MFR of iron sucrose injection
1.0. PRODUCT INFORMATION :
master formula record iron sucrose injection 530 liters
|GENERIC NAME||Iron Sucrose Injection|
|Each ml contains|
|Ferric Hydroxide in Complex with Sucrose Eq. to Elemental Iron||20 mg|
|Water for Injection||q. s.|
|STANDARD BATCH SIZE:||530 liters|
|PRIMARY PACK DECRIPTION||5 ml Amber Glass Ampoule|
|PRODUCT DECRIPTION||Brown coloured Clear Solution
|STORAGE CONDITION||Store at controlled room temperature. Do not freeze.|
2.0. TABLE OF CONTENT :
|Sr. No.||Contents||Page No.|
|2.0||TABLE OF CONTENT|
|3.0||BILL OF RAW MATERIAL|
|5.0||BATCH MANUFACTURING PROCESS|
|6.0||YIELD AND ACCOUNTABILITY|
3.0. BILL OF RAW MATERIAL :
|Standard Qty (Kg)||Overages(%)||Batch Qty (Kg)|
|1.0||Iron Sucrose||20 mg||213.000 kg||about 2%||213.000 kg|
|2.0||Sodium Hydroxide Pellets *||–||
|3.0||Water for Injection (WFI)||–||Q.S.||–||Q.S.|
* This Quantity Use To adjust pH only.
4.0. CALCULATION :
Note: The Required quantity of API is taken as per calculation by using the below the mentioned formula.
In above table the quantity of Iron Sucrose is taken on anhydrous basis.
Each ml Contains:
Ferric Hydroxide in complex with sucrose Equivalent to Elemental Iron 20 mg
Water for Injection Q.S
Assay on Anhy. Basis: __________ % Water………………. %
Iron Sucrose = Label Claim (20) x100 x100x530 (Batch Size)
Assay x (100-Water) x1000
5.0. BATCH MANUFACTURING PROCESS :
A. Ensure That compounding Vessel is cleaned before starting the procedure.
B. Collect Water for Injection in a Mixing vessel send BET sample and cool up to 50- 55°C with continuous nitrogen Purging.
C. From the step 1st take as per Batch according Water for Injection a side in other SS vessel for final volume make up.
D. Add and dissolve Iron Sucrose with continuous stirring and check the clarity of solution.
E. Check the initial ph (PH RANGE 10.5 to 11.1) and Adjust pH of bulk solution with 10% Sodium hydroxide solution solution.
finally make up the volume with W.F.I. and then check the final ph.
F. Intimate the IPQA to collect Bulk solution and send to QC for analysis.
5.1 FILTRATION :
A. Ensure that Bulk solution Release from QC Department.
B. Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
C. Check the Pre and Post Filter Integrity.
5.2 FILL VOLUME DETAILS
A. Fill volume for 5 ml
B. Standard fill volume -5.3 ml
C. Lower fill volume -5.1 ml
D. Upper fill volume -5.4 ml
A. Ensure the nitrogen purging throughout the process.
B. Always use nose mask, hand gloves while processing.
C. All the contact parts of the Equipment, Filtration Assembly , Filling M/C parts and Accessories should be sterilize, at the time of use
6.0. YIELD AND ACCOUNTABILITY :
A. Bulk yield (After filtration) between 98 -100 %.
B. After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.