Performance Qualification Report for steam steriliser

Performance Qualification Report for Steam Sterilizer

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 to comply with the acceptance criteria as per the protocol. Date of qualification started /Date of Report

Steam Quality Tests (Dt:____________)

Test Acceptance criteria Observations
Run – 1 Run – 2 Run – 3
Steam Non-Condensable Gas NMT 3.5%. 0.49 0.49 0.49
Super Heat NMT 25oC 19.8 oC 19.5 oC 19.7 oC
Steam Dryness NLT 0.95 0.984 0.970 0.984

Vacuum Leak Test (Dt:                                       )

Test Acceptance criteria Observations (mbar/min)
Run 1 Run 2 Run 3 Run 4
Vacuum Leak NMT 1.3 mbar/min

Bowie – Dick Test (Dt: ______________)

Test Acceptance criteria Observations (Complies/ Doesn’t complies)
Run – 1 Run – 2 Run – 3
Bowie – Dick Test Uniform change throughout the indicator. Complies Complies Complies

Heat Distribution – Empty Chamber

Run No. 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 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. 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 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. 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 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. 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 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. 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 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. 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 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)

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 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)

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 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

Date of Run Sterilization Hold F0 Value Bio-challenge

Study

Hold period (Minutes) Pressure

(Kg/cm2)

Min. Max. Min. Max. Min. Max.
Acceptance criteria 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 and 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

All test procedures are executed and verified as per the protocol.
All acceptance criteria outlined 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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