Master Formula of Chlorphenarmine Maleate, Ammonium Chloride and Sodium Citrate Expectorant

PURPOSE: This master Formula Records (MFR) 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 MFR. 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 : Liquid Section

PRODUCT NAME: Chlorphenarmine Maleate, Ammonium Chloride and Sodium Citrate Expectorant	BATCH SIZE: 4000 LTRS.
PRODUCT REFERENCE CODE:	UNIT SIZE: 100 ML
GENERIC NAME: N.A.	PACK SIZE: 6X16X100 ml
DOSAGE FORM: SYRUP	STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT	EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml cotains:

Chlorphenarmine Maleate I.P. 2.5 mg

Ammonium Chloride I.P. 125 mg

Sodium Citrate I.P. 55 mg

EQUIPMENTS TO BE USED

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Sugar Syrup Manufacturing Tank
2	Charging Tank – 8000 Ltrs.
3	Filter Press
4	Storage Tank – 5000 Ltrs
5	Linear Bottle Washing Machine
6	Digipack Bottle Filling And Sealing Machine
8	Automatic Bottle Labelling Machine
9	Shrink Packing Machine

RAW MATERIALS:.

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	AMMONIUM CHLORIDE	I.P.	100.00	10.00	110.00 KGS
2.	ASPARTUM	I.P.	2.600		2.600 KGS
3	C.P.M	I.P.	2.000	5.00	2.100 KGS
4	CITRIC ACID	I.P.	3.200		3.200 KGS
5	MENTHOL	I.P.	0.200		0.200 KGS
6	ORANGE FLAVOUR	F.G	8.000		8.000 LTRS
7	SODIUM BENZOATE	I.P.	20.000		20.000 KGS
8	SODIUM CITRATE	I.P.	44.000	10	48.400 KGS
9	SPIRIT CHLOROFORM	I.P.	40.000 .		40.000 BTLS
10	SUNSET YELLOW SUPRA	I.P.	140.000		140.000 GMS
11	PHARMAGRADE SUGER	F.G	2000.000		2000.000 KGS

PACKING MATERIALS:.

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	100 ML AMBER ROUND BOTLS.	40000.000		40000.000NOS
2.	ADHESIVE TAPE ROLL BROWN	5.000		5.000 NOS
3	LABEL	40416.000	3.000	40419.000 NOS
4	UNIT CARTON	40000.000	2.000	40002.000 NOS
5	CORRUGATED BOX T – 10	417.000		417.000 NOS
6	GUM ACCACIA POWDER	3.000		3.000 NOS
7	PILFER PROOFS 25 MM	40000.000		40000.000 NOS
8	SHRINK FILM 220 X 220 MM	6667.000		6667.000NOS

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

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-11 to storage tank L-15 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 40000 Bottles.
Expected Practical Yield is 40000 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine and operate it as per its SOP .

Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine for filling and Sealing of the bottles as per its SOP.

Fill 100 ml syrup in amber round glass bottle and use 25 mm PP Cap to seal the bottle mouth.

Inspect the 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 unit carton individually.

Make a group of 6 bottles packed in unit cartons.

Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine as per its SOP.

Pack such 16 shrinked packets in the Corrugated box T-10. Thus each corrugated box contains 6×16 x100 ml filled and sealed bottles.

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

MANUFACTURING PROCESS:

I) Preparation of Sugar Syrup:

Take Purified water 700 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.

Run the steam into the jacket so as to heat the water.

Add 2000 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 Sugar Syrup Storage Tank through transfer pump.

Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank through transfer pump.

II) Addition of Ingredients into the Charging Tank while stirring continuously:

Dissolve 20.0 kgs of Sodium Benzoate in 100 Ltrs of Purified water and add to the bulk batch.

Dissolve 3.20 kgs of Citric Acid in 10 Ltrs of Purified water and add to the bulk batch.

Dissolve 2.6 kgs of Aspartum in 100 Ltrs of Purified water and add to the bulk batch.

Dissolve 2.1 kgs of C.P.M. in 12 Ltrs of water and add add to the bulk batch.

Dissolve 110 kgs of Ammonium Chloride in 250 Ltrs of Purified water and add to the bulk batch.

Dissolve 48 kgs of Sodium Citrate in 150 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.200 kgs of Menthol in 40 x 450 ml of Spirit Chloroform and add to the bulk batch.

Dissolve 140 gms of Sunset Yellow Supra in 3 Ltrs of hot Purified water and add to the bulk batch.

Add 8.0 Ltrs of Orange Flavour to the bulk batch.

Make up the volume with Purified water and mix until homogeneous.

Check the pH of Solution to be in between 5.0 – 5.5.

Filter the batch through Filter Press by operating it as per its SOP and transfer it to the Storage Tank .

Send the sample to 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 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 Manager 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 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 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.