POVIDONE IODINE SOLUTION
Sumber: archive.org (drugsformulations.com)
MFR of POVIDONE-IODINE SOLUTION
October 5, 2020
iamraj
EXTERNAL PREPARATION
0
POVIDONE-IODINE SOLUTION
TUJUAN: THIS MATER FORMULA RECORDS (MFR) IS WRITTEN TO DESCRIBE THE FORMULAE, MANUFACTURING PROCEDURE, SPECIFICATIONS, PACKING DETAILS OF DOSAGE FORM.
RUANG LINGKUP: THIS MFR IS PERFORMED AND IS APPLIED DURING THE MANUFACTURING OF DOSAGE FORM.
TANGGUNG JAWAB / AKUNTABILITAS: 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.
SALINAN DIBAGIKAN KEPADA:
Salinan Utama : MANAGER QUALITY ASSURANCE
Salinan No. 1 : PRODUCTION PHARMACIST
Salinan No. 2 : MANAGER QUALITY CONTROL
Salinan No. 3 : EXTERNAL PREPARATION SECTION
NAMA PRODUK: POVIDONE-IODINE SOLUTION
UKURAN BATCH: 1000 LTRS.
PRODUCT REFERENCE CODE:
UKURAN UNIT: 100ML
GENERIC NAME: POVIDONE-IODINE SOLUTION U.S.P.
UKURAN KEMASAN: 72 X 100 ML
BENTUK SEDIAAN: SEMI LIQUID
STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT
TANGGAL KEDALUWARSA: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING
KOMPOSISI:
Povidone – Iodine U.S.P. 5% w/v
(Available Iodine 0.5 % w/v)
PERALATAN YANG DIGUNAKAN:
SR. NO.
NAME OF EQUIPMENT
ASSEMBLING
AS PER SOP NO.
CLEANING
AS PER SOP NO.
1
Charging Tank
2
Storage Tank – III
3
Manual Bottle Filling Machine
4
Semi Auto Bottle Sealing Machine
5
Semi Auto Labelling Machine
6
Shrink Packing Machine
BAHAN BAKU:
S.NO.
INGREDIENTS
STD
Theoretical Quantity Req.
Overages %
Total Quantity Used
1.
BENZYL ALCOHOL
U.S.P.
20.0000
20.000 KGS
2
POVIDON IODINE
U.S.P.
50.000
10.00
55.000 KGS
BAHAN KEMASAN:
S.NO.
NAME OF THE MATERIAL
THEORETICAL QUANTITY REQ.
FOR
RECORD
TOTAL QUANTITY USED
1
100 ML AMBER RD. BOTLS
10000.000
10000.000 NOS
2
ADHESIVE TAPE ROLL BROWN
4.000
4.000 NOS
3
CORRUGARED BOX E-24
152.000
152.000 NOS
4
GUM ACCACIA
1.100
1.100 KGS
5
P.P CAPS 25 MM
10000.000
10000.000 NOS
6
LABELS
10142.000
3.000
10145.000 NOS
7
UNIT CARTON
10000.000
2.000
10002.000
8
SHRINK FILM 240 X 220 MM
1667.000
1670.000
9
HANDLE WITH CARE STICKER
138.000
145.000
SPESIFIKASI PEMBUATAN:
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.
HASIL:
THEORETICAL HASIL IS 10000 BOTTLES.
EXPECTED PRACTICAL HASIL IS 10000 + 2% BOTTLES.
DETAIL PENGEMASAN:
Wash the bottles manually.
Transfer the lotion from charging tank to manual bottle filling machine E-04 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 E-05 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
PROSES PEMBUATAN:
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.
PENGENDALIAN DALAM PROSES :
THE FOLLOWING PENGENDALIAN DALAM PROSES SHOULD BE MAINTAINED DURING THE PROCESSING:
CHECK RAW MATERIALS USED FOR MANUFACTURING TUJUAN ARE ALL APPROVED AND HAVE ‘RELEASED’ LABELS FIXED ON IT.
ALL WEIGHED BAHAN BAKU 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.
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.
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 labeling 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’.
MFR of POVIDONE-IODINE SOLUTION
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