Performance Qualification Report for steam sterilizer
- 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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