1.1 Verification and sequential operation of sterilization cycles
1.1.1 Test procedure: The prime objective of this test is to
verify the physical qualification and integrity of the Autoclave. A minimum of
three observations to be made.
1.1.2 Vacuum leak test
1.1.2.1 Objective : To check the sequential operation of vacuum leak test cycle
1.1.2.2 Procedure :
· Ensure that all the critical instruments are in
a calibrated state.
· Select the vacuum leak test cycle from HMI as
per SOP.
· During vacuum leak test, the equipment should
operate as follows:
· Vacuum level reaches in the chamber and note the
reading (P1) by manual observation in PLC. (Negative pressure should
less than -0.85 bars).
· 2nd: Hold the vacuum for 5 minutes i.e. delay
before hold (Should not be more than 5 min and less than 2 minutes).
· 3rd: Note the reading (P2)
after 5 minutes delay period.
· 4th: Continue holding of vacuum
for further 10 minutes.
· 5th: Note the reading (P3) of
vacuum after the 10 minutes.
· Equipment the operator is to note the pressure
of P1, P2 and P3 from print out.
· Calculate the rate of vacuum drop as per the
following formula
Rate
of vacuum drop =
· Attach the cycle printout with
the identification of all sequential steps.
1.1.2.3 Acceptance criteria: The maximum acceptable leak should be less
than 10mm of Hg/ 10 minutes of hold.
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