Thursday, December 30, 2021

In process parameters during tablet/capsule/dry syrup manufacturing at Granulation stage

 Following parameters checked during granulation process 

1. Angle of repose- 

Angle of repose of any solid in pulverized form represent an angle measured in theta, 

Angle of repose = tan-¹(2h/d), unit is degree (°)

Acceptance =

 < 25° = Excellent 

25°-30°= Good

30°-40°= Average 

>40°= Bad 

2. LOD ( Loss on Drying ) 

Test is designed to measure the amount of water and volatile matters in a sample when the sample is dried under specified conditions eg. 100° C for 5 minutes 

Formula 

LOD = Initial weight before drying - final weight after drying / initial weight before drying ×100

3. Compressibility index 

Measure of the propensity of a powder to be Compressed also known as Carr's index 

Formula 

Carr's index = true density - bulk density / bulk density ×100

Acceptance 

<15% = Good flow 

>25% = Poor flow 

15%- 25% = Smooth for compression 

4. Bulk density and tap density 

Bulk density = density of powder in ML ( gm per ml )

Tap density = density of powder in ML after tapping at specified power in specified time.

Instrument used - sieve Shaker ( 20#, 40# ,60#)

eg. 

Blend weight = 50gm

Initial vol. of blend = 74ml 

After 500 tap blend = 64ml

After 750 tap blend = 64ml 

BD = 

50/74= 0.68%

TD=

50/64= 0.78%

Procedure for Calibration of Balances in pharmaceutical industry

 MONTHLY CALIBRATION OF BALANCES 

For monthly Calibration of Balances check following parameters-

1. Accuracy - verify the balance with minimum weight (least count × 100), 5%, 20%, 50%, 90% capacity of respective balance capacity.

Tolerance - the variation if any should be ± least count of the balance or ± 0.2% of certified standard weight used whichever is higher 

 2. Reproducibility - 

Check the reproducibility by using minimum standard weight of balance capacity. Place the weight in the middle of the weighing pan observe the displayed value 

Then calculate the %RSD by following formula 

RSD= SD×100 / X 

Where, 

X= mean of the individual value

Acceptance = %RSD should not be more than 2.0%

3. Eccentricity 

Eccentricity is the difference between the weight placed in centre and at peripheral points of the weighing pan