Performance Qualification Report for steam steriliser

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.TestAcceptance criteriaObservations
Run – 1Run – 2Run – 3
1Steam Non-Condensable GasNMT 3.5%.0.490.490.49
2Super HeatNMT 25oC19.8 oC19.5 oC19.7 oC
3Steam DrynessNLT 0.950.9840.9700.984
  • Vacuum Leak Test (Dt:                                       )
S. No.TestAcceptance criteriaObservations (mbar/min)
Run 1Run

2

Run

3

Run

4

1Vacuum LeakNMT 1.3 mbar/min0.0100.0100.0100.012
  • Bowie – Dick Test (Dt: ______________)
S. No.TestAcceptance criteriaObservations (Complies/ Doesn’t complies)
Run – 1Run – 2Run – 3
1Bowie – Dick TestUniform change throughout the indicator.CompliesCompliesComplies
  • Heat Distribution – Empty Chamber
Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1302121.0121.81.11.235.4757.01No growth
2302121.1123.11.11.234.8557.46No growth
3301121.0122.71.11.234.2557.16No growth

 

  • Heat Distribution & Penetration – Rubber Stopper Holding Canister
Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1303121.0122.51.11.234.8856.42No growth
230   3121.0122.51.11.235.8357.72No growth
330   2l121.0122.61.11.236.5457.97No growth

 Heat Distribution & Penetration – Filling Machine Parts

Run No.Date of RunSterilization Hold F0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1302121.0122.71.11.240.4056.28No growth
2302121.0122.71.11.240.1356.89No growth
3304121.0122.51.11.240.6256.10No growth

 Heat Distribution & Penetration – Filtration Accessories

Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1303121.0122.51.11.234.1852.72No growth
2302121.0122.61.11.238.7355.21No growth
3302121.1122.51.11.234.9153.87No growth

 

  • Heat Distribution & Penetration – Garments Load (Minimum)
Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1312121.0122.51.11.233.4645.99No growth
2302121.0122.51.11.234.7957.22No growth
3313121.0122.31.11.234.4656.88No growth

 

Heat Distribution & Penetration – Garments Load (Maximum)

Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1302121.0122.51.11.237.4355.45No growth
2303121.0122.51.11.240.1156.11No growth
3302121.0122.31.11.242.5456.27No growth

 Heat Distribution & Penetration – Rubber Stoppers(minimum)

Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1301121.0122.41.11.238.5155.21No growth
2303121.1122.91.11.243.4764.02No growth
3302121.1123.01.11.243.3563.34No growth

Heat Distribution & Penetration – Rubber Stoppers(maximum)

Run No.Date of RunSterilization HoldF0 ValueBio-challenge

Study

Hold period (Minutes)Lag periodHold Temperature (0C)Pressure (Kg/cm2)
Min.Max.Min.Max.Min.Max.
Acceptance criteria à30NMT

5 min.

1211241.11.2NLT

31.00

No growth should be observed
1302121.0122.41.11.241.5563.68No growth
2302121.1122.91.11.244.7963.47No growth
3302121.1123.01.11.241.2354.27No growth

 Heat Distribution & Penetration – Media vessels with WFI water

Run No.Date of RunSterilization Hold F0 ValueBio-challenge

Study

Hold period (Minutes)Pressure

(Kg/cm2)

Min.Max.Min.Max.Min.Max.
Acceptance criteria àNLT 15NMT

5 min.

1211241.11 1.2NLT

31.00

No growth should be observed
1302121.0122.91.11.233.5748.11No growth
2302121.0122.91.11.235.9153.93No growth
3303121.0122.91.11.235.1263.68No 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

ChecksObservations (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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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