Ivermectin Tablet 12 mg USP
TABLE OF CONTENTS
|3.0||LIST OF EQUIPMENTS|
|6.0||MANUFACTURING PROCESS FLOW CHART|
|MANUFACTURING PROCESS DETAILS|
|Product Name||Ivermectin Tablets 12mg USP|
|Product Description||White colored, round shaped, un-coated tablet having one side mid break line and other side plain.|
|Each un- coated tablet contains:
Ivermectin USP 12 mg
|Batch Size||1,00,000 Tablets|
|Average Weight||300 mg (Uncoated tablets)|
|Shelf Life||24 months|
|Storage||Store in a cool, dry and dark place below 250C|
|Drug Category||Anti-Parasitic drug|
|Material Name||Grade||Category||Quantity per Unit (In mg)||Batch Qty.
|MCCP Ph-102 **||USP||Diluent||255mg||25.500 kg|
|Magnesium Stearate||USP||Anti-Adherent||3 mg||0.300 kg|
|Sodium Starch Glycolate||USP||Binder||15 mg||1.500 kg|
|Croscarmellose Sodium||USP||Disintegrant||15 mg||1.500 kg|
* Actual quantity of Ivermectin used in batch manufacture is based on assay on dried basis.
** Final Quantity to be adjusted.
|DISPENSING WEIGHT CALCULATION FOR IVERMECTIN:
Based on the assay value, appropriate calculation method shall be used for dispensing weight calculation of Ivermectin:
Dispensing weight of Ivermectin = Theoretical weight of Ivermectin x 100 x 100
Assay on anhydrous basis (100 – water content)
LIST OF EQUIPMENT:
|5.||Halogen Moisture Balance|
|7.||Blister Packing Machine|
- API Description: A off white or almost white color powder. Protected from moisture during storage.
- All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25 0C and relative humidity NMT 60%).
- When working with Active Ingredients and drug product or mixture of Active Ingredients and Excipients, wear gloves and mask to avoid exposure and contact with any body parts.
- All activities shall be performed as per current SOPs. Take the line clearance from QA before starting the manufacturing operation during batch to batch and product to product change over.
- Do not overwrite the entry. In case of mistake, cancel the entry by single line with sign & date and make correct entry.
MANUFACTURING PROCESS DETAILS:
STEP – I (SIFTING):
- Check Sieve Integrity (before sifting and after sifting).
- Set the Vibro Sifter and sieve the Dispensed Materials as per Sieve Sizes mentioned below
|Material Name||Std. Qty. (kg)||Sieve No.|
|MCCP Ph-102||25.500 kg||40#|
|Magnesium Stearate||0.300 kg||60#|
|Sodium Starch Glycolate||1.500 kg||60#|
|Croscarmellose Sodium||1.500 kg||60#|
STEP-II (PRE- MIXING):
- Sift Ivermectin IP (1.200 kg) with Sodium Starch Glycolate IP (0.300 kg) in sifter using 60# sieve for homogeneous mixing.
- Transfer Material of step (a) in Bin Blender and add Cross Carmellose Sodium IP (1.500 kg) and mix for 10 min at 10 RPM.
- Load the material of step (b) and MCCP Ph 102 (25.500 Kg) in Bin blender & mix for 30 min at 10 RPM.
- Add sifted Magnesium Stearate (0.900 Kg) in Bin Blender of Step-II(c) & mix for 05 minutes at 10 RPM.
STEP- IV (BLEND SAMPLE ANALYSIS):
After completion of lubrication, collect the composite blend sample (Qty. 10 gm) and send to QC for analysis according to the table below:
|Appearance of blend
|White color free flowing granular powder
90 % to 110 %
95 % to 105 %
STEP – XI:
- Take Tare Weight of two Poly-lined HDPE Containers, record the Tare Weigh in BMR and unload the above blended material from Double cone blender in Poly-lined HDPE Containers and weigh the material with containers and record the Gross Weight of the material and calculate the Net Weight of the material as per given formula:
Net Weight = Gross Weight – Tare weight
- Affix the status label with following details – Product Name, Batch No., Batch Size, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Containers.
- Batch Yield of Lubricated granules:
Theoretical Batch Yield: 30.000 kg (100 %)
Actual Batch Yield Limit NLT 29.700 kg (NLT 99 %)
STEP – XII:
- Clean all equipments used in the granulation as per respective equipment cleaning SOP.
STEP – I:
- After receiving of QC approval for the blend, verify the Net Weight of the received blend as per status label in Granules Day Store.
- Set the 35 stations (B-Tooling) Compression Machine. Compress the blend as per below parameters and Perform the Initial In Process checks.
- After Initial setting, continue the compression with the blend as per the following parameters and In Process checks under controlled environmental condition.
|Sr. No.||Parameters||Standard||No. of Tablets||In-Process Frequency|
|1.||Machine Speed||15 RPM -18 RPM||—–||—–|
|2.||Upper Punch Size||9.0 mm||—–||—–|
|3.||Lower Punch Size||9.0 mm||—–||—–|
|4.||Avg.- Diameter||9.0 mm||6/Individual||1 hours|
|5.||Thickness of Tablets||4.40 mm ± 0.2 mm||6/Individual||1 hours|
|6.||Weight of 20 Tablets||6.000 gm. ± 2%||20/Composite||30 minutes|
|7.||Product Description||White colored, round shaped, un-coated tablet having one side mid break line and other side plain.||20/Composite||30 minutes|
|8.||Uniformity of Weight||300 mg ± 5%||20/Composite||01 hour|
|9.||Average Weight of Tablets||300 mg ± 2%||20/Individual||30 minutes|
|10.||Hardness||NLT 4 kg/cm2||6/Individual||30 minutes|
|11.||Disintegration Time||NMT 15 minutes||6/Composite||01 hour|
|12.||Friability||NMT 1.0 % w/w||20/Composite||01 hour|
- Collect the compressed tablets in SS Container, when SS containers are filled with tablets, transfer the tablets in two Poly-lined HDPE Containers as given in below Step-II.
STEP – II
- Send the composite sample of compressed tablets (Qty. 30 tablets) to QC department for analysis.
STEP – III:
- Take Tare Weight of two Poly-lined HDPE Containers, record the Tare Weight in BMR and transfer the compressed tablets in Poly-lined HDPE Containers and weigh the compressed tablets with containers and record the Gross Weight of the compressed tablets and calculate the Net Weight of the material as per given formula:
Net Weight = Gross Weight – Tare weight
- Affix the status label with following details – Product Name, Batch No., Batch Size, Avg. Weight, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Container.
- Batch Yield of Compressed Tablets:
Theoretical Batch Yield: 30.000kg (100 %).
Actual Batch Yield Limit NLT 29.700kg (NLT 99 %).
STEP – IV:
- After completion of compression clean the Compression Machine as per cleaning SOPs
- After receiving of QC approval for the compressed Tablet, pack the Tablets in Blister pack as per current approved packaging instructions.
- Details of Primary Packaging Material are mentioned below:
Blister packing / Equipment name: Blister Packing machine.
|Parameters to be Monitored:|
|Blister Forming Temperature||140oC to 150oC|
|Sealing Temperature||145oC to 150oC|
|Pack size||Foil||210 mm|
|Analysis required||Physical & visual evaluation|
|Acceptance Criteria||Printing should sharp & legible. Leak test should pass|
Finished Product Specification
- Analyse the finished product samples as per current Standard Testing Procedure.