SOP for Bowie dick test

  • Objective:
  • To lay down a procedure for bowie dick test
  • Scope:
  • This SOP is applicable for Bowie Dick test in pharmaceutical plant.
  • Responsibility:
  • Production Officers /Executive shall be responsible for follow the procedure mentioned in this SOP..
  • Accountability:
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure
  • MMI : Man Machine Interface
  • PLC : Programmable Logic Controlle
  • 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, pure steam, plant steam and compressed air.
  • Check the pressure of compressed air should not be less then 6.0 kg/cm².
  • Open the valve of plant steam supply line and ensure that the pressure of plant steam supplied to the autoclave in the pressure gauge is not less than 2 kg/cm².
  • Open the valve on pure steam supply line and ensure that the pressure of pure steam supplied to the autoclave in the pressure gauge is Not Less Than 2 kg/cm².
  • Load the bowie dick test kit in the Bung processor cum Steam Sterilizer (Keep the kit at 200mm from the bottom of chamber) as per validated loading pattern.
  • Press the “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
  • Select the Cycle No.on the MMI of the Bung processor cum Steam Sterilizer. Check and verify the standard parameter of bowie dick test on man machine interface (MMI)  as per mentioned below:
  • Set Parameter:
Sr.NoParametersSet value of cycle
1Pre Vacuum-0.500 Bar
2Pre pressure0.500 Bar
3No of pre pulses3 Nos
4Heat up 1110.0 °C
5Heat up Hold 15 min
6Heat up 2115.0 °C
7Heat up Hold 23 min
8Heat up 3118.0 °C
9Heat up Hold 32 min
10Heat up control Band0.4 °C
11Sterilization Hold temperature122.0°C
12Sterilization Hold time1020 seconds
13Temperature control Band0.2 °C
14Over shoot temperature124.0 °C
15Sterilization stop temperature120.9 °C
16Sterilization Reset temperature120.8 °C
17Process End pressure-0.050 Bar
18Exhaust ON5 sec
19Exhaust OFF55 sec
  • On completion of the sterilization according to the set parameter, indicator of “process end” will glow on sterile side door and the process will stop, displaying the message ‘Process End’ on MMI.
  • Check the cycle graph for Bowie Dick test load for temperature and time during the sterilization hold.
  • Check the uniform color of Bowie dick paper is dark brown after the cycle.
  • If the graph does not match the cycle will be considered invalid. Repeat the Bowie Dick test. Inform the deviation to the Quality Assurance Department. Carry out the further processing as per the suggestions from the quality assurance.
  • Record the cycle details of Operation in the Equipment Logbook as per SOP and get it checked by the Concerned Supervisor / Officer
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    DateRevision Number
    Reason for Revision
    00New SOP

 

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