Friday, 5 July 2019

Performance Qualification of Autoclave

Performing the Performance Qualification.
Perform the Operational Qualification as per the check list which contains points defined in the installation requirement that the HORIZONTAL AUTOCLAVE –I, is supposed to fulfill. In addition, list out control points installed and check the temperature and pressure conditions achieved after the HORIZONTAL AUTOCLAVE –I, has been started after shut down. Note down all the observations in the Operational Qualification Report. The HORIZONTAL Autoclave –I, shall be handed over to Quality Control only after successful completion of Operational Qualification. 
Record all observations and deviations in the report. In case of deviation prepare a deviation report with justification and get it approved by Head Quality assurance, Head Quality Control.
Check list for Performance Qualification: -
Test  ( S) Required
Test Description
Acceptance Criteria
Checked by
To check the steam is ready or not.
Start the steam valve of the main  steam line which is coming into the autoclave 
It should ready.

To check the steam valve is working
Operate the steam valve of the steam line closing & opening it.
Steam valve should be operating smoothly.

To check the condensate.
Start the steam & insert it into the jacket of autoclave & check the condensate is operating.
Should be operated &after condensation water from it is released into drainage.

Temperature Indicator.
Start the autoclave (Seam) inside the chamber by closing the door tightly & observe the desired temperature is record or not.  
It should show the required temperature (1210C.)

To check pressure is reaches as per required & is shown by pressure gauge.
Start the autoclave (Seam) inside the chamber by closing the door tightly & observe the desired pressure is record / shown or not.  
It should show the required pressure.(1.2Kg/CM2)

To check the leakage of pressure or steam from the autoclave.
Close the door tightly &start the steam inside the chamber & observe for leakage.
It should not be leak.

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.