Performing the
Performance Qualification.
Perform the
Operational Qualification as per the check list which contains points defined
in the installation requirement that the Double Door Autoclave, is supposed to
fulfill. In addition, list out control points installed and check the
temperature and pressure conditions achieved after the Double Door Autoclave has
been started after shut down. Note down all the observations in the Operational
Qualification Report. The Double Door Autoclave 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: DOUBLE DOOR AUTOCLAVE
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Test ( S)
Required
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Test Description
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Acceptance Criteria
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Results
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Checked by
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To check the automatic door opening and closing.
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Check the opening and closing of door.
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The door opening and closing should be automatically controlled by
electro-pneumatic circuit.
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To check the steam valve is working
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Operate the steam valve of the steam line closing
& opening it.
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Steam valve should be operate smoothly.
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To check the door safety.
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Open both the door of autoclave.
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Both the doors should not open simultaneously due to
door interlock system.
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To check the sterilization set point .
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Start the autoclave (Steam) inside the chamber by
closing the door tightly & observe the desired temperature is record or
not.
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It should show the set point of 122 +/- 1°C for
variable time.
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To check the chamber and jacket pressure is
reaches as per required & is shown by pressure gauge.
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Start the autoclave (Steam) inside the chamber by
closing the door tightly & observe the desired pressure is record / shown
or not.
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It should show the required pressure.(1.2Kg/CM2)
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To check the leakage of pressure or steam from
the autoclave.
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Close the door tightly &start the steam
inside the chamber & observe for leakage.
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It should not be leak.
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Test ( S)
Required
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Test Description
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Acceptance Criteria
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Results
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Checked by
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To check the sterilization time, condensate drain
temperature and chamber temperature at multiple points.
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The autoclave have necessary provision for all
these process control parameters.
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All these parameters should be controlled by
autoclave.
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To check the performance pf following cycles.
Standard sterilization cycle
Slow steam sterilization cycle.
HPHV Cycle
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The autoclave is started as per the operating
procedure and the performance for various cycle is checked.
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The autoclave should be capable of performing all
the listed cycles.
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