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Performance Qualification Report for steam steriliser

  • REPORT APPROVAL

Performance Qualification is verified that all test cases required by the protocol are completed, reconciled and included in the qualification summary report.

Signatures in the block below indicate that all items in this Qualification Report have been reviewed and found to be acceptable.

  • SUMMARY REPORT

Data generated during qualification is reviewed and found complies with the acceptance criteria as per the protocol.

Date of qualification started
Date of Report
  • Steam Quality Tests (Dt:                                      )
S. No. Test Acceptance criteria Observations
Run – 1 Run – 2 Run – 3
1 Steam Non-Condensable Gas NMT 3.5%. 0.49 0.49 0.49
2 Super Heat NMT 25oC 19.8 oC 19.5 oC 19.7 oC
3 Steam Dryness NLT 0.95 0.984 0.970 0.984
  • Vacuum Leak Test (Dt:                                       )
S. No. Test Acceptance criteria Observations (mbar/min)
Run 1 Run

2

Run

3

Run

4

1 Vacuum Leak NMT 1.3 mbar/min 0.010 0.010 0.010 0.012
  • Bowie – Dick Test (Dt: ______________)
S. No. Test Acceptance criteria Observations (Complies/ Doesn’t complies)
Run – 1 Run – 2 Run – 3
1 Bowie – Dick Test Uniform change throughout the indicator. Complies Complies Complies
  • Heat Distribution – Empty Chamber
Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 2 121.0 121.8 1.1 1.2 35.47 57.01 No growth
2 30 2 121.1 123.1 1.1 1.2 34.85 57.46 No growth
3 30 1 121.0 122.7 1.1 1.2 34.25 57.16 No growth

 

  • Heat Distribution & Penetration – Rubber Stopper Holding Canister
Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 3 121.0 122.5 1.1 1.2 34.88 56.42 No growth
2 30    3 121.0 122.5 1.1 1.2 35.83 57.72 No growth
3 30    2l 121.0 122.6 1.1 1.2 36.54 57.97 No growth

 Heat Distribution & Penetration – Filling Machine Parts

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 2 121.0 122.7 1.1 1.2 40.40 56.28 No growth
2 30 2 121.0 122.7 1.1 1.2 40.13 56.89 No growth
3 30 4 121.0 122.5 1.1 1.2 40.62 56.10 No growth

 Heat Distribution & Penetration – Filtration Accessories

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 3 121.0 122.5 1.1 1.2 34.18 52.72 No growth
2 30 2 121.0 122.6 1.1 1.2 38.73 55.21 No growth
3 30 2 121.1 122.5 1.1 1.2 34.91 53.87 No growth

 

  • Heat Distribution & Penetration – Garments Load (Minimum)
Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 31 2 121.0 122.5 1.1 1.2 33.46 45.99 No growth
2 30 2 121.0 122.5 1.1 1.2 34.79 57.22 No growth
3 31 3 121.0 122.3 1.1 1.2 34.46 56.88 No growth

 

Heat Distribution & Penetration – Garments Load (Maximum)

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 2 121.0 122.5 1.1 1.2 37.43 55.45 No growth
2 30 3 121.0 122.5 1.1 1.2 40.11 56.11 No growth
3 30 2 121.0 122.3 1.1 1.2 42.54 56.27 No growth

 Heat Distribution & Penetration – Rubber Stoppers(minimum)

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 1 121.0 122.4 1.1 1.2 38.51 55.21 No growth
2 30 3 121.1 122.9 1.1 1.2 43.47 64.02 No growth
3 30 2 121.1 123.0 1.1 1.2 43.35 63.34 No growth

Heat Distribution & Penetration – Rubber Stoppers(maximum)

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Lag period Hold Temperature (0C) Pressure (Kg/cm2)
Min. Max. Min. Max. Min. Max.
Acceptance criteria à 30 NMT

5 min.

121 124 1.1 1.2 NLT

31.00

No growth should be observed
1 30 2 121.0 122.4 1.1 1.2 41.55 63.68 No growth
2 30 2 121.1 122.9 1.1 1.2 44.79 63.47 No growth
3 30 2 121.1 123.0 1.1 1.2 41.23 54.27 No growth

 Heat Distribution & Penetration – Media vessels with WFI water

Run No. Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Pressure

(Kg/cm2)

Min. Max. Min. Max. Min. Max.
Acceptance criteria à NLT 15 NMT

5 min.

121 124 1.1 1 1.2 NLT

31.00

No growth should be observed
1 30 2 121.0 122.9 1.1 1.2 33.57 48.11 No growth
2 30 2 121.0 122.9 1.1 1.2 35.91 53.93 No growth
3 30 3 121.0 122.9 1.1 1.2 35.12 63.68 No growth
As load is a liquid load no biological indicator is used. During actual liquid nutrient media sterilization growth promotion testing as well as sterility of the media for each load shall be checked, to ensure that there is no adverse effect on the sterility and growth promotion capability of the liquid media after the steam sterilization cycle.

 Summary of observations

Checks Observations (Yes/No) Reviewed By

Sign/ Date

All test procedures executed and verified as per the protocol.
All acceptance criteria set forth in the Performance Qualification were met

 

Deviation if any: (If required attach separate sheet)

 CONCLUSION

The equipment is qualified / not qualified for the Performance. Hence, it is ready / not ready for “Routine Use”.

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