SMP Format (Standard Manufacturing Process)

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MANUFACTURING PROCESS

GRANULATION

1- Preparation of past

    Dissolve the Kollidon in purified water with constant stirring in slurry mixer till clear solution is obtained.

a- Granulating agent	xx kg
b- Purified Water	xx Liters

2-Add this paste to choline comp. along with water

Note: - Heater should be OFF during preparation of slurry.

2- Screening & Blending

Pass the following ingredients through mesh no 30 SS screen.

c- Ingredients	xx kg
d- Ingresdients	xx kg
e- Croscarmellose Sodium	xx kg
f- orange flavour	xx q.s
g- Boric Acid	xx kg

1-Blend the above ingredients for 10 min in mixer granulator at stir speed-1.

2- Add the whole above paste into the blended powder in high speed mixer granulator & put ON stir speed 1 & chop-1 to get the wet mass of desired consistency for 30±-10Min & discharge the granules in to the container.

3-Drying

Dry the wet mass in Fluid bed dryer for semi drying with normal air stream for 2 hours ± 15 Min.

Parameters	Desired Setting
a-Inlet air flap	50-100%
b- Outlet air flap	100%
c-Interval	30 Sec.
d-Shaking	30 Sec.
e-Inlet air temperature	Normal Air

2- Pass the semi dry mass through mesh No.12 SS screen fitted with oscillating granulator to make granules.

3- Again dry the semi dried granules in fluid bed dryer in normal air than hot air for 2 hours ± 15 Min complete drying until the desired moisture is reached.

Parameters	Desired Setting
a-Inlet air Flap	50-100%
b- Outlet Air Flap	100%
c-Interval	30 Sec.
d-Shaking	30 Sec.
e-Inlet Air Temperature	55±10°c
f-Exhaust Temperature	40±10°c
g-Moisture Content	Not More Than 3.5%

4- Screen the dried granules through mesh No.12 SS screen by oscillating granulator to make granules of 12 mesh.

 4- Lubrication

Pass the following ingredients through mesh No. 16 & 30 S.S. Screen.

Sodium Starch Glycolate	xxx kg
Avicel ph xx	xxx kg
Colloidal Silicon Dioxide	xxx kg

1-Add above sieved material into the dried grains & mix for 10 min in a Multi Directional Movement Mixer

Magnesium Stearate

xxx kg

2-Lubricate the granules for 2-3 min.

5- Sample to Quality Control for analysis

COMPRESSION

1- Adjust the machine speed pressure at proposed weight of tablets by using rotary compression machine ZP-124-Y .Fitted with chromed oblong biconvex shaped dies & punches.

2- Sample to Quality Control for Physical & Chemical tests.

3- De-dust the tablets by using Rotary Sifter machine.

Ø  Sample Sent  to Quality Control for Physical & Chemical test.

Footer:  Q.C/ Production Manager sign and stamp