Design Qualification of Gelatin Colour Mixer

Design Qualification of Gelatin Colour Mixer

  • 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
    • CLIENT:
      • To Check and Approve the design qualification.
    • 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.
  • 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.
  • 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
  • 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
Description Specification
1.Equipment Description
Name Gelatin Colour Mixer
Surface Finish mirror (Internal)

Matt (External)

Overall Dimension 1620 mm(L) X 690 mm(W)
System Height Max. : 2270 mm

Min. : 1600 mm

Stirrer Dimension 680 mm(H) X 560 mm(W)
2.Stirrer Motor with Gear Box
Make SEW – Eurodrive
Type SAF 77 DT 132S4
Power Rating 1.5 KW / 3 Ph / 1440 RPM
Output RPM 29
Charging Port 4” triclover conn., 100 mm
Sight Glass Flanged, 100 mm
Light Glass Flanged, 75 mm
Air vent with valve 1” triclover conn. 25 mm
Vacuum Gauge valve 1” triclover conn. 3/8” mm
Vacuum connection 1” triclover conn. 25 mm
Spare 25 mm
4. Vacuum Gauge
Make Wika
Range -760 to 0 mmHg
Accuracy ± 1%
Least Count 20 mmHg
Type EN837-1
5. Motor (Hydraulic Power Pack)
Make Crompton Greaves
Type 3 Phase Induction Motor
Power Rating 0.75 KW / 1.0 HP / 415 V/ 50 +/- 5 Hz
RPM 1440
6. Pressure Gauge
Make Mass
Type Glycerin Filled
Range 0 to 160 Kg/cm2
Least Count 2 Kg/cm2
Location Hydraulic Power Pack
7. Hydraulic Oil Tank
Make Module Engineering Co.
8. Hydraulic Cylinder
Size 100 X 675 X 70 mm
9. Solenoid Valve
Make Rexroth
Model No. 13 W 06
10. Solenoid Coil
Make Bosch
Power Rating 230 V / 50-60 Hz
Location Hydraulic Power Pack
11. Flow Control valve
Make Flutec
Type TCV- 8 – ¼”
Regulator Range 0 to 9
12. Limit Switch
Make Bhartia Cutler Hammer
Power Rating AC 15 at  415 V / 1.5 A

DC 13 at  240 V / 0.1 A

13. Digital Voltmeter
Make KEW
Model DPM – 48
Type AC Voltmeter
Power Rating 230 VAC
Input (Max.) 750 VAC
14. Digital Ammeter
Make KEW
Model DPM – 48
Type AC Ammeter
Power Rating 230 VAC
Input (Max.) 20A AC
15. Single Mechanical Seal                          
Size 60 mm
Make Burgmann
16. Control Panel
Voltmeter ON / OFF Switch 01 No.
Voltmeter Digital Indicator 01 No.
Amp. Digital Indicator 01 No.
R,Y,B Phase Indicator 01 No. each
Main ON /OFF Switch 01 No.
Control ON /OFF Switch 01 No.
Emergency Switch 01 No.
Cylinder Motor ON /OFF Push Button 01 No. each
Cylinder Motor Trip Indicator 01 No.
Cylinder UP / DOWN Push Button 01 No. each
Cylinder Moving UP / DOWN Indicator 01 No. each
I – Bolt Open Push Button 01 No.
I – Bolt Open Indicator 01 No.
Mixing ON /OFF Push Button 01 No. each
Motor Trip Indicator 01 No.
Mixing ON indicator 01 No.
Description Specification
Electrical connection To be provided
Vacuum Connections To be provided
  • Enclosures
Sr. No. Description Drawing No
1 General arrangement drawing of Gelatin colour  Mixer
Description Specification
Top Dish End 4 mm AISI 316 L
Body Flange for Top Dish 35 mm AISI 316 L
Pad Plate for Agitator 45 mm AISI 316 L
Pad Plate for L.G.,S.G. 35 mm AISI 316 L
Cover for L.G., S.G.  16 mm AISI 304
Rod for N4,5,6,7 56 mm AISI 316 L
Shaft for Mixing & Deaeration Head 65 mm AISI 316 L
Rod for N1 AISI 316 L
‘O’ Ring for T/C 1”, 3/2”, 2”. 3”,4” Silicon
Gasket for Body Flange 608 X 622 X 7 mm Silicon
Sight Glass 12 mm X 100 mm Toughened Glass
Light Glass 12 mm X 75 mm Toughened Glass


  • Critical instruments for calibration
  • Following critical instruments shall be in calibrated state before installation of the machine.
  • Pressure Gauge (Hydraulic)
  • Vacuum Gauge
  • Change in the agreed design shall be addressed through the well-defined Change control procedure.
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
MOC Material of Construction



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