Design Qualification of Gelatin Colour Mixer

Gelatin Colour Mixer 

A Gelatin Colour Mixer is a semi-automatic machine used for mixing color and another additive with melted gelatin mass. The machine is provided with an in-built hydraulic system to lift / down the top lid. The top lid has an I-bolt to fix the jacketed storage vessel with it. The stirrer is detachable from the main shaft which enhances the ease of cleaning. The main control panel is located at the back side of the machine and is provided with various ON /OFF switches, START / STOP push buttons, and indicators. The main stirrer motor is coupled with a gearbox which gives an output RPM of 29.

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 the 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 about its design qualification viz.

  • Machine overview
  • General arrangement drawing
  • Equipment orientation with the 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 unauthorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, the Change control procedure shall be followed and documented.

To ensure the proper installation and commissioning of the equipment.

OPERATING CONTROL PANEL:

The Non-flame-proof panel is made of an SS sheet. It is located on the back side of the machine. The 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 the 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 is housed inside the SS box and located at the back side of the machine.

The main power panel consists of an electrical power circuit, MCB

TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -SUB-COMPONENTS USED / BOUGHTOUTS

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)
  1. Stirrer Motor with gearbox
  2. Nozzles: 4” tri-clover Conn., 100 mm
  • Charging Port
  • Sight Glass
  • Light Glass
  • Air vent with valve
  • Vacuum Gauge valve
  • Vacuum connection
  1. Vacuum Gauge
  2. Motor (Hydraulic Power Pack)
  3. Pressure Gauge
  4. Hydraulic Oil Tank
  5. Hydraulic Cylinder
  6. Solenoid Coil 
  1. Flow Control valve
  2. Limit Switch
  3. Digital Voltmeter
  4. Digital Ammeter
  5. Single Mechanical Seal
  6. 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 Color 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: The following critical instruments shall be in the 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

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