1.0 OBJECTIVE:
To
lay down the procedure for Operation of Rotary tablet press ZP-17 for proper
and continuous compression of tablets from granulated material.
2.0 SCOPE:
This
SOP shall be applicable for the operation of Rotary tablet press ZP-17 in compression
area at Production department of Pharmaceutical Industry.
3.0 RESPONSIBILITY:
3.1
Supervisor/
Machine Operator.
3.2
Production
Pharmacist.
4.0 ACCOUNTABILITY:
4.1
Manager-Production
department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Rotary tablet
press Machine.
6.0 PROCEDURE:
6.1 Start-up &
Operation:
6.1.1
Before starting
the machine carefully inspect the punches and dies that their edges should be
sharp without kink, cracks or deformation and they are properly mounted.
6.1.2
Before mounting
the dies and punches ensure that the machine is free by rotating manually and
also ensure that the rotation is correct.
6.1.3
Inspect that the
granulated material is dry and the water context present is within limits.
6.1.4
Pour the material
into the feed hopper, turn the turret by handle wheel manually and regulate the
file and pressure until the desired weight and hardness of the tablets is
obtained.
6.1.5
Start the motor
and engage the clutch to proceed with operation.
6.1.6
During the
operation regularly inspect the quality of the tablets produced. If any fault
is found necessary adjustment should be made.
6.1.7
Adjust the speed
of the machine as required.
6.1.8
During operation
if any abnormal noise is heard, stop the machine at once to locate the cause
and remedy to trouble.
6.2 Stop-Over:
6.2.1
Switch off the
machine.
6.2.2
Switch off the
main power supply.
6.2.3
Remove any
left-over powder from the feed hopper.
6.2.4
Remove punches and
dies if new batch is to be started.
6.2.5
Carry out cleaning
procedure as described earlier.
6.2.6
Affix “To be Cleaned”
label & fill the “Equipment Log Book”.
6.3 Precautions:
6.3.1
All protective
guards of the machine should never be removed during operation.
6.3.2
Moist material
should never be used, because it will stick on the punches.
6.3.3
Never pick the
tablets with fingers while the machine is running to avoid accident.
6.3.4
Never operate the
machine in the opposite direction because this can cause damage to the machine
and dies and punches.
7.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1
Not Applicable.
9.0 ANNEXURES:
9.1
Not Applicable.
10.0
ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard operating
procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
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