Sterile processing
AAMI ST108 water quality
ST108 defines two water qualities for device reprocessing. Critical water is for the final rinse and anywhere water touches a device after cleaning. Utility water is for washing, flushing, and intermediate rinses.
| Parameter | Limit |
|---|---|
| pH @ 25 °C | 5.0 – 7.5 |
| Conductivity | < 10 µS/cm |
| Total alkalinity | < 8 mg/L as CaCO₃ |
| Total hardness | < 1 mg/L as CaCO₃ |
| Bacteria | < 10 CFU/mL |
| Endotoxin | < 10 EU/mL |
| TOC | < 1.0 mg/L |
| Chloride | < 1 mg/L |
| Iron, copper, manganese, zinc, aluminum | < 0.1 mg/L each |
| Nitrate, phosphate, sulfate, silicate | < 1 mg/L each |
| Color and turbidity | Colorless, clear, no sediment |
| Parameter | Limit |
|---|---|
| pH @ 25 °C | 6.5 – 9.5 |
| Conductivity | < 500 µS/cm |
| Total alkalinity | < 400 mg/L as CaCO₃ |
| Total hardness | < 150 mg/L as CaCO₃Soften above this unless detergent chemistry tolerates it. |
| Bacteria | < 500 CFU/mL< 10 CFU/mL and < 10 EU/mL when used as final rinse after chemical HLD. |
| Chloride | < 250 mg/L |
| Silicate | < 50 mg/L |
Steam
ST108 also addresses the water used to make steam for sterilization. Size the steam generator's feed to the sterilizer maker's instructions for use and the facility's water management plan, and record which source feeds which sterilizer.
Monitoring at a glance
- Conductivity · Daily · After last treatment step
- pH, alkalinity, hardness · Monthly · After last treatment step
- Bacteria (HPC) and endotoxin (LAL) · Monthly · Loop out and loop return
- pH, conductivity, alkalinity, hardness; bacteria and endotoxin · Monthly · First point of use (chemistry); each point of use (bacteria, endotoxin)
- Utility water chemistry and bacteria · Quarterly · Treatment system and point of use
Frequencies are the standard's recommended minimums. A water management team and a documented risk assessment are expected.
