SOP For Installation qualification of 300 L Gelatin Melting Reactor
- PURPOSE:
- To describe the Installation Qualification of 300 L Gelatin Melting Reactor 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:
- The scope of this document applies to the installation qualification of 300 L Gelatin Melting Reactor.
- RESPONSIBILITIES:
- It is the responsibility of the Manufacturer to perform all the specifications verification checks and 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, 300 L Gelatin Melting Reactor 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.
- 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 is available.Review the documents and drawings for completeness and exactness with the installed units. Attach the copies of the drawings to this document 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:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Verification of Technical Specification for In-House & sub-components / Bought out items
- Purpose
- To verify that each major component of the, 300 L Gelatin Melting Reactor are 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, 300 L Gelatin Melting Reactor are 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.
- Major Components Results
Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Sign. | Date |
1. Equipment Description | |||||
Name | 300 L Gelatin Melting Reactor | ||||
Job No. | V – 060008 | ||||
Model | 300 Ltrs. GMR | ||||
Capacity | Working : 300 L
Gross : 440 L |
||||
Make | Pharmalab | ||||
Design condition | Shell : -1 to ATM bar g @
130ºC Jacket :- 3 bar g @ 150ºC |
||||
Surface Finish | mirror (Internal)
Matt (External) |
||||
Agitator | Anchor Type, with side Teflon Scrapper | ||||
Platform Dimension | 3020 mm(L) X 2740 mm(W) | ||||
Platform Height From Ground | 2200 mm | ||||
Total Height of System | 3440 mm | ||||
Discharge Height from ground | 1420 mm | ||||
Safety Railing Height from Platform | 915 mm | ||||
2. Mechanical Seal | |||||
Make | Burgmann | ||||
Type | Single Mechanical Seal | ||||
Sr. No. | |||||
Size | 75 mm | ||||
3. Stirrer Motor | |||||
Make | SEW – Eurodrive | ||||
Type | SAF 87 DV 132S4 | ||||
Sr. No. | |||||
Power Rating | 5.5 KW/7.5 HP / 415 V / 1430 RPM | ||||
Output RPM | 52 | ||||
4. 3 Way control Valve for HWS | |||||
Type | Pneumatic control ball valve | ||||
Size | 25 NB | ||||
Rating | ASME 150 # | ||||
Actuator (Double acting) | MD 50 – F04 | ||||
System Tag No. | CV 40152 | ||||
Operating Pressure | 80 PSI | ||||
Sr. No. | |||||
Make | Micro Pneumatics | ||||
5. Vacuum Pump Motor (M1) | |||||
Type | 3 Phase Induction Motor | ||||
Make | Crompton Greaves | ||||
Sr. No. | |||||
Power Rating | 3.7 KW / 5 HP / 415 V / 2840 RPM | ||||
6. Vacuum Pump Motor (M2) | |||||
Type | 3 Phase Induction Motor | ||||
Make | Crompton Greaves | ||||
Sr. No. | |||||
Power Rating | 3.7 KW / 5 HP / 415 V / 2840 RPM | ||||
7. Vacuum Pump | |||||
Type | VWS 500 | ||||
Make | PPI Systems | ||||
Sr. No. | |||||
Power Rating | 5 HP / 2880 Rpm | ||||
Capacity | 50 m3/ hr. | ||||
8. Vacuum Pump | |||||
Type | VWS 500 | ||||
Make | PPI Systems | ||||
Sr. No. | |||||
Power Rating | 5 HP / 2880 Rpm | ||||
Capacity | 50 m3/ hr. | ||||
9. Vacuum Gauge | |||||
Make | Arihant | ||||
Range | -760 to 0 mm Hg | ||||
Least Count | 10 mm Hg | ||||
Location | Vacuum Pump Motor (M1) | ||||
10. Vacuum Gauge | |||||
Make | HTI | ||||
Range | -760 to 0 mm Hg | ||||
Least Count | 10 mm Hg | ||||
Location | Vacuum Pump Motor (M2) | ||||
11. Flow Regulator | |||||
Make | Mascon | ||||
Type | BSP | ||||
Sr. No. | |||||
Location | Vacuum Pump Motor (M1) | ||||
12. Motor (Hydraulic Power Pack) | |||||
Type | 3 Phase Induction Motor | ||||
Make | Crompton Greaves | ||||
Machine No. | NDA 4DVJ | ||||
Power Rating | 0.75 KW / 1 HP / 415 V / 1410 RPM | ||||
13. Pressure Gauge | |||||
Make | Mass | ||||
Sr. No. | |||||
Range | 0 – 160 Kg / cm2 | ||||
Least Count | 2 Kg / cm2 | ||||
Location | Hydraulic Power Pack Motor | ||||
14. Flow Control Valve | |||||
Make | Flowtec | ||||
Type | TVC 8 – ¼” | ||||
Regulator Range | 0 – 9 | ||||
Location | Hydraulic Power Pack Motor | ||||
15. Solenoid Valve | |||||
Make | Rexroth | ||||
Sr. No. | |||||
Model | 09W06 | ||||
Location | Hydraulic Power Pack Motor | ||||
16. Ball valve for Air Vent | |||||
Size | ½” | ||||
make | Seeco | ||||
Sr. no. | |||||
17. 2 Way Control Valve for HWR | |||||
Type | Pneumatic control ball valve | ||||
Size | 25 NB | ||||
Rating | Asme 150 # | ||||
Actuator (Double acting) | MD – 40 – F – 03 | ||||
System Tag No. | CV 40139 | ||||
Operating Range | 80 PSI | ||||
Sr. No. | |||||
Make | Micro Pneumatics | ||||
18. 2 Way Control Valve for Vacuum | |||||
Type | Pneumatic control ball valve | ||||
Size | 25 NB | ||||
Rating | PN 10 | ||||
Actuator (Double acting) | MD – 40 – F – 03 | ||||
Operating Range | 80 PSI | ||||
Sr. No. | |||||
Make | Micro Pneumatics | ||||
19. ‘Y’ Type Flush bottom Valve | |||||
Size | 65 X 64 | ||||
End Connection | T / C | ||||
Sr. No. | |||||
20. Ball Valve for Liquid Suction | |||||
Type | Single piece ball valve | ||||
Size | 1” | ||||
21. Ball Valve for Gelatin Suction | |||||
Type | Single piece ball valve | ||||
Size | 50 mm | ||||
End Connection | T / C | ||||
Sr. No. | |||||
22. Pressure Switch | |||||
Make | Indfos | ||||
Sr. No. | |||||
Type | RT 116 | ||||
23. Temp. Sensor | |||||
Type | PT – 100, 3 wire type | ||||
Sr. No. | |||||
Make | Radix | ||||
Range | 0 – 2500C | ||||
24. Vacuum sensor cum Transmitter | |||||
Range | -1 to 0 Bar | ||||
Power Rating | 10 – 30 VDC | ||||
Sr. No. | |||||
Make | Wika | ||||
Model | UT – 10 | ||||
Location | Detachable Top Dish | ||||
25. Pressure Gauge for Jacket | |||||
Make | Wika | ||||
Sr. No. | |||||
Range | 0 -10 Kg/cm2 | ||||
Model | EN 837 – 1 | ||||
26. FRL Unit | |||||
Type | LFR – D – Mini | ||||
P1 max. | 16 bar | ||||
P2 max. | 12 bar | ||||
Make | Festo | ||||
Model | 159605 U 223 | ||||
Location | Control Panel | ||||
27. Pressure Gauge | |||||
Make | Festo | ||||
Range | 0-16 bar | ||||
Least Count | 0.2 bar | ||||
Sr. No. | |||||
Location | FRL Unit | ||||
28. Solenoid Valve | |||||
Make | Festo | ||||
Model | MFH – 5 – 1/8 | ||||
Operating Pressure | 1.8 – 8 bar | ||||
Qty. | 04 Nos. | ||||
29. Control Panel | |||||
R,Y,B Phase Indicator | 01 No. each | ||||
Touch Screen | 01 No. | ||||
Start Push Button | 01 No. | ||||
Emergency Push Button | 01 No. | ||||
Main ON / OFF Switch | 01 No. | ||||
Location | Platform | ||||
30. Programmable Logical controller (PLC) | |||||
Make | Allen Bradley | ||||
Model | Micro logics 1200 | ||||
Input | 14 Nos. | ||||
Relay Output | 10 Nos. | ||||
31. Halogen Lamp | |||||
Make | Philips | ||||
power Rating | 50 W / 12 V | ||||
32. Variable Frequency Drive (VFD) | |||||
Make | Allen Bradley | ||||
Model | Power Flex 40 | ||||
Cat No. | 22B – DO 12 N 104 | ||||
Sr. No. | |||||
Motor Rating | 5.5 kw / 7.5 HP | ||||
Power Rating | Input : 3 Phase / 380 – 480 V
Output : 3 Phase / 0 – 400 V |
||||
33. Spray Ball | |||||
Size | 20 mm | ||||
Make | Pharmalab | ||||
34. Safety Valve for Jacket | |||||
Size | 20 NB | ||||
Type | Spring loaded | ||||
Make | Seeco | ||||
Sr. No. | |||||
35. Touch Screen | |||||
Model | Prizm – 285 | ||||
Make | Renu Elec. |
- Conclusions / Comments:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- 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 | Observation | Initial / Date
mm/dd/yy |
|
Electrical connection | |||
Vacuum | |||
Hot Water | |||
Compressed Air |
- Conclusions / Comments:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Material of Construction Verification
- Rationale – To verify that all assembly of Pharmalab, 300 L Gelatin Melting Reactor has been manufactured as per the specification provided by the customer based on the MOC certificates supplied by the vendor / moly testing unit.
- Test equipment – Moly testing unit (To identify AISI 304 and AISI 316 L 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 SS 316 L & if the solution turns pink and immediately vanishes, then it is SS 304
- Acceptance Criteria
- All material of construction for the Pharmalab, 300 L Gelatin Melting Reactor shall meet the MOC provided in Design Qualification.
- Material of Construction verification Results
Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Sign. | Date |
Main Shell (5 mm) | aisi 316 L | ||||
Top Dish (5 mm) | aisi 316 L | ||||
Bottom Dish (6 mm) | TP 316 L | ||||
Body Flange (35 mm) | aisi 316 L | ||||
Jacket Shell (4 mm) | SA 240, TP 304 | ||||
Jacket Dish (4 mm) | SA 240, TP 304 | ||||
Stiffener (5 mm) | SS 304 | ||||
Insulation Shell (2 mm) | SS 304 | ||||
Cover for hand hole (14 mm) | AISI 316 L | ||||
Rod for N1, 3A, 3B, 4, 5, 6
(56 mm ) |
AISI 316 L | ||||
Rod for Nozzle N2
(65 mm ) |
AISI 316 L | ||||
Pipe for liquid suction
(1” od X 16 G) |
AISI 316 L | ||||
Pad Plate for L.G. Nozzle – 8
(35 mm) |
AISI 316 L | ||||
Cover for L.G. and S.G.(16 mm) | AISI 304 | ||||
Pipe for Nozzle 9, 10
(1” NB X SCH 40) |
AISI 304 | ||||
Plate flange for Nozzle 9, 10 ( 16 mm) | AISI 304 | ||||
Rod for Nozzle 10,11 (65 mm) | AISI 304 | ||||
Pipe for Nozzle 11 ¾” O.D. X 16 SWG | SS 304 (ASTM A 249) | ||||
Rod for thermowell (13 mm) | AISI 316 L | ||||
Pad Plate for Agitator (45 mm) | AISI 316 L | ||||
Plate for Agitator ( 8 mm) | AISI 316 L | ||||
Shaft for Top Agitator (75 mm) | AISI 316 L | ||||
Shaft for Bottom Agitator
(95 mm) |
AISI 316 L | ||||
‘O’ Ring(1”, 1 1/2”,2”) | Food Grade Silicon Transparent Rubber | ||||
Body Flange Gasket (850 X 750 X 3 mm) | White silicon | ||||
Site Glass (12 mm) | Toughened glass | ||||
Light Glass ( 12 mm) | Toughened glass | ||||
Scrapper | Teflon |
- Conclusions / Comments:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Critical Instrument Calibration Verification
- Rationale – To verify that all critical instruments for the Pharmalab, 300 L Gelatin Melting Reactor has been calibrated before starting the Operational Qualification.
- Test equipment – Calibrated Dead Weight Pressure Standard
- 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 Pharmalab, 300 L Gelatin Melting Reactor shall be in a state of calibration.
- Instrumentation List Results
Description | Make | Model | Sr. No. | Set point Operating Range | Current
Calibration |
|
Yes /No | Sign / Date | |||||
Pressure Gauge (Hydraulic Power pack) | Mass | – | 0 – 160 Kg / cm2 | |||
Pressure Gauge for Jacket | Wika | EN 837 – 1 | 0 – 10 Kg / cm2 | |||
Pressure Gauge | Festo | – | 0 – 16 bar | |||
Vacuum Sensor Cum Transmitter | Wika | – | -1 to 0 bar | |||
Vacuum Gauge (M1) | Arihant | – | – | -760 to 0 mm Hg | ||
Vacuum Gauge (M2) | HTI | – | – | -760 to 0 mm Hg | ||
Temp. Sensor with head mounted Transmitter | Radix | PT – 100 | 0 2500C |
- Conclusions / Comments:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- 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 Instruments Calibration verification |
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
Sr. No. | Item Name | Remarks | Signature and Date |
- Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
- Prepared by Reviewed By Approved by
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