SOP For Design Qualification of Raw Gelatin Storage Vessel

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.
  • 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.
  • 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
DescriptionSpecification
1. Equipment Description
NameRaw Gelatin Storage Vessel
Surface Finishmirror (Internal)

Matt (external)

Overall Dimension900 mm (D) X 1130 mm(H)
Nozzle02 Nos.

N1 : Outlet connection

N2 : Vent connection

Main ShellShell : 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

SupportAISI 304 legs (04 Nos.) with SS castor wheel
CapacityWorking :- 150 L

Gross :-  165 L

MOCContact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

2. Butterfly Valve
TypeManual Butterfly Valve with triclover ends
MakeMondentic
Size50.80 mm
MOCAISI 316 L
GasketEPDM
3. Vent Valve for Jacket Connection
TypeManual Ball Valve with triclover ends
MakeMondentic
Size3/4”
MOCSS 316 L
4. Castor Wheel
MOCSS castor with PU coated nylon wheel
TypePin Mounted
Qty.04 Nos.
  • ENCLOSURES
Sr. No.DescriptionDrawing No.
1General arrangement drawing of Raw Gelatin Storage VesselS 150 RPB
  •  MOC OF CONTACT PARTS:
DescriptionSpecification
Main Shell, 2.5 mmAISI 316 L
Top Cover, 1.6 mmAISI 316 L
Bottom Cone, 2.5 mmAISI 316 L
Pipe for Leg, 40 NB x Sch.10AISI 304
Rod for N1, 75 mmAISI 316 L
Rod for N2, 35 mmAISI 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
cGMPcurrent Good Manufacturing Practices
GEPGood Engineering practices
NFLPNon Flame Proof
SSStainless Steel
DQDesign Qualification
FATFactory acceptance test
MOCMaterial of Construction
EPDMEthylene Propylene Diene Monomer

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