1.0 Purpose
1.1 To define a standard operation procedure of Tablet Compression Machine
2.0
Scope
2.1 This Sop is applicable for operation of Tablet Compression Machine of tablet manufacturing area at "NAME" Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Only concern operator is
responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He
also maintains log book.
3.2
Sr. Officer-
Production/Officer- Production is responsible for monitoring day to day
activity.
3.3
Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 Not Appreciable
5.0 Materials and Equipment
5.1 Tablet Compression Machine
6.0 Precaution / Health and Safety Considerations
6.1 Do not run the machine under power without all guards being fixed in correct position.
6.2 Keep the isolator switch to ‘OFF’ position while moving the hand wheel.
6.3 Never rotate the machine backwards when the punches are in position.
6.4 Keep the safety guards closed when the machine is in operation.
6.5 Do not put your hand inside machine when the machine is in operation.
7.0 Procedure
7.1 Instruction
7.1.1 Ensure
that all lubricators are filled to the correct level.
7.1.2 Ensure
that the upper and lower punches are moving freely. At the first sign of
sluggishness stop the machine, remove the upper and lower punches, clean and
lubricate it with grease.
7.1.3 Ensure
isolator switch on the wall is in ‘OFF’ position and oil cup valves closed
during break time.
7.1.4 Regulate
the speed of the machine only when the motor is running.
7.1.5 Ensure
tablet thickness control is set to maximum before fitting punches.
7.1.6 Ensure
that the lower punch anti turning plugs are fitted and are working correctly.
7.1.7 When
the punches and dies are fitted, do not run the machine without granules unless
the pressure adjusting wheel is completely released. Failure to this would
cause damage to the punch faces.
7.1.8 Always
use die locating bush at the time of fitting dies.
7.1.9 Do not
apply much force at the time of tightening the die holding screw. Too much
force may crack the die table.
7.2
Operation
7.2.1 Before starting operation, the operators and the production
personnel with this operation must ensure that the room is properly cleaned and
all materials of previous product are removed.
7.2.2 Examine Machine for cleanliness including rinse water
result, dust-extraction unit and area.
7.2.3 Check punches and dies cleanliness.
7.2.4 Rotate hand wheel and check that turrets rotates freely.
7.2.5 Check that pressure wheels are free and pressure is
released.
7.2.6 Checked that sockets of upper/lower punches and dies are
properly cleaned.
7.2.7 Fit dies using die rod. Ensure that die is fitted in
turret, Tighten die holding screws.
7.2.8 Fit lower punches using thin coat of Food Grade Oil on punch
barrel. Ensure that punches are freely
moving by pushing the punch tips through the die and allowing the punches to
drop back freely on its own weight.
Tighten lower punches with plugs using anti turning strip.
7.2.9 Rotate hand wheel and check that all lower punches moves
freely fit upper punches.
7.2.10 Close lower punch guard covers and fit the feed frame check
the clearance with turret.
7.2.11 Fix hopper in such way, so as to give 3-5 mm clearance from
turret for free flow of granules to the feed
frame.
7.2.12 Rotate hand wheel and check that machine is free.
7.2.13 Fit the acrylic guard. Check the condition of oil cups for
any spillage of oil, which may contaminate the
product. Clean if necessary.
7.2.14 Before starting the operation production person get the
line clearance from QA person and affix the status label with Product Name,
batch details to equipment.
7.2.15 Load granules in hopper and rotate machine by hand to fill
feed frame and dies.
7.2.16 Apply pressure just to form tablet. Check weight of the
tablet. Further increase the pressure to produce
required thickness of the tablet.
7.2.17 After completion the operation, to stop the machine (push
the red button).
7.2.18 Affix the “To be Cleaned” label and keep the record in
Machine Logbook (Annexure-I).
8.0
Reference
Document
8.1 In-house
9.0
Annexure
9.1 Annexure-I : Format of ‘Machine Logbook’
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
|
|
11.0
Training
11.1 Head of Production or his nominee give
the training of production operator and worker.
