SOP for sterilization of cartridge Filter

SOP for sterilization of cartridge Filter

  • Objective:
  • To lay down a procedure for sterilization of cartridge filter.
  • Scope:
  • This SOP is applicable for sterilization of cartridge filter pre assembled in filter housings.
  • Responsibility:
  • Production Officers / Executive.
  • Accountability:
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure
  • MMI : Man Machine Interface
  • PLC : Programmable Logic Controller

Cetirizine Dihydrochloride 10 mg Tablet

  •  Procedure
  • Controlled area operation
  • 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 cartridge filters pre assembled in filter housings in the Bung processor cum Steam Sterilizer as per validated loading pattern.
  • 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
  • Select the Cycle No. 6 on the MMI of the Bung processor cum Steam Sterilizer. Check and verify the standard parameter of cartridge filter cycle 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 pulses1 No
4Heat up 1110.0 °C
5Heat up Hold 15 min
6Heat up 2115.0 °C
7Heat up Hold 25 min
8Heat up 3118.0 °C
9Heat up Hold 34 min
10Heat up control Band0.2 °C
11Sterilization Hold temperature122.0°C
12Sterilization Hold time25 min
13Temperature control Band0.2 °C
14Over shoot temperature124.0 °C
15Sterilization stop temperature120.9 °C
16Sterilization Reset temperature120.5 °C
17Post vacuum-0.700 Bar
18Vacuum Hold Time15 min
19Post Pressure-0.100 Bar
20No of post pulses1 No.
21Process End pressure-0.050 Bar
22Exhaust ON5 sec
23Exhaust 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 cartridge Filters load for temperature and time during the sterilization hold.
  • If the graph does not match the cycle will be considered invalid. Don’t unload the Cartridge Filters in the aseptic Area. Repeat the sterilization cycle. 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 Batch production record, get it checked by the Concerned Supervisor / Officer
  • Aseptic Area Operation :
  • After completion of cycle light of “Process End” is glow.
  • Ensure that Non sterile side door is close before open the door of sterile side and press the switch to open the sterile side door.
  • Aseptic personnel unload the sterilized Cartridge Filters in cooling zone (class 100) as per SOP .
  • 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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