White Paper: Detection of Pyrogens Adsorbed to Intraocular Lenses
Improving Patient Safety Through Better Pyrogen Detection
Pyrogen contamination on medical devices remains a significant challenge for manufacturers striving to protect patient safety and meet global regulatory expectations. This white paper, co-authored by Walter Zwisler, General Manager of Cormica Zwisler, explores the limitations of traditional endotoxin methods when pyrogens are adsorbed onto device surfaces and highlights the value of complementary in-vitro approaches such as the Monocyte Activation Test (MAT). The study offers important insights for ophthalmic device developers and aligns with Cormica’s mission to improve patients’ lives by enabling clients to launch and release safer products quickly and confidently.
Why This Research Matters:
This white paper was first issued in 2009, yet the core scientific principles and challenges described remain highly relevant under today’s regulatory expectations. While specific standards have evolved, the mechanisms of pyrogen adsorption, the role of MAT, and the limitations of traditional endotoxin methods continue to shape how manufacturers approach pyrogen control and risk assessment.
As device designs, materials, and global regulations become increasingly complex, understanding the strengths and limitations of different pyrogen testing strategies is essential for ensuring patient safety and regulatory confidence.
Cormica’s Expertise in Pyrogen Testing
Cormica’s group of laboratories builds on decades of experience in pyrogen detection and supports manufacturers with:
- Bacterial Endotoxin Testing (BET)Â using multiple LAL methodologies
- Monocyte Activation Testing (MAT)Â as a method for the detection of pyrogens in products
- Recombinant Testing
Our global laboratory network provides manufacturers with high-quality, GMP– and ISO 17025-aligned testing to accelerate product development, regulatory submissions, and ongoing compliance.
Authors:
This white paper was published in 2009 and authored by:
Liliana Werner, MD, PhD; Manfred Tetz, MD; Khalid Mentak, PhD; Margaret Aldred; and Walter Zwisler, PhD.
Walter Zwisler, PhD
Now General Manager of Cormica Zwisler, Walter contributed to this research through his work in advanced pyrogen detection. The other authors represent leading academic and industry institutions outside Cormica. We present the paper unchanged in its original form to preserve scientific accuracy and authorship integrity.
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