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

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 Gear Box
  2. Nozzles: 4” triclover 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 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