Sunday , August 9 2020
Home / email / Design Qualification of Raw Gelatin Storage Vessel

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
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

For More Pharma Updates Visit –https://pharmaguidances.com

About Pharma Editor

Check Also

Risk Assessment Sample Format on Tablets Manufacturing Process

Pharma Editor