As we know that stirrer is used for Mixing of solid ingredients in the solvent.
1.0 OBJECTIVE:
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 .
3.0 RESPONSIBILITIES :
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.
4.0 EQUIPMENT DESCRIPTION :
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.
5.0 ACCEPTANCE CRITERIA:
Qualification of the equipment should meet the acceptance criteria outlined in the following steps.
- Calibration status report of Multimeter device
| Sr.No. | Device | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Multimeter | It shall be calibrated for its performance. |
- Installation verification report
| Sr.No. | Check points | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Check the condition of the equipment on receipt visually. | Visually there should not be any abnormality. | ||
| 2 | Check the levelling of the equipment using level indicator. | Air bubble shall be at centre position of level indicator. | ||
| 3 | Check 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 points | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Tank diameter | 2 feet or more | ||
| 2 | Electrical | Flameproof | ||
| 3 | Discharge | 1” BSP outlet with ball valve | ||
| 4 | Speed control | 960 rpm propeller agitator with speed control VFD. | ||
| 5 | Discharge height | 2 feet mm from ground level | ||
| 6 | Agitator | 1 HP, Speed variable up to 960 rpm, shaft diameter 20 mm, Top tank mounting. | ||
| 7 | Castor wheels | Shall be provided for ease in movement of the machine. | ||
| 8 | Motor | 1 HP, Make: Hindustan | ||
| 9 | Emergency push button | Make: Tecknic | ||
| 10 | Variator | Make: Delta |
- Utility verification report
| Sr.No. | Utility | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Electricity | Three phase, 410 V ± 5% and 50 Hz ± 5% |
- Safety features verification report
| Sr.No. | Safety features | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Earthing | Earthing shall be provided to equipment. | ||
| 2 | AC motor | AC motor shall be covered with SS guards. | ||
| 3 | Emergency stop | Emergency stop button shall be provided on operating panel. |
- Material of construction (MOC) and test certificate verification checklist
| Sr.No. | Components | Acceptance criteria | Observation | Checked by date/sign |
| 1 | MOC of contact parts i.e. shell, lid, dish, flange and ball valve | SS 316 L and mirror finished. | ||
| 2 | Motor | It shall be tested for its performance. | ||
| 3 | AC drive | It shall be tested for its performance. |
- Operational verification report
| Sr.No. | Operation | Acceptance criteria | Observation | Checked by date/sign |
| 1 | Turn the main ON/OFF switch at ON position. | Red indication lamp should glow. | ||
| 2 | Press the start button. | Green indication lamp should glow and equipment should start. | ||
| 3 | Rotate 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. | ||
| 4 | Press the emergency stop button. | Rotation of agitator shall be stopped immediately. |
| Sr.No. | Operation | Acceptance criteria | Observation | Checked by date/sign |
| 5 | Release the emergency stop button and re-start the equipment. | Agitator of equipment should re-start. | ||
| 6 | Press 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. | Procedure | Observation | Checked by date/sign |
| 1 | Stirring: Add the Isopropyl Alcohol (IPA), Hydroxy Propyl Methyl Cellulose (HPMC) and Methylene Chloride into 420 L tank, stir for 15 minutes. |
| Sr.No. | Procedure | Observation | Checked by date/sign |
| 2 | Milling: 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. | ||
| 3 | Stirring: Add the step No. 2 solution and polyethylene glycol into step No. 1 with continuous stirring for 30 minutes. | ||
| 4 | Filtration: 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:
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6.0 DEVIATION REPORT:
| Sr. No. | Deviation (s) | Justification for acceptance criteria | Impact on installation, operation and performance |
7.0 CHANGE CONTROL:
Mention change control number if any
8.0 LIST OF ANNEXURE :
Mention annexure number if any
9.0 SUMMARY OF QUALIFICATION AND CONCLUSION :
Mention in details i.e what parameters you have checked and what is your observation
10.0 CERTIFICATION OF QUALIFICATION :
Qualification is satisfactory Yes/No
Hence Overhead Stirrer with Tank-150 L is suitable for routine use. Yes/No
Head – QA
Pharmaceutical Updates 