Table of Content
- Objective
- Scope
- Responsibility ( Client & Manufacturer )
- Machine Description
- Technical Specification
- Technical 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
- Safety features and alarms
- FAT procedure
- Reference Documents
- GA Drawing
- Catalog
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 user's requirement it complies with the Scope of Supply.
Scope
The scope of this qualification document is limited to the Preliminary Design Qualification of the Rapid Mixer Granulator. This pre-qualification document is part of an ordering activity for the Rapid Mixer Granulator.
Responsibilities
Client
- To provide the datasheet 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.
- Machine overview
- P & ID 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
- Brief process description
- Safety features and alarms
- 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 unauthorized 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 an 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:Â Rapid Mixer Granulator
Service:Â Wet Mixing and granulation
Volume: 400 Liters Gross & 320 liters Working
Capacity / Output:Â 150 Kgs at 0.5 Kgs/ Liters bulk density of powder
Material of Construction:
Design Feature:
Operating Feature:
Documents to be provided
- As Built Drawings
- Material TC
- Motor TC
- Gear Box TC
- Operation / Instruction Manual
- 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.
ALSO READ:Â Qualification of Walking Type Stability Chamber
Lid
The lid consists of
- Flange matching the bowl flange.
- Counterweight
- Viewport & 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 gearbox 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 were 12provided for bowl and discharge opening. Pump and piping are offered as an option.
Mounting
- MS Rectangular stand supports the entire assembly of the bowl, drive, and platform. The stand is provided with SS304 covers on all sides.
Controls
- Phase Indication Lamps (In Main Panel)
- Rotary Main switch
- Voltmeter (In Main Panel)
- Current display for each motor
- Timer for Cycle Time
- Auto manual operation
- Slow - Fast – Stop operation for both agitators
- Indications for lid open
- Discharge operation
- Pressure switch for no air no operation
- Process display
- Emergency Off Push button
- Contactors, relays, MCBs, etc.,.
Note :
For Ex-proof 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:Â Non Exproof , TEFC
Electricals:Â Operator panel in ExProof (Main panel to be mounted outside FLPÂ area, MMI is mounted on the machine)
Details of Utilities
Utilities
Identification Of Component For Calibration
- Voltmeter
- Ammeter
Safety Features
- Overload Relay for the motor.
- All moving parts are provided with limit switches.
- All sharp edges were removed.
- Lid and discharge are provided with limit switches so that impellers and discharge do not operate with lids opened.
- The chopper motor is interlocked with the main motor.
- The machine will not operate in case air pressure is low.
- Earth arrangement was provided for the machine.
Fat Procedure
Factory Acceptance Test Procedure shall be as follows:
- After the completion of the erection work of the machine, the 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:
- Test Criteria
- Design Verification Checklist
- Deficiency & Corrective Action Report
- Pre-installation requirements
- Final report
Reference Documents
Manufactures Brochure (s) / Manual(s). (Title and Location ) to be supplied with the Installation qualification documents
- Instruction & Maintenance Manual
- Calibration certificates
- Material of construction certificates
- GA drawing
ALSO READ:Â SOP for Operational Qualification
Tags
Qualification
