SOP For Validation of Autoclave

SOP For validation of Autoclave is described in this post which you can follow in the section of the Quality Assurance Department.

INTRODUCTION:

Items that are to be sterilized but which cannot withstand the high temperature of the dry heat sterilizer are sterilized by steam in an autoclave at a temperature of 121°C

Depending upon the various loads to be sterilized in the autoclave, a time temperature relationship has to be established for each load to achieve sterilization of the load.

In order to establish the time temperature relationship required for sterilization, each load of the autoclave has to be validated using a calibrated multi probe digital temperature indicator having a minimum of 6 probes, and using a standard loading pattern of the autoclave for the various loads.

OBJECTIVE:

The objectives of this process (wet heat Sterilization) validation study is to

Ensure and justify, through continuous process monitoring, and documentation, the precision and consistency in the output against the already established Acceptance Criteria.

Identify and solve the problem(s), if any, encountered during the process.

Establish confidence on existing sterilization operation.

Find ways and means to increase productivity and improve quality.

Assure that complete process is under control.

REQUIREMENT

Procedure of the Sterilization of rubber stoppers and flip off / tear off seals.

Procedure for the operation of autoclave.

6 probe digital temperature indicator.

PRECAUTIONS

Material to be sterilized should be properly washed.

Material should be properly closed in the containers.

Bio indicators should be used in each load.

LOAD PATTERN DETERMINATION:

Description: Max. Load ( # of stoppers and seals as per batch size)

Rubber stoppers: ___________________________________________

Flip off / tear off seals: ______________________________________

HEAT PENETRATION TEST:

Each standard load or item must be validated. The loading pattern used should be same as used in heat distribution test. The validation must be performed under normal operating conditions e.g. washed and wrapped items should be treated using normal processes and usual conditions in order to provide meaningful information. Place at least 6 thermocouples inside the product or equipment that is loaded into the chamber under standard load conditions. One thermocouple must be placed in the cold spot which was determined from previous heat distribution studies of the same standard load with the article being sterilized is located in this area. The thermocouple must be placed inside it.

NOTE:

Each item must have at least one thermocouple placed in its most inaccessible location. One thermocouple must be placed in the cold spot. Keep one probe near the steam drain. Note the location of each probe and mark the diagram showing load pattern and locations of probes with validation report.

Release steam into the chamber and note start up time and temperature of digital thermometer. Continue recording time, digital thermometer temperature and temperature of each probe every minute.

Bio-Indicator Test:

For challenge test of autoclave following bio indicators are to be used.

Geo-Bacillus Steriothermophyllus Spores.

Procedure:

Place bio indicator strips at different places in the autoclave with the full load.

Run the autoclave as per the SOP.

After the completion of the autoclave cycle take out the bio indicators and transfer them to the microbiology lab for further processing.

Equipment Identification and Calibration Status

Name of Equipment:

Identification No.:

Location:

Loading Capacity: