- Leading innovation for endotoxin detection products, services and software
- Gain from Lonza’s endotoxin expertise
- WinKQCL™ software platform has supported the pharmaceutical industry worldwide for over 20 years
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Endotoxin Detection: A Brief History
Ever since the pharmaceutical industry began manufacturing injectables, pyrogen detection tests have been an absolute necessity. Pyrogens are substances that can cause fever, shock and even death if high levels are introduced into the body. Endotoxins are natural compounds found in the outer cell membrane of Gram-negative bacteria and are released upon cell lysis. Endotoxins are a type of pyrogen. Today, endotoxin detection tests are performed on raw and in-process materials and for the final release of products in the pharmaceutical and medical device industries. Read more…
Lonza provides solutions for endotoxin detection methods:
- PYROGENT-5000 Kinetic Turbidimetric LAL Assays
- Chromogenic LAL Tests
- Fluorescent Test
Recognizing the importance that software plays in accurate analysis and reporting, Lonza has made significant investments in software and has its own in-house development systems and programmers, dedicated to producing robust endotoxin detection software.
WinKQCL™ Software is Lonza’s industry leading endotoxin detection and analysis software offering a fully-integrated solution for quantitative endotoxin detection testing, data management and reporting needs. WinKQCL™ Software meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving.