MASTER FORMULA OF PIPERAZINE SYRUP

MASTER FORMULA OF PIPERAZINE SYRUP

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 and cGMP Administrator are accountable for the strict adherence to the master 

COPY ISSUED TO:

1. Master Copy :  Manager Quality Assurance

2. Copy No.   1 : Production Pharmacist

3. Copy No .  2 : Manager Quality Control

4. Copy No .  3 :  cGMP Administrator

5.  Copy No.  4 : Liquid Section

PRODUCT NAME:PIPERAZINE SYRUPBATCH SIZE:  600 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  30 ML
GENERIC NAME: N.A.PACK SIZE:  12 x 12 x 30 ML
DOSAGE FORM: SYRUPSTRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENTEXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION: 

Each 5 ml contains:

Piperazine Citrate                                    U.S.P.

Equ. To Piperazine Hexahydrate          500 mg 

SPECIMEN LABEL : 

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Sugar Syrup Manufacturing Tank
2Charging Tank – III – 1000 Ltrs.
3Filter Press
4Storage Tank – I – 1000 Ltrs
5Linear Bottle Washing Machine
6Linear Bottle Filling and Sealing Machine
7Automatic Bottle Labelling Machine
8Shrink Packing Machine

 RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.CITRIC ACID  I.P.0.1500.150 KGS
2.GLYCERINE       I.P.30.00030.000 KGS
3.METHYL PARABEN SODIUMI.P.0.6000.600 KGS
4ORANGE FLAVOURF.G.1.5001.500 LTR.
5PROPYL PARABEN SODIUMI.P.0.1200.120 KGS
6PIPERAZINE CITRATEU.S.P75.00010.0082.500 KGS
7SODIUM BENZOATEI.P.3.0003.000 KGS
8SUNSET YELLOW SUPRAI.P.5.4005.400 GMS
9SUGARF.G.240.00240.00 KGS
10TARTRAZINE SUPRAF.G0.0300.030 KGS

 Packing materials: 

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

RECORD

TOTAL QUANTITY USED
1.32 ML AMBER ROUND BOTTELS20000.00020000.00 NOS
2.ADHESIVE TAPE ROLL BROWN3.0003.000 NOS
3LABEL20138.003.00020142.000 NOS
4UNIT CARTON20000.0002.0020002.000 NOS
5GUM ACCACIA2.0002.000 KGS
6CORRUGATED BOXES N – 08139.000139.000 KGS
7PILFER PROOF CAPS  25 MM20000.00020000.000 NOS
8SHRINK FILM 220 X 220 MM1667.0001667.000 NOS

MANUFACTURING SPECIFICATION:

1. Average fill of each Bottle is 30 ml.

2.Volume variation limit allowed in each filled Bottle is 30 ml to 31 ml.

3.Make up the final volume of the syrup accurately.

4.Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.

5.Transfer the syrup from charging tank to storage tank after complete charging of batch.

6.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:

1.Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.

2.Transfer the Syrup from storage tank to digipack Bottle Filling and Sealing Machine L-25 for filling and sealing of the bottles as per its SOP No- SOP/OL/017/MO/I.

3.Fill 30 ml syrup in amber glass bottle and use 25 mm PP Cap to seal the bottle mouth.

4.Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.

5.Label every inspected bottle by using the Automatic Bottle Labelling Machine L-26 as per its SOP.

6.Pack each filled and sealed bottle in unit carton individually.

7.Make a group of 12 bottles packed in unit cartons.

8.Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine L-27 as per its SOP.

9.Pack such 12 shrinked packets in the Corrugated box N-08.  Thus each corrugated box contains 12 x 12 x 30 filled and sealed bottles.

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

MANUFACTURING PROCESS:

I)    Preparation of Sugar Syrup:

1.  Take DM water 50 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank L-03.

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

3.  Add 240 kgs of sugar into the tank and start stirring by operating the tank .

4.  Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.

5.  Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank L-04 through transfer pump.

6.  Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank L-08 through transfer pump.

II)   Addition of Ingredients into the Charging Tank L-08 while stirring continuously:       

1.Dissolve 0.600 kgs of Methyl Paraben Sodium, 0.120 kgs of Propyl Paraben Sodium in 3 Ltrs of DM water and add to the bulk batch.

2.Dissolve 0.150 kgs of Citric Acid in 1 Ltrs of DM water and add to the bulk batch.

3.Dissolve 3.0 kgs of Sodium Benzoate in 10 Ltrs of DM water and add to the bulk batch.

4.Dissolve 75.0 kgs of Piperazine Citrate in 150 Ltrs of DM water and add to the bulk batch.

5.Add 30 kgs of Glycerine, 1.5 Ltrs of Orange Flavour and 6   x 450 ml of Spirit chloroform to the bulk.

6.Dissolve 5.4 Gms of Sunset Yellow Supra and 0.030 kg of Tartrazine Supra in 1 Ltr of DM water and add to the bulk batch.

7.Make up the volume with DM water to 600 Ltrs and mix until homogeneous.

8.Check the pH of Solution to be in between 4.5 – 5.0.

9.Filter the batch through Filter Press L-21 by operating it as per its SOP and transfer it to the Storage Tank.

10. Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

1.Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

2. 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 and QC/QA Manager.

3.Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

4.Final volume should be made as per Standard Operating Procedure using correct dipstick in the Assistant Manufacturing Chemist.

5.pH of the bulk should be checked and it should be with in specified limits.

6.Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

7.The Assistant Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

8.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

9.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.

10.Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.

11.The labels and cartons should be checked thoroughly for proper batch coding.

12.Intimation should be sent to Quality Control Department for finished product sampling and testing.

13.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.

14. It will be ensure that filling or packaging equipment has been properly cleaned.

15.Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

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