SOP for Design Qualification of Capsule Printing machine

SOP for Design Qualification of Capsule Printing machine

  • OBJECTIVE
  • To design, engineer, and supply the Capsule Printing Machine and to provide assurance that the machine is manufactured as per the URS and it comply 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 Capsule Printing Machine. This qualification document is part of a validation activity for the Capsule Printing Machine.
  • 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,
  • 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
  • Capsule Printing Machine prints by offset gravure. Monograms or trademarks are etched on the surface of a gravure roll. The etched areas are filled with ink. A flexible thin blade wipes extra ink from the surface.The etched areas remain full.
  • An offset roll rotates in contact with the gravure roll. Ink is transferred from the etched areas to the offset roll. When the offset roll contacts the object ink is again transferred to print the capsule.
  • Control / Electrical Panel
  • Operating Control Panel
  • The Non Flame proof control panel is made of MS covered with SS cover.

It is located on the Machine.

  • Control panel contains.
  • START / STOP Switch
  • Auto/Jog Rotary Switch
  • Jog Push Button
  • Emergency Stop
  • Speed Adjustor Knob with Lock
  • TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
Description Specification
1. Equipment Description  
Name Capsule printing machine
Make Parle Pharma Machineries
Model Scorpio PPMPT -32-I
Sr.No. 102
Overall dimensions 1820(H)X1210(W)X1180(L)[mm]
Inclined Control Hand wheel 02 No’s
2.                  Main  Motor
Type 3 Phase induction motor
Model BN80 B4
RPM 1400
Power Rating 0.75KW /  230V / 50Hz
Make Bonfliglioli Riduttori
3.                  Indexing Gear Box
Type AS25/P P90
Mount Pos. B3
Ratio 93
Make Bonfliglioli
4          Main Gear Box
Type WSS/UF  CI HS RS
Code 132379
Mount Pos. B3
Ratio 10
Make Bonfliglioli
Description Specification
5          VFD
Model ATV11HU18M2A
Power Rating 0.75KW,200/240V,

50/60Hz

Make Telemecanique
6           Air Switch
Qty 02No’s
Solenoid Valve 01 each
7           Pressure Gauge
Range 0-10 kg / cm2
Least Count 0.2 kg / cm2
Make Legris
Location FRL Unit
  • DETAILS OF UTILITIES
DESCRIPTION SPECIFICATIONS
Electrical connection To be provided
Compressed Air To be provided
  • MATERIAL OF CONSTRUCTION
Description      Specification
Hopper
Ink reservoir
Feed Disc
Metal Disc
Disc Nut
Gravure Roll
Lower Offset Roll
Upper Offset Roll
Air Nozzles
Air Ejector Nozzle
Exit Chute
  • ENCLOSURES
Sr. No. Description Drawing No.
1 General arrangement drawing of Capsule Printing Machine  

 

  • CHANGE CONTROL PROCEDURE

Change in the agreed design shall be addressed through the well-defined Change control procedure.

  • DESIGN QUALIFICATION REPORT
  • APPENDIX
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

 

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