SOP for Operation of Vacuum Leak Test

  • Objective:
  • To lay down a procedure for operation of vacuum leak test
  • Scope:
  • This SOP is applicable for operation of vacuum leak test.
  • Responsibility:
  • Production Officers / Executive.
  • Accountability:
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure
  • MMI : Man Machine Interface
  • NST : Non sterile side
  • Procedure
  • Switch ON the machine with the key.
  • Ensure that autoclave chamber is dry and temperature is ambient.
  • Check the cleaning of chamber and all around the machine.
  • Check the availability of soft water and compressed air.
  • Check the pressure of compressed air should not be less then 6.0 kg/cm².
  • Press the “NST door close switch” to close the door.
  • Check the pressure of following mentioned below on front of the panel :-
  • Jacket Pressure : 0.0 Kg/cm²
  • Sterile side gasket : 3.0 Kg/cm²
  • Non sterile gasket : 3.0 Kg/cm²
  • Chamber pressure : 0.0 Kg/ cm²
  • Check and verify the standard parameter of vacuum leak test on man machine interface (MMI) for cycle no.1 as per mentioned below:
  • Set Parameter:
  • Pre – Vacuum : -0.850 BAR.
  • Delay Before Hold : 5 MIN.
  • Vacuum Hold Time : 10 MIN.
  • Acceptable Leakage  : 0.013 BAR.
  • Process End Pressure : – 0.050 BAR.
  • Press “start” on main menu display.
  • Press “Select Process” to select the cycle.
  • Press “Print Para” to take print of the cycle.
  • Press “starts process” to start the selected vacuum leak test cycle no.1.
  • The vacuum pump starts and the display of vacuum can be observed on the process recorder screen and the MMI screen.
  • When the Vacuum process reaches -0.850 BAR, the vacuum pump stops, simultaneously the process recorder records the first process reading.
  • The process recorder records the second vacuum reading after a gap of five minutes from the first reading.
  • The process recorder records the third vacuum reading after a gap of 10 minutes, from the second reading.
  • Calculate the vacuum drop during the 10 minutes period (second reading – first reading).
  • Calculate the vacuum drop rate i.e. (second reading – first reading /10).
  • The vacuum drop rate should not be more than 13 millibar = 0.013 bar in 10 minutes.
  • If the chamber of autoclave fails in vacuum leak test, the autoclave shall be given for maintenance .The sterilization load shall be taken only after the chamber passes in vacuum leak test.
  • Vacuum leak test of chamber is to be done once every day before start of any operation.
  • Record the Operation in the equipment log book as per SOP and get it checked by production officer / supervisor.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    DateRevision Number
    Reason for Revision
    00New SOP

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