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Performance Qualification of Autoclave

The document provides a checklist for performing the performance qualification of a horizontal autoclave. The performance qualification involves checking that the autoclave meets temperature, pressure, and other operational requirements. Observations and any deviations are recorded in a report. If deviations occur, a deviation report with justification must be prepared and approved by quality assurance and control heads. The autoclave can only be handed over to quality control once operational qualification is successfully completed.

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202 views2 pages

Performance Qualification of Autoclave

The document provides a checklist for performing the performance qualification of a horizontal autoclave. The performance qualification involves checking that the autoclave meets temperature, pressure, and other operational requirements. Observations and any deviations are recorded in a report. If deviations occur, a deviation report with justification must be prepared and approved by quality assurance and control heads. The autoclave can only be handed over to quality control once operational qualification is successfully completed.

Uploaded by

jaimurugesh
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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: -
EQUIPMENT / SYSTEM: HORIZONTAL AUTOCLAVE-I
Test   ( S) Test Description Acceptance Criteria Results Checked by
Required
To check the Start the steam valve It should ready.
steam is ready of the main   steam
or not. line which is coming
into the autoclave 
To check the Operate the steam Steam valve should
steam valve is valve of the steam be operating
working line closing & smoothly.
opening it.
To check the Start the steam & Should be operated
condensate. insert it into the &after condensation
jacket of autoclave water from it is
& check the released into
condensate is drainage.
operating.
Temperature Start the autoclave It should show the
Indicator. (Seam) inside the required temperature
chamber by closing (1210C.)
the door tightly &
observe the desired
temperature is
record or not.  
To check Start the autoclave It should show the
pressure is (Seam) inside the required pressure.
reaches as per chamber by closing (1.2Kg/CM2)
required & is the door tightly &
shown by observe the desired
pressure gauge. pressure is record /
shown or not.   
To check the Close the door It should not be leak.
leakage of tightly &start the
pressure or steam inside the
steam from the chamber & observe
autoclave. for leakage.

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