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)
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 steam is ready or not.
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Start the steam valve of the main steam line which is coming into the
autoclave
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It should ready.
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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 operating smoothly.
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To check the condensate.
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Start the steam & insert it into the jacket of
autoclave & check the condensate is operating.
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Should be operated &after condensation water
from it is released into drainage.
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Temperature Indicator.
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Start the autoclave (Seam) inside the chamber by
closing the door tightly & observe the desired temperature is record or
not.
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It should show the required temperature (1210C.)
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To check pressure is reaches as per required
& is shown by pressure gauge.
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Start the autoclave (Seam) 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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