Pharma Tips

Auto Clave Standard Operating Procedure

By: Pharma Tips | Views: 3403 | Date: 29-Aug-2011

A chamber for sterilizing with steam under pressure. The original autoclave was essentially a pressure cooker. The steam tightened the lid. The device was called an autoclave (from the Greek auto, self + clavis, key) meaning self-locking.

SOP FOR CALIBRATION

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:

A chamber for sterilizing with steam under pressure. Theoriginal autoclave was essentially a pressure cooker. The steam tightened the lid. Thedevice was called an autoclave (from the Greek auto, self + clavis, key) meaningself-locking.

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.

SOP FOR OPERATION AND CLEANING


1.0 Purpose :

This SOP provides an authorised procedure for operating and
cleaning of an Autoclave

2.0 Scope :

This procedure applicable to Vertical Autoclave used for media and
Culture destruction in microbiology department.
(Identification number)

3.0 Responsibility :

Microbiologist QC , Q.C.Manager.

4.0 Procedure :


4.1.0 OPERATION:

4.1.1 Ensure that the equipment is clean.
4.1.2 Connect the equipment to the main power supply.
4.1.3 Open valve and fill with purified water up to the indicator level.
4.1.4 Loosen the butterfly knobs and lift up the lid of the autoclave using leg operated paddle and slide it on its one side.
4.1.5 Load the items to be destructed and close the lid and tighten any two opposite knobs evenly until cover is securely fastened
4.1.6 Switch on the autoclave.
4.1.7 Allow the pressure to reach upto 5 lbs, then open the pressure valve and release the vapour along with the water droplets.
4.1.8 Close the pressure release valve allow the pressure to reach upto 15 to 18 lbs and it maintains the pressure range constantly by safety
        valve.
4.1.9 Allow the process till the validated time required for destruction.
4.1.10 After sterilisation, as per the holding time the autoclave switch OFF.
4.1.11 Open the safety valve to release the steam.
4.1.12 After the pressure gauge shows ‘0’ reading, open the lid and remove the destructed items.
4.1.13 Close the lid properly and disconnect the equipment from the power supply.
4.1.14 Enter the details in the media destruction log book.
a) Load number.
b) Autoclave holding time ( From - To).
c) Pressure ( 15lbs to 18lbs).
d) Sign.

4.2.0 Cleaning:

4.2.1 Ensure that the equipment is isolated from the power before starting the cleaning activity.
4.2.2 The outside of the autoclave should be wiped with a wet sponge and allow to dry.
4.2.3 Clean the chamber with 0.1% SLS solution using the sponge.
4.2.5 Wash thoroughly with water till it is free from the SLS and rinse with distilled water.
4.2.6 Enter the cleaning details in the log book.
4.2.7 Frequency: Once in a week.

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