What is ST108 Sterile Processing Critical Water?

Critical water for sterile processing, according to the AAMI ST108 standard, is water that meets the water quality measurement values detailed in the table below. To achieve these values, the water generally requires extensive treatment by a multi-step process that includes pretreatment like softening and filtration, total dissolved solids reduction with reverse osmosis and or deionization (e.g., RO and/or DI) as well as storage, and distribution. A final treatment step in water purification is often required to provide a level of assurance that microorganisms and inorganic and organic material are removed.

Additional considerations for Critical Water:

Quality Standards for Critical Water
Critical water must meet stringent quality standards to ensure its suitability for use in sterilization and other critical processes. This typically involves purification methods mentioned above.

Validation of Critical Water
The quality of critical water is validated through regular water testing and monitoring to ensure that it meets the required standards for purity and sterility. Parameters such as microbial contamination levels, total dissolved solids (TDS), conductivity, pH, and endotoxin levels need to be monitored to conform to the AAMI ST108 standard.

Applications for Critical Water
Critical water is used in various stages of the sterile processing, including cleaning, rinsing, and sterilization of medical instruments and equipment as well as for feedwater for steam production. It may also be used in the preparation of sterile solutions and for other critical tasks where the presence of contaminants could compromise patient safety or the effectiveness of medical procedures.

Documentation for Critical Water
Detailed documentation of critical water quality, testing procedures, and validation results is essential to ensure compliance with regulatory requirements such as AAMI ST108 and quality standards. This documentation helps to demonstrate that critical water has been tested, logged and meets the necessary criteria for use in sterile processing.

Critical water for sterile processing plays a vital role in maintaining the sterility and safety of medical devices and equipment used in healthcare facilities by ensuring that critical water meets stringent quality standards as those laid out in AAMI ST108 . Check with the experts at Legionella Control Systems for more information about using Critical Water for all stages of medical device processing.