SOP on sterilization of vial filling and bunging machine parts

  • Objective:
  • To lay down a procedure for sterilization of vial filling and bunging machine parts.
  • Scope
  • This SOP is applicable for sterilization of vial filling and bunging machine parts.
  • Responsibility
  • Production Officers/ Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • Procedure
  • Controlled Area Operation.
  • Load the trolley with washed machine parts as per the attached validated loading pattern and diagram.
  • 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
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 10 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 Vial Filling & bunging machine parts load, for Temperature and time during the sterilization hold
  • Check the temperature control chart for the steam sterilization cycle parameters.
  • No. of Vacuum Pulses  :  01
  • Vacuum for Pulsing  :  -0.500 bar
  • Steam Pressure for Pulsing  : 0.500 bar
  • Sterilization Temperature Range  : 1210C to 1240C
  • During Sterilization Hold Period
  • Sterilization Hold Time : 25 minutes
  • Sterilization pressure during : Not Less Than 1.110 bar
  • Sterilization hold time
  • Vacuum Cycle : 30 minutes
  • If the thermograph of the cycle matches the Master chart, inform the Critical Area Personnel for unloading of the Sterilized Vial filling & bunging machine parts. Attach the Thermograph in the Batch Production Record (BPR)
  • If the thermograph does not match the Master chart the cycle will be considered invalid. Do not unload the Vial Filling & bunging machine parts 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 vial filling & bunging machine parts.
  • Transfer the sterilized vial filling & bunging machine parts to the vial filling room through dynamic pass box (between cooling zone & vial filling room).
  • 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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