Standard Operating Procedure of Tablet Compression Machine Operation in Pharma is describe in this post.
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1 PURPOSE
1.1 It is established to provide a system of operation for Tablet compression machine.
2 SCOPE
2.1 It is applicable to Production Department of Pharmaceuticals.
3 RESPONSIBILITIES & AUTHORITIES
3.1 Supervisor
3.2 Machine Operator
4 REFERENCE
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of GMP Techniques
6 PROCEDURE
6.1 Startup & Operation
6.1.1 Select the set of dies and punches with respect to the product to be compressed on the machine
6.1.2 Inspect the punches and dies carefully. Their edges should be sharp without kink, cracks or deformation and properly mounted in position.
6.1.3 Before the start up the machine and before assembling dies and punches make sure that all the other parts of the machine have been assembled properly after thorough cleaning.
6.1.4 After setting of the dies and punches, oil the upper cam track with about 10 drops of liquid paraffin oil.
6.1.5 On each upper pressure roller, put approximately 5 drops of Liquid paraffin oil.
6.1.6 With the help of oil can, oil the lower punch heads and cams (apply about 20ml oil).
6.1.7 Before starting the machine, open the oil cups provided and adjust the oil flow to 4 drops per minute. Start the machine and after 15 minutes stop the oil flow. Repeat after every 2 hours.
6.1.8 For all compression machines, use one stroke oil pump so as to lubricate pressure rollers and pins.
6.1.9 Check the position of feed frame, it should be aligned and placed according to the position feed hopper.
6.1.10 Make sure the position of feed hopper is according to the feed frame, its position can be move lower or upward by rotating the by rotating the feed hopper positioning knob.
6.1.11 Check the machine for free rotation manually by rotating the handle wheel, in case of any problem call to engineering department for your convenience
6.1.12 Before pouring the dried grains into the feed hopper make sure that line clearance for the respective product has been taken from Quality assurance department and grains has been released from QC department for further process.
6.1.13 Fill the in process label according to the respective product and paste on door of the compression machine
6.1.14 Put “ON” the power supply.
6.1.15 Pour the material to be compressed carefully with the help of S.S scoop into the feed hopper, rotate the turret by handle wheel manually
6.1.16 Power ON the machine by rotating machine key in clockwise direction, and then pressing ON button and then run the machine slowly by rotating regulator in clockwise direction
6.1.17 Adjust the fill weight of grains into the dies by rotating knob clock wise or anticlockwise direction according to the tablet weight.
6.1.18 Similarly adjust pressure of weight to get required hardness of the tablet according to the written procedure in BMR (Batch Manufacturing Record )
6.1.19 After adjusting desired weight and hardness of the tablets get about 30-50 tablets initially and check their average weight and weight variation on weighing balance as well as hardness of tablet with the help of Monsanto Hardness Tester.
6.1.20 Put the initial readings in pre check control sheet in the BMR (Batch manufacturing Record).
6.1.21 After confirming the desired weight and hardness of the tablet send sample to QC (Quality Control) department for physical analysis.
6.1.22 During operation regularly inspect the quality, weight, as well as hardness of the tablet and put their reading in the Batch control sheet in BMR.
6.1.23 In case of any problem call to production supervisor, ultimately he will ask from production pharmacist for any advice
6.1.24 Set the speed of the machine to requirement.
6.2 STOP OVER
6.2.1 Put “OFF” the machine.
6.2.2 Put “OFF” the power supply.
6.2.3 Wipe out the remaining powder from the feed hopper.
6.2.4 Replace punches and dies if new batch is to be started.
6.3 PRECAUTION
6.3.1 All protective guards of the machine should be intact.
6.3.2 Handle the punches and dies very carefully to avoid any damage.
6.3.3 Never use moist material. It will stick on the punches.
6.3.4 Never pick the tablets with fingers during machine in operation.
6.3.5 Never operate the machine in the anti direction. This can cause damage to the machine, dies and punches.
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