Master SOP For RMG Core
Master SOP For RMG Core
AUTHORIZATION:
------- PREPARED BY REVIEWED BY APPROVED BY
Name
Designation
DRUG SOP No. PR-OP-RMG-0344 Effective Date
INTERNATIONAL Revision No. Nil Next Review Date
LIMITED(UNIT-3) Page No. Page 2 of 5 Superseded Revision No. None
Department Production
TABLE OF CONTENTS
1. PURPOSE 3
2. SCOPE 3
3. RESPONSIBILITIES 3
5. PROCEDURE 3
6. REFERENCES 4
7. ANNEXURE 4
8. REVISION HISTORY 4
1.0 PURPOSE: To lay down an approved procedure for operation of Rapid Mixing
Granulator.
2.0 SCOPE: This SOP is applicable for operation of Rapid Mixing Granulator in granulation
area at Drug International Ltd, (Unit-3), 31/1, Satrong Road, Goplapur, Tongi Industrial
Area, Tongi, Gazipur.
3.0 RESPONSIBILITY
3.1 Operator: Operation as per laid down procedure.
3.2 Production Officer: Training & Monitoring the effective implementation.
3.3 Asst. Production Manager: Overall responsible for implementation.
4.0 ABBREVIATIONS AND DEFINITIONS:
4.1 Abbreviation
RMG: Rapid Mixing Granulator
5.0 PROCEDURE
5.1 General Condition:
5.1.1 Wear the hand gloves and secondary gown.
5.1.2 Before starting the operation check the air leakage at sealing points of cover & impeller.
5.1.3 Check electrical wire.
5.1.4 Check discharge valve, milling speed, Air valve, impeller speed, chopper speed, before
start the operation.
5.1.5 Make sure during operation BMR is available.
5.1.6 Permit trained personnel only to setup and operate machine.
5.2 Precaution
5.2.1 Don’t touch the PLC without any permission.
5.2.2. Don’t Load the material without of its capacity.
5.2.3 Check the air pipe line to affix properly.
5.2.4 If any problem of the machine press emergency stop as early as possible
5.3 Operating Procedure
5.3.1 Check cleanliness of machine. It should be visually cleaned.
5.3.2 Switch ON the main switch.
5.3.3 Set the chopper speed and impeller speed.
5.3.4 Press the Cover close key to close the cover.
5.3.5 To ensure the effectiveness of the machine run in empty condition. If no
abnormalities are seen then load the materials.
5.3.6 Transfer the granules in RMG Bowl and close the lid.
5.3.7 Press starts key to run the machine & adjust the mixing speed by pressing the speed
control key as per BMR.
5.3.8 Press chopper key to start the chopper at certain time.
5.3.9 After completion of dry mixing & wet mixing, Discharge the material to SS Drum
through discharging line.
5.3.10 Press all keys to stop the mixing & chopper.
5.3.11 Switch off the main switch of Rapid mixing granulator.
5.3.12 Record the operational activities in the (Log book: Equipment Operation and
Cleaning: LB-PR-0001) with duly signed.
6.0 REFERENCES
6.1 Machine Instruction and Operation Manual
7. ANNEXURE