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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