Qualification of Autoclave – SOP

By / Microbiology / Microbiology, SOP /

Autoclave Qualification Procedure

  • Qualification of Autoclave covers below points
    • Physical verification
    • Temperature profiling
    • Chemical Indicator
    • Acceptance criteria
    • Frequency
1.0 OBJECTIVE :
  • To provide a procedure for qualification of steam Autoclave.
2.0 SCOPE :
  • This procedure is applicable for autoclave machine in Microbiology Section
3.0 RESPONSIBILITY :
  • Microbiologist
4.0 ACCOUNTABILITY:
  • Head of Department
5.0 PROCEDURE :

For qualification of autoclave protocol will be made by quality assurance department on yearly basis.

Qualification of Autoclave is performed by outside agency on yearly basis and obtained report is checked by microbiology and quality assurance department.

The report is kept in custody of quality assurance department.

5.1  Qualification of Autoclave consists of following stages:

  • Physical verification:
    • Physical functioning of pressure gauge, temperature gauge will be checked by Microbiology department.
    • Proper functioning of steam trap valve and calibration of pressure gauge, temperature gauge will be carried out by outside agency.
  • Temperature profiling:
    • Record the parameter for the sterilization cycle to be operated during the test for empty cycle 121°C,15 lbs for 30 minutes.
    • Purpose of empty cycle is to check the heat distribution throughout the chamber.
    • Place 16 temperature mapping probe into chamber through the port of the autoclave chamber, also place one chemical indicator strip along with temperature mapping probe.
    • Suspend the probes in the chamber in different position so that probes do not touch any part of the autoclave.
    • Connect the probes to a data logger.
    • Operate the autoclave and start the autoclave data logger to record the actual temperature within the sterilization chamber with respect to time.
    • Follow same procedure for half loaded cycle and full loaded cycle at 121°C, 15 lbs for 15 minutes.
    • Purpose of half loaded and fully loaded cycle is to check the heat penetration throughout chamber and detect the cold spot in the autoclave.
  • Chemical Indicator:
    • Colour change from yellowish to Brownish black after completion of cycle.

5.2 Acceptance criteria:

  • Uniform distribution and penetration of heat in the autoclave chamber.

5.3 Frequency :

  • Yearly by outside agency.

6.0 ABBREVIATIONS:
AbbreviationExpanded form
°CDegree Celsius
lbsPound

7.0 ANNEXURES:

Nil

8.0 SOP REFERENCES
  • Manual

END OF THE SOP