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User Requirement Specification For Granulator (Super Mixer) Process Requirement No Requirement Yes/No

The document provides requirements for a granulator including: 1) Process requirements such as a capacity of 300 liters and speed ranges for the chopper and impeller. 2) Safety requirements including an interlock system, explosion proof motor, and emergency stop. 3) GMP requirements for monitoring critical parameters via a control panel and alarms for system failures.

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216 views7 pages

User Requirement Specification For Granulator (Super Mixer) Process Requirement No Requirement Yes/No

The document provides requirements for a granulator including: 1) Process requirements such as a capacity of 300 liters and speed ranges for the chopper and impeller. 2) Safety requirements including an interlock system, explosion proof motor, and emergency stop. 3) GMP requirements for monitoring critical parameters via a control panel and alarms for system failures.

Uploaded by

ike maya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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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
7

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