There are multiple professional organizations that establish specific standards according to their fields of study. The most common of these organizations are:
- Clinical & Laboratory Standards Institute (CLSI); formerly known as the National Committee for Clinical Laboratory Standards (NCCLS)
- College of American Pathologists (CAP) (follows CLSI standards)
- American Society for Testing & Materials (ASTM)
- United States Pharmacopeia (USP)
American Society for Testing and Materials (ASTM)
Standard Specification for Reagent Grade Water
Type I | Type II | Type III | Type Iv | |
---|---|---|---|---|
Electrical Conductivity Max (pX/cm @ 25C) | 0.056 | 1.0 | 0.25 | 5.0 |
Electrical Resistivity Min (MOhms-cm @ 25C) | 18 | 1.0 | 4.0 | 0.2 |
pH @ 25°C | - | - | - | 5.0-8.0 |
TOC max (µg/L) | 100 | 50 | 200 | No Limit |
Sodium max (µg/L) | 1 | 5 | 10 | 50 |
Silica max. (µg/L) | 3 | 3 | 500 | No Limit |
Chloride max (µg/L) | 1 | 5 | 10 | 50 |
When bacterial levels need to be controlled, reagent grade types should be further discussed as follows:
Type A | Type B | Type C | |
---|---|---|---|
Total Bacterial Count Max CFU/100ml | 1 | 10 | 1000 |
Endotoxin max. IU.ml | 0.03 | 0.025 | - |
Clinical and Laboratory Standards Institute (CLSI) (CAP)
CLRW | Type I | Type II | Type III | ||
---|---|---|---|---|---|
Bacteria | Bacteria (CFU/ml) | <10 | <1 | <100 | <1000 |
Pyrogens | (Eu/ML) | - | <0.03 | n/a | n/a |
Ions | Resistivity (MΩ-cm @ 25C) | >10 | >18 | >1 | >0.05 K50Ω |
Colloids | Silica (ppb) | - | <10 | <100 | <1000 |
Particles | Particles >0.2 µm (units/mL) | Include 0.22 µ filtration | <1 (0.22 µ filtration required) | n/a | n/a |
Organics | Total Organic Carbon ppb | <500 | <10 | <50 | <200 |
United States Pharmacopoeia Standards (USP)
Purified Water | WFI Water | |
---|---|---|
Electrical Conductivity Max (µS/cm @ 25C) | <1.3 | <1.3 |
Total Organic Carbon (TOC) (ppm) | <0.5* | <0.5* |
Endotoxin (EU/ml) | n/a | <0.25 |
Bacteria (guideline only) | <100 cfu/ml | <10 cfu/100ml |
* Or pass oxidisable substance test |
When bacterial levels need to be controlled, reagent grade types should be further discussed as follows:
Type A | Type B | Type C | |
---|---|---|---|
Total Bacterial Count Max CFU/100ml | 1 | 10 | 1000 |
Endotoxin max IU.ml | 0.03 | 0.25 | - |