1.0 Purpose
1.1 To lay down a procedure for the Preventive Maintenance for Rapid Mixer Granulator.
2.0 Scope
2.1 This procedure is applicable for the Preventive Maintenance of Rapid Mixer Granulator to be followed at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only trained Technician/ Engineering Officer is responsible for execution of this procedure.
3.2. Head of Engineering and Maintenance shall be responsible for the implementation of this SOP.
3.3 Head of QA / designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
4.1 SOP : Standard Operating Procedure.
4.2 QA : Quality Assurance
4.3 RMG : Rapid Mixer Granulator
4.4 FRL : Filter Regulator Lubricator
4.5 CTC : Carbon Tetra Chloride
4.6 PLC : Programmable Logic Controller
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 Used necessary safety wears doing the work.
6.2 Ensure covers and guards are properly fixed.
7.0 Procedure
7.1. General Conditions
7.1.1 Refer the master plan of preventive maintenance.
7.1.2 Equipment shall be available for preventive maintenance.
7.1.3 Clean oil / grease stain and remove unwanted materials, spares after completion of work.
7.2. Procedure for Preventive Maintenance of Rapid Mixer Granulator
7.2.1 Ensure that electrical supply is in off position in main panel and display “Under Maintenance” on the panel board and guard are properly fixed.
7.2.2 The Technician or above has to ensure and verify the check points for the preventive maintenance as shown in the Annexure-I and Annexure- II.
7.2.3 After the completion of preventive maintenance, check the machine for smooth operation.
7.2.4 Remove “Under Maintenance” on the panel board after completion of the Maintenance.
7.2.5 The Technician perform the job will enter his name / sign in “Done by” column and responsible Engineer / Officer, Production will put sign in “Checked By” column.
7.3 Monthly preventive maintenance is to be carried out as per the following check points:
7.3.1 Check the lubrication oil in the FRL unit and if required top up with specified lubricant.
7.3.2 Check the oil level in the gearbox through view glass and should be ¾th in level.
7.3.3 Check the solenoid valves and coils condition.
7.3.4 Check the chopper motor gland and if required replace.
7.3.5 Check the pneumatic cylinder functioning.
7.3.6 Check the Lid gasket condition.
7.4 Quarterly preventive maintenance is to be carried out as per the following check points:
7.4.1 Check the gearbox oil condition and replace if required.
7.4.2 Check the tension of the motor belts and if required adjust the slackness.
7.4.3 Check and clean the Teflon ring, if found damage replace with new one.
7.4.4 Check the pneumatic cylinder seals and discharge chute seals and chopper motor seals, if damaged replace.
7.4.5 Check all electrical starters and contactor if required clean with CTC solution.
7.4.6 Check all the inter locks are working properly.
7.4.7 Check the PLC lines and controls for proper functioning.
8.0 Reference Document
8.1 In-House,
9.0 Annexure
9.1 Annexure –I : Preventive
Maintenance Checklist of Rapid Mixer Granulator (Monthly)
9.2 Annexure –II : Preventive
Maintenance Checklist of Rapid Mixer Granulator (Quarterly)
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head
of Engineering and Maintenance or his nominee give the training of Technician
and Operators.
Annexure
–I
|
Preventive
Maintenance Checklist of Rapid Mixer Granulator (Monthly) |
|
Area : |
|
Date: |
|
|
Equipment
No : |
|
Frequency: |
Monthly |
|
Sl. No. |
Description
of the Job |
Observation |
Corrective
Action |
Spared
Used |
|
|
1. |
Before starting Preventive
Maintenance of RMG “switch off” the panel board. |
Š
Ok /
Š Not
Ok |
|
|
|
|
2. |
Put “Under Maintenance” on panel
board. |
Š
Ok /
Š Not
Ok |
|
|
|
|
3. |
Check the lubrication oil in
the FRL unit and if required top up with specified lubricant.. |
Š
Ok /
Š Not
Ok |
|
|
|
|
4. |
Check the oil level in the
gearbox through view glass and should be ¾th in level. |
Š
Ok /
Š Not
Ok |
|
|
|
|
5. |
Check the solenoid valves
and coils condition. |
Š
Ok /
Š Not
Ok |
|
|
|
|
6. |
Check the chopper motor
gland and if required replace. |
Š
Ok /
Š Not
Ok |
|
|
|
|
7. |
Check the pneumatic cylinder
functioning. |
Š
Ok /
Š Not
Ok |
|
|
|
|
8. |
Check the Lid gasket
condition. |
Š
Ok /
Š Not
Ok |
|
|
|
|
|
|||||
|
…………………………………. Done By |
…………………………………. Checked By |
||||
Annexure –II
|
Preventive Maintenance Checklist of Rapid Mixer
Granulator ( Quarterly) |
|
Area : |
|
Date: |
|
|
Equipment
No : |
|
Frequency: |
Quarterly |
|
Sl. No. |
Description
of the Job |
Observation |
Corrective Action |
Spared
Used |
|
|
1. |
Before starting Preventive
Maintenance of RMG “switch off” the panel board. |
Š
Ok /
Š Not
Ok |
|
|
|
|
2. |
Put
“Under Maintenance” on panel board. |
Š
Ok /
Š Not
Ok |
|
|
|
|
3. |
Check the gearbox oil
condition and replace if required. |
Š
Ok /
Š Not
Ok |
|
|
|
|
4. |
Check the tension of the
motor belts and if required adjust the slackness. |
Š
Ok /
Š Not
Ok |
|
|
|
|
5. |
Check and clean the Teflon
ring, if found damage replace with new one. |
Š
Ok /
Š Not
Ok |
|
|
|
|
6. |
Check the pneumatic cylinder
seals and discharge chute seals and chopper motor seals, if damaged replace. |
Š
Ok /
Š Not
Ok |
|
|
|
|
7. |
Check all electrical
starters and contactor if required clean with CTC solution. |
Š
Ok /
Š Not
Ok |
|
|
|
|
8. |
Check all the inter locks
are working properly. |
Š
Ok /
Š Not
Ok |
|
|
|
|
9. |
Check the PLC lines and
controls for proper functioning. |
Š
Ok /
Š Not
Ok |
|
|
|
|
|
|||||
|
…………………………………. Done By |
…………………………………. Checked By |
||||
