PANTOPRAZOLE SODIUM 40 MG TABLETS IP
Sumber: archive.org (drugsformulations.com)
MFR of Pantoprazole Sodium 40 mg Tablets IP
TABLE OF CONTENTS
S.NO.
TITLE
Page No
1.0
PRODUCT DETAILS
2 of 11
2.0
MANUFACTURING FORMULA
2 of 11
3.0
LIST OF EQUIPMENTS
2 of 11
4.0
GENERAL PRECAUTIONS
3 of 11
5.0
MANUFACTURING INSTRUCTIONS
3 of 11
6.0
PROSES PEMBUATAN DETAILS
6.1
GRANULATION
3 of 11
6.2
COMPRESSION
6 of 11
6.3
COATING
7 of 11
6.4
BRAND DETAILS
11 of 11
1.0 PRODUCT DETAILS:
NAMA PRODUK
Pantoprazole Sodium Tablets IP
Product Description
Yellow color, round shape, biconvex, enteric coated tablets having both side plain
Strength
Pantoprazole Sodium – 40 mg
Label claim
Each enteric coated tablet contains:
Pantoprazole Sodium IP
equivalent to Pantoprazole 40 mg
UKURAN BATCH
5,00,000 Tablets
Average Weight
110 mg (Uncoated tablets)
121 mg (Enteric coated tablets)
Shelf Life
24 months
Storage
Store in a cool, dry and dark place below 25 0 C
Drug Category
Proton-Pump Inhibitors
2.0 MANUFACTURING FORMULA:
Material Name
Grade
Category
Quantity per Unit (In mg)
Overages
Batch Qty.
(In kg)
Dry Mixing
Pantoprazole Sodium
IP
API
40Â mg
13 %
22.600 kg
Mannitol
IP
Diluent
32 mg
—-
16.000 kg
Cross Carmellose Sodium
IP
Disintegrant
3.5 mg
1.750 kg
Sodium Carbonate
IP
Alkaline
8 mg
4.000 kg
Binder
PVPK-30
IP
Binder
2.5 mg
—-
1.250 kg
Isopropyl Alcohol (IPA)
IP
Solvent
0.047 ml
—-
23.500 liter
Lubricant
Talcum
IP
Anti-caking agent
2.8 mg
—-
1.400 kg
Cross Carmellose Sodium
IP
Disintegrant
3.5 mg
—-
1.750 kg
Crospovidone XL
IP
Disintegrant
5 mg
—-
2.500 kg
Aerosil
IP
Glidant
2.5 mg
—-
1.250 kg
Calcium Stearate
IP
Anti-adherent
5 mg
—-
2.500 kg
3.0 LIST OF EQUIPMENTS:
Sr. No.
Machineries/Equipments
Capacity
Equipment ID.
1.
Weighing Balance
100 kg
SC/PD/WBL/03
2.
Vibro Sifter
(with SS Sieves  No’s 14,20, 40, 60,80)
30 inch dia
SC/PD/SFT/01
SC/PD/SFT/02
3.
Mass Mixer with propeller
100 liter
SC/PD/MSM/01,SC/PD/MSM/02
4.
Portable Stirrer
—
SC/PD/STR/01,SC/PD/STR/02
5.
Tray Dryer
48 Trays
SC/PD/TRD/01,SC/PD/TRD/02
SC/PD/TRD/03,SC/PD/TRD/04
6.
Double Cone Blender
200 liter
SC/PD/DCB/01
7.
Halogen Moisture Balance
—
SC/QC/007
8.
Compression Machine
35 Station
SC/PD/CPM/02,SC/PD/CPM/06
9.
SS Containers
30 liter (02 No’s)
—
10.
Poly-lined HDPE Containers with lid
30 liter (08 No’s)
—
11.
Polybags
2 kg (01 No.),
5 kg (01 No.),
10 kg (01 No.)
12.
Filter Cloth 100 #
0.5 Meter
4.0 GENERAL PRECAUTIONS:
API Description: A white to off white powder .(Light Sensitive)
All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25 0 C 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.
Use Sodium Lamp and Black Poly-bags at every Step.
MANUFACTURING INSTRUCTIONS:
All the Activity shall be performed as per current SOPs.
Take the line clearance of every machine from QA before starting the manufacturing operation during batch to batch and product to product change over.
Do not overwrite any entry. In case of mistake, cancel the entry by single line with sign & date and make correct entry.
6.0 PROSES PEMBUATAN DETAILS:
6.1 GRANULATION:
NOTE: Turn ON the sodium lamp and switch OFF all lights before starting the operation and use black polybags to store the materials.
STEP – I (SIFTING):
Check Sieve Integrity (before sifting and after sifting).
Set the Vibro Sifter (capacity: 30 inch dia) and sieve the Dispensed Materials as per Sieve Sizes mentioned below:
Material Name
Std. Qty. (kg)
Sieve No.
Dry Mixing
Pantoprazole Sodium IP
22.600 kg
40 #
Mannitol IP
16.000 kg
40 #
Cross Carmellose Sodium IP
1.750 kg
60 #
Sodium Carbonate IP
4.000 kg
80 #
Binder
PVPK-30 IP
1.250 kg
20 #
Isopropyl Alcohol IP (IPA)
23.500 liter
NA
Lubricant
Talcum IP
1.400 kg
60 #
Cross Carmellose Sodium IP
1.750 kg
60 #
Crospovidone XL
2.500 kg
60 #
Aerosil IP
1.250 kg
14 #
Calcium Stearate
2.500 kg
60 #
NOT
Collect sifted Pantoprazole Sodium IP (22.600 kg), Mannitol IP (16.000 kg), Cross Carmellose Sodium IP (1.750 kg) and Sodium Carbonate (4.000 kg) into two Poly-lined HDPE Containers (capacity : 30 liter each).
Collect sifted PVPK-30 IP (1.250 kg) in Polybag (capacity: 2 kg).
Collect the sifted Talcum IP (1.400 kg), Cross Carmellose Sodium IP (1.750 kg), Crospovidone XL IP (2.500 kg), Aerosil IP (1.250 kg) in Polybag (capacity : 10 kg).
Collect the sifted Calcium Stearate IP (2.500 kg) in Polybag (capacity: 5 kg )
STEP – II (BINDER PREPARATION):
Take Isopropyl Alcohol (23.500 liter) in SS Container (capacity: 30 liter) and add PVPK-30 IP (1.250 kg) in it. Mix together by Portable Stirrer continuously stirring till dissolved properly in IPA.
Mixing Time: 10 minutes (To be validated in next batch)
Filter the solution with  filter cloth 100 # in SS Container (capacity: 30 liter).
STEP – III (DRY MIXING):
Transfer the sifted Pantoprazole Sodium IP, Mannitol IP, Cross Carmellose Sodium IP and Sodium Carbonate in Mass Mixer (capacity: 100 liter) and dry mix the materials till uniform mixing.
Mixing Time: 10 minutes.(To be validated in next batch)
Mixing Speed: 36 RPM
Paddle (Blades) Timing: 05 minutes in clockwise direction & 05 minutes in anti-clockwise direction.
STEP –IV (BINDING OF DRY MIX MATERIAL):
Slowly add the binder of Step-II in dry mix materials of Step-III and mix for 10 minutes till uniform binding and after binding, collect the wet mass into sixteen Trays (capacity: 3.000 kg each).
Mixing Time: 10 minutes
Mixing Speed: 36 RPM
Paddle (Blades) Timing: 05 minutes in clockwise direction & 05 minutes in anti-clockwise direction.
STEP –V (DRYING):
Dry the wet mass of Step -IV as follows:
Load these sixteen trays in Tray Dryer.
First air dry the granules for 30 minutes in Tray Dryer. Ensure that Heaters are in OFF mode during air drying . After 30 minutes of air drying, Switch ON the heaters and set the temperature at 35 o C and dry the granules , until the LOD of granules is between 1.0 to 1.5% at 105 o C checked by Halogen Moisture Balance.
Air Drying Time: 30 minutes (Heaters should be OFF)
Drying Time: 04 to 05 Hours. (To be validated in next batch)
Drying Temperature: 35 0 C (After Air Drying)
Raking Frequency: After every 30 minutes.
STEP-VI (SIZING/MILLING):
Check Sieve Integrity (before sifting and after sifting).
Set the Vibro Sifter and fix the sieve 40 # and sieve the dried material of Step-V. Collect the sized material into two Poly-lined HDPE containers (capacity: 30 liter each).
STEP – VII (PRE –LUBRICATION):
Load the sized granules of Step-VI in Double Cone Blender (capacity : 200 liter) and add sifted Talcum IP , Cross Carmellose Sodium IP, Crospovidone XL IP and Aerosil IP, mix properly till uniform mixing of sized material with Pre-Lubricating Material.
Mixing Time: 30 minutes (15 minutes clockwise direction and 15 minutes anti-clockwise direction)
Mixing Speed: 10 RPM
STEP – VIII (LUBRICATION):
Add the sifted Calcium Stearate IP in Pre- Lubricated Material of Step-VII and mix properly till uniform mixing of materials with Calcium Stearate IP.
Mixing Time: 05 minutes (clockwise direction)
Mixing Speed: 10 RPM.
STEP- IX (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:
Test
Specification
Appearance of  blend
Blend Uniformity
Blend Assay
LOD
Bulk Density
Tapped Density
Compressibility Index
Hausner Ratio
Off white free flowing granular powder
90 % to 110 %
98 % to 103 %
1.0 % to 1.5 %
To be established in next batch
To be established in next batch
To be established in next batch
To be established in next batch
STEP – X:
Take Tare Weight of two Poly-lined HDPE Containers (capacity: 30 liter each), record the Tare Weight in BMR and unload the above blended material from Double Cone Blender in Poly-lined HDPE Containers (capacity: 30 liter each) 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 – NAMA PRODUK, BATCH NO., BATCH SIZE, MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINER.
BATCH HASIL OF LUBRICATED GRANULES:
THEORETICAL BATCH HASIL: 55.000 KG (100 %)
ACTUAL BATCH HASIL LIMIT NLT 54.450 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH)
STEP – XI:
Clean all equipments used in the granulation as per respective equipment cleaning SOP.
6.2 COMPRESSION:
NOTE: Turn ON the sodium lamp and switch OFF all lights before starting the compression and use black polybags to store the tablets.
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.
After confirmation continue the compression with 35 stations (B-Tooling) Compression Machine. Compress the blend as per the following parameters and In Process checks under controlled environmental condition.
S.No.
Parameters
Standard
No. of Tablets
In-Process Frequency
1.
Feed frame alignment and adjustment
Should be satisfactory
—–
—–
2.
Lower Weight Assembly
Should be satisfactory
—–
—–
3.
Hydraulic Pressure
5 -6 Tones
—–
—–
4.
Machine Speed
20 RPM -22 RPM
—–
—–
5.
Common Name of Die
Peace
6.
Upper Punch Size
6.5 Â mm
—–
—–
7.
Lower Punch Size
6.5 Â mm
—–
—–
8.
Diameter of the tablet
6.5 mm
6/Individual
2 hours
9.
Thickness of Tablets
3.17 mm ± 0.2 mm
6/Individual
2 hours
10.
Weight of 20 Tablets
2.200 gm. ± 2 %
20/Composite
30 minutes
11.
Product Description
Off white color, round shape, biconvex, uncoated tablet having both side plain
20/Composite
30 minutes
12.
Uniformity of Weight
NMT 02 tablets out of 20 deviate from the standard average weight by more than 3 % and no single tablet deviates from the standard average weight by more than 5 %
20/Composite
01 hour
13.
Standard Average Weight of Tablets
110 mg ± 2 %
20/Individual
30 minutes
14.
Hardness
NLT 3.0 kg/cm 2
6/Individual
30 minutes
15.
Disintegration Time
NMT 15 min
6/Composite
01 hour
16.
Friability
NMT 1%
20/Composite
01 hour
Collect the compressed tablets in SS Container (capacity: 20 liter each on both sides), when SS containers are filled with tablets, transfer the tablets in two Poly-lined HDPE Containers as given below in Step-III.
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 (capacity: 30 liter each), record the Tare Weight in BMR and transfer the compressed tablets in Poly-lined HDPE Containers (capacity: 30 liter each) 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 – NAMA PRODUK, BATCH NO., BATCH SIZE, AVG. WEIGHT MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINER.
BATCH HASIL OF COMPRESSED TABLETS:
THEORETICAL BATCH HASIL: 55.000 KG (100 %)
ACTUAL BATCH HASIL LIMIT NLT 54.450 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH)
STEP – IV:
After completion of compression of tablets, clean the Compression Machine as per cleaning SOP.
NOTE: For this product the lot size of 500000 tablets is taken which is divided into different sub lots (batches of different quantities) as per the order of the customers.
IN ORDER TO STANDARDIZED THE COATING PROCEDURE WE ARE TAKING THE UKURAN BATCH OF 100000 TABLETS FOR COATING IN THIS MFR.
6.3 COATING: FOR 100000 Tablets:
NOTE: Switch ON sodium lamp and Switch OFF all lights and use black polybags to store the tablets.
Verify the Net Weight of the received compressed tablets for coating as per status label and after confirmation continue for tablet coating.
STEP – I (COATING MATERIALS SEAL COAT DETAILS):
Sr. No
Material Name
Batch Quantity
1.
Instacoat Solution Transparent IC-S-1643
0.110 kg
2.
Isopropyl Alcohol IP
0.630 liter
3.
Dichloromethane USP
1.470 liter
STEP – II (COATING MATERIALS ENTERIC COATING DETAILS):
Sr. No
Material Name
Batch Quantity
1.
Instacoat EN Solution White IC-EN-001
1.100 kg
2.
Isopropyl Alcohol IP
6.270 liter
3.
Dichloromethane USP
14.630 liter
4.
Yellow oxide of iron
0.055 kg (To be validated according to the reference sample of product)
NOTE:
Color: As per packing material /according to the brands/products. The color and quantity of color to be used may vary from product to product as per the reference sample.
.STEP-III (LIST OF EQUIPMENTS FOR COATING):
Sr. No.
Machineries/Equipments
Capacity
Equipment ID.
1.
Coating  Machine and Coating Pan
24″
SC/PD/COT/04
2.
Spray Gun
01
—
3.
Filter Cloth 100 #
0.5 Meter
—
4.
Portable Stirrer
—
—
5.
SS Containers
10 liter (02 No’s), 30 liter (02 No’s)
—
6.
Poly-lined HDPE Containers with lid
30Â liter (01 No.)
—
STEP – IV (PREPARATION OF SEAL COAT SOLUTION):
Take Isopropyl Alcohol IP (0.630 liter) and Dichloromethane USP (1.470 liter) in SS Container (capacity: 10 liter) and add Instacoat Solution Transparent IC-S-1643 (0.110 kg), mix together by Portable Stirrer properly continuously stirring till uniform mixing achieved.
Speed of stirrer: Constant.
Mixing Time: 15 minutes (To be validated in next batch)
Filter the seal coating solution with Filter Cloth 100 # in SS Container (capacity: 10 liter).
Keep the solution for 10 minutes and after 10 minutes start the Seal Coating process with Seal coating solution
STEP – V (COATING PROCEDURE FOR SEAL COAT OF TABLETS):
NOTE: Use sodium lamp and switch OFF lights and use black polybags to store the tablets.
Coating will be done in one lot, take total compressed tablets for coating (11.000 kg).
Load the tablets in coating pan (Capacity: 24″), start the hot air blower, set the inlet air temperature at 60°C to 65°C and start the exhaust fan & warm the tablets bed 30°C to 35°C.
After warming up the tablets, take weight of 100 warm tablets and also take weight of 100 tablets after Seal Coat and record the weight in BMR for calculation of weight buildup of tablets after Seal Coat.
Set the coating parameter as given in below table and start the coating process by starting coating spray through gun.
After completion of Seal Coating, calculate the weight gain by using below Formula in the table.
Parameter
Specification
No. of Baffles in coating pan
03
No. of Guns
01
Inlet Temperature
60°C to 65°C (To be validated in next batch)
Peristaltic Pump Speed
2 – 4 RPM (To be validated in next batch)
Atomization
2.5 to 3.0 kg/cm 2
Gun to Tablet Bed Distance
10 inch
BED Temperature
30 0 C to 35 0 C (To be validated in next batch)
Pan RPM
13 to 15 RPM
% Weight Gain
(Up to 1 %)
Weight of tablets after  Seal Coat – Weight of uncoated warmed tablets   x 100
Weight of tablets after Seal Coat
Seal Coating Time
02 Hour (To be validated in next batch)
STEP – VI (PREPARATION OF ENTERIC COATING SOLUTION):
Take Isopropyl Alcohol IP (6.270 liter) and Dichloromethane USP (14.630 liter) in SS Container (capacity; 30 liter) and add Instacoat EN Solution White IC-EN-001(1.100 kg), mix together by Portable Stirrer properly continuously stirring till uniform mixing achieved.
Speed of stirrer: Constant.
Mixing Time: 15 minutes (To be validated in next batch)
After uniform mixing add color Yellow oxide of iron IP (0.055 kg) in the above solution and mix for 05 minutes with stirrer till uniform mixing achieved.
Filter the Enteric coating solution with Filter Cloth 100 # in one SS Container (capacity: 30 liter)
Keep the solution, after completion of Seal Coating, start the enteric coating process with enteric coating solution.
STEP – VII (COATING PROCEDURE FOR ENTERIC COATING OF TABLETS):
Set the coating parameter as given in below table and start the enteric coating process by starting coating spray through gun.
Parameter
Specification
No. of Baffles in coating pan
03
No. of Guns
01
Inlet Temperature
60°C to 65°C (To be validated in next batch)
Peristaltic Pump Speed
2 – 4 RPM (To be validated in next batch)
Atomization
2.5 to 3.0 kg/cm 2
Gun to Tablet Bed Distance
10 inch
BED Temperature
30 0 C to 35 0 C (To be validated in next batch)
Pan RPM
13 to 15 RPM
% Weight Gain
(8 to 10 %)
Weight of Enteric Coated Tablets – Weight of Seal Coated Tablets   x 100
Weight of Enteric Coated Tablets
Enteric Coating Time
Coating Time: 06 Hours (To be validated in next batch)
After completion of Enteric coating, take weight of 100 Enteric coated tablet and record the weight in BMR and calculated the weight gain by using Weight Gain Formula given in above table of Step- VII
STEP – VII (COATING IN-PROCESS CHECK PARAMETERS):
After completion of Enteric Coating perform the In Process checks as per below parameters.
S.No.
Parameters
Standard
No. of Tablets
In-Process Frequency
1
Product Description
Yellow color, round shape, biconvex, enteric coated tablet having both side plain
20 No.
After batch completion
2
Weight of 20 Tablets after coating
2.420 gm.(8 % to 10 % weight gain)
20 No.
3
Average Weight after coating
121 mg .(8 % to 10 % weight gain)
20 No.
4
Individual Tablets Weight Variation
NMT 02 tablets out of 20 deviate from the standard average weight by more than 3 % and no single tablet deviates from the standard average weight by more than 5 %
20 No.
5
Thickness
3.88 mm ± 0.2 mm
6 No.
6
Disintegration Time (Acid Medium)
In 0.1M HCl – Should not crack in two hours
6 No.
7
Disintegration Time (In Phosphate Buffer)
Should disintegrate within one hour in mixed phosphate buffer pH = 6.8
—
8
Dissolution in Acid Medium (Gastro Resistance)
Pantoprazole Sodium (as Enteric Coated tablet)
Should be dissolved less than 15 %
20 No.
9
Dissolution in Phosphate Buffer
Pantoprazole Sodium (as Enteric Coated tablet)
Should be dissolved more than 80 %
—
STEP – IX:
Send the composite sample of coated tablets (Qty.30 tablets) to QC department for analysis.
STEP – X:
Take Tare Weight of one Poly-lined HDPE Containers (capacity: 30 liter ), record the Tare Weight in BMR and transfer the coated tablets in Poly-lined HDPE Containers (capacity: 30 liter each) and weigh the coated tablets with containers and record the Gross Weight of the coated 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 – NAMA PRODUK, BATCH NO., BATCH SIZE, AVG. WEIGHT, MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINERS.
BATCH HASIL OF COATED TABLETS:
THEORETICAL BATCH HASIL: 12.100 KG (100 %)
ACTUAL BATCH HASIL LIMIT NLT 11.979 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH).
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