MASTER FORMULA OF SODIUM ALGINATE ,SODIUM& CALCIUM BICARBONATE SUSPENSTION
MASTER FORMULA OF SODIUM ALGINATE ,SODIUM& CALCIUM BICARBONATE SUSPENSTION
PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.
RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.
COPY ISSUED TO:
- Master Copy: Manager Quality Assurance
- Copy No. 1: Production Pharmacist
- Copy No. 2: Manager Quality Control
- Copy No. 3: Tablet Section
| PRODUCT NAME: SODIUM ALGINATE ,SODIUM& CALCIUMBICARBONATE SUSPENSTION – 200 ML | BATCH SIZE: 1000 LTRS. |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 200 ml |
| GENERIC NAME: N.A. | PACK SIZE: 30 x 200 ml |
| DOSAGE FORM: SUSPENSION | STRENGTH: N.A. |
| DEPARTMENT: LIQUID DEPARTMENT | EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
Each 10 ml contains:
Sodium alginate B.P. 500 mg
Sodium bicarbonate B.P. 267 mg
Calcium carbonate B.P 160 mg
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. |
| 1 | Charging Tank – IV – 1300 Ltrs. | ||
| 2 | Colloid Mill | ||
| 3 | Charging Tank – V – 3500 Ltrs. | ||
| 4 | Storage Tank – III – 3500 Ltrs | ||
| 5 | Linear Bottle Washing Machine | ||
| 6 | Digipack Bottle Filling and Sealing Machine | ||
| 7 | Automatic Bottle Labelling Machine |
RAW MATERIALS:-
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1. | AEROSIL | I.P. | 0.500 | 0.500 KGS | |
| 2. | CALCIUM CARBONATE | I.P. | 16.000 | 5.00 | 16.800 KGS |
| 3 | MINT FLAVOUR | F.G. | 1.500 | 1.500 LTRS. | |
| 4 | ASPARTUM | I.P. | 0.500 | 0.500 KGS | |
| 5 | ERYTHROCIN COLOUR | FCF | 2.500 | 2.500 GMS | |
| 6 | SODIUM BICARBONATE | I.P. | 26.700 | 5.00 | 28.035 KGS |
| 7 | CMC SODIUM | I.P. | 0.500 | 0.500 KGS | |
| 8 | SODIUM ALGINATE | I.P. | 50.000 | 5.00 | 52.500 KGS |
| 9 | CITRIC ACID | I.P. | 0.100 | 0.100 KGS | |
| 10 | METHYL PARABEN SODIUM | I.P. | 1.000 | 1.000 KGS | |
| 11 | PROPYL PARABEN SODIUM | I.P. | 0.250 | 0.250 KGS | |
| 12 | SODIUM BENZOATE | I.P. | 1.000 | 1.000 KGS | |
| 13 | SORBITOL SOLUTION | I.P. | 100.00 | 100.00 KGS | |
| 14 | SPIRIT CHLOROFROM | I.P. | 3.150 | 3.150 LTRS | |
| 15 | XANTHAN GUM | I.P | 2.500 | 2.500 KGS |
PACKING MATERIAL:-
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR RECORD | TOTAL QUANTITY USED |
| 1. | 200 ML AMBER . BTLS | 5000.000 | 5000.000 NOS | |
| 2. | CORRUGATED BOX | 167.000 | 167.000 NOS | |
| 3 | ADHESIVE TAPE ROLL BROWN | 3.000 | 3.000 NOS | |
| 4 | ALCEDEX 200 ML (LABEL) | 5167.000 | 3.000 | 5170.000 NOS |
| 5 | ALCEDEX 200 ML (DIBBI) | 5000.000 | 2.000 | 5002.000NOS |
| 6 | GUM ACCACIA | 1.000 | 1.000 KGS | |
| 7 | PILFER PROOFS 25 MM | 5000.000 | 5000.000 NOS |
MANUFACTURING SPECIFICATION:
- Average fill of each Bottle is 200 ml.
- Volume variation limit allowed in each filled Bottle is 200 ml to 202 ml.
- Make up the final volume of the suspension accurately.
- Colloid the completely charged batch using Colloidal Mill L-20 by operating it as per its SOP.
- Transfer the suspension from charging tank L-10 to storage tank L-14 after complete charging of batch.
- Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 250 C and Relative Humidity not more than 40.
Yield:
- Theoretical Yield is 5000.00 Bottles.
- Expected Practical Yield is 5000.00 + 2% Bottles.
Packing Details:
- Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.
- Transfer the Suspension from storage tank to Digipack Bottle Filling and Sealing Machine L-25 for filling and then sealing of the bottles as per its SOP.
- Fill 200 ml suspension in 200 ml amber rd. tonus bottle and use 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 L-26.
- Pack each filled and sealed bottle in unit carton individually.
- Pack 30 filled and sealed bottle in each corrugated box B-03.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
Soak 0.500 kgs of C.M.C.Sodium and 2.50 kgs of Xanthan gum in 40 Ltrs of D.M. water in Stainless Steel Containers and keep it for 6 hours.
Charge 100 kgs of Sorbitol to charging tank L-09.
Addition of Ingredients into the Charging Tank L-09 while stirring continuously:
Dissolve1.00kgs methyl Paraben Sodium and 0.250 kgs propyl Paraben Sodium & add to the bulk batch.
Dissolve 1.000 kgs of Sodium benzoate in 5 Ltrs of DM water and add to the bulk batch.
Dissolve 0.500 kgs of Aspartum in 2.0 Ltrs of DM water and add to the bulk batch.
Dissolve 0.100 kgs of Citric Acid in 2.0 ltrs of D.M water and add to the bulk batch.
Slowly transfer 16.80 kgs of Calcium carbonate to the bulk batch.
Add 200 Ltrs of D.M. Water to the bulk batch.
Slowly transfer 28.035 kgs of Sodium bicarbonate to the bulk batch.
Slowly add 52.50 kgs of Sodium Alginate and to the bulk batch.
Add 0.500 kgs of Aerosil to the bulk batch.
Add previously soaked CMC sodium and Xanthan gum to the bulk batch.
Add 1.50 ltrs mint flavour to the bulk batch.
Dissolve 2.5 gms of Erythrocin colour to the 2.00 ltrs of D.M water and add to the bulk batch. Mix the whole batch for 1 hour and then colloid the batch.
Colloid the batch through Colloid Mill L-20 by operating it as per its SOP. and transfer it to the Charging Tank L-10.
Dissolve 0.050 kgs of Menthol in 2.250 lIters of Spirit Chloroform and add to the bulk batch.
Make up the volume with DM water to 1000 Ltrs and mix until homogeneous.
Leave the Suspension to settle for overnight or for minimum 8 hours.
Again check the volume and make up with DM water to 1000 Ltrs and mix until homogeneous.
Check the self pH of Solution to be in between 8.0 – 9.0
Send the sample to Quality Control Department for bulk testing.
Transfer it to the Storage Tank.
IN-PROCESS CONTROLS:
The following in-process controls should be maintained during the processing:
Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
Final volume should be made as per Standard Operating Procedure using correct dipstick in the Assistant Manufacturing Chemist.
pH of the bulk should be checked and it should be with in specified limits.
Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and 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, net volume should be less than 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 Quality Control Department for finished product sampling and testing.
After the completion of labelling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.
It will be ensure that filling or packaging equipment has been properly cleaned.
Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.
