MOIST HEAT STERILIZER

1. Objective:

To lay down a Standard Operating Procedure for Moist Heat Sterilizer with circular chart

2. Scope:

This procedure provides a Standard method to operate the Moist Heat Sterilizer with circular chart.

3. Responsibility:

v Operator.

v Senior Chemist.

v Head - Production.

4. Procedure:

4.1. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/051

4.2. Open the pressure lock door by turning the handle anti-clockwise, till the quick throw handle easily pushed down.

4.3. Load the materials to be sterilized into the chamber by keeping the materials in trolley with proper labeling.

4.4. Close the pressure lock door by pulling up the quick throw handle, after which the handle is to be turned clockwise till it is reasonably tight.

4.5. Open the bypass valve of the moisture separator for 5 minutes to remove all the condensed water which is already present, from the line and then close it.

4.6. Open the main line steam inlet valve.

4.7. Switch on the solenoid jacket steam valve, it will allow the steam inside of the jacket and due to this, pressure will gradually build up in the jacket.

4.8. Safety valve will open, if the inside pressure exceeds 15 lbs. So it will maintain the constant pressure in it.

4.9. Switch on the Inner solenoid steam valve, it will allow the steam inside of the chamber and due to this, pressure will gradually build up in it.

4.10. Open the outlet valve of the chamber and switch on the vacuum pump to suck out the air from the chamber to atmosphere to avoid the formation of air pocket.

4.11. After few minutes, close the outlet valve and switch off the Vacuum pump.

4.12. Drain the condensed steam for few minutes from the chamber by opening the bypass valve of the chamber.

4.13. Check thermograph for recording chart, ink and then put it on.

4.14. ‘Exposure Period & Temperature’ should be as per the validated time for various loads.

For Example:

§ 121⁰C/15 lbs for machinery parts, Latex gloves, tanks, sterile area dresses.

§ 116⁰C/10 lbs for Autoclaving (Non-aseptic) pharmaceutical products.

4.15. Switch off the solenoid jacket steam valve, Inner solenoid steam valve and close the Main steam valve.

4.16. Allow the steam to exhaust until both the pressure gauge indicates zero psi by opening the outlet steam valve of the chamber.

4.17. Prior to unloading the sterilized load on the sterile side, make sure that the sterilized load has been cooled to room temperature and the door of Non-sterile area side has been closed.