Multivitamin Syrup
Multivitamin Syrup -Syrup Multivitamins are commonly used for the diagnosis or treatment of Dietary supplements, brain development, eye disorders, diarrhea, and anemia. It has some side effects such as vomiting, constipation, increased thirst, and calcium in blood.
This blog describes the formulae, manufacturing procedure, specifications, and packing details of the multivitamin Syrup.
It is the responsibility of the Manufacturing Chemist to follow and adhere to these procedures. The Production Pharmacist, QC/QA Manager, and cGMP Administrator are accountable for the strict adherence to the master.
BATCH SIZE: 2000 LTRS, EXPIRY DATE: 36 MONTHS, UNIT SIZE: 100 ml
| COMPOSITION: | ||
| Each 5 ml contains: | ||
| Vitamin B1 | BP. | 5 mg |
| Vitamin B12 | BP | 2.5 mcg |
| Vitamin B2 5 phosphate Sodium Equ. to Vitamin B2 | BP | 2.5 mg |
| D-Panthenol | BP | 2.5 mg |
| Nicotinamide | BP | 25 mg |
| Vitamin B6 | BP | 1.5 mg |
EQUIPMENT TO BE USED:
Sugar Syrup Manufacturing Tank
Sugar Storage Tank
Charging Tank.
Filter Press
Storage Tank
Linear Bottle Washing Machine
Digipack Bottle Filling and Sealing Machine
Automatic Bottle Labelling Machine
Raw Material Used
| INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| CITRIC ACID | B.P. | 1.600 | 1.600 KGS | |
| D – PANTHENOL | B.P. | 1.000 | 20.00 | 1.200 KGS |
| SODIUM BENZOATE | B.P. | 10.000 | 10.000 KGS | |
| LIQUID GLUCOSE | B.P | 200.000 | 200.000 KGS | |
| METHYL PARABEN SODIUM | B.P. | 2.000 | 2.000 KGS | |
| NIACINAMIDE | B.P. | 10.000 | 20.00 | 12.00 KGS |
| ORANGE FLAVOUR | F.G. | 1.000 | 1.000 LTRS. | |
| PROPY PARABEN SODIUM | B.P. | 0.250 | 0.250 KGS | |
| SUGAR | F.G. | 1200.00 | 1200.00 KGS | |
| CARMOISINE COLOUR | FCF | 2.000 | 2.000 GMS | |
| LEMON FLAVOUR | F.G | 1.000 | 1.000 LTRS | |
| PINEAPPLE FLAVOUR | F.G. | 1.000 | 1.000 KGS | |
| VITAMIN – B1 HCL | B.P. | 2.00 | 60.00 | 3.200 KGS |
| VITAMIN B2 – 5 PHOSPHATE | BP. | 1.000 | 56.00 | 1.560 KGS |
| VITAMIN – B6 HCL | B.P. | 0.600 | 50.00 | 0.900 KGS |
| RASPBERRY FLAVOUR | F.G. | 1.000 | 1.000 LTRS | |
| VITAMIN – B12 | B.P. | 1.000 | 100.00 | 2.000 GMS |
Packing Material Used
PACKING MATERIAL USED:
| NAME OF THE MATERIAL | TOTAL QUANTITY USED |
| 100 ML AMBER BTLS | 10000.000 NOS. |
| ADHESIVE TAPE ROLL | 6.000 NOS |
| LABEL | 10241.000 NOS |
| UNIT CARTONS | 10002.000 NOS |
| CORRUGATED BOXES | 238.095 NOS |
| GUM ACACIA | 1.000 KGS |
| PILFER PROOFS – 25 MM | 10000.000 NOS |
MANUFACTURING SPECIFICATION:
The average fill of each Bottle is 100 ml.
The volume variation limit allowed in each filled Bottle is 100 ml to 101 ml.
Make up the final volume of the syrup accurately.
Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.
Transfer the syrup from charging tank L-10 to storage tank L-14 after completing the charging of the batch.
Mix the batch, Fill the bottles, and also perform the primary packing of bottles at a temperature not more than 25˚C.
Yield:
The theoretical Yield is 20000 Bottles.
Expected Practical Yield is 20000 + 2% Bottles.
Packing Details:
Wash the bottles on the Linear Bottle Washing Machine and operate it as per its SOP.
Transfer the Syrup from the storage tank to the Digipack Bottle Filling and Sealing Machine for filling and then sealing of the bottles as per its SOP.
Fill 100 ml syrup in an amber glass brute bottle and use a 25 mm PP Cap to seal the bottle mouth.
Inspect each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.
Label every inspected bottle by using the Automatic Bottle Labelling Machine.
Pack each filled and sealed bottle in a unit carton individually.
Pack the 42-unit cartons in specified corrugated boxes to give a pack size of 42 x 100 ml.
Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
Preparation of Sugar Syrup:
Take Purified water 400 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.
Run the steam into the jacket to heat the water.
Add 1200 kgs of sugar into the tank and start stirring by operating the tank.
Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.
Transfer the prepared Sugar Syrup to the Sugar Syrup Storage Tank through a transfer pump.
Transfer the 200 kg Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigorously for half an hour to dissolve it in the Sugar Syrup completely.
Transfer the prepared Syrup from the Sugar Syrup Storage Tank to the Charging Tank through the transfer pump.
Addition of Ingredients into the Charging Tank while stirring continuously:
Dissolve 2.0 kgs of Methyl Paraben Sodium, and 0.500 kgs of Propyl Paraben Sodium in 10 Ltrs of Purified water and add to the bulk batch.
Dissolve 1.600 kgs of Citric Acid in 6 Ltrs of Purified water and add to the bulk batch.
Dissolve 10.0 kgs of sodium benzoate in 30 Ltrs of Purified water and add to the bulk batch
Dissolve 1.20 kgs of D – Panthenol in 5 Ltrs of Purified water and add to the bulk batch.
Dissolve 12.00 kgs of Niacinamide in 30 Ltrs of Purified water and add to the bulk batch.
Dissolve 3.200 kgs of Vitamin B1 HCl in 10 Ltrs of Purified water and add to the bulk batch.
Dissolve 1.560 kgs of Vitamin B2/5 Phosphate in 10 Ltrs of Purified water.
Dissolve 0.900 kgs of Vitamin B6 HCl in 5 Ltrs of Purified water and add to the bulk batch.
Dissolve 2.000 gms of carnosine color in 1Ltrs of Purified water and add to the bulk batch.
Add 1.0 Ltrs of LEMON Flavour to the bulk batch
Add 1.0 Ltrs of Orange Flavour to the bulk batch.
Add 1.0 Ltrs of pineapple Flavour to the bulk batch.
Add 1.0 Ltrs of raspberry flavor to the bulk batch.
Make up the volume with Purified water and mix until homogeneous.
Check the pH of the Solution to be between 4.0 and 4.5.
Filter the batch through Filter Press by operating it as per its SOP and transferring it to the Storage Tank.
Send the sample to the Quality Control Department for bulk testing.
IN-PROCESS CONTROLS:
The following in-process controls should be maintained during the processing:
Check Raw materials used for manufacturing purposes are all approved materials and have ‘Released’ labels fixed on them.
All weighed Raw materials should be counter-checked by the Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of the Production Pharmacist and QC/QA Manager.
Physical characteristics of Raw materials like color, odor, and consistency are checked before compounding.
The final volume should be made as per Standard Operating Procedure using the correct dipstick in the Manufacturing Chemist.
pH of the bulk should be checked and it should be within specified limits.
Bulk samples should be sent for analysis to the Quality Control Department before starting the filling and sealing stage.
The Manufacturing Chemist should check intermittently filled volume at 30-minute intervals and the record for the same should be kept in Batch Manufacturing Record.
The net volume should be checked for all the filling nozzles and in no case, the net volume should be less than the volume claimed on the label.
Limit for Volume Variation: Volume claimed on the label + 2ml
Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.
Suspensions should be filled under constant slow-speed stirring to maintain uniformity of contents.
The labels and cartons should be checked thoroughly for proper batch coding.
Intimation should be sent to the Quality Control Department for finished product sampling and testing.
After the completion of labeling and packaging, the coded labels and cartons should be accounted for, and rejected printed material should be destroyed in the presence of the QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record
It will be ensured that filling or packaging equipment has been properly cleaned.
Filling or packaging of the next product should not commence until the ‘Line Clearance’ has been given by the IPQA.
