Strength of the product :-
Shelf Life :- 24 Months
1. INGREDIENTS :-
Each Sugar coated Tablet contains
VitaminB1 HCl BP 1mg.
VitaminB2 BP 1mg. .
Niacinamide BP10mg.
Description of the product
Red coloured sugar coated biconvex tablet.
VitaminB1 HCl BP 1mg.
VitaminB2 BP 1mg. .
Niacinamide BP10mg.
Description of the product
Red coloured sugar coated biconvex tablet.
Punch Size:- 7.2mm SC
Average weight for Tablet
135 mg-core 265mg-coated.
135 mg-core 265mg-coated.
Batch Size:- 10,00,000Tablets
Shelf Life :- 24 Months
1. INGREDIENTS :-
2. INGREDIENTS (Sugar Coating):-
Equipments
Electronic Digital Balance – Avery
Avery Balance
Mixer
Comminuting Mill
Multimill
Sifter
Fluid Bed Drier
Tray Drier
Double cone blender
Steam Jacketed Vessel
Compression:-
Rotary Machine:- 16 / 27 / 35 Stations
Coating:-
Equipment Name
Electronic Balance
Coating Pan/Neocota
Coating Vessel
Colloid mill
Polishing Pan
Packing:-
Equipment Name
Imprinting Machine
Strip Packing Machine
Blister Packing Machine
Alu-Alu Packing Machine
Manufacturing Process
SIFTING OF RAW MATERIALS
1. Sift Vitamin B2 1.100 kgs through 30 # mesh
2. Sift Niacin amide 10.500 kgs through 30 # mesh
3. Sift Lactose61.000 kgs through 30 # mesh
4. Sift Starch 35.100 kgs through 150 # mesh
5.Sift Di basic calcium phosphate 25.000 kgs through 30 # mesh.
Place the sifted material in the Mixer, Run for 30 minutes.
a) The following Materials are For paste preparation
6. Starch 4.000 kgs
7. Gelatin 0.400 kgs
8. EDTA 0.050 kgs
9. Thiourea 0.100 kgs
10.Citric acid 0.800 kgs
11. Propyl paraben sodium 0.100 kgs
12. Purified water 40 litre.
b) Take 7 liters of purified warm water to make Slurry with Starch.
c) Soak Gelatin in 3litres of boiling water and add to this EDTA, Thiourea, propyl paraben sodium. Add this solution to starch slurry.
e) Add 30 liters of Boiled Water into the slurry and mix well until uniform paste is formed.
Transfer the paste into mixer. Run for 15 minutes, till the uniform granules are formed.
Record excess quantity of water added, if required.
Pass the wet granules through Cadmill/Multimill(through3/8 inch or 9.5mm ss mesh).
Transfer the wet granules into the Tray Drier and dry at 50c for 4-5 hours/Fluid Bed Drier and dry at50 degree c for 10 mts for initial drying.
Sift the semi-dried granules through 20 ss mesh.
Mill the tops remaining on the 20 ss mesh through1/16 inch or1.5 mm ss mesh.
Reload the semidried, size reduced granules into the Tray Drier and dry at 50 degree c for 2-3 hour/Fluid Bed Drier and dry at 50 degree c for 8 minutes for final drying till the moisture content reaches between 1 and 2 %.
Weigh the dried granules
Record the weight of the dried granules in BMR.
Transfer the dried granules into the Mixer/Double cone blender.
The following lubricants are
13. Sift Vitamin B1 Hydrochloride1.200 kgs through 30 # mesh
14.Sift Talc 1.200 kgs through 30 # mesh
15. Sift Magnesium stearate 0.800 kgs through 30 # mesh
16.Sift Starch quantity sufficient to135.000 kgs through 150 # mesh.
Place the sifted materials into the Mixer/Double cone blender. Run for 15 minutes.
Record quantity of starch added.
Transfer into polylined containers and label them as lubricated granules
Record the total number of containers in BMR
Record the total quantity of lubricated granules
Transfer to quarantine.
After getting approval from QC transfer to Compression area.
Compression
Clean the machine
After getting the line clearance from QA and set the Punches and Dies
as per Work order
SUGAR COATING PROCEDURE
METHOD OF MANUFACTURING
SUGAR COATING PROCEDURE:
DIVIDE THE TABLETS INTO 2,50,000 x 4 LOTS:-
SEALING:
Sieve the tablets and sealed with 3.328 kgs of shellac in 3.8 litres of Iso propyl alcohol with 0.830 litres of Castor oil. Divide the shellac solution into 4 lots. Coat the shellac solution over the tablet and dry the tablets keeping the blower temperature at 60oC.
PREPARATION OF DUSTING POWDER:
Sift of sugar powder 15.584 kg, Calcium carbonate 15.584 kg and Talcum 15.584 kg through 100 or 80# and mix well.
SUB COATING:
Load the sealed tablets into the coating pan. Boil 21.7 liters of purified water in a stainless steel vessel. To this dissolve 0.039 kg of Methyl paraben, 0.008 kg of propyl paraben, 2.170 kg of Gelatin 2.170 kg of Gum Acacia and 34.720 kg of sugar. Stir well and allow it to boil. Filter it and label it as Acacia Gum syrup. Take about 23.4 litres of the syrup and divide it into 4 lots.From 1 lot add the required quantity of the syrup over the tablets mix well and dusting to be done with the powder already mixed. Dry the tablets keeping the blower temp.50°c. The remaining gum syrup is used for preparing smoothing suspension.
SMOOTHING:
Boil 29.4 liters of purified water in a stainless steel vessel. To this dissolve 0.059 kg of Methyl paraben, 0.012 kg of Propyl paraben .Add 58.760 kg of sugar. Stir well until it gets dissolved. Filter the syrup through the filter cloth. To this syrup add 6.188 kg of Calcium carbonate, 9.828 kg of Talc, 5.460 kg of sugar powder, 20 liters of Acacia gum syrup and 0.152 kg of colouring agents. Stir well and label it as smoothing suspension. Divide the suspension in to 4 lots. From one lot use the required quantity is added over the tablets at regular interval time, mix well and dry the tablets keeping the blower temp.at 50°c.
COLOUR SYRUP:
Boil 6.500 liters of purified water in a stainless steel vessel. To this add 13.000 kg of sugar and add 0.108 kg of colouring agents. Stir well till they get completely dissolved . Filter it and label it as colour syrup. Divide the syrup in to 4 lots, use one part of the syrup over the tablets at regular interval of time, mix well and dry the tablets keeping the temp.at 50°c.
FINAL COLOURING:
After cooling the tablets to room temp, the coated tablets are to be loaded in the pan. Add the required quantity of colour syrup over the tablets mix well. The pan mouth should be closed with a lid. Run the pan for 30mts. Inch the pan for another 75mts with regular interval of time. After that the tablets are transferred to polishing pan.
POLISHING:
Melt Bees wax 0.031kg and Carnuba wax 0.062 kg blend with 3.120 liters of Carbon Tetra Chloride. Filter and divide the solution in to 4 lots. Use one lot of polishing solution on tablets slowly, run the pan till the tablets gets polished.
Use Exhaust and dehumidifier till the carbon tetra chloride smell gets exhausted.
Then run the pan with A/C and Dehumidifier till the tablets get polished.
The polished tablets should be packed in a polylined container.
The same procedure should be followed for the remaining 4 lots.
Send the representative samples to Q.C for analysis.
NOTE:
Colour syrup, colour paste, AG Syrup and the smoothing suspension should be warmed before use.
SIFTING OF RAW MATERIALS
1. Sift Vitamin B2 1.100 kgs through 30 # mesh
2. Sift Niacin amide 10.500 kgs through 30 # mesh
3. Sift Lactose61.000 kgs through 30 # mesh
4. Sift Starch 35.100 kgs through 150 # mesh
5.Sift Di basic calcium phosphate 25.000 kgs through 30 # mesh.
Place the sifted material in the Mixer, Run for 30 minutes.
a) The following Materials are For paste preparation
6. Starch 4.000 kgs
7. Gelatin 0.400 kgs
8. EDTA 0.050 kgs
9. Thiourea 0.100 kgs
10.Citric acid 0.800 kgs
11. Propyl paraben sodium 0.100 kgs
12. Purified water 40 litre.
b) Take 7 liters of purified warm water to make Slurry with Starch.
c) Soak Gelatin in 3litres of boiling water and add to this EDTA, Thiourea, propyl paraben sodium. Add this solution to starch slurry.
e) Add 30 liters of Boiled Water into the slurry and mix well until uniform paste is formed.
Transfer the paste into mixer. Run for 15 minutes, till the uniform granules are formed.
Record excess quantity of water added, if required.
Pass the wet granules through Cadmill/Multimill(through3/8 inch or 9.5mm ss mesh).
Transfer the wet granules into the Tray Drier and dry at 50c for 4-5 hours/Fluid Bed Drier and dry at50 degree c for 10 mts for initial drying.
Sift the semi-dried granules through 20 ss mesh.
Mill the tops remaining on the 20 ss mesh through1/16 inch or1.5 mm ss mesh.
Reload the semidried, size reduced granules into the Tray Drier and dry at 50 degree c for 2-3 hour/Fluid Bed Drier and dry at 50 degree c for 8 minutes for final drying till the moisture content reaches between 1 and 2 %.
Weigh the dried granules
Record the weight of the dried granules in BMR.
Transfer the dried granules into the Mixer/Double cone blender.
The following lubricants are
13. Sift Vitamin B1 Hydrochloride1.200 kgs through 30 # mesh
14.Sift Talc 1.200 kgs through 30 # mesh
15. Sift Magnesium stearate 0.800 kgs through 30 # mesh
16.Sift Starch quantity sufficient to135.000 kgs through 150 # mesh.
Place the sifted materials into the Mixer/Double cone blender. Run for 15 minutes.
Record quantity of starch added.
Transfer into polylined containers and label them as lubricated granules
Record the total number of containers in BMR
Record the total quantity of lubricated granules
Transfer to quarantine.
After getting approval from QC transfer to Compression area.
Compression
Clean the machine
After getting the line clearance from QA and set the Punches and Dies
as per Work order
SUGAR COATING PROCEDURE
METHOD OF MANUFACTURING
SUGAR COATING PROCEDURE:
DIVIDE THE TABLETS INTO 2,50,000 x 4 LOTS:-
SEALING:
Sieve the tablets and sealed with 3.328 kgs of shellac in 3.8 litres of Iso propyl alcohol with 0.830 litres of Castor oil. Divide the shellac solution into 4 lots. Coat the shellac solution over the tablet and dry the tablets keeping the blower temperature at 60oC.
PREPARATION OF DUSTING POWDER:
Sift of sugar powder 15.584 kg, Calcium carbonate 15.584 kg and Talcum 15.584 kg through 100 or 80# and mix well.
SUB COATING:
Load the sealed tablets into the coating pan. Boil 21.7 liters of purified water in a stainless steel vessel. To this dissolve 0.039 kg of Methyl paraben, 0.008 kg of propyl paraben, 2.170 kg of Gelatin 2.170 kg of Gum Acacia and 34.720 kg of sugar. Stir well and allow it to boil. Filter it and label it as Acacia Gum syrup. Take about 23.4 litres of the syrup and divide it into 4 lots.From 1 lot add the required quantity of the syrup over the tablets mix well and dusting to be done with the powder already mixed. Dry the tablets keeping the blower temp.50°c. The remaining gum syrup is used for preparing smoothing suspension.
SMOOTHING:
Boil 29.4 liters of purified water in a stainless steel vessel. To this dissolve 0.059 kg of Methyl paraben, 0.012 kg of Propyl paraben .Add 58.760 kg of sugar. Stir well until it gets dissolved. Filter the syrup through the filter cloth. To this syrup add 6.188 kg of Calcium carbonate, 9.828 kg of Talc, 5.460 kg of sugar powder, 20 liters of Acacia gum syrup and 0.152 kg of colouring agents. Stir well and label it as smoothing suspension. Divide the suspension in to 4 lots. From one lot use the required quantity is added over the tablets at regular interval time, mix well and dry the tablets keeping the blower temp.at 50°c.
COLOUR SYRUP:
Boil 6.500 liters of purified water in a stainless steel vessel. To this add 13.000 kg of sugar and add 0.108 kg of colouring agents. Stir well till they get completely dissolved . Filter it and label it as colour syrup. Divide the syrup in to 4 lots, use one part of the syrup over the tablets at regular interval of time, mix well and dry the tablets keeping the temp.at 50°c.
FINAL COLOURING:
After cooling the tablets to room temp, the coated tablets are to be loaded in the pan. Add the required quantity of colour syrup over the tablets mix well. The pan mouth should be closed with a lid. Run the pan for 30mts. Inch the pan for another 75mts with regular interval of time. After that the tablets are transferred to polishing pan.
POLISHING:
Melt Bees wax 0.031kg and Carnuba wax 0.062 kg blend with 3.120 liters of Carbon Tetra Chloride. Filter and divide the solution in to 4 lots. Use one lot of polishing solution on tablets slowly, run the pan till the tablets gets polished.
Use Exhaust and dehumidifier till the carbon tetra chloride smell gets exhausted.
Then run the pan with A/C and Dehumidifier till the tablets get polished.
The polished tablets should be packed in a polylined container.
The same procedure should be followed for the remaining 4 lots.
Send the representative samples to Q.C for analysis.
NOTE:
Colour syrup, colour paste, AG Syrup and the smoothing suspension should be warmed before use.
Packing
Suitable packing shell be done according to the packing needs
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