SOP for sterilization of Miscellaneous Items

  • SOP for sterilization of Miscellaneous Items
  • Objective:
  • To lay down a procedure for sterilization of miscellaneous Items.
  • Scope:
  • This SOP is applicable for sterilization of Miscellaneous Items.
  • Responsibility:
  • Officers/above (Production-Injectable) is responsible for sterilization of Miscellaneous Items.
  • Accountability:
  • Production Head is accountable for the implementation and compliance of this SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure
  • MMI : Man Machine Interface
  • PLC : Programmable Logic Controller
  • ltr : liter

ALBENDAZOLE TABLET

  • Procedure
  • Controlled area operation
  • Miscellaneous items load consists of following items: Pressure vessel 10 ltr, Pressure vessel 50 ltr, S.S. buckets, Sponge pieces, lint free duster, S.S. Spoons, S.S. forceps, scoop, Measuring cylinder, Exposure stands, silicon tubings, cartridge filters, housing of cartridge filters, S.S. trays, waste bins etc.
  • Cartridge filters to be sterilized in miscellaneous Items load are air filters and disinfectant filtration filters used in the cooling room, No product filter should be sterilized in miscellaneous items load.
  • 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 that pressure of compressed air should not be less than 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 all the miscellaneous Items in the Bung processor cum Steam Sterilizer as per validated loading pattern.
  • Check all items as per “Checklist for miscellaneous items load”.
  • 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 miscellaneous Items 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 miscellaneous Items 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 miscellaneous Items 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 operation time details in equipment log book as per SOP on equipment operation, cleaning and maintenance of log book – Injectable and get it checked by production officer
  •     Critical Area Operation :
  • At the completion of sterilization cycle, light of Process End indicator will glow.
  • Ensure that Non sterile side door is closed before opening the door of sterile side and press the switch to open the sterile side door.
  • Aseptic area personnel shall unload the sterilized miscellaneous Items in cooling zone   (class 100) as per SOP on Operation on Bung processor cum steam sterilizer.
  • Forms and Records:
  • Checklist for miscellaneous items load – Annexure-1
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    DateRevision Number
    Reason for Revision
    00New SOP

Annexure-1

Check list for miscellaneous items load

Date    :

Load No         :

Sr. noItems Description Max Allowable QtyQty loaded Loaded byChecked by
1Pressure vessel 20 ltrs.1
2Pressure vessel 50 ltrs1
3SS buckets2
4Sponge pieces10
5Lint Free duster10 
6SS spoon5 
7SS Forceps8 
8SS Scoop1 
9Measuring cylinders2 
10Exposure Stands14 
11Silicon tubings1
12Cartridge filters4
13Housing for Cartridge filters4
14SS trays2
15Waste bins2
16Others 

 

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