.jpeg "Preventive Maintenance of Tablet Compression Machine")
1.0 Purpose
1.1 To lay down a procedure for the Preventive Maintenance for Compression Machine.
2.0 Scope
2.1 This procedure is applicable for the Preventive Maintenance of Compression Machine 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 Qty : Quantity
4.4 St : Station
4.5 EN : Engineering
4.6 No. : Number
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 Compression Machine
7.2.1 Ensure that electrical supply is in off position in main panel and display “Under Maintenance” on the panel board and inform all the concerned.
7.2.2 The Technician / Operator 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 Quarterly preventive maintenance is to be carried out as per the following check points:
7.3.1 Check the force feeder, motor & gear box for normal functioning. Check the Worm wheel & worm shaft, if worn out, replace it.
7.3.2 Check the force feeder impeller blades for normal free rotation. (If not proper, check side clearance, check bearings. if worn, replaces and realigns the impeller Blades.
7.3.3 Check all adjustment rollers of tablet weight, thickness working (If not Check Adjusting nuts on the tie rods, check drive key, if parts are worn, replace Parts).
7.3.4 Check the working of automatic intermittent lubrication system. (If not Satisfactory, check oil level in the reservoir, check if the tubing is punctured, Replace the part). (Oil used is Enclo-68).
7.3.5 Check the Power pack assembly for normal functioning. (If not satisfactory).
7.3.6 Check the oil level in the reservoir through the oil level indicator). (Oil used is EnkI0-32) (Note: Oil level is checked when the overload is set at zero pressure).
7.3.7 Check the clutch assembly for proper engagement/disengagement. (If any of the Parts/pads of the Dutch assembly has worn, repair/replace it).
7.3.8 Check the free movement of compression rollers.
7.3.9 Check the all-electrical terminal connections and tighten the same.
7.3.10 Check the variable speed pulley/belt for proper functioning (if the pulley is worn out, remove it & replace it, ensure that the pulley is lubricated). Also checks the belt for any wear/tear if needed replace the belt. (Ensure proper alignment in between drive pulley & driven pulley.)
7.3.11 Check the pressure adjustment assembly. (If any of the part is worn out, replace it}.
7.3.12 Check belt pads/oil cups used for lubrication of punches.
7.4 Half Yearly Preventive Maintenance is to be carried out as per the following check points.
7.4.1 Check the main gear box/motor for normal operation. (If not proper, check the Bearings if worn replace it else lubricate them, check worm gear if worn out, Advisable to replace it). Top up Enklo-68 gear box oil in Gear box.
7.4.2 Check all interlocks of the machine for proper operation.
7.4.3 Check the electrical panel for any loose connection. (If observed tightened.)
7.4.4 Check the all-electrical controls, switches for normal working. (If observed).
7.4.5 Check the proper earthing.
8.0 Reference Document
8.1 In-House,
9.0 Annexure
9.1 Annexure –I : Preventive
Maintenance Checklist of Compression Machine (Quarterly)
9.2 Annexure –II : Preventive
Maintenance Checklist of Compression Machine (Half Yearly)
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 Compression Machine (Quarterly) |
|
Area : |
|
Date: |
|
|
Equipment
No : |
|
Frequency: |
Quarterly |
|
Sl. No. |
Description
of the Job |
Observation |
Corrective
Action |
Spared
Used |
|
|
1. |
Before
starting Preventive Maintenance of Compression Machine “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 force feeder, motor & gear box for normal functioning. |
Š Ok / Š
Not Ok |
|
|
|
|
4. |
Check
the force feeder impeller blades for normal free rotation. |
Š Ok / Š
Not Ok |
|
|
|
|
5. |
Check
all adjustment rollers of tablet weight, thickness working satisfactory |
Š Ok / Š
Not Ok |
|
|
|
|
6. |
Check
the working of automatic intermittent
lubrication system for its Satisfactory working |
Š Ok / Š
Not Ok |
|
|
|
|
7. |
Check
the Power pack assembly for normal for its Satisfactory working. |
Š Ok / Š
Not Ok |
|
|
|
|
8. |
Check
the clutch assembly for proper engagement/disengagement. |
Š Ok / Š
Not Ok |
|
|
|
|
9. |
Check
the free movement of compression rollers. |
Š Ok / Š
Not Ok |
|
|
|
|
10. |
Check
the variable speed pulley/belt for proper functioning |
Š Ok / Š
Not Ok |
|
|
|
|
11. |
Check
the pressure adjustment assembly, pressure relief valve for normal working |
Š Ok / Š
Not Ok |
|
|
|
|
12. |
Check
belt pads/oil cups used for lubrication of punches. |
Š Ok / Š
Not Ok |
|
|
|
|
|
|||||
|
…………………………………. Done By |
…………………………………. Checked By |
||||
Annexure
–II
|
Preventive
Maintenance Checklist of Compression Machine (Half
Yearly) |
|
Area : |
|
Date: |
|
|
Equipment
No : |
|
Frequency: |
Half Yearly |
|
Sl. No. |
Description
of the Job |
Observation |
Corrective
Action |
Spared
Used |
|
|
1. |
Before starting Preventive
Maintenance of Compression Machine “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 main gear
box/motor for normal operation. (If not proper, check the Bearings if worn
replace it else lubricate them, check worm gear if worn out, Advisable to
replace it). Top up gear box oil in Gear box. |
Š Ok / Š
Not Ok |
|
|
|
|
4. |
Check all interlocks of the
machine for proper operation. |
Š Ok / Š
Not Ok |
|
|
|
|
5. |
Check the electrical panel
for any loose connection. (If observed tightened.) |
Š Ok / Š
Not Ok |
|
|
|
|
6. |
Check the all-electrical
controls, switches for normal working.
(If observed). |
Š Ok / Š
Not Ok |
|
|
|
|
7. |
Check the proper earthing. |
Š Ok / Š
Not Ok |
|
|
|
|
|
|||||
|
…………………………………. Done By |
…………………………………. Checked By |
||||
