SOP FOR THE TEST OF STEAM PENETRATION UNIFORMLY IN AUTOCLAVE/ MOIST HEAT STERILIZER WITH USE OF CHEMICAL INDICATOR

1.0 Objective:

To study steam penetration evenly in Autoclave/ Moist heat sterilizer with the use of a chemical indicator using Autoclave tape and Sterigage 3M Strips.

2.0 Scope:

This procedure is applicable to study even and rapid steam penetration in Autoclave/Moist heat sterilizers.

3.0 Responsibility:

Microbiologist.

Assistant Microbiology.

Area Incharge/Machine Operator.

Production Pharmacist.

4.0 Accountability:

Production Manager

Quality Control Manager

5.0 Equipment and Materials

Autoclave or moist heat sterilizer

Chemical indicator

Test pack

Stopwatch

6.0 Procedure:

Place the chemical indicator i.e. (autoclave tape or 3M strip) according to the location chart plan on the selected locations on all shelves to check the steam penetration in all chambers.

Set and run the autoclave cycle at standard temperature/pressure/time i.e. 121oC/15psi/15 minutes.

After the completion of the cycle remove and observe the chemical indicator visually for even color changes i.e. (white bands must be converted to black bands indicating effective heat penetration throughout the cycle) in this case the test must be considered satisfactory

No change or brown color will indicate ineffective sterilization and the test must be considered as unsatisfactory. 

7.0 Records

The following records should be maintained for each test:

Date of test

The person who performed the test

8.0 Results of the test

In case of unsatisfactory performance inspects the previous performances of the autoclave from the logbook.

In case of any defect or problem in the autoclave paste the label OUT OF ORDER/NOT IN USE and send the autoclave to the engineering department for maintenance and repair and record the maintenance of the machine in the equipment repair logbook.

9.0 Disposal

The test pack should be disposed of in accordance with the facility's biohazardous waste disposal procedures.

1.0 Interpretation

If the chemical indicator has changed color, the autoclave or moist heat sterilizer is functioning properly and is capable of achieving the desired sterilization conditions. If the chemical indicator has not changed color, the autoclave or moist heat sterilizer is not functioning properly and should be repaired or replaced.

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You may like to read these links: 

1. List of All SOPs and Documents for the In-vivo Laboratory.

2. List of All SOPs and Documents for In-vitro Laboratory

3. List of All SOPs and Documents for the Animal House Facility

4. List of All SOPs and Documents for Clinical Research

5. SOP FOR PROCUREMENT, STORAGE, AND HANDLING OF BIOLOGICAL INDICATORS

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