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Cascada™ AN-Water System: UMF Bacterial Challenge
  Cascada™ AN-Water System: UMF Bacterial Challenge


Introduction
The Cascada AN-water System is fed with partially purified water. The unit produces extremely high ultrapure water for critical laboratory applications suitable for all analytical and pharmaceutical applications. It incorporates a 0.05 µm ultra-microfilter (UMF) to remove bacteria.

When challenged with 2.6 x 106 CFU/mL of typical waterborne bacteria under standard flow conditions, the ultra-microfilter in the Cascada AN-water System produced water with a bacteria content below the detection limit of 0.01 CFU/mL, a log10 reduction of > 8 CFU/mL.

These results demonstrate that even in the extremely unlikely event of a very high level of bacteria reaching the UMF, there would be no breakthrough into the product water.


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Results
Sample Bacteria Concentration
Pre UMF 2.6 x 106 CFU/mL
Post UMF 0 minutes < 0.01 CFU/mL
Post UMF 1 minute < 0.01 CFU/mL
Post UMF 2 minutes < 0.01 CFU/mL
Post UMF 5 minutes < 0.01 CFU/mL
Log10 Reduction > 8 CFU/mL

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Method
A challenge was prepared by inoculating 200 mL of sterile peptone water with 10 mL of purified water and agitating and incubating for 2 days at 27 °C to produce a culture of bacteria commonly found in purified water. After dilution to 25 liters, the water contained 2.6 x 106 CFU/mL.

This challenge was pumped through the UMF under normal operating conditions and samples taken before and after each UMF. The bacteria present were measured by filtration and incubation on R2A agar at 27 °C for 5 days.


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