Month: October 2021


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Overhead Stirrer with Tank Qualification Report

As we know that stirrer is used for Mixing of solid ingredients in the solvent.


To verify and document the installation, operation and performance of Overhead Stirrer with Tank-XYZ L and to ascertain that the machine operates as designed and performs to meet the predefined acceptance criteria.

2.0 SCOPE:

The scope of this qualification report is limited to Overhead Stirrer with Tank-420 L having ID no. XYZ .


Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.

Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.

Production Officer/Executive: To execute qualification study in co-ordination with other departments.

Head Maintenance: To review the qualification documents.

Head Quality Assurance: To approve the qualification report.


Equipment comprises shell, bottom dish, lid, flange, ball valve, agitator, flame proof motor, variable frequency drive (VFD) and emergency OFF button. All contact parts is SS 316 L and mirror finished.


 Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

  • Calibration status report of Multimeter device
Sr.No.DeviceAcceptance criteriaObservationChecked by date/sign
1MultimeterIt shall be calibrated for its performance.  
  • Installation verification report
Sr.No.Check pointsAcceptance criteriaObservationChecked by date/sign
1Check the condition of the equipment on receipt visually.Visually there should not be any abnormality.  
2Check the levelling of the equipment using level indicator.Air bubble shall be at centre position of level indicator.  
3Check the major components and their electrical cables for housing and anchoring.Major components and their electrical cables shall be securely housed and anchored.  
  • Technical and sub components specification verification report
Sr.No.Check pointsAcceptance criteriaObservationChecked by date/sign
1Tank diameter2 feet or more    
3Discharge 1” BSP outlet with ball valve  
4Speed control960 rpm propeller agitator with speed control VFD.  
5Discharge height2 feet mm from ground level  
6Agitator1 HP, Speed variable up to 960 rpm, shaft diameter 20 mm, Top tank mounting.  
7Castor wheelsShall be provided for ease in movement of the machine.  
8Motor1 HP, Make: Hindustan  
9Emergency push buttonMake: Tecknic  
10VariatorMake: Delta    
  • Utility verification report
Sr.No.Utility Acceptance criteriaObservationChecked by date/sign
1ElectricityThree phase, 410 V ± 5% and 50 Hz ± 5%    
  • Safety features verification report
Sr.No.Safety featuresAcceptance criteriaObservationChecked by date/sign
1EarthingEarthing shall be provided to equipment.  
2AC motorAC motor shall be covered with SS guards.  
3Emergency stopEmergency stop button shall be provided on operating panel.  
  • Material of construction (MOC) and  test certificate  verification checklist
Sr.No.ComponentsAcceptance criteriaObservationChecked by date/sign
1MOC of contact parts i.e. shell, lid, dish, flange and ball valveSS 316 L and mirror finished.  
2MotorIt shall be tested for its performance.  
3AC driveIt shall be tested for its performance.  
  • Operational verification report
Sr.No.OperationAcceptance criteriaObservationChecked by date/sign
1Turn the main ON/OFF switch at ON position.Red indication lamp should glow.  
2Press the start button.Green indication lamp should glow and equipment should start.  
3Rotate speed spot in clockwise direction step by step up to last point.Agitator speed shall be raised gradually.Rotation of agitator shall be smooth and noise and vibration free.  
4Press the emergency stop button.Rotation of agitator shall be stopped immediately.  
Sr.No.OperationAcceptance criteriaObservationChecked by date/sign
5Release the emergency stop button and re-start the equipment. Agitator of equipment should re-start.  
6Press the stop button.Green indication lamp should turn OFF and equipment should stop.  
  • Performance verification report    Performance of equipment is verified by simulating the normal operation for preparation of colour coating solution. After completion of preparation, physically checked the colour coating solution for its appearance. Observation of procedure followed for preparation of colour coating solution:

            Product name:                                           

            Batch No.:

           Colour coating solution quantity:

Sr.No.ProcedureObservationChecked by date/sign
1Stirring: Add the Isopropyl Alcohol (IPA), Hydroxy Propyl Methyl Cellulose (HPMC) and Methylene Chloride into 420 L tank, stir for 15 minutes.  
Sr.No.ProcedureObservationChecked by date/sign
2Milling: Add Colour, Isopropyl Alcohol (IPA) and Titanium Dioxide into container and stir manually for about 10 minutes and pass through Colloidal Mill for 15 minutes milling.  
3Stirring: Add the step No. 2 solution and polyethylene glycol into step No. 1 with continuous stirring for 30 minutes.  
4Filtration: Filter the coating solution through 100 # sieve.  
  • Acceptance criteria:
    • Colour coating solution should be clear and free from fines of colour material.
    • Mechanical operation should be satisfactory.
    • Observation of colour coating solution:








Sr. No.Deviation (s)Justification for acceptance criteriaImpact on installation, operation and performance


Mention change control number if any


Mention annexure number if any


Mention in details i.e what parameters you have checked and what is your observation


  Qualification is satisfactory                                                                   Yes/No

  Hence Overhead Stirrer with Tank-150 L is suitable for routine use.    Yes/No

                                                                                                                           Head – QA

Procedure for action to be taken on the adverse report of environmental monitoring of sterile Area


 (For alert limit)

  • If the colony forming units exceed the alert limit

a) Increase the frequency of cleaning from once to twice a shift.

b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP

    and Cleaning of the processing area is carried out as per respective SOP .

    (For action limit)

  • If the colony forming units exceed the action limit, investigate / check the following whether
  • Entry / Gowning procedure is followed.
  • Cleaning is done as per SOP in processing and filling area.
  • Disinfectant schedule is followed as per respective SOP
  • Prolonged Maintenance job performed if any.
  • Personnel traffic in the area is increased.
  • Major Power shut down has occurred.
  • Positive pressure in the area is disturbed.
  • Operator with history of adverse fingerprint reports worked in the area.
  • Time of plate exposure.
  • Any other incidence, which can increase the bioburden of the area, took place.
  • Inform to QC dept. through QA dept. in writing the outcome of above investigation with Products / Batches manufactured and filled during the period.
  • During the investigation period, increase the frequency of cleaning to twice a shift.
  • Request QC dept. to identify the organism and suggest suitable disinfectant for the organism identified.
  • Proceed as per the suggestions given by QC dept.