SOP for Qualification of Autoclave

Learn how to prepare a procedure for Qualification of Autoclave in the microbiology Laboratory.

1.0 PURPOSE

To describe the procedure for qualification of autoclave machine in a microbiological laboratory.

2.0 SCOPE

This SOP is applicable for qualification of autoclave machine in the Microbiology Laboratory.

3.0 RELATED DOCUMENTS

User Manual

4.0 RESPONSIBILITY

4.1 Executive, Microbiology is responsible for qualification procedure.

4.2 Senior Executive/ Executive, Microbiology is responsible for supervising the qualification procedure.

4.3 Head of Quality Assurance will be responsible for effective implementation and training of procedure.

5.0 ACCOUNTABILITY

Head of Department

6.0 PRECAUTIONS

Should maintain all safety safeguards in place for the microbiology lab.

Read also: SOP for Maintenance of Stock Cultures in Microbiology

7.0 PROCEDURE

The quality assurance department will perform an annual qualification of autoclave protocol.

Every year, an outside organization qualifies for autoclaves; the Department of Microbiology and Quality Assurance then reviews the report.

The quality assurance section is in charge of keeping the report.

7.1 Autoclave qualification includes the following steps:

7.1.1 Physical Confirmation:

7.1.1.1 The Microbiology Department will examine the physical operation of the pressure and temperature gauges.

7.1.1.2 An independent organization will perform the proper operation of the steam trap valve and the calibration of the pressure and temperature gauges.

7.1.2 Temperature Profiling:

7.1.2.1 Take note of the sterilizing cycle’s operating parameters, which are 121°C, 15 pounds, and 30 minutes for the empty cycle.

7.1.2.2 The empty cycle’s goal is to examine how evenly the heat is distributed throughout the chamber.

7.1.2.3 Insert 16 temperature mapping probes into the autoclave chamber through its port, then add a chemical indicator strip on top of each probe.

7.1.2.4 Position the probes in the chamber such that they hang in various positions and are not in contact with any autoclave components.

7.1.2.5 Connect a data logger to the probes.

7.1.2.6 Run the autoclave and turn on the autoclave data logger to keep track of the sterilizing chamber’s real temperature over time.

7.1.2.7 Use the same approach for cycles that are half-loaded and fully loaded at 121°C, 15 pounds, and 15 minutes.

7.1.2.8 The half-loaded and fully-loaded cycles are used to test the heat distribution within the chamber and identify any cold spots within the autoclave.

7.1.3 Chemical Indicator:

After the cycle is complete, the color changes from yellowish to brownish-black.

7.2 Acceptance requirements:

Equal heating and heat penetration across the autoclave chamber.

7.3 Recurrence:

 Annually by an external agency.

8.0 ABBREVIATIONS

8.1 SOP: Standard Operating Procedure

9.0 ANNEXURES

Nil