MAGALDRATE AND SIMETHICONE SUSPENSION

PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure 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:

1. Master Copy: Manager Quality Assurance

2. Copy No. 1: Production Pharmacist

3. Copy No. 2: Manager Quality Control

PRODUCT NAME: MAGALDRATE & SIMETHICONE SUSPENSION (170 ML)	BATCH SIZE: 1000 LTRS.
PRODUCT REFERENCE CODE:	UNIT SIZE: 170 ml
GENERIC NAME: N.A.	PACK SIZE: 72 x 170 ml
DOSAGE FORM: SUSPENSION	STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml contains:

Magaldrate B.P. 480 mg

Simethicone B.P. 20 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 MATERIAL:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	AEROSIL	I.P.	1.000		1.00 KGS
2.	ALUMINIUM HYDROXIDE (PASTE)HYROXIDEGGGPASTE ASTE	I.P.	230.000	5.00	241.500 KGS
3	RASPBERRY FLAVOUR	F.G.	2.500		2.500 LTRS.
4	ASPARTUM	I.P.	0.500		0.500 KGS
5	METHYL PARABEN PLAIN	I.P.	0.100		0.100 KGS
6	CMC SODIUM	I.P.	4.000		4.000 KGS
7	MAGNESIUM HYDROXIDE PASTE	I.P.	254.000	5.00	266.700 KGS
8	MENTHOL	I.P.	0.100		0.100 KGS
9	PROPYLENE GLYCOL	I.P.	5.000		5.000 KGS
10	PROPYL PARABEN PLAIN	I.P.	0.250		0.250 KGS
11	SODIUM CITRATE	I.P.	2.000		2.000 KGS
12	SORBITOL SOLUTION	I.P.	150.00		150.00 KGS
13	SPIRIT CHLOROFROM	I.P.	2.250		2.250 LTRS
14	SIMETHICONE 30%	U.S.P	13.333	5.00	14.000 KGS
15	ERYTHROCIN COLOUR	FCF	75.000		75.000 GMS
16	XANTHAN GUM	I.P	1.000		1.000 KGS

PACKING MATERIAL: –

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	170 ML WHITE RD. BTLS	5882.000		5882.000 NOS
2.	CORRUGATED BOX	82.000		82.000 NOS
3	ADHESIVE TAPE ROLL BROWN	2.000		2.000 NOS
4	AMGEL-4 170 ML (LABEL)	5964.000	3.000	5967.000 NOS
5	AMGEL-4 170 ML(DIBBI)	5882.000	2.000	5884.000NOS
5	GUM ACCACIA	1.000		1.000 KGS
6	PILFER PROOFS 25 MM	5882.000		5882.000 NOS
7.	GUM ACCACIA	1.000		1.000
8.	SHRINK FILM 310X250 MM	980.000		980.000

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 170 ml.

Volume variation limit allowed in each filled Bottle is 170 ml to 172 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.

Dried Aluminium Hydroxide Gel contains 47.5% of Aluminium Oxide.

Aluminium Hydroxide Gel (Paste) contains 7.50 ± 0.25% of Aluminium Oxide.

Yield:

Theoretical Yield is 5882.00 Bottles.

Expected Practical Yield is 5882.00 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP NO- SOP/OL/016/MO/I.

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 No- SOP/OL/017/MO/I.

Fill 170 ml suspension in 170 ml white glass 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.

Make a group of 6 bottles packed in unit carton

Wrap this bundle in the thermoplastic film and shrink pack it by operating shrink packing machine l-27 as per its SOP.

Pack 72 filled and sealed bottle in each corrugated box A-01A.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Soak 4.00 kgs of C.M.C.Sodium and 1.00 kgs of xanthan gum in 30 Ltrs of Purified water in Stainless Steel Containers and keep it for 6 hours.

Charge 150 kgs of Sorbitol to charging tank L-09.

Addition of Ingredients into the Charging Tank while stirring continuously:

Dissolve 2.0 kgs of Sodium citrate in 5 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.500 kgs of Aspartum in 0 Ltrs of Purified water and add to the bulk batch.

Slowly transfer 241.500 kgs of Aluminium Hydroxide Paste to the bulk batch.

Add 200 Ltrs of Purified Water to the bulk batch.

Slowly transfer 266.700 kgs of Magnesium Hydroxide Paste to the bulk batch.

Add 1.00 kgs of Aerosil to the bulk batch.

Hot P.Gand dissolve1.00kgs methyl Paraben plain and 0.250 kgs propyl Paraben plain and add to the bulk batch.

Slowly transfer 14.0kgs of Simethicone to the bulk.

Add previously soaked CMC sodium and xanthan gum to the bulk batch.

Dissolve 75 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 0.100 kgs of Menthol in 2.250 liters of Spirit Chloroform and add to the bulk batch.

Make up the volume with Purified 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 Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production 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.

Intermittently filled volume should be checked at 30 minutes interval by the Assistant Manufacturing Chemist 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 ‘Line Clearance’ has been given by the IPQA.