Installation qualification of Gelatin Melting Reactor
PURPOSE:
To describe the Installation Qualification of the Gelatin Melting Reactor and its accessories and to define the Specification of the system:
Ensure that the equipment meets the specifications 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 pieces of equipment will be installed under current Good Manufacturing Practices.
SCOPE:
The scope of this document applies to the installation qualification of the Gelatin Melting Reactor.
RESPONSIBILITIES:
It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests concerning installation qualification and compiling data in coordination with the client.
It is the responsibility of the client to check and approve the installation qualification.
PROCEDURE:
The following requirements/practices apply to, Gelatin Melting Reactor Installation Qualification activities:
Verify that systems are installed by 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 labeled with a unique ID number.
INSTALLATION QUALIFICATION TESTS:
The table below lists the tests to be performed as part of the Installation Qualification phase.
| CRITICAL FEATURE |
| Documents & Drawings Verification |
| Verification of Technical Specifications for In-house & sub-components / bought-out items |
| Utility Verification |
| Material of construction verification |
| 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 below are 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 conform 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.
| Description |
| Installation, Operation, and Maintenance Manual |
| General arrangement drawing |
Verification of Technical Specifications for In-House & sub-components / Bought out items
Purpose
To verify that each major component of the, 300 L Gelatin Melting Reactor 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 the 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 the design qualification and on the latest revision of drawings must be present, documented, and tagged.
Major Components Results
Utility Verification
Rationale – To verify that all necessary utilities are correctly installed.
Procedure – Confirm that utility 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.
Utility Specification Results
| Description |
| Electrical connection |
| Vacuum |
| Hot Water |
| Compressed Air |
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 the battery & keep the anode at one end of the material and the cathode at the 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 |
| 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 |
Critical Instrument Calibration Verification
Rationale – To verify that all critical instruments for the Pharmalab, 300 L Gelatin Melting Reactor have been calibrated before starting the Operational Qualification.
Test equipment – Calibrated 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 | Set point Operating Range |
| Pressure Gauge (Hydraulic Power pack) | Mass | 0 – 160 Kg / cm2 |
| Pressure Gauge for Jacket | Wika | 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 | 0 2500C |
Installation Qualification Tests Status
The table below lists the tests performed and related results.
| Critical Feature (Verification of Technical Specifications for In-House & Sub-contract / bought-out items.) |
| Utility Verification |
| Material of Construction Verification |
| Critical Instruments Calibration verification |
Data Analysis, Summary of IQ & Recommendations
Note: Any changes made in the system must be recorded in this sheet.
CONCLUSION
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