Quality Control Test For Capsule

Raw Material Testing:

GELATIN
            BLOOM
            VISCOSITY
            MOISTURE
            PH
            ISO IONIC POINT,PH
            PARTICLE SIZE
            SO2 (PPM MAX)
            H2O2
            CLARITY
            MICROBIAL STANDARDS
Water
Fill material – powder
                      Semi solid  
                      Liquids-suspension, emulsion, solutions 

I.P.Q.C:
DURING FILLING

WEIGHT VARIATION TEST
MOISTURE CONTENT
LOCK LENGTH

 Final Product Q.C :
*    PHARMACOPIEAL STANDARDS
            UNIFORMITY OF MASS
            UNIFORMITY OF CONTENT
            DISINTEGRATION TEST
            DISSOLUTION TEST
            MICROBIAL TEST
*    INDUSTRIAL STANDARDS
            DIMENSION
            CAPSULE SHAPE   
            SOLUBILITY            ODOUR

 EQUIPMENT VALIDATION:
EQUIPMENT
COMPONENT
INSTRUMENTED
PARAMETER MEASURED
ZANASI LZ64
PISTON
COMPRESSION FORCE
RENTENTION FORCE
EJECTION FORCE
DRAG FORCE
H & K GKF330
TAMPING PINS
TAMPING FORCE
MACOFOR 13/2
DOSATOR
POWDER BED HOLDER
PISTON SHAFT
PISTON TIP
DOSATOR MOVEMENT
PISTON MOVEMENT
COMPRESSION FORCE
EJECTION FORCE
RADIAL FORCE AT TUBE TIP
mG2
DOSATOR PISTON
PUNCHES
TAMPING PINS
UPPER PUNCH MOVEMENT
LOWER PUNCH MOVEMENT
UPPER PUNCH FORCE
LOWER PUNCH FORCE
PIN MOVEMENT
COMPRESSION FORCE

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