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Water for Sterilizing Medical Devices (AAMI ST108)

Water for Sterilizing Medical Devices

Water for sterilization has a new requirement and standard. This applies to surgical tools and instruments, and is useful to feed steam sterilizers and autoclaves.

Medical Surgical Devices Require Sterilization

New Standard

AAMI calls the new standard for water for sterilizing medical devices “Water for the Processing of Reusable Medical Devices”. This is technically AAMI ST108. The Association for the Advancement of Medical Instrumentation (AAMI) led this effort and instituted this new protocol.  The Technical Information Report (TIR34) was published in 2014.

Water Technologies

Water quality is an important consideration for all stages of medical device manufacturing and reprocessing. SnowPure Water Technologies provides components for several parts of these systems.

The new AAMI Standard (108) no longer allows a direct water feed to sterile processing.

Sterile Water Loop

In fact, a sterile water loop is now required. It must have a velocity of 3-5 feet per second (fps) being recirculated continuously through a UV (254 nm), with an endotoxin filter to ensure that the last water that touches surgical instruments is free of bacteria and endotoxins. This higher quality water protects equipment, lowers rates of infection, and improves patient outcomes.

An RO system followed by SnowPure Electropure EDI is an ideal solution to feed the loop for meeting these new standards. SnowPure has an additional advantage with our “DER” EDI which removes endotoxins during the purification process. These are sanitary style EDI modules which are specifically designed to efficiently trap >95% of endotoxins when using SnowPure’s operational procedures.

Opportunities for SnowPure OEMs

This new standard provides an excellent opportunity for SnowPure OEMs to develop sterile water systems to target the large medical device market, as well as hospitals. Water system flows are generally in the 1 to 10 gpm (225 to 2,225 l/hr) range with the loop pump sized from 5 to 20 gpm (1.4 to 5.5 m3/hr), but may be larger.

A schematic RO-DER or RO-EDI and loop system is shown below:

Sterile Water System for Medical Devices

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