Complete Pharma Solution
- PURPOSE:
- To describe the Installation Qualification of Gelatin Storage 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:
- The scope of this document applies to the installation qualification of Gelatin Storage Vessel.
- 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 Gelatin Storage 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.
- 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 |
| Documents & Drawings Verification | |
| Verification of Technical Specification for
In-House & sub-components / bought out items |
|
| Utilities 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 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. | Sign. | 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 Gelatin Storage Vessel 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 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 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 | Gelatin Storage Vessel | ||||
| Surface Finish | mirror (Internal) & Matt (external) | ||||
| Overall Dimension | 900 mm (D) X 960 mm(H) | ||||
| Design Condition | Shell: -1 to Atm. Bar g @120 0C
Jacket: FOW @120 0C |
||||
| Nozzle | 07 Nos.
N1 : Outlet connection N2 : Product Thermowell N3 : Water Inlet N4 : drain N5 : Vent connection N6 : Heater Connection N7 : 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 :- AISI 316 L
Non – Contact :- AISI 304 Gasket:- Silicon |
||||
| 2. Ball Valve for Outlet Connection | |||||
| type | Manual Ball Valve | ||||
| size | 50 mm | ||||
| MOC | AISI 316 L | ||||
| End Connection | T/C | ||||
| Make | Seeco | ||||
| type | Manual Ball Valve | ||||
| Sr. No. | 2253/06 | ||||
| 3. Ball Valve for Jacket Inlet Connection | |||||
| type | Manual Ball Valve | ||||
| size | 25 mm | ||||
| MOC | AISI 316 L | ||||
| End Connection | T/C | ||||
| Make | Seeco | ||||
| Sr. No. | 78/06 | ||||
| 4. Temp. Sensor | |||||
| Type | PT-100, 3 Wire | ||||
| Mounting | ½” BSP | ||||
| Accuracy | ± 1 % | ||||
| Range | 0-200 0C | ||||
| Make | Radix | ||||
| Sr. No. | 19001497 | ||||
| 5. Heater | |||||
| type | Water Immersion Heater with Plug Pin | ||||
| Power Rating | 2 KW / 230 V | ||||
| Qty. | 02 Nos. | ||||
| 6. Thermostat | |||||
| Qty. | 02 Nos. | ||||
| Range | 25 to 150 0C | ||||
| Power Supply | 240 Volts | ||||
| Make | Girish Ego | ||||
| Model | 210 C & 210 | ||||
| 7. Temp. Indicator Cum Controller | |||||
| Range | 0 – 200 0C | ||||
| Power Supply | 230 Volts | ||||
| Make | Radix | ||||
| Sr. No. | |||||
| 8. Castor Wheel | |||||
| MOC | SS castor wheel with PU coated nylon | ||||
| Type | Pin Mounted | ||||
| Diameter | 4” | ||||
| Qty. | 04 Nos. | ||||
- 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 |
|
| Potable Water | To be provided | |||
- Conclusions / Comments:
- Material of Construction Verification
- Rationale – To verify that all assembly of Gelatin 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 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 L & if the solution turns pink and immediately vanishes, then it is AISI 304.
- Acceptance Criteria – All material of construction for the Gelatin Storage Vessel shall meet the MOC provided in Design Qualification.
- Material of Construction verification Results
| Part Description & Size | Material | Meets
Spec. (Yes/No) |
Verification Source | Sign. | Date |
| 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 |
- Conclusions / Comments:
- Critical Instruments Calibration Verification
- Rationale – To verify that all critical instruments for the Gelatin Storage 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.
- Acceptance Criteria – All critical instrumentation for the Gelatin Storage Vessel shall be in a state of calibration.
- Instrumentation List Results
| Description | Make | Model | Serial No. | Certificate No. | Current Calibration | |
| Yes/No | Sign / Date | |||||
| Temperature Sensor | ||||||
- 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 | ||||
| Documents & Drawings Verification | |||||
| Verification of Technical Specification for In-House & Sub-contract / bought out items. | |||||
| Utilities Verification | |||||
| Material of Construction Verification | |||||
| Critical Instruments Calibration Verification | |||||
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
Sr. No. |
Item Name |
Remarks |
Signature and Date |