- Installation Qualification of Ointment Manufacturing VesselPURPOSE
- To describe the Installation Qualification procedure to be used during qualification of Ointment Manufacturing Vessel, its accessories and to define the Specification of the system in order to
- Ensure that the equipment meets the specification as per Design Qualification.
- Aid verification of the installation as per equipment general arrangement drawing
- Ensure that the system installation meets acceptance criteria
- Ensure that the equipments will be installed in accordance with current Good manufacturing Practices.
- SCOPE
- This procedure applies to the installation qualification of Ointment Manufacturing Vessel.
- RESPONSIBILITIES
- It is the responsibility of the Manufacturer to perform all the tests with respect to Installation Qualification and compiling data in co-ordination with client.
- It is the responsibility of the client to check and approve the Installation Qualification.
- PROCEDURE
- The following requirement / practices apply to Ointment Manufacturing Vessel, Installation Qualification activities:
- Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
- General arrangement drawing.
- Installation specification; and
- Equipment manuals
- Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
- Verify that major components are tagged or labelled with a unique ID number.
- INSTALLATION QUALIFICATION TESTS
- The table below lists the tests to be performed as part of the Installation Qualification phase.
| TEST NUMBER | CRITICAL FEATURE |
| 5.1 | Documents & Drawings Verification |
| 5.2 | Verification of Technical Specification for
In-House & sub-components / bought out items |
| 5.3 | Utilities Verification |
| 5.4 | Material of construction verification |
| 5.5 | Critical Instrument Calibration Verification |
- Documents & Drawings Verification
- Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.
- Test equipment – None Required.
- Procedure –
- Verify that the required documents and drawings listed in the table 5.1.5 are available.
- Review the documents and drawings for completeness and exactness with the installed units.
- Attach the copies of the drawings or reference the location from where they can be easily retrieved.
- Any items in the installation, which are not conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.
- Acceptance Criteria –
- The documents must be accurate and complete.
- The drawing information must correspond to the physical installation.
- Documentation Verification Results.
| Sr. No. | Description | Document No. | Verified By | Date |
| 1 | Installation, Operation and Maintenance Manual | |||
| 2 | General arrangement drawing |
- Conclusions / Comments:
- Verification of Technical Specification for In-House & sub-components / Bought out items
- Purpose – To verify that each major component of the Ointment Manufacturing Vessel, is present and identified.
- Test Equipment – None Required
- Procedure
- Confirm that identification nameplates have been applied to the units and that these indicate the following (where applicable).
- Type
- Identification (Tag) No.
- Manufacturer
- Model Number
- Confirm that the various components of Ointment Manufacturing Vessel, is present and tagged as per specifications and drawings, in the proper number and configuration.
- Note any deviations or discrepancies and recommend follow up action if required.
- Acceptance Criteria
- All units and parts specified in design qualification and on latest revision of drawings must be present, documented and tagged.
- Components Result
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Initials | Date | ||
| A Ointment Manufacturing Vessel | |||||||
| 1. Ointment Manufacturing Vessel | |||||||
| Model | GMV 400 Liters | ||||||
| Make | |||||||
| Dimension | 2100 mm (L) X 2100 mm (H) X 1200 mm(W) | ||||||
| Design conditions | Jacket: 3 kg/cm2 – working
4.5 kg/cm2 – Test Shell: 3 kg/cm2 – working 4.5 kg/cm2 – Test At 600 mmHg of vacuum |
||||||
| Finish | Internal– Mirror
External – Matt |
||||||
| Capacity | 400 Liters (Gross)
350 Liters (Working ) |
||||||
| Insulation | Rock wool, 50 mm Thickness, | ||||||
| Shell | Cylindrical with flat bottom, 6 mm Thickness, AISI 316 with lift up type lid opening | ||||||
| Baffles | 2 Nos., AISI 316 | ||||||
| Supporting Structure | SS Pipes support mounted on floor | ||||||
| Scrapper | Teflon scrapper bolted to anchor | ||||||
| 2. Motor (Gelatin Mixing Vessel) | |||||||
| Sr. No. | 427677 | ||||||
| Make | Hindustan Motors | ||||||
| Type | 3 Ph, induction motor, STD TEFC electric motor | ||||||
| Power Rating | 3 HP / 2.2 KW / 50 Hz / 415 V / 1425 RPM | ||||||
| 3. Gear Box | |||||||
| Sr. No. | 5 B 6125 | ||||||
| Make | Greaves | ||||||
| Type | V 500 ZW | ||||||
| Ratio | 50:1 | ||||||
| 4. Motor (Homogenizer) | |||||||
| Sr. No. | 426117 | ||||||
| Make | Hindustan Motors | ||||||
| Type | 3 Ph, induction motor, STD TEFC electric motor | ||||||
| Power Rating | 10 HP / 7.5 KW / 50 Hz / 415 V / 1440 RPM | ||||||
| 5. Filling Pump | |||||||
| Sr. No. | 060622276 | ||||||
| Make | Positive Metering Pumps | ||||||
| Model | PL3530GMP | ||||||
| Type | Plunger / Reciprocating type | ||||||
| Power Rating | 1 HP | ||||||
| Capacity | 0 – 600 LPH | ||||||
| 6. Filling Pump Motor | |||||||
| Sr. No. | 0606H429871 | ||||||
| Make | Hindustan Motors | ||||||
| Type | 3 Ph, induction motor, STD TEFC electric motor | ||||||
| Power Rating | 1 HP / 415 V / 1405 RPM | ||||||
| 7.Temperature Sensor | |||||||
| Make | Nikesh Ind. | ||||||
| Model | PT 100 | ||||||
| Range | 0-400 0C | ||||||
| 8. Temp. Indicator cum controller for main vessel | |||||||
| Make | Selectron | ||||||
| Type | DTC 203 | ||||||
| Sr. No. | 0604J03-1721 | ||||||
| Incoming signal | RTD PT – 100, 3 Wire | ||||||
| Voltage | 230 vAC / 50 Hz | ||||||
| 9.RPM Indicator for Anchor | |||||||
| Make | Selectron | ||||||
| Type | PIC 101 | ||||||
| Sr. No. | 0604N03-730 | ||||||
| Power Rating | 230 VAC / 50 Hz | ||||||
| 10. RPM Indicator for Homogenizer | |||||||
| Make | Selectron | ||||||
| Type | PIC 101 | ||||||
| Sr. No. | 0604N03-724 | ||||||
| Power Rating | 230 VAC / 50 Hz | ||||||
| 11. Timer For Homogenizer | |||||||
| Make | Selectron | ||||||
| Type | XT 56 | ||||||
| Sr. no. | 0604V03-14341 | ||||||
| Power Rating | 230 VAC | ||||||
| 12. Pressure gauge | |||||||
| Make | LA | ||||||
| Range | 0-10.6 Kg/cm2 | ||||||
| Least Count | 2 Kg/cm2 | ||||||
| 13. Water Level Controller | |||||||
| Make | Minilec | ||||||
| Model | WLC D1 | ||||||
| Sr. No. | 5 A 6746 | ||||||
| Supply | 240 VAC | ||||||
| 14.Variable Frequency Drive (Anchor) | |||||||
| Make | Allen Bradley | ||||||
| Model | Power Flex 4 | ||||||
| Power Rating | 3 HP / 3 PH / 415 VAC | ||||||
| 15. Variable Frequency Drive (Homogenizer) | |||||||
| Make | Allen Bradley | ||||||
| Model | Power Flex 40 | ||||||
| Power Rating | 10 HP / 3 PH / 415 VAC | ||||||
| 16.Control Panel | |||||||
| RYB phase indicator | 01 No. | ||||||
| RPm meter for anchor & homogenizer | 01 No. each | ||||||
| Process timer | 01 No. | ||||||
| ON / OFF push button for anchor meter | 01 No. | ||||||
| ON / OFF push button for homogenizer | 01 No. | ||||||
| Process timer switch | 01 No. | ||||||
| Potentiometer | 01 No. | ||||||
| Emergency push button | 01 No. | ||||||
| Steam ON selector switch | 01 No. | ||||||
| Machine lamp selector switch | 01 No. | ||||||
| B Storage Vessel | |||||||
| Qty. | 01 No. | ||||||
| Gross capacity | 200 Ltrs. | ||||||
| Shell | Cylindrical with conical bottom | ||||||
| Product outlet | 50 mm (D) Discharge with valve | ||||||
| C Jacketed Storage Vessel | |||||||
| 1.0 Storage Vessel | |||||||
| Qty. | 01 No. | ||||||
| Shell | Cylindrical with conical bottom | ||||||
| Product outlet | 50 mm (D) Discharge with valve | ||||||
| Support structure | 04 Nos. | ||||||
| Nozzle for water inlet | 40 mm | ||||||
| Nozzle for water outlet | 40 mm | ||||||
| Jacket vent | 25 mm | ||||||
| 2.0 Temperature Sensor | |||||||
| Make | Nikesh Ind. | ||||||
| Model | PT 100, | ||||||
| Range | 0-400 0C | ||||||
| 3.0 Electric Heater | |||||||
| Type | SS tubular, immersion Heater | ||||||
| Power Rating | 4 KW | ||||||
| Qty | 03 Nos | ||||||
| 4.0 Digital Temp. Indicator Cum Controllers | |||||||
| Make | Slectron | ||||||
| Model | DTC 503 | ||||||
| Sr. No. | 0604J03-1644 | ||||||
| Power Rating | 270 VAC / 50-60 Hz | ||||||
| 5.0 Pressure Gauge | |||||||
| Make | LA | ||||||
| Range | 0-10.6 Kg/cm2 | ||||||
| Least Count | 2 Kg/cm2 | ||||||
| 6.0 Control Panel | |||||||
| Type | Box type | ||||||
| Main ON / OFF Switch | 01 No. | ||||||
| ON /OFF push button for electric heater | 01 No. | ||||||
- Conclusions / Comments:
- Utilities Verification
- Rationale – To verify that all necessary utilities are correctly installed.
- Procedure –
- Confirm that utilities connections are configured as per specification and in compliance with local codes.
- Record the results in the table below. Note any deviations or discrepancies.
- Acceptance Criteria
- All services and connections must be installed and documented.
- Utilities Specification Results
| Description | Specified | Observation | Initial / Date
mm/dd/yy |
| Power Consumption | |||
| GMV Agitator Motor | 3 HP | ||
| Homogenizer Motor | 10 HP | ||
| Filling Pump – 1 | 1 HP | ||
| Vacuum Pump | 3 HP | ||
| Cooling Water | |||
| Salts free cooling water | 150C for OMV and Mechanical Seal | ||
| Pneumatic Supply | |||
| Compressed Air Supply | 8 kg/cm2 | ||
| Steam | |||
| Steam | 5 kg/ cm2 | ||
- Conclusions / Comments:
- Material of Construction Verification
- Rationale – To verify that all assembly of Ointment Manufacturing Vessel, has been manufactured as per the specification provided by the customer.
- Test equipment – Moly testing unit (To identify AISI 304 and AISI 316 materials)
- Procedure –
- Put a drop of Molybdenum solution on the material to be tested.
- Take battery & keep anode at one end of the material and cathode at Moly drop.
- If the solution turns pink and stays for around one minute, then it is AISI 316 & if the solution turns pink and immediately vanishes, then it is AISI 304.
- Acceptance Criteria
- All material of construction for the Ointment Manufacturing Vessel, shall meet the MOC provided in Design Qualification.
- Material other than AISI 316 and AISI 304 are verified based on their material testing certificates provided by the Manufacturer.
- Material of Construction verification Results
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Initials | Date |
| Shell | AISI 316 | ||||
| Top Dish | AISI 316 | ||||
| Jacket | AISI 304 | ||||
| Cladding | AISI 304 | ||||
| Supporting Structure | AISI 304 | ||||
| Driven Shaft | AISI 316 | ||||
| Anchor | AISI 316 | ||||
| Homogenizer Shaft | AISI 316 | ||||
| Piping | AISI 316 | ||||
| Working Platform | AISI 304 | ||||
| Control Panel | AISI 304 | ||||
| Torrospherical Top dish sealing Gasket | Food Grade White Silicon Gasket | ||||
| scraper | Teflon | ||||
| Bottom cone of storage Vessel | AISI 316 |
Conclusions / Comments:
- Critical Instrument Calibration Verification
- Rationale – To verify that all critical instruments for the Ointment Manufacturing Vessel has been calibrated before starting the Operational Qualification.
- Procedure –
- Verify that all critical instruments are calibrated using an approved procedure, against a traceable standard.
- Note any deviations or discrepancies and recommend follow up actions if required.
- For all critical instruments, attach copies of calibration certificates to this protocol.
- Acceptance Criteria
- All critical instrumentation for the Ointment Manufacturing Vessel shall be in a state of calibration.
- Instrumentation List Results
| Description | Make | Model | Serial No | Set point Operating Range | Current
Calibration |
|
| Yes/ No | Sign / Date | |||||
| Temperature Sensor (Jacketed Vessel) | ||||||
| Temperature Sensor (Main Vessel) | ||||||
| Temp. indicator cum controller (Main Vessel) | ||||||
| Temp. indicator cum controller (Storage Vessel) | ||||||
| Pressure Gauge (Jacketed Vessel) | ||||||
| Pressure Gauge (Main Vessel) | ||||||
- Conclusions / Comments:
- Installation Qualification Tests Status
- The table below lists the tests performed and related results.
| Test Number | Critical Feature | Pass | Fail | Deviation Found | |
| Yes | No | ||||
| 5.1 | Documents & Drawings Verification | ||||
| 5.2 | Verification of Technical Specification for In-House & Sub-contract / bought out items. | ||||
| 5.3 | Utilities Verification | ||||
| 5.4 | Material of Construction Verification | ||||
| 5.5 | Critical Instrument Calibration Verification | ||||
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
Sr. No. |
Item Name |
Remarks |
Signature & Date |
- Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
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