Design Qualification of Gelatin Storage Vessel
- OBJECTIVE:
- To design, engineer and supply the Gelatin Storage Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
- SCOPE:
- The scope of this qualification document is limited to the Design Qualification of Gelatin Storage Vessel. This qualification document is part of a validation activity for the Gelatin Storage Vessel.
- RESPONSIBILITIES:
- CLIENT:
- To Check and Approve the design qualification.
- CLIENT:
- MANUFACTURER:
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Machine overview
- General arrangement drawing
- Equipment orientation with layout
- Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Details of Utilities,
- Identification of components for calibration
- Material of construction of all components
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no unauthorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
- To ensure the proper installation and commissioning of the equipment.
- MACHINE DESCRIPTION:
- Gelatin Storage Vessel is used for intermediate storage of gelatin. Gelatin Storage Vessel is comprised of following components.
- Shell
- Cylindrical, Vertical, AISI 316 L shell with top flat and bottom tapered flat end, having detachable cover on top. Surface finish is Mirror.
- Jacket
- Cylinder, vertical, AISI 304 jacket shell with bottom tapered flat end and stiffeners are provided at bottom dish of main shell.
- Insulation and Cladding
- 50 mm RBFG insulation with 2 mm thick AISI 304 welded cladding. The outside surface finish is Matt.
- Supporting
- AISI- 304 platform with 04 Nos. of SS castor wheels are provided.
- TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
| Description | Specification |
| |
| 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 |
| 3. Ball Valve for Jacket Inlet Connection | |
| type | Manual Ball Valve |
| size | 25 mm |
| MOC | AISI 316 L |
| End Connection | T/C |
| Make | Seeco |
| 4. Temp. Sensor | |
| Type | PT-100, 3 Wire |
| Mounting | ½” BSP |
| Accuracy | ± 1 % |
| Range | 0-200 0C |
| Make | Radix |
| 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 |
| 7. Temp. Indicator Cum Controller | |
| Range | 0 – 200 0C |
| Power Supply | 230 Volts |
| Make | Radix |
| 8. Castor Wheel | |
| MOC | SS castor wheel with PU coated nylon |
| Type | Pin Mounted |
| Diameter | 4” |
| Qty. | 04 Nos. |
- DETAILS OF UTILITIES
| Description | Specified |
| Potable Water | To be provided |
- ENCLOSURES
| Sr. No. | Description | Drawing No. |
| 1 | General arrangement drawing of Gelatin Storage Vessel | S 150 PBGF |
- MOC OF CONTACT PARTS:
| Description | Specification |
| 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 |
- IDENTIFICATION OF COMPONENT FOR CALIBRATION
- In the Jacketed Planetary Mixer, following are the components, which needs calibration. They shall be calibrated during/ before installation of the equipment at the site:
- Following are the components:
- Temperature Sensor
- CHANGE CONTROL PROCEDURE:
- Change in the agreed design shall be addressed through the well-defined Change control procedure.
- DESIGN QUALIFICATION REPORT:
- LIST OF ABBREVIATIONS
| cGMP | current Good Manufacturing Practices |
| GEP | Good Engineering practices |
| SS | Stainless Steel |
| KW | Kilo Watt |
| DQ | Design Qualification |
| FAT | Factory acceptance test |
| VFD | Variable frequency drive |
| MMI | Man machine interface |
| MOC | Material of Construction |
| RBFG | Radial Basis Function Gaussian |