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Design Qualification of Gelatin Storage Vessel

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.
  • 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,
  • 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
  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
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

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