How to use the 4-level steam indicator strips correctly? Operation Guide and FAQ

1. Overview of 4-level steam indicator strips

The 4-level steam indicator strips are an important tool for sterilization process validation. They are made of 240 g/m2 cardboard and special steam sterilization indicators. These indicator strips are designed for high-pressure steam sterilizers and comply with ISO 11140-1 and EN 867 international standards. They can visually display whether the sterilization process has reached the preset critical conditions (temperature and time).

Product Features:

Autoclavable: Yes

Material: High-quality cardboard + special indicator

Color change: blue → black (after reaching sterilization conditions)

Standard sterilization parameters: 121°C/15 minutes or 134°C/3.5 minutes

2. Operation Guide

• Preparation before use

Check the integrity of the package to ensure that the indicator strip is not damaged

Confirm that the sterilized items are suitable for steam sterilization

Understand the type of sterilizer and preset parameters (temperature and time)

• Correct placement method

Place the indicator strip inside each sterilization package

For large sterilization packages, it is recommended to place it at the geometric center

Avoid direct contact with the inner wall of the sterilization package or metal instruments

Place multiple indicator strips at different positions in the sterilizer to monitor uniformity

• Sterilization process monitoring

Run the sterilization program

Observe whether the sterilizer parameters meet the preset conditions

Record the temperature and time data during the sterilization process

• Post-sterilization inspection

Immediately check the color change of the indicator strip after removing the sterilization package

Complete color change (blue → black) indicates that the sterilization conditions have been reached

Partial color change or no color change indicates that there may be problems in the sterilization process

Record the inspection results and save the records

3. Precautions

Storage conditions:

Temperature: 15-30°C

Humidity: <70%RH

Avoid direct sunlight

Keep away from chemical reagents

Usage restrictions:

Cannot be used for dry heat sterilization or chemical sterilization

Cannot replace biological indicators

Cannot be used as the only criterion for judging sterilization effect

Quality control:

Regularly check the perfor

Safety protection:

mance of the sterilizer

Use other monitoring methods (such as biological indicators) in conjunction

Establish a complete sterilization monitoring record system

Wear gloves when handling discolored indicator strips

Dispose of used indicator strips according to medical waste disposal procedures

4. FAQ

Q1: Why does the indicator strip not change color completely?

A: Possible reasons include:

Sterilization temperature does not reach the preset value

Insufficient sterilization time

Insufficient steam saturation

Improper placement of the indicator strip

Sterilizer failure

Q2: Can the indicator strip be reused after it changes color?

A: No. The Level 4 steam indicator strip is a one-time use product. After the color changes, its monitoring function is completed and it cannot be reused.

Q3: Which sterilizers can the indicator strip be used for?

A: Applicable to all high-pressure steam sterilizers that meet the standards, including:

Gravity displacement sterilizer

Pre-vacuum sterilizer

Pulsating vacuum sterilizer

Q4: How long is the shelf life of the indicator strip?

A: Usually 2-3 years (specific details are subject to the product packaging label), and it should be stored in a dry, light-proof, and temperature-appropriate environment.

Q5: Will the color of the indicator strip fade after it changes color?

A: Under normal conditions, the black color after the color change is stable and will not fade. However, it should be avoided from long-term exposure to strong light.