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Abbott AEROSET - Specifications; Water; USP Purified and WFI Requirements

Abbott AEROSET
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PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution Hardware
AEROSET
®
System Troubleshooting Guide 231
94816-107—November 2004
Specifications
Water
USP Purified and WFI Requirements
Purified Water Water for Injection
Conductivity Not greater than 2.1 mS/cm at
25°C*
Not greater than 2.1 mS/cm at
25°C*
pH 5.0 to 7.0 5.0 to 7.0
Total Organic Carbon Not greater than 500 ppb Not greater than 500 ppb
Total Bioburden Does not exceed
10,000 CFU/100 mL
Does not exceed
10,000 CFU/100 mL
Endotoxin N/A Not more than 0.25 Endotoxin
Unit per mL
Coliform Level Zero per 100 mL Zero per 100 mL
* Refer to USP 24/NF19 Monograph <645> “Water Conductivity” if conductivity meter is not
temperature compensated, or conductivity value exceeds 2.1 mS/cm at 25°C.
NOTE: The above USP specifications are derived from the ASTM Type III Specification.

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