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Design Qualification of Medicament Preparation Vessel

  • OBJECTIVE:
  • To design, engineer and supply the Medicament Preparation 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 Medicament Preparation Vessel. This qualification document is part of a validation activity for the Medicament Preparation 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 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:
  • Medicament Preparation Vessel is used for mixing of ingredients and medicament. Medicament Preparation 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 dished end and closure, stiffeners are provided on main shell.
  • Insulation and Cladding
  • 50 mm RBFG insulation with 1.6 mm thick AISI 304 welded cladding. The outside surface finish is Matt.
  • Support
  • 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 Medicament Preparation Vessel
Surface Finish mirror (Internal)

Matt (external)

Overall Dimension 780 mm (D) X 1150 mm(H)
Nozzle 05 Nos.

N1 : Outlet Connection

N2 : Jacket Connection

N3 : Jacket Connection

N4 : Jacket Vent Connection

N5: Dial type Temp. Gauge

Connection

Insulation RBFG type, 50 mm (T), 2 mm (T) SS 304 cladding
Support AISI 304 legs (04 Nos.) with SS castor wheel
Capacity Working :- 150 L

Gross :-  170 L

MOC Contact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

Design Condition Shell: -1 to Atm.Bar [email protected]0C

Jacket :- 2.5 Bar [email protected]0C

2. Flush Ball Valve for Product Outlet
Type Manual Ball Valve
Make Seeco
Size 1 ½ ”
Mounting Pad Welded
MOC AISI 316 L
3. Vent Valve for Jacket
Type Manual Ball Valve
Make Seeco
Mounting 3/8” BSP
MOC AISI 304
4. Castor Wheel
MOC SS castor with PU coated nylon wheel
Qty. 04 Nos.

Swivel: 02 Nos.

Brake : 02 Nos.

  • DETAILS OF UTILITIES
Description Specified
Hot Water To be provided
Chilled water To be provided

 

  •  ENCLOSURES
Sr. No. Description Drawing No.
1 General arrangement drawing of Medicament Preparation Vessel
  •  MOC OF CONTACT PARTS:
Description Specification
Main Shell, 4 mm AISI 316 L
Top Cover, 1.6 mm AISI 316 L
Body Flange, 20 mm AISI 316 L
Bottom Dish, 4 mm AISI 316 L
Jacket Shell, 3 mm AISI 304
Jacket Dish, 3 mm AISI 304
Jacket Closer, 5 mm AISI 304
Jacket Stiffener, 3 mm AISI 304
Insulation Shell, 1.6 mm AISI 304
Pipe for Leg, 2” NB x Sch.10 AISI 304
Pipe for N2, 3, 1” NB x Sch.40 AISI 304
Plate flange for N2 & N3, 16 mm AISI 304
Tube for N4, 5/8” O.D. x 16 SWG AISI 304
Rod for  N4, 35 mm AISI 304
Rod for  N5, 35 mm AISI 304
‘O’ Ring Food Grade Transparent Silicon Rubber

 

  • 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
MS Mild steel
NFLP Non Flame Proof
SS Stainless Steel
KW Kilo Watt
DQ Design Qualification
FAT Factory acceptance test
VFD Variable frequency drive
RPM Revolution per minute
MMI Man machine interface
SCADA Supervisory control and data acquisition
MCB Miniature circuit breaker
VFD Variable Frequency Drive
MOC Material of Construction

 

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