Sterilization control indicators

Sterilization control indicators are strips of heat-resistant paper with markings and film that show whether the sterilization process has been successful. They have markings and two colored dots: an indicator dot (which changes color) and a comparison standard dot (to observe changes).

What are sterilization indicators used for?
Control is a crucial aspect of sterilization. Questions often arise: how can one be sure that the instrument is sterile? How to check the operation of a dry heat sterilizer? How to prove to the client and inspecting authorities that all standards have been met? This is where indicators come into play.

They are placed inside a sterilization pouch and distributed in 5 control points throughout the sterilization chamber (similar to an envelope).
After sterilization, they are affixed to the sterilization control journal, filling in all other fields.
This serves as the primary evidence that sterilization has been successful.
Many professionals believe that using indicators is not mandatory since sterilization pouches already have indicators. However, this is not entirely accurate.

What types of sterilization indicators are there?
External indicators are placed on the sterilization pouch or distributed throughout the sterilization chamber. If any indicator fails to change color, the instruments cannot be considered sterilized, and the sterilization process needs to be repeated. If some indicators do not change color even after the second or third cycle, the dry heat sterilizer is not functioning correctly, and assistance from the manufacturer's service center is required.
After sterilization, the 5 indicators are affixed to the sterilization control journal.
Internal indicators are placed inside the sterilization pouch or affixed on top if there is no indicator initially on the sterilization pouch.

Classes of sterilization indicators
Sterilization control indicators have classes, which represent the parameters at which the indicators change color. We will describe all of them, but focus on classes 1 and 4.

Class 1 indicators are placed outside the sterilization pouch or inside, alongside the instruments (external and internal). If the color changes, it indicates that the pouch has been processed. This is a crucial distinction between a sterilized and non-sterilized pouch.
Class 2 indicators test the effectiveness and quality of the vacuum pump and air circulation in the sterilization chamber. They are not used for sterilization control.
Class 3 indicators only react to 1 critical parameter, usually temperature.
Class 4 indicators simultaneously test several parameters of the sterilization process. The indicator dot changes color only when the required temperature, maintained for the necessary duration, is achieved.
Class 5 indicators are integrating, reacting to all critically important parameters of the sterilization process.
Class 6 indicators are emulating indicators. They record multiple modes and react to almost all possible parameters.
Indicators on sterilization pouches belong to class 1. Consequently, they change color as soon as the sterilization chamber reaches the required temperature.

Class 4 indicators are the most suitable for use and for controlling the operation of dry heat sterilizers.

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