Sterilization Monitoring Guidelines - Revolutionary Science SANICLAVE FRONT-LOADER Series Instruction Manual

Saniclave Front-Loading Series

STERILIZATION MONITORING GUIDELINES

Note
Revolutionary Science provides the following information only for reference. The user
must contact state and local government for proper regulations regarding sterilizer
use and sterilization monitoring. Additionally, the Centers for Disease Control and
Prevention (CDC), American Dental Association (ADA) and the Organization for
Safety and Asepsis Procedures (OSAP) may be contacted for further information
regarding infection control.
Physical Monitors
Sterilizer malfunctions may be detected by pressure and temperature measurement
devices. The sterilizer's programming aborts the cycle and displays a message on
the display screen if physical conditions exceed the proper limits.
Note
Only FDA cleared chemical indicators and biological indicators designed for steam
sterilization are to be used. Additionally, such indicators must be compatible with the
cycle parameters of the Saniclave. When monitoring the cycle with such indicators,
load the chamber according to your facility's standard operating procedures.
Chemical Indicators
The purpose of chemical indicators (CI) is to determine whether the sterilization
cycle parameters are sufficient to accomplish an effective sterilization. CIs are not
intended to be used to validate the sterility of the load. However, if the CI shows
failure, the load must be considered non-sterile and the load configuration and
sterilizer shall be investigated, due to the fact that proper cycle parameters may
have not been correctly achieved. Note: Wrapping, packing and loading improperly
may result in failures. In addition, the failure may be a result of sterilizer malfunction.
Check load configuration and verify that it is in accordance with the manufacturer's
instructions. Also, check the CI's instructions for proper use, storage and disposal.
Only CI's that are cleared by the FDA and labeled for use with the same cycle
parameters (of exposure time and temperature) of the Saniclave shall be used to
monitor sterility conditions of loads processed in Saniclave.
17319 Lake Blvd. Shafer, MN 55074 | 800-775-7942 | Fax: 775-218-7015 | support@revsci.com | revsci.com
18