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Design Qualification for Rapid Mixer Granulator


Table of Content
  1. Objective
  2. Scope
  3. Responsibility ( Client & Manufacturer )
  4. Machine Description
  5. Technical Specification
  6. Technical Specifications of the sub – components/ bought out items, and their make, model & quantity, and backup records/ brochures
  7. Details of Utilities
  8. Identification of components for calibration
  9. Safety features and alarms
  10. FAT procedure
  11. Reference Documents
  12. GA Drawing
  13. Catalogue

Objective
To design, engineer, and supply the Rapid Mixer Granulator for Powder & Granules as per cGMP guidelines and to provide assurance that the machine is manufactured as per the users requirement it complies with Scope of Supply.

Scope
The scope of this qualification document is limited to the Preliminary Design Qualification of Rapid Mixer Granulator. This pre qualification document is part of a ordering activity for the Rapid Mixer Granulator.

Responsibilities

Client
  • To provide the data sheet for the requirement.
  • To perform the Factory Acceptance Test (FAT).
Manufacturer
  • To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
  1. Machine overview
  2. P & ID drawing
  3. Equipment orientation with layout
  4. Specifications of the sub – components/ bought out items, and their make, model & quantity, and backup records/ brochures
  5. Details of utilities
  6. Identification of components for calibration
  7. Material of construction of all components
  8. Brief process description
  9. Safety features and alarms
  10. Pre – installation requirements
  • To facilitate the client for the Factory acceptance test of the machine at their works/ site.
  • 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. It 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
  • This equipment is a agitator mixer, in which a bottom entry agitator performs the function of wet mixing, and a side mounted chopper blade breaks the lumps into granules. Discharge is side mounted.
Technical Specifications
Equipment:   Rapid Mixer Granulator
Service:          Wet Mixing and granulation
Volume:         400 Liters Gross & 320 liters Working
Capacity / Output:    150 Kgs at 0.5 Kgs/ Liters bulk density of powder

Material of Construction:

Design Feature:

Operating Feature:

Documents to be provided
  1. As Built Drawings
  2. Material TC
  3. Motor TC
  4. Gear Box TC
  5. Operation / Instruction Manual
  6. Guarantee Certificate

General Description of Machine
Bowl
The bowl consists of
  • Flat bottom
  • Central cylindrical shell
  • Inverted conical frustum at the top.
  • Flanged lid with counter weight for easy opening
  • Side mounted chopper assembly
  • Side mounted discharge.
  • Bottom entry main agitator.


Lid
The lid consists of
  • Flange matching the bowl flange.
  • Counter weight
  • View port & Small part addition inlet
  • Air vent with filter

Main Agitator
The main drive consists of
  • 750/1440 rpm, 30 / 40 HP dual speed motor
  • Profiled machined blade
  • Teflon Seal to avoid powder entering the shaft
  • Belt drive between gear box and motor.

Chopper
Consists of
  • 1440 & 2800 rpm, dual speed 4 / 5 HP motor
  • Specially designed blade
  • Teflon Seal to avoid powder entering the shaft
  • Directly mounted motor.

Discharge
  • Side mounted discharge valve, located on shell near bowl bottom.
  • Pneumatically operated.
  • Discharge hinged for opening and cleaning.
  • Height to suit FBD Bowl or co.-mill with FBD Bowl.

Cleaning
  • The bowl is to be cleaned in place. Spray nozzles provided for bowl and discharge opening. Pump and piping is offered as an options.

Mounting
  • MS Rectangular stand supports the entire assembly of bowl, drive and platform. The stand is provided with SS304 covers on all side.

Controls
  1. Phase Indication Lamps ( In Main Panel)
  2. Rotary Main switch
  3. Voltmeter ( In Main Panel)
  4. Current display for each motor
  5. Timer for Cycle Time
  6. Auto manual operation
  7. Slow - Fast – Stop operation for both agitators
  8. Indications for lid open
  9. Discharge operation
  10. Pressure switch for no air no operation
  11. Process display
  12. Emergency Off Push button
  13. Contactors, relays, MCB's, etc.,.

Note :
For Exproof models, the main panel is to be mounted outside the FLP area, Only MMI and FLP operator panel is provided near the machine.

Technical Specification of Components & Sub – Components Used / Bought Outs.
Drive:         Non Exproof , TEFC
Electricals: Operator panel in ExProof ( Main panel to be mounted outside FLP area, MMI is mounted on the machine )

Details of Utilities

Utilities


Identification Of Component For Calibration
  1. Voltmeter
  2. Ammeter

Safety Features
  1. Overload Relay for motor.
  2. All moving parts are provided with limit switches.
  3. All sharp edges removed.
  4. Lid and discharge provided with limit switches so that impellers and discharge do not operate with lids are opened.
  5. Chopper motor interlocked with main motor.
  6. Machine will not operate in case air pressure is low.
  7. Earth arrangement provided for machine.

Fat Procedure
Factory Acceptance Test Procedure shall be as follows:
  • After the completion of erection work of the machine, client shall be informed to perform the factory acceptance test (FAT).
  • Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:
  1. Test Criteria
  2. Design Verification Check List
  3. Deficiency & Corrective Action report
  4. Pre – installation requirements
  5. Final report

Reference Documents
Manufactures Brochure (s) / Manual(s). (Title and Location ) to be supplied with the Installation qualification documents
  1. Instruction & Maintenance manual
  2. Calibration certificates
  3. Material of construction certificates
  4. GA drawing


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