SOP on sterilization of garment and surgical hand gloves

  • Objective
  • To lay down a procedure for sterilization of garments and surgical hand gloves.
  • Scope
  • This SOP is applicable for sterilization of garments and surgical hand gloves.
  • Responsibility
  • Production Officers /Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • LAF : Laminar Air Flow
  • Procedure
  • Controlled Area Operation
  • Load the trolley with garment bags as per the attached, validated loading pattern.
  • Operate the sterilizer as per SOP.
S.No. Parameters Set value in cycle
01. Pre vacuum -0.500 bar
02. Pre pressure 0.500 bar
03. No. of pre pulses 3 no.
04. Heat up 1 / Hold 1 110 0 C / 5 min
05. Heat up 2 / Hold 2 115.0 0 C / 5 min
06. Heat up 3 / Hold 3 118.0 0 C / 4 min
07. Heat up controlled band 0.2 0 C
08. Sterilization hold temperature 122.0 0 C
09 Sterilization hold time 25 min

 

10. Temperature control band 0.2 0 C
11. Overshoot temperature 124 0 C
12. Sterilizations stop temperature 120.9 0 C
13. Sterilization reset temperature 120.5 0 C
14. Post vacuum -0.700 bar
15. Vacuum hold time 15 min
16. Post pressure -0.100 bar
17. No. of post pulses   3
18. Process end pressure  -0.050 bar
19. Exhaust on 5 sec
20. Exhaust off  55 sec
  • On Completion of the cycle, check the cycle thermograph against the Master chart for garments and hand gloves load, for Temperature and time during the sterilization hold.
  • Check the temperature control chart for the steam sterilization cycle parameters.
  • No. of Vacuum Pulses  : 03
  • Vacuum for Pulsing  :  -0.500 bar
  • Steam Pressure for Pulsing : 0.500 bar
  • Sterilization Temperature Range  : 121 to 124 degree centigrade
  • During Sterilization Hold Period
  • Sterilization Hold Time : 25 minutes
  • Sterilization pressure during : Not Less Than 1.110 bar
  • Sterilization hold time
  • Vacuum Cycle : 45 minute
  • If the thermograph of the cycle matches the Master chart, inform the Aseptic area Personnel for unloading of the Sterilized garments and hand gloves. Attach the thermograph in the Batch Production Record (BPR).
  • If the thermograph does not match the Master chart the cycle will be considered. Do  not unload the garments and hand gloves 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 Log book as per SOP and the Batch production record, get it checked by the Concerned Officer
  • Aseptic area operation
  • Unload the trolley in cooling zone (class 100 area) containing the sterilized garments and the hand gloves.
  • Transfer the sterilized bags & surgical hand gloves to double door garment cubicle in aseptic change room 3rd
  • Store the sterilized garment and surgical hand gloves sets in garment cubicle.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision

     

    00 New SOP

     

 

 

 

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