Design Qualification of Medicament Preparation Vessel

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
DescriptionSpecification
1. Equipment Description
NameMedicament Preparation Vessel
Surface Finishmirror (Internal)

Matt (external)

Overall Dimension780 mm (D) X 1150 mm(H)
Nozzle05 Nos.

N1 : Outlet Connection

N2 : Jacket Connection

N3 : Jacket Connection

N4 : Jacket Vent Connection

N5: Dial type Temp. Gauge

Connection

InsulationRBFG type, 50 mm (T), 2 mm (T) SS 304 cladding
SupportAISI 304 legs (04 Nos.) with SS castor wheel
CapacityWorking :- 150 L

Gross :-  170 L

MOCContact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

Design ConditionShell: -1 to Atm.Bar g@1200C

Jacket :- 2.5 Bar g@1200C

2. Flush Ball Valve for Product Outlet
TypeManual Ball Valve
MakeSeeco
Size1 ½ ”
MountingPad Welded
MOCAISI 316 L
3. Vent Valve for Jacket
TypeManual Ball Valve
MakeSeeco
Mounting3/8” BSP
MOCAISI 304
4. Castor Wheel
MOCSS castor with PU coated nylon wheel
Qty.04 Nos.

Swivel: 02 Nos.

Brake : 02 Nos.

  • DETAILS OF UTILITIES
DescriptionSpecified
Hot WaterTo be provided
Chilled waterTo be provided

 

  •  ENCLOSURES
Sr. No.DescriptionDrawing No.
1General arrangement drawing of Medicament Preparation Vessel
  •  MOC OF CONTACT PARTS:
DescriptionSpecification
Main Shell, 4 mmAISI 316 L
Top Cover, 1.6 mmAISI 316 L
Body Flange, 20 mmAISI 316 L
Bottom Dish, 4 mmAISI 316 L
Jacket Shell, 3 mmAISI 304
Jacket Dish, 3 mmAISI 304
Jacket Closer, 5 mmAISI 304
Jacket Stiffener, 3 mmAISI 304
Insulation Shell, 1.6 mmAISI 304
Pipe for Leg, 2” NB x Sch.10AISI 304
Pipe for N2, 3, 1” NB x Sch.40AISI 304
Plate flange for N2 & N3, 16 mmAISI 304
Tube for N4, 5/8” O.D. x 16 SWGAISI 304
Rod for  N4, 35 mmAISI 304
Rod for  N5, 35 mmAISI 304
‘O’ RingFood 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
cGMPcurrent Good Manufacturing Practices
GEPGood Engineering practices
MSMild steel
NFLPNon Flame Proof
SSStainless Steel
KWKilo Watt
DQDesign Qualification
FATFactory acceptance test
VFDVariable frequency drive
RPMRevolution per minute
MMIMan machine interface
SCADASupervisory control and data acquisition
MCBMiniature circuit breaker
VFDVariable Frequency Drive
MOCMaterial of Construction

 

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

About Pharma Editor

Check Also

User requirement specification (URS) of Tablets Automatic Coating Machine

User requirement specification (URS) of Tablets Automatic Coating Machine User requirement specification (URS) of Tablets …

error: Content is protected !!