Installation Qualification of Gelatin Storage Vessel

Installation Qualification of Gelatin Storage Vessel

To describe the Installation Qualification of the Gelatin Storage Vessel and its accessories and to define the Specification of the system to:

• 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 equipment will be installed according to current Good Manufacturing Practices.

SCOPE: The scope of this document applies to the installation qualification of the Gelatin Storage Vessel.

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 Storage Vessel 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 Instruments 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 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 Gelatin Storage 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 the Gelatin Storage Vessel 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
• Gelatin Storage Vessel
• Surface Finish: mirror (Internal) & Matt (external)
• Overall Dimension
• Design Condition:
• Shell: -1 to Atm. Bar g @120 ⁰C
• Jacket: FOW @120 ⁰C
• Nozzle:
• Outlet connection, Product Thermowell, Water Inlet, drain, Vent connection, Heater Connection, Level Glass.

Main Shell:

Shell:  600 X 625 X 3 mm Thick,

Heads: 1.6 mm (T) Detachable flat cover on top and tapered bottom flat cover with 5 mm (T)

Jacket: Shell: 670 X 600 X 2.5 mm (T), Closure: 4 mm (T)

Insulation: Type: RBFG, 50 mm (T)

Cladding: 2 mm (T), AISI 304 welded cladding

Support: AISI 304 Platform (04 Nos.) with SS castor wheel

Capacity: Working: – 150 L & Gross: – 170 L

MOC:

Contact Part- AISI 316 L

Non-Contact Part:-  AISI 304

Gasket: – Silicon

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
• Potable Water

Material of Construction Verification

Rationale – To verify that all assembly of the Gelatine Storage Vessel 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 AISI 316 L & if the solution turns pink and immediately vanishes, then it is AISI 304.

Acceptance Criteria – All material of construction for the Gelatine Storage Vessel shall meet the MOC provided in the Design Qualification.

Material of Construction Verification Results

• Main Shell (3 mm): AISI 316 L
• Top Cover (1.6 mm): AISI 316 L
• Body Flange (20 mm): AISI 316 L
• Bottom cover (5 mm): AISI 316 L
• Jacket Shell (2.5 mm): AISI 304
• Jacket Closer (4 mm): AISI 304
• Jacket Bottom Cover (2.5 mm): AISI 304
• Insulation Shell (2 mm): AISI 304
• Rod for N1 (75 mm): AISI 316 L
• Rod for N2 (30 mm): AISI 316 L
• Rod for N3, 4, 5 (35 mm): AISI 304
• Rod for N6, 7 (65 mm): AISI 304
• ‘O’ Ring for T/C, 2”: Silicon
• Level Glass (5 mm X 30 mm): Toughen glass

Critical Instruments Calibration Verification

Rationale – To verify that all critical instruments for the Gelatine Storage Vessel have 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.

Acceptance Criteria – All critical instrumentation for the Gelatine Storage Vessel shall be in a state of calibration.

• Instrumentation List Results
• Temperature Sensor

Installation Qualification Tests Status: The table below lists the tests performed and related results.

Critical Feature :

Documents & Drawings Verification

Verification of Technical Specifications for In-House & Sub-contract / bought-out items.

Utility Verification :

Material of Construction Verification

Critical Instruments Calibration Verification