Sterilization Integrator

Approx. Rs 7,000 / PackGet Latest Price

Product BrochureProduct Details:

Instructions For Use

• Place a steamplus integrator inside each pack load middle of the load or inside the densest pack to be sterlized
• Process the load according to the sterilizer manufacturer
• Release the load if the dark bar on the steamplus integrator has the blue safe area do not release the load if we dark bar has not entered into the blue safe area

• This product is tested to ST-60 and ISO 11140-1:2005 performance claims of Class 5 integrating integrators.
• 4" strip has distinct pass/fail criteria and allows for easy removal from packs.
• The STEAMPlus is FDA cleared as equivalent in performance to a biological indicator, and offers the highest level of sterility assurance from a chemical indicator.
• The STEAMPlus does not replace the routine use of a biological indicator.

Introduction

The SteamPlus Sterilization Integrator is an advanced technology chemical indicator that provides a simple, accurate method of assuring that proper conditions for sterilization have been met during a sterilizer cycle. For use with all steam processes (gravity, prevacuum and IUSS), the SteamPlus Integrator has documented performance equivalent to a biological indicator. Strip lot number and expiration date are printed on front side for easy reading

Description

The SteamPlus Sterilization Integrator is engineered to integrate the three (3) critical variables of sterilization: time, temperature, and saturated steam. This information is displayed in a precise, easy-to-read format. When the dark bar enters the blue SAFE area, sterilization criteria has been met. If the dark bar does not reach the blue SAFE area, proper conditions for sterilization have not been achieved and the processed pack or load should not be released. The SteamPlus Sterilization Integrator has been tested to the AAMI ST-60 and ISO 11140-1:2014 standards performance requirements. Note: The FDA does not recognize Type 3, 4 or 5 indicators as defined in ISO 11140-1:2014.

How to Use the SteamPlus Steam Sterilization Integrator

1. Place a SteamPlus Integrator inside each pack or minimally in every load (i.e. middle of the load or inside the densest pack) to be sterilized.
2. Process the load according to the sterilizer manufacturer’s instructions.
3. Release the load or pack if the dark bar on the SteamPlus Integrator has entered the blue SAFE area. If the dark bar has not entered into the blue SAFE area, Do not release the load or pack.

While the SteamPlus Integrator is FDA cleared as equivalent in performance to a biological indicator, it does not replace the need to run a weekly or preferably daily BI test. However, it can be used as part of the immediate load release criteria for non-implant loads. Implant loads should be quarantined until BI results are known.