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Povidone – Iodine Liquid Solution

Posted on August 23, 2020February 11, 2023 By ABHA

Povidone – Iodine Liquid

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 formula.

COPY ISSUED TO:

Master Copy : Manager Quality Assurance

Copy No. 1 : Production Pharmacist

Copy No. 2 : Manager Quality Control

Copy No. 3 : External Preparation Section

PRODUCT NAME:  Povidone – Iodine LiquidBATCH SIZE:  1000 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  100ml
GENERIC NAME: POVIDONE-IODINE SOLUTION U.S.P.PACK SIZE: 72 x 100 ML
DOSAGE FORM: SEMI LIQUIDSTRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Povidone – Iodine          U.S.P.     5% w/v

(Available Iodine 0.5 % w/v)

EQUIPMENTS TO BE USED:

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Charging Tank – E02(1200 Lts)
2Storage Tank – III – 5000 Ltrs
3Manual Bottle Filling Machine
4Semi Auto Bottle Sealing Machine
5Semi Auto Labelling Machine
6Shrink Packing Machine

RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.BENZYL ALCOHOLU.S.P.20.000020.000 KGS
2POVIDON IODINEU.S.P.50.00010.0055.000 KGS

PACKING MATERIALS:

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

RECORD

TOTAL QUANTITY USED
1100 ML AMBER RD. BOTLS10000.00010000.000 NOS
2ADHESIVE TAPE ROLL BROWN4.0004.000 NOS
3CORRUGARED BOX E-24152.000152.000 NOS
4GUM ACCACIA1.1001.100 KGS
5P.P CAPS 25 MM10000.00010000.000 NOS
6LABELS10142.0003.00010145.000 NOS
7UNIT CARTON10000.0002.00010002.000
8SHRINK FILM 240 X 220 MM1667.0001670.000
9HANDLE WITH CARE STICKER138.000145.000

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 solution accurately.

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

Yield:

Theoretical Yield is 10000 Bottles.

Expected Practical Yield is 10000 + 2% Bottles.

Packing Details:

Wash the bottles manually.

Transfer the lotion from charging tank to manual bottle filling machine  for filling of the bottle as per its SOP.

Fill 100 ml of solution in 100ml Amber colored glass bottles.

Sealing of filled bottle is done on semi-automatic bottle sealing machine  as per its SOP.

Label each filled and sealed bottle manually.

Pack such 72 labeled bottles in a specified Corrugated box .

Seal each corrugated box with adhesive tape on both side

 MANUFACTURING PROCESS:

To the charging tank  add 55.0 kgs of Povidone Iodine.

Add 300 Ltrs of  purified water to it and let it to wet for overnight.

Add 20.0 kgs of Benzyl Alcohol to it.

And stir well for 90 minutes.

Transfer this 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 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 MFR using correct dipstick in the  Manufacturing Chemist.

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

Only after receiving the Bulk Test Report from Q.C. Dept. start 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. 

OTHER RELATED POST: Povidone Iodine Ointment

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