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MFR of Deflazacort Tablets

Posted on March 3, 2021February 8, 2023 By ABHA

MFR of Deflazacort  Tablets

TABLE OF CONTENTS 

S.NO.TITLEPage No.
1.0PRODUCT DETAILS
2.0MANUFACTURING FORMULA
3.0LIST OF EQUIPMENTS
4.0GENERAL PRECAUTIONS
5.0MANUFACTURING INSTRUCTIONS
6.0

 

 

 

MANUFACTURING PROCESS DETAILS
6.1GRANULATION
6.2COMPRESSION

 1.0 PRODUCT DETAILS:

Product NameDeflazacort  Tablets
Product DescriptionWhite color round shape, uncoated tablet having one side mid break line and other side plain.
Strength 6 mg
Label claim

 

Each uncoated tablet contains:

Deflazacort – 6 mg

Batch Size5,00,000 Tablets
Average Weight110 mg
Shelf Life24 months
StorageStore in a cool, dry and dark place below 25 0C.
Drug CategoryCorticosteroids Drug

2.0 MANUFACTURING FORMULA:

Material NameGradeCategoryQuantity per Unit (In mg)Batch Qty.

 (In kg)

Dry Mixing
Deflazacort—API6 mg3.000 kg
Sodium Starch GlycolateIPDisintegrant3.33 mg1.665 kg
TalcumIPAnti-caking agent5  mg2.500 kg
StarchIPDiluent10  mg5.000 kg
AerosilIPGlidant1.5 mg0.750 kg
Lubricant
MCCP PH-112IPDiluent83.17 mg41.585 kg
Magnesium StearateIPAnti- Adherent1 mg0.500 kg

3.0 LIST OF EQUIPMENTS:

Sr. No.Machineries/EquipmentsCapacityEquipment ID.
1.Weighing Balance100 kg
2.Vibro Sifter30 inch dia.
3.Octagonal Blender60 liter
4.Double Cone Blender200 liter
5.Compression Machine35 Station
6.Halogen Moisture Balance—

4.0 GENERAL PRECAUTIONS:

  • API Description: A white or creamy white color crystalline powder.
  • 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.

5.0 MANUFACTURING INSTRUCTIONS:

  • 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:

6.1 GRANULATION:

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
Deflazacort3.000 kg60 #
Sodium Starch Glycolate IP1.665 kg60 #
Talcum IP2.500 kg60 #
Starch IP5.000 kg100 #
Aerosil IP0.750 kg14 #
Lubricant
MCCP-PH-112 IP41.585 kg30 #
Magnesium Stearate IP0.500 kg30 #
  • Collect sifted Deflazacort IP (3.000 kg) in one Polybag (capacity: 5.0 kg)
  • Collect sifted Sodium Starch Glycolate IP (1.665 kg),Talcum IP (2.500 kg), Starch IP (5.000 kg) and Aerosil IP (0.750 kg) in one Polybag (capacity: 10 kg).
  • Collect sifted MCCP PH-112 IP (41.585 kg) in two Polybag (capacity: 25 kg each)
  • Collect sifted Magnesium Stearate IP (0.500 kg) in one Polybag (capacity: 1.0 kg)

STEP – II (DRY MIXING):

  • Transfer sifted Sodium Starch Glycolate IP, Talcum IP, Starch IP and Aerosil IP in Octagonal Blender (capacity: 60 liter) and mix for 10 minutes.
  • Mixing Time: 10 minutes (clockwise direction)
  • Mixing Speed: 15 RPM
  • Add sifted Deflazacort in the material of Step-II (a) and mix for 10 minutes.
  • Mixing Time: 10 minutes (clockwise direction)
  • Mixing Speed: 15 RPM
  • Unload the material of Step-II (b) from Octagonal blender in one Polybag (capacity: 20 kg).

STEP – III (PRE-LUBRICATION):

Load the mixed material of Step –II(c) in Double Cone Blender (capacity: 200 liter) from Polybag and add sifted MCCP PH 112 IP in Double cone blender and mix properly till uniform mixing.

  • Mixing Time: 30 minutes (15 minutes clockwise direction and 15 minutes anti-clockwise direction)
  • Mixing Speed: 10 RPM 

STEP – IV (LUBRICATION):

Add the sifted Magnesium Stearate IP in Pre Lubricated Materials of Step-III in Double Cone Blender and mix properly till uniform mixing of materials with Magnesium Stearate IP.

  • Mixing Time: 05 minutes.
  • Mixing Speed: 10 RPM.

STEP- V (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:

TestSpecification
Appearance of blend

Blend Uniformity

Blend Assay

LOD

Bulk Density

Tapped Density

Compressibility Index

Hausner Ratio

White color 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

To be established in next batch

STEP – VI:

  • 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 – Product Name, Batch No., Batch Size, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Container.
  • Batch Yield of Lubricated granules:
  • Theoretical Batch Yield: 55.000 kg (100 %)
  • Actual Batch Yield Limit NLT 54.450 kg (NLT 99 %) (To be established in next batch).

STEP – VII:

  • Clean all equipments used in the granulation as per respective equipment cleaning SOP.
    • COMPRESSION:

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 (D-Tooling) Compression Machine of the blend as per the following parameters and In Process checks under controlled environmental condition.
S.No.ParametersStandardNo. of TabletsIn-Process Frequency
1.       Feed frame alignment and adjustmentShould be satisfactory—–—–
2.       Lower Weight AssemblyShould be satisfactory—–—–
3.       Hydraulic Pressure5 – 6 Tones—–—–
4.       Machine Speed20 RPM -22 RPM­—–—–
5.       Upper Punch Size6.5 mm with break line­—–—–
6.       Lower Punch Size6.5 mm—–—–
7.       Length of Tablets.6.5 mm—–—–
8.       Width of Tablets6.5 mm6/Individual2 hours
9.   Thickness of Tablets2.5 mm ±.2 mm6/Individual2 hours
10.   Weight of 20 Tablets2.200 gm. ± 2%20/Composite30 minutes
11.   Uniformity of WeightNMT 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/Composite01 hour
12.   Standard Average Weight of Tablets110 mg ± 2 %20/Individual30 minutes
13.   HardnessNLT 3.0 kg/cm26/Individual30 minutes
14.   Disintegration TimeNMT 15 min (IHS NLT 3 minute)6/Composite01 hour
15.   FriabilityNMT 1%20/Composite01 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 in below 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 – Product Name, Batch No., Batch Size, Avg. Weight, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Containers.
  • Batch Yield of Compressed Tablets:
  • Theoretical Batch Yield: 55.000 (100 %)
  • Actual Batch Yield Limit NLT 54.450 kg (NLT 99 %) (To be established in next batch)

STEP – IV:

  • After completion of compression clean the Compression Machine as per cleaning SOP.

 

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Bliss GVS Pharma Ltd-Vacancies for M.Pharm, B.Pharm, MSc in QA, QC, Production Apply

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Zydus Lifesciences -Walk In Interview on 19th March 2025

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Ipca -Walk In Interview For QA/ QC and Maintenance Dept on 23/03/2025

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Torrent Pharma-Walk In Drive for M.Pharm, MSc as ADL Executive on 23rd MARCH, 2025

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Gufic Biosciences-walk in for B.Pharm, MSc, BSc in Quality Control, Production on 22/03/2025 

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Intas- Walk In Interview For Fresher on 22nd March 2025 

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Indeed Jobs-Symed Labs Ltd (Viyash Life Sciences) – Walk-In Drive for Quality Control / Quality Assurance / EHS / ETP on 17th-21st Dec’ 2024

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Indeed Jobs- Siflon Drugs & Pharmaceuticals Pvt. Ltd -Interview on 17th & 18th Dec’ 2024

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Indeed Jobs SRF- Walk In Interview For Multiple Openings on 17th December 2024

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Indeed Jobs Bafna Pharmaceuticals Walk-In Interview on 22nd December 2024.

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