Automating quality control testing for radiopharmaceutical production
This webinar showcases a rapid microbial method that can help to address the time to result challenge posed by short shelf-life radiopharmaceuticals.
Microbiological QC testing of radiopharmaceuticals is a high-stakes, time-sensitive process complicated by radioactive hazards, short product lifespans, and the need for aseptic assurance.
Innovations in rapid microbiological testing improve the reliability and safety of these life-saving compounds while reinforcing regulatory compliance.
Full workflow automation mitigates many of the critical challenges posed by radiopharmaceutical production including:
- A short half-life
The half-life for most radiopharmaceuticals range from seconds to a few hours, limiting the time available for microbiological assays before the product must be administered to patients.
- Radiation hazard and handling
Radiopharmaceuticals emit ionising radiation, posing health risks to laboratory personnel and affecting the performance and reliability of microbiological assays. Radiation can inhibit microbial growth, leading to false-negative results. It also complicates sample handling and requires specialised shielding and remote handling equipment.
- Aseptic manufacturing requirements
Because terminal sterilisation is often not possible due to degradation of the radiolabelled compound, radiopharmaceuticals must be manufactured under strict aseptic conditions. Ensuring aseptic integrity during manufacturing, compounding, and QC testing is critical and requires rigorous environmental monitoring, bioburden and water testing.
This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.
Growth Direct removes the human element and can detect colonies several generations before they become visible to the naked eye. Additionally, result digitisation enables sample tracking through the full chain of custody.
Key learning points:
- Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
- Learn about ITM’s implementation journey and considerations when evaluating the technology
- Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).
SPEAKERS
Johannes Oberdörfer – Field Application Scientist, Rapid Micro Biosystems
As a Field Application Scientist at Rapid Micro Biosystems®, Johannes Oberdörfer is responsible for the successful implementation and integration of the Growth Direct® System within companies across Europe.
He supports customers to evaluate and disrupt their traditional methods to successfully implement state-of-the-art automation in the QC Microbiology space. His role involves driving the transformation of labs in through automation, innovation and digitalisation.
He was project lead for the global implementation of the Growth Direct® System.
Kathrin Bui – Quality Control Microbiology Intern, ITM
Kathrin Bui is a Master’s student in Biotechnology at Weihenstephan University of Applied Sciences.
She has three years of experience in Quality Control Microbiology and is currently working as an intern in the department while completing her Master’s thesis on validating the Growth Direct system for microbial enumeration.
FAQs
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 20 November 2025, at 15:00 UK time
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
