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

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
3.Nozzles
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.

• DETAILS OF UTILITIES

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

• MOC OF CONTACT PARTS:

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 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
MOC	Material of Construction