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Thursday, October 9, 2008

PROCEDURE FOR CALIBRATION OF AUTOCLAVE -SOP

1.0. PURPOSE:
This SOP provides an authorised procedure to carry out calibration & validation of Autoclave.
2.0. SCOPE:
This SOP provides the relevant methodology for the calibration and validation of Autoclave.
3.0. RESPONSIBILITY :
Q.C. Microbiologist.
4.0. ACCOUNTABILITY:
Manager-Quality Control
5.0. DEFINITIONS:
6.0. FREQUENCY:
6.1 Chemical Indicator - Every load.
6.2 Biological Indicator - Every Month.
7.0 Procedure :
7.1 Calibration:
7.1.1 Calibrate the temperature indicator, pressure gauge and probe once in a year by external agency or whenever any replacement or maintenance done on the apparatus.
7.1.2 Place the Benzoic acid AR grade as a chemical indicator for temperature calibration in regular sterilisation cycle . It melts at 121°C.
7.1.3 Maintain the records, and abort the particular load used for calibration.
7.2 Validation:
7.2.1 Perform the validation of autoclave during installation of Equipment and revalidation.
7.2.2 Heat distribution studies on empty chamber 3 times by using a multi-point data logger.
7.2.3 All probes must reach temperature 121°C to 124°C. Pressure must be with in 15 to 18 lbs maintain the same for 15 minutes cycle.
7.2.4 Heat distribution studies on minimum load of a load pattern one time by using a multi-point data logger.
7.2.5 All probes must reach temperature 121°C to 124°C. Pressure must be with in 15 to 18 lbs maintain for 15 minutes, & find the lag time.
7.2.6 Heat distribution studies on maximum load of a load pattern three time by using a multi-point data logger.
7.2.7 All probes must reach temperature 121°C to 124°C. Pressure must be with in 15 to 18 lbs maintain for 15 minutes, and find the lag time.
7.2.8 Heat penetration studies on minimum load of a load pattern three times by using a multi-point data logger.
7.2.9 All probes must reach temperature 121°C to 124°C. Pressure must be with in 15 to 18 lbs maintain for 15 minutes, and find the lag time.
7.2.10 Heat penetration studies on maximum load of a load pattern three times by using a multi-point data logger.
7.2.11 All probes must reach temperature 121°C to 124°C. Pressure must be with in 15 to 18 lbs maintain for 15 minutes, and find the lag time.
7.2.12 With the above heat penetration study the maximum lag time plus 15 minutes is regular operating cycle of the validated load pattern.
7.2.13 Microbial Challenge Test:
7.2.13.1 Keep spores suspension of Bacillus Stearothermophilus of having population 10 6 at various location of the autoclave along with probes during maximum load heat penetration study.
7.2.13.2 Sterilised spore ampoules incubate at 55° to 60°C for 120 hours.
7.2.13.3 Spore ampoules should not show any colour change at the end of the incubation.
7.2.13.4 Maintain the records.
7.3 Cleaning:
7.3.1 Ensure that the equipment is isolated from the power before starting the cleaning activity.
7.3.2 The outside of the autoclave should be wiped with a wet sponge and allow to dry.
7.3.3 Clean the chamber with 0.1% SLS solution using the sponge.
7.3.4 Wash thoroughly with purified water till get free from the detergent.
7.3.5 Enter the cleaning details in the log book.

1 comment:

sarbudeen said...

good very nice information about quality