Sei sulla pagina 1di 11

Client

Document Preliminary Design Qualifications


Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 1 of 11

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

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 2 of 11

1.0 Objective

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

2.0 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.

3.0 Responsibilities

Client
To provide the data sheet for the requirement.
To perform the Factory Acceptance Test (FAT).

Manufacturer
1. To design, engineer and provide the complete technical details of the equipment
pertaining to its design qualification viz.

i. Machine overview
ii. P & ID drawing
iii. Equipment orientation with layout
iv. Specifications of the sub components/ bought out items, and their make,
model & quantity, and backup records/ brochures
v. Details of utilities
vi. Identification of components for calibration
vii. Material of construction of all components
Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 3 of 11

viii. Brief process description


ix. Safety features and alarms
x. Pre installation requirements
2. To facilitate the client for the Factory acceptance test of the machine at their works/
site.
3. To confirm the safe delivery of the equipment to the user site.
4. 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.
5. To ensure the proper installation and commissioning of the equipment.

4.0 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.

5.0 Technical Specifications

Equipment Rapid Mixer Granulator

Service Wet Mixing and granulation

Volume 400 Litres Gross


320 litres Working

Capacity / Output 150 Kgs at 0.5 Kgs/ Liters bulk density of powder

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 4 of 11

MOC
SNo Item Description / Specification
1 Contact Parts SS316
2 Non Contact Exposed Parts SS304.
3 Non Contact Internal Parts Cladded / Covered with
SS304.
4 Elastomers in contact with product Silicon
5 Elastomers not in contact with product Food Grade Neoprene.

Design Features
SNo Item Description / Specification
1 Temperature Ambient to 120 degrees C
2 Pressure Atmospheric
3 Major Dimensions As per our standards.
4 GA Drawing No. B&A/GEN/RMG
5 Product Safety All internal surfaces have smooth rounded
edges. Internal surfaces smooth mirror
Polished.
6 Speed Main agitator 60/120 dual speed approx
Chopper dual speed 1400 & 2800 approx
7 Drive Non Ex proof TEFC
8 Electricals Non Ex proof TEFC

Operating Features
SNo Item Description / Specification

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 5 of 11

1 Charging Through the top of the bowl manually or by


bin loading arrangement ( Optional ).
2 Discharge Through pneumatically operated side
discharge valve directly into Cone mill or FBD
bowl.
3 Mobility The machine is to be placed in one location.
4 Cleaning To be cleaned manually or optionally a CIP
system can be provided.

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.

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 6 of 11

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.

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 7 of 11

Height to suit FBD Bowl or comill 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, Mcbs,etc,.

Note :

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 8 of 11

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.

6.0 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 )

7.0 Details Of Utilities

Utilities
SNo Utiity Specification Unit Quantity
1 Power 3 Phase, 410 HP 45
Volts, 50 Hz.,
2 Compressed 3 Kgs/cm2 CFM 10
Air
3 Steam 3 Kgs/cm2 Kgs NA
4 Space mm * mm * mm L * b * ht 2000 * 2000 * 3500 (
Required tentative )

8.0 Identification Of Component For Calibration

1. Voltmeter

2. Ammeter

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 9 of 11

9.0 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.

10.0 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

11.0 Reference Documents

Manufactures Brochure (s)/ Manual (s). ( Title and Location ) to be supplied with the
Installation qualification documents

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 10 of 11

1. Instruction & Maintenance manual


2. Calibration certificates
3. Material of construction certificates
4. GA drawing

Bought Out Brand


Motor Hindustan
Gear Box Shanti/CPEC
Electricals Siemens / L&T
Push Buttons Technic
Variator Schneider, Telemechanic
PLC Schneider, Telemechanic
Pneumatics Festo / Dancal

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature
Client
Document Preliminary Design Qualifications
Equipment Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date
Page Page 11 of 11

CHOPPER MOTOR COUNTER WEIGHT

DISCHARGE

STAIRCASE PLATFORM

OPERATING PANEL
BOWL

CONTROL PANEL

DRIVE ASSEMBLY

STAIRCASE AND PLATFORM DEPEND ON MACHINE HEIGHT


MACHINE HEIGHT DEPENDS ON fbd BOWL HEIGHT

TITLE RAPID MIXER GRANULATOR PRODUCTION MODELS


Designers and Manufacturers of Pharmaceutical Machineries
Phone (9122):23747768/69 CLIENT B&A/GEN/RMG
(9122) 23782714
Fax (9122) :23747768
Mobile: 98210 78933 DATE 27/06/05
E-Mail :smrabee@vsnl.net
SCALE NTS CHKD. SMR

Prepared By Checked By
Name Minu Pathak S M Rabee
Date
Signature