Installation Qualification of Ointment Manufacturing Vessel

 

• 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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