. His way to go was:

· a 125 mL volume container

· a closed system

· a 47 mm membrane

· 2 canisters

· a needle and a Y-piece to connect tubing to the 2 canisters.

This was the start of the Steritest™ adventure!


Is the Steritest™ system the result of in-depth market research or of a gut feeling?

The Steritest™ system was developed to address a need clearly expressed by customers in the pharmaceutical industry, at a global level, to improve the reliability and robustness of the test for sterility.


How much time was required to develop the Steritest™ system and introduce it to the market?

More than 2 years were needed to develop a solution, because there were several issues to deal with. The concept was unique and innovative, a revolution in the sterility testing world, which required hard work from a multidisciplinary, audaciously bold, and creative team.


What was the biggest challenge during development, and how did you solve it?

Equal splitting into the 2 canisters needed quite some effort. We had to work on the plastic tubing and eventually we came to the conclusion that we had to replace the classical vacuum pump by a peristaltic one.

The marketable product resulted from a close collaboration with a local partner, specialized in industrial engineering, and the courage and conviction of a curiosity-driven and motivated team.


Which three words would best characterize the Steritest™ system?

Only one: extraordinary. Our pharma customers’ need was clear: they had a high level of false positive test results, leading to significant drug quarantine costs and time wasted on follow-up tests. All this had to stop. We felt the mission to find a radical solution, a solution to this worldwide issue in the industry.

Did you imagine back in 1974 that the Steritest™ system would become the standard for sterility testing in the pharmaceutical industry, something they all use, like a Petri dish or a pipette?

We had high hopes, justified by the enormous market size. The issue was a global one, and we strongly believed in our solution.

45 years after market introduction, the Steritest™ system remains the reference for sterility testing. How do you feel about that?

I am personally very proud to have contributed to the creation of Steritest™ system, a reliable solution that helps customers and patients all over the world.


Concluding remarks from Estelle Zelter, Global Product Manager Sterility Testing:

This year, the Steritest™ system celebrates its 45th anniversary as a commercial product. Curiosity and innovation still motivate the teams at Merck. Like Fernand Burghard and his colleagues did, we listen carefully to our customers in order to continuously improve our existing products while respecting regulatory requirements. At the same time, we look to the future, developing breakthrough technologies and innovative products. Over the 45 years, the Steritest™ system has been refined. There’s a fully compliant portfolio for sterility testing that includes membrane filtration devices, pumps and accessories, culture media and fluids, and related services. The many years of experience have yielded comprehensive method development & consultancy expertise, validation protocols (IQ/OQ/PQ & requalification), service plans and trainings (Sterility Testing remote school, advanced operator training, …), of which we today are proud.


Want to discuss with our experts? Contact us! We’re as much willing as ever to help you solve your challenges. Or discover the latest features of our Steritest™ NEO system.

NOW IS THE TIME for Animal Welfare in Pharma

Symposium - Animal Welfare in Pharma Join us at a symposium to celebrate the 60th anniversary of the 3Rs guiding principles (Reduction, Refinement and Replacement) for ethical use of animals in lab testing. Experts from the pharma industry will present ongoing initiatives to apply the 3Rs principles throughout the pharma process: from the drug development to production and batch release; there are many ways to avoid the use of animals.

NOW IS THE TIME for Animal ... 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monocyte activation test - live webinar

Monocyte activation test: a powerful tool to assess pyrogenic risk in the pharmaceutical process

Microbial risk in the pharmaceutical manufacturing process cannot be limited to viable microorganisms. Even if drug substances are manufactured in clean conditions and final drug products are sterilized, some subcellular microbial components may remain at the end of the manufacturing process.

To minimize the risk of subcellular microbial components remaining in the final drug product, a risk assessment approach of the whole manufacturing process can be applied, as described by Friedrich von Wintzingerode¹.

These subcellular contaminants often include Pathogen Associated Molecular Pattern (the so-called PAMPs) that can trigger the human immune system leading to inflammatory response and constitute a pyrogenic risk for patients. That’s why ensuring the absence of such components in the final drug product before batch release is key for product quality and patient safety.

In any case, testing for endotoxins in the final drug product before batch release is currently a minimum requirement from regulations. To reinforce the risk management approach, a new recommendation was added to the European Pharmacopeia chapter 5.1.10 « Guidelines for using the test for bacterial endotoxins » requiring users to carefully evaluate the risk for pyrogens (i.e. endotoxins and non-endotoxin pyrogens) before implementing the Bacterial Endotoxin Test (BET) as the sole pyrogenicity test. This is because the BET is designed to detect endotoxins only, leaving room for missing non-endotoxin pyrogens that could be responsible for fever reaction in patients.

The EP chapter 5.1.10 also indicates that “To rule out the presence of non-endotoxin pyrogens in substances or products, the use of the monocyte-activation test (2.6.30) is recommended at release or during development of the production process”. Indeed, the Monocyte Activation Test (MAT), mimics the human immune reaction to pyrogens by detecting all kinds of pyrogens that trigger the monocytes through the toll-like receptor (TLR) pathway, making it a powerful tool to assess pyrogenic risk in pharmaceutical process.

The PyroMAT™ System, our ready-to-use MAT kit using a monocytic cell line, has demonstrated the ability to detect a wide range of pyrogens. Each batch of PyroMAT™ cells is qualified for the expression of all the surface TLRs to ensure the detection of both endotoxins and non-endotoxin pyrogens. With our PyroMAT™ System, we provide a new solution for sensitive, robust, and easy-to-perform pyrogen testing.

New tools to assess the risk of microbial impurities in the pharmaceutical manufacturing process

Join the live webinar on April 9^th, 2019, 10:00 am CEST

Register Now

For more information about the PyroMAT™ System, click here

¹ von Wintzingerode F. Biologics Production: Impact of Bioburden Contaminations of Non-Sterile Process Intermediates on Patient Safety and Product Quality.  Am Pharm Rev. 2017 Apr;20(3)

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

PyroMAT™ System: Have you heard about the latest solutions for pyrogen detection?

PyroMAT™ System: Have you heard about the latest solutions for pyrogen detection?

The PyroMAT™ system is the only cell-line based Monocyte Activation Test (MAT) provided as a ready-to-use kit on the market: a new solution for sensitive, robust, and easy-to-perform pyrogen test

Make the move to the monocyte activation test—the only method that detects the full range of endotoxin and non-endotoxin pyrogens and contributes to the reduction of animal consumption for testing purposes.

Want to know more about our solutions? Join our live webinar on October the 25^th and find out more about the new PyroMAT™ System.

Register today