Manufacturing Procedure of Ornidazole Tablets

 Manufacturing Procedure of Ornidazole Tablets

 

Bill of Material

Ingredient

Pharmaceutical role

Ornidazole Active
Microcrystalline Cellulose Diluent
Lactose Monohydrate Diluent
Silica, Colloidal Anhydrous Surfactant
Povidone (K-30) Binder
Water, Purified Vehicle
Sodium Lauryl sulphate Surfactant
Talc Granular former
Magnesium Stearate Lubricant
Croscarmellose Sodium Disintegrating
Opadry Green Coloring

Agent

  • Manufacturing Procedure 
    • Step – I:-Sift, Lactose Monohydrate, Silica, Colloidal Anhydrous, Ornidazole, Cellulose, Micro-crystalline through Vibro Sifter fitted with sieve of mesh size 60, and collect the sifted material in IPCs.
    • Step – II:-Perform dry mixing  of the materials of  Step – I in Rapid Mixer Granulator. Mix for 5 minutes at mixer slow speed and chopper off.
    • Step – III:-Prepare binder solution by dissolving Povidone (K-30) in water, purified in S.container stir it with the help of mechanical stirrer
    • Step – IV:-Preparation of Granules by wet granulation Add binder solution of step – III to the mixed mass of step -II in RMG and knead for 5 minutes.  Add water, purified if required to achieve granulation end point . Record the critical parameters ,Mixer Amperage, Chopper Amperage, Effective kneading time, Extra quantity of Water, purified added , Total quantity of Water, purified consumed.
    • Step – V:-Dry the granules of step – IV  in FBD(with raking at regular intervals) at an inlet air  temperature of 50-55°C to a L.O.D of 1.0-2.0% w/w.Record the critical parameters, Inlet air temperature, Outlet air temperature, Bed temperature,Exhaust flap opening , LOD of granules, Drying time .
    • Step – VI:-Mill the dried granules of step – V in Sifter cum multimill fitted with screen of 1.5mm for both Sifter and Miller. Collect the granules in blender’s bin & weighing is done by using a calibrated balance
    • Step – VII :- Lubrication of Granules
    • Step – VII A:-Sift Talc, Magnesium Stearate ,Sodium Laurilsulfate ,Croscarmellose Sodium through Vibro Sifter fitted with sieve of mesh size 60, and collect the sifted material in IPCs.
    • Step – VII B:Load the material of step – VII A in blender’s bin of of step – VII B  and blend it for 10 minutes at 6 rpm.
    • Step – VIII :-Weighing of lubricated granules is done  by using a calibrated balance and calculate the final yield..
    • Step – IX :-Inform to IPQA Department through In-process Analytical Request  to collect the sample of blended granules of step VII B, IPQA personnel  send the sample to Quality Control Department for testing as per In-process Specification.
    • Step – X :-After getting quality control approval take line clearance from IPQA as per SOP. for Tablet Compression area and all equipment there in to be used for this operation
    • Step – XI :-After getting approval from IPQA Department, compress the blend of step VII B, into tablets of required specification  using 37 station compression machine fitted with dies and standard  punches. Dedust the tablet by using tablet dedusting machine.
  • COMPRESSED TABLET SPECIFICATIONS
    • Description : Cream  coloured ,,biconvex,uncoated  tablets scored on one side and Plain on the other.
    • Average mass    : 700 mg
    • Uniformity of mass : Individual weight of 20 tablets should not deviate by more than 5.0 % of the Average mass.
    • Disintegration Time: Not More Than 15 Minutes
    • Thickness = 5.0 ± 0.2 mm
    • Length = 17.80 ± 0.05 mm
    • Width  = 7.75 ± 0.05 mm
    • Hardness = 100-200 N
    • Friability                                    : NMT 1.0 %w/w
  • Carry out in-process control /check as per SOP .
    • Step – XII :-Weigh and calculate the final yield of core Tablet.
    • Step – XIII :-Inform to IPQA Department through In-process Analytical Request to collect the sample of tablets for analysis as per approved in process specification.
    • Step -IVX :-After getting quality control approval take line clearance from IPQA, coat the Tablets of step XI as per required  specification
    • Step -XV:- Preparation of coating dispersion –Take total amount of water, purified in S.S container and stir with mechanical stirrer.Add Opadry  Green slowly & stir the dispersion for 45 minutes, avoid lumps formation and pass through 200 mesh nylon cloth and divide into two equal parts by weight.
    • Step -XVI:- Charge the dedusted tablets into coating pan , heat the core tablets bed with filtered warm air to a temperature 35 – 40Rotate the pan at 1.5 – 8 rpm and spray the coating dispersion, continue  with intermittently spraying and drying till required weight build up is achieved. Ensure homogeneity of  the coating solution . Dry the tablets completely.Calculate the percentage weight build up for complete batch.Repeat the procedure for second lot.
  • COATED TABLET SPECIFICATIONS
  • Description : Green coloured,biconvex,film coated tablets scored on one side and plain on other
  • Average mass    : 720 mg
  • Uniformity of mass : Individual weight of 20 tablets should not deviate by more than 5.0 % of the Average mass.
  • Disintegration Time: Not More Than 30 Minutes
  • Thickness = 5.1 ± 0.20 mm
  • Length = 17.80 ± 0.05 mm
  • Width  = 7.75 ± 0.05 mm
  • Step -XVII:-Weigh the coated tablets using calibrated balance and calculated actual yield.
  • Step -XVIII:-Inform to IPQA Department through In-process Analytical Request to collect the sample of tablets for analysis as per approved in process specification.
  • Step -XXIX:-After getting approval from IPQA Department, pack the approved tablets of step-XVII as per  approved BPR .

Critical Process Variables

Stage Equipment

Name

Process Variables Observation

 

Sifting (Lactose Monohydrate,

Silica,ColloidalAnhydrous,

Ornidazole,

Cellulose Microcrystalline)

 Vibrosifter

 

 

 

Sieve size  

 

Integrity of sieves Before
After
Sifting time
Dry mixing RMG

 

 

Running capacity of RMG (%)  

 

Mixer speed  

 

Mixing time  

 

Preparation of Binder solution

 

S.S. Containers

 

Operational capacity of container
Total time taken for preparation of binder solution
Wet Granulation RMG % Occupancy of RMG
Mixer speed
Chopper speed
Effective kneading time
Capacity of RMG
Binder addition time
Amperage load of mixer
Amperage load of chopper
Drying  FBD Inlet air temperature
Outlet air temperature
Bed temperature
Air Velocity
Drying time
LOD of granules (After complete drying)
Sizing Sifter cum multimill

 

 

Screen size
Milling speed
Integrity of screen
Sifting of Post Granulation Ingredients Vibro sifter Sieve Size
Integrity of Sieve
Sifting time
Blending

 

Conta Blender Blender speed
Blending time
Capacity of Blender
Compression 37 station Double rotary compression machine Machine Speed
Feed frame (open/ forced)
Dies and Punches
Preparation of coating solution. Mechanical stirrer Avoid lumps solution
Stirrer Speed
Film Coating Autocoater Spray rate
Spray Pattern
Total coating Time
Inlet air temperature
Bed temperature
Outlet air temperature
Charge size
% weight gain

Representative Sample   :A sample collection from one location / place; representing the  the characteristics of the whole batch / lot.

Composite Sample : A desired amount of sample shall be taken after collection of samples  from different location in one sample bag.

 

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