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
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)
- Stirrer Motor with Gear Box
- Nozzles: 4” triclover Conn., 100 mm
Charging Port
Sight Glass
Light Glass
Air vent with valve
Vacuum Gauge valve
Vacuum connection
- Vacuum Gauge
- Motor (Hydraulic Power Pack)
- Pressure Gauge
- Hydraulic Oil Tank
- Hydraulic Cylinder
- Solenoid Coil
- Flow Control valve
- Limit Switch
- Digital Voltmeter
- Digital Ammeter
- Single Mechanical Seal
- Control Panel
Voltmeter ON / OFF Switch
Voltmeter Digital Indicator
Amp. Digital Indicator
R,Y,B Phase Indicator
Main ON /OFF Switch
Control ON /OFF Switch
Emergency Switch
Cylinder Motor ON /OFF Push Button
Cylinder Motor Trip Indicator
Cylinder UP / DOWN Push Button
Cylinder Moving UP / DOWN Indicator
I – Bolt Open Push Button
I – Bolt Open Indicator
Mixing ON /OFF Push Button
Motor Trip Indicator
Mixing ON indicator
DETAILS OF UTILITIES
Electrical connection
Vacuum Connections
Enclosures
General arrangement drawing of Gelatin colour Mixer
MOC OF CONTACT PARTS:
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
‘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
cGMP: current Good Manufacturing Practices
GEP: Good Engineering practices
MS: Mild steel
NFLP: Non Flame Proof
SS: Stainless Steel