Sterility Testing for Radiopharmaceuticals
& product specific Validation.
Fast. Safe. GMP and FDA compliant.
We are the specialist and ensure your sterility tests are regulatory-proof, even with short half-lives, high radioactivity doses, and complex formulations.
The FDA requires that microbiological methods are demonstrated to be suitable for each product before routine use (product-specific suitability testing).
For radiopharmaceuticals, this is essential because:
- Radioactivity can inhibit microbial growth,
- Short shelf lives demand special test strategies,
- Complex carrier solutions can impact test results.
Our experts tailor each test precisely to your product – ensuring maximum safety and regulatory compliance.
Two established Methods – Ph.Eur. 2.6.1 & USP <71>:
- Membrane Filtration – Filtering the product through a microbe-retaining membrane, followed by incubation in growth media.
- Direct Inoculation – Directly adding the product into growth media and monitoring for microbial growth.
Both methods are validated for each specific product – even under radiopharmaceutical conditions.
Product specific Validation
for Sterinow®.
As exclusive validation partner of TRASIS, we support the introduction of the patented Sterinow® cassette into your routine.
- We develop product-specific suitability testing in accordance with FDA and GMP standards.
- We take care of the method validation required by regulations – directly with your products.
- We ensure that the automation solution is included in your approval dossiers (NDA/BLA).
The product from Trasis: Sterinow®
Automated sterility testing for radiopharmaceuticals.
Sterinow® is an automated cassette-based solution for sterility testing using membrane filtration.
- Compatible with US and EU pharmacopoeia
- Testing starts immediately after production – no waiting times
- Significantly reduces radiation exposure (ALARA principle)
- Combines control and testing in a single run (aerobic & anaerobic)
- Reduces running costs by up to 70%
- Can be integrated into the TRASIS ecosystem for radiopharmaceutical production
Your advantages of the cooperation between Trasis & CUP Contract Labs:
- FDA- and GMP-compliant, product-specific validation of your Sterinow® application
- Many years of experience with highly radioactive samples and complex radiopharmaceuticals
- Safe, fast, and regulatory-compliant testing process
- Seamless collaboration with TRASIS for technical integration and regulatory implementation
Customer Voices
Collaborating with Cup Lab felt immediately natural.
We’re both driven by the same passion: pushing boundaries, staying precise, and ultimately making a difference for patients.
Like Trasis, Cup Lab is a human-sized company, with deep expertise, especially in quality control solutions, and a real sense of purpose.
When we bring their know-how together with our technology and creative drive, something special happens: we unlock smarter, faster, and more adaptable solutions for nuclear medicine.
But beyond the technical aspects, this partnership is about something deeper — a shared vision for what radiopharma can become.
That’s what makes it so exciting. I genuinely look forward to what we’ll achieve, side by side.
