Standard Operating Procedure For Steam Sterilization Of Filled Goods By Autoclaving

by Pharmadocx Consultants

SUBJECT:  Procedure For Steam Sterilization Of Filled Goods By Autoclaving.

PURPOSE: To lay down procedure for  steam sterilization of filled goods by autoclaving.

RESPONSIBILITY  :   Production Manager.

INTRODUCTION:- Autoclaving is of moist heat sterilization method. Steam under  pressure destroys micro organisms by causing protein coagulation or denaturation. Air inside the Autoclave should be replaced by saturated steam. Autoclave should not be opened at high temperature as it can be fatal.


1) Autoclave attached with temperature gauze from 0° to 150° C. and pressure gauze of range 0 to 30 PSI.

2) Signaloc Indicator of sky blue colour, make Johnson & Johnson.

3) Electric supply.


1)         Check water level of autoclave, make it up to the mark with purified water I. P.

2)         Place all goods to be sterilized in the S.S. tray & place the tray in side the   autoclave. Place a  Signaloc Indicator marked with date, batch no., time over the tray.

Author: (Production Manager)Checked by: (QA Manager)Authorized by: (Director Administration)
Date:Date :Date :

(Review date on or before 12 months from date of authorization

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

15 June 2023

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