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USER REQUIREMENT SPECIFICATION FOR GRANULATOR (SUPER MIXER)

PROCESS REQUIREMENT
No Requirement Yes/No
1 Capacity of 300 liters
2 Speed range of chopper 0-3000 rpm
3 Speed range of impeller 0 -100 rpm
4 Single nozzle sprayer with adjustable droplet
5 Material SS316L mirrorless for product contact
6 Suction charging material
7 Set point of parameters should not be affected by power failure
8 Airseal impeller with sensor
9 Side chopper
10 Three blade impeller including scrapper
11 380 volt - 3000 watt electricity
12 Solution tank for binder with pressure
13 PLC control

SAFETY REQUIREMENT
No Requirement Yes/No
1 Interlock system
2 Explosion proof motor
3 Tank pressure 10 bar
4 Grounded electricity
5 Emergency stop
6 Power failure safety

GMP REQUIREMENT
No Requirement Yes/No
1 Control and monitoring of critical parameter via control panel
2 System failure alarm (audio-visual), including airseal failure
3 Run, start, stop and fault indication on control panel
4 access level control
5 process stopped during failure
GMP Business
No Equipment Equipment Use H M L H L
1 Super Mixer granulation process X X
1.1 Impeller speed to mix product in defined speed X X
Mixing time to mix product in defined time X X
1.2 Chopper speed to mix granule in defined speed X X
granulating time to mix granule in defined time X X
1.3 Sprayer to charge API X X
to spray binder X X
1.4 Suction charging material to charge material to mixing tank X X
Overall Impact
Direct Impact
Direct Impact
Direct Impact
Direct Impact
Direct Impact
Direct Impact
Direct Impact
Indirect impact
Test Items/ Funtion/ Process/
No Failure Mode
Component

1 Material suction charging Pressure to low

2 Mixing process impeller not working


Friction of impeller and tank during mixing

Airseal not function

chopper speed uncontrolled

Low pressure for droplet spraying

3 Cleaning of equipment inadequate cleaning

4 Interlock function interlock not function


Risk Analysis Risk Evaluation
Risk and conceivable malfunction/ consequences
Overall Risk
O S D Risk accepted

Material is not transferred completely to the tank H M L M No

Non homogen granulating mixture L H H H No


Contamination L H H H No

Granule trapped in motor, contamination from motor


to granules L H H H No

particle size of granule not meet requirement L H H H No

API content not homogen L H H H No

Contamination of residue L H H H No

safety incident L H H H No
Qualification Step Risk After Control Measure
Risk Control/Action for
Correction
DQ IQ OQ PQ Risk Accepted

SOP mentioning that


operator must visually
check the transfer
completeness X Yes

calibrate pressure regulator X Yes


calibration of speed and
time X Yes
metal detector on tablet X Yes

SOP on checking condition


before starting process X Yes
Preventive maintenance X Yes

Preventive maintenance X Yes


check of alarm function X Yes
calibration of speed and
time X Yes

calibrate pressure regulator X Yes

detail cleaning SOP X Yes


validation of cleaning
procedure X Yes
regular checking of
interlock function X Yes
IQ
1 Drawing checking
2 checking completeness of all component
3 checking completeness of certificate (materials, calibrations)
4 labelling of equipment
5 equipment specification

OQ
1 verify IQ report
2 verify impeller speed
3 verify timer
4 verify chopper speed
5 verify pressure regulator
6 verify alarm function
7 verify compressed air supply
8 verify spray droplet and spray rate
9 verify SOP on cleaning, operation, and maintenance
10 verify interlock testing
11 verify stop during failure

PQ
1 verify OQ report
2 Granule mass is formed

Calibration plan
1 speed
2 time
3 pressure

Preventive Maintenance Plan


1 regular check and replacement of seal
2 checking of leakage in suction line
3 grease for motor
4 checking of impeller and chopper motor
5 checking of distance of tank bottom and impeller
6 checking of alarm function
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