Guaiphenesin ,Terbutaline sulphate ,Bromhexine hydrochloride and Menthol Syrup

Guaiphenesin ,Terbutaline sulphate ,Bromhexine hydrochloride and Menthol Syrup

PURPOSE: This Master Formula Record (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 SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master

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: Guaiphenesin ,Terbutaline sulphate ,Bromhexine hydrochloride and Menthol SyrupBATCH SIZE:  1000 LTRS.
PRODUCT REFERENCE CODE:UNIT SIZE:  100 ML
GENERIC NAME: N.A.PACK SIZE:  72 x 100 ml
DOSAGE FORM: SYRUPSTRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml contains:

Guaiphenesin                                    B.P.      50  mg

Terbutaline sulphate                       U.S.P.   1.25  mg

Bromhexine hydrochloride               B.P.     4 mg

Menthol                                                B.P.         0.5 mg 

 EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Sugar Syrup Manufacturing Tank
2Sugar Storage Tank
3Charging Tank – 3500 Ltrs.
4Filter Press
5Storage Tank –  3500 Ltrs
6Linear Bottle Washing Machine
7Digipack Bottle Filling and Sealing Machine
8Automatic Bottle Labelling Machine
9Shrink Packing Machine

RAW MATERIAL:-

S.NOINGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.BROMHEXINE HCLB.P.0.80010.000.880 KGS
2.ASPARTUM (p)B.P.0.7500.750 KGS
3GUAIPHENESINB.P.10.0005.0010.500 KGS
4MENTHOLB.P.0.6230.623 KGS
5CARMOISINE COLORF.C.F5.0005.000 GMS
6SUNSET YELLOW SUPRABRB.P.2.0005.002.100 KGS
7POT.GUAICOL SULPHONATEB.P.20.0005.0021.000 KGS
8LIQUID GLUCOSEB.P400.00400.00 KGS
10MENTHOLB.P.0.9000.900 KGS

.200

11ORANGE FLAVOURF.G5.0005.000 LTRS
13P.GB.P45.96045.960 KGS
14 BENZOIC ACIDB.P.1.0001.000 KGS
15SPIRIT CHLOROFORMB.P.18.00018.000 LTRS
16TARTRAZINE SUPRAFCF0.1000.100 GMS
17SUGARF.G1400.001400.000 KGS

 PACKING MATERIAL

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.100 ML AMBER ROUND BTLS20000.00020000.000 NOS
2.ADHESIVE TAPE ROLL BROWN3.0003.000 NOS
3LABEL20208.3333.00020211.333 nos
4UNIT CARTON20000.0002.00020002.000 NOS
5CORRUGATED BOX208.333208.333 NOS
6GUM ACCACIA2.0002.000 KGS
7P. P. CAPS  25 MM(NEOMED)20000.00020000.000 NOS
8SHRINK FILM 220 X 220 MM3333.3333333.333 NOS

 MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

Volume variation limit allowed in each filled Bottle is 100 ml to 102 ml.

Make up the final volume of the syrup accurately.

Filter the completely charged batch using Filter Press  by operating it as per its SOP.

Transfer the syrup from charging tank to storage tank  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 20000 Bottles.

Expected Practical Yield is 20000 + 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 then Sealing of the bottles as per its SOP.

Fill 100 ml syrup in White glass round 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 12 shrinked packets in the Corrugated box. Thus each corrugated box contains 6 x 12 x 100 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 450 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.

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

Add 1400 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 400 kgs Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigrously for half an hour to dissolve it in the Sugar Syrup completely.

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 1.0 kgs of Benzoic acid in 30 Ltrs of hot purified water and add to the bulk batch.

Dissolve 0.880 kgs of C.P.M in 4 Ltrs of purified water and add to the bulk batch.

Dissolve 4.00 kgs of Aspartame in 10 Ltrs of purified water and add to the bulk batch.

Dissolve 0.450 kgs of Bronopol in 3 Ltrs of water and add add to the bulk batch.

Dissolve 1.760 kgs of bromhexine hcl and 21.00 kg Potassium.guaicol sulphonate in 45.906kg of hot P.G and add to the bulk batch.

Dissolve 2.1 kgs of Dextromethorphan HBr in 15 Ltrs of hot purifed water and add add to the bulk batch

Dissolve 0.900 kgs of Menthol in 18ltrs of Spirit Chloroform and add to the bulk batch

Dissolve 0.100 kgs of tartrazine Supra in 3 Ltrs of hot purifed water and add to the bulk batch.

Dissolve 20 gms  of brilliant blue Colour in 1 Ltr of water and add add to the bulk batch.

Add 8.0 Ltrs of Orange Flavour to the bulk batch.

Make up the volume with purifed 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 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 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 IPQA has given the ‘Line Clearance’.

 

OTHER RELATED POST – MASTER FORMULA OF AMOXYCILLIN CAPSULES IP