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Cascada™ BIO-Water Systems: Endotoxin Challenge
  Cascada™ BIO-Water Systems: Endotoxin Challenge


Introduction
The Cascada BIO-water System is fed with partially purified water. It produces extremely high ultrapure water for life science applications, suitable for all molecular, pharmaceutical, and microbiological applications. Low endotoxin levels are key for many of these applications.

When given an extreme challenge of 10,000 EU/mL (50 million EU in total), the Cascada BIO-water System removed the endotoxin to below the detection limit of 0.001 EU/mL. This represents a log10 reduction of greater than 7.


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Results
Product Water Endotoxin (EU/mL)
Pre-challenge < 0.001
During challenge after 1 liter < 0.001
During challenge after 2 liters < 0.001
During challenge after 3 liters < 0.001
During challenge after 4 liters < 0.001
During challenge after 5 liters    < 0.001
Post-challenge after 5 liters < 0.001
Post-challenge after 10 liters < 0.001
Post-challenge after 15 liters < 0.001
Post-challenge after 25 liters < 0.001

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Method
A Cascada BIO-water System was fed with water containing an endotoxin challenge prepared from standard purified lipopolysaccharide from E. coli 055:B5. The challenge contained 10,000 EU/mL. The total challenge was 50,000,000 EU. Water was repeatedly dispensed and sampled at 5 minute intervals from the Cascada BIO-water unit during the challenge, which was recirculated within the unit, and afterwards. The endotoxin concentration was measured with an Ati 320 kinetic LAL analyzer.

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