Design Qualification of Gelatin Colour Mixer

Design Qualification of Gelatin Colour Mixer

  • OBJECTIVE:
  • To design, engineer and supply the Gelatin Colour Mixer 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 Gelatin Colour Mixer. This qualification document is part of a validation activity for the Gelatin Colour Mixer
  • 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
  • Safety features and alarms
  • 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:
  • Gelatin Colour Mixer is semi automatic machine used for mixing colour and other additive with melted gelatin mass. Machine is provided with in built hydraulic system to lift up / down the top lid. Top lid has I -bolt to fix jacketed storage vessel with it. Stirrer is detachable from main shaft which enhance the ease of cleaning. Main control panel is located at the back side of the machine and provided with various ON /OFF switches, START / STOP push button and indicators. Main stirrer motor is coupled with gear box which give output RPM of 29.
  • OPERATING CONTROL PANEL:
  • The Non-flame proof panel is made of SS sheet. It is located at the back side of the machine. Operating panel consists of
  • Main ON / OFF Switch
  • Control ON / OFF Switch
  • Cylinder UP / DOWN push button
  • Mixing START / STOP push button
  • Emergency Push Button
  • I -Bolt opened push button
  • Digital Voltmeter and Ammeter
  • Y,R,B indicator
  • Indicator for each push button / switch
  • MAIN ELECTRIC PANEL:
  • The main Non-Flame Electrical proof power panel housed inside SS box and located at the back side of the machine.
  • Main power panel consists of – Electrical power circuit, MCB
  • TECHNICAL  SPECIFICATIONS  OF  COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
DescriptionSpecification
1.Equipment Description
NameGelatin Colour Mixer
Surface Finishmirror (Internal)

Matt (External)

Overall Dimension1620 mm(L) X 690 mm(W)
System HeightMax. : 2270 mm

Min. : 1600 mm

Stirrer Dimension680 mm(H) X 560 mm(W)
2.Stirrer Motor with Gear Box
MakeSEW – Eurodrive
TypeSAF 77 DT 132S4
Power Rating1.5 KW / 3 Ph / 1440 RPM
Output RPM29
3.Nozzles
Charging Port4” triclover conn., 100 mm
Sight GlassFlanged, 100 mm
Light GlassFlanged, 75 mm
Air vent with valve1” triclover conn. 25 mm
Vacuum Gauge valve1” triclover conn. 3/8” mm
Vacuum connection1” triclover conn. 25 mm
Spare25 mm
4. Vacuum Gauge
MakeWika
Range-760 to 0 mmHg
Accuracy± 1%
Least Count20 mmHg
TypeEN837-1
5. Motor (Hydraulic Power Pack)
MakeCrompton Greaves
Type3 Phase Induction Motor
Power Rating0.75 KW / 1.0 HP / 415 V/ 50 +/- 5 Hz
RPM1440
6. Pressure Gauge
MakeMass
TypeGlycerin Filled
Range0 to 160 Kg/cm2
Least Count2 Kg/cm2
LocationHydraulic Power Pack
7. Hydraulic Oil Tank
MakeModule Engineering Co.
8. Hydraulic Cylinder
Size100 X 675 X 70 mm
9. Solenoid Valve
MakeRexroth
Model No.13 W 06
10. Solenoid Coil
MakeBosch
Power Rating230 V / 50-60 Hz
LocationHydraulic Power Pack
11. Flow Control valve
MakeFlutec
TypeTCV- 8 – ¼”
Regulator Range0 to 9
12. Limit Switch
MakeBhartia Cutler Hammer
Power RatingAC 15 at  415 V / 1.5 A

DC 13 at  240 V / 0.1 A

13. Digital Voltmeter
MakeKEW
ModelDPM – 48
TypeAC Voltmeter
Power Rating230 VAC
Input (Max.)750 VAC
14. Digital Ammeter
MakeKEW
ModelDPM – 48
TypeAC Ammeter
Power Rating230 VAC
Input (Max.)20A AC
15. Single Mechanical Seal                         
Size60 mm
MakeBurgmann
16. Control Panel
Voltmeter ON / OFF Switch01 No.
Voltmeter Digital Indicator01 No.
Amp. Digital Indicator01 No.
R,Y,B Phase Indicator01 No. each
Main ON /OFF Switch01 No.
Control ON /OFF Switch01 No.
Emergency Switch01 No.
Cylinder Motor ON /OFF Push Button01 No. each
Cylinder Motor Trip Indicator01 No.
Cylinder UP / DOWN Push Button01 No. each
Cylinder Moving UP / DOWN Indicator01 No. each
I – Bolt Open Push Button01 No.
I – Bolt Open Indicator01 No.
Mixing ON /OFF Push Button01 No. each
Motor Trip Indicator01 No.
Mixing ON indicator01 No.
  • DETAILS OF UTILITIES
DescriptionSpecification
Electrical connectionTo be provided
Vacuum ConnectionsTo be provided
  • Enclosures
Sr. No.DescriptionDrawing No
1General arrangement drawing of Gelatin colour  Mixer
  • MOC OF CONTACT PARTS:
DescriptionSpecification
Top Dish End 4 mmAISI 316 L
Body Flange for Top Dish 35 mmAISI 316 L
Pad Plate for Agitator 45 mmAISI 316 L
Pad Plate for L.G.,S.G. 35 mmAISI 316 L
Cover for L.G., S.G.  16 mmAISI 304
Rod for N4,5,6,7 56 mmAISI 316 L
Shaft for Mixing & Deaeration Head 65 mmAISI 316 L
Rod for N1AISI 316 L
‘O’ Ring for T/C 1”, 3/2”, 2”. 3”,4”Silicon
Gasket for Body Flange 608 X 622 X 7 mmSilicon
Sight Glass 12 mm X 100 mmToughened Glass
Light Glass 12 mm X 75 mmToughened Glass

 

  • Critical instruments for calibration
  • Following critical instruments shall be in calibrated state before installation of the machine.
  • Pressure Gauge (Hydraulic)
  • Vacuum Gauge
  • 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
MOCMaterial of Construction

 

 

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