SOP For Design Qualification of Raw Gelatin Storage Vessel
- OBJECTIVE:
- To design, engineer and supply the Raw 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 Raw Gelatin Storage Vessel. This qualification document is part of a validation activity for the Raw 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
- Details of Utilities,
- Material of construction of all components
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no un-authorized 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.
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- MACHINE DESCRIPTION:
- Raw Gelatin Storage Vessel is used storage and transferring of raw material. Raw Gelatin Storage Vessel is comprised of following components.
- Shell
- Cylindrical, Vertical, AISI 316 L shell with top flat and bottom conical end, having detachable cover on top. Surface finish is Mirror.
- Supporting
- 04 Nos. of leg support with SS castor wheel are provided.
- TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
| Description | Specification |
| 1. Equipment Description | |
| Name | Raw Gelatin Storage Vessel |
| Surface Finish | mirror (Internal)
Matt (external) |
| Overall Dimension | 900 mm (D) X 1130 mm(H) |
| Nozzle | 02 Nos.
N1 : Outlet connection N2 : Vent connection |
| Main Shell | Shell : 760 X 180 X 2.5 mm Heads : 1.6 mm (T)
Detachable flat cover on top and 2.5 mm (T) conical dish at bottom |
| Support | AISI 304 legs (04 Nos.) with SS castor wheel |
| Capacity | Working :- 150 L
Gross :- 165 L |
| MOC | Contact :- AISI 316 L
Non – Contact :- AISI 304 Gasket:- Silicon |
| 2. Butterfly Valve | |
| Type | Manual Butterfly Valve with triclover ends |
| Make | Mondentic |
| Size | 50.80 mm |
| MOC | AISI 316 L |
| Gasket | EPDM |
| 3. Vent Valve for Jacket Connection | |
| Type | Manual Ball Valve with triclover ends |
| Make | Mondentic |
| Size | 3/4” |
| MOC | SS 316 L |
| 4. Castor Wheel | |
| MOC | SS castor with PU coated nylon wheel |
| Type | Pin Mounted |
| Qty. | 04 Nos. |
- ENCLOSURES
| Sr. No. | Description | Drawing No. |
| 1 | General arrangement drawing of Raw Gelatin Storage Vessel | S 150 RPB |
- MOC OF CONTACT PARTS:
| Description | Specification |
| Main Shell, 2.5 mm | AISI 316 L |
| Top Cover, 1.6 mm | AISI 316 L |
| Bottom Cone, 2.5 mm | AISI 316 L |
| Pipe for Leg, 40 NB x Sch.10 | AISI 304 |
| Rod for N1, 75 mm | AISI 316 L |
| Rod for N2, 35 mm | AISI 316 L |
| ‘o’ Ring for T/C, 2” | Silicon |
- 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 |
| NFLP | Non Flame Proof |
| SS | Stainless Steel |
| DQ | Design Qualification |
| FAT | Factory acceptance test |
| MOC | Material of Construction |
| EPDM | Ethylene Propylene Diene Monomer |
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