Quality Control Test For Capsule
Raw Material Testing:
I.P.Q.C:
Final Product Q.C :
PHARMACOPIEAL
STANDARDS
INDUSTRIAL
STANDARDS
EQUIPMENT VALIDATION:
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
DURING FILLING
WEIGHT VARIATION TEST
MOISTURE CONTENT
LOCK LENGTHFinal Product Q.C :
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UNIFORMITY
OF MASS
UNIFORMITY
OF CONTENT
DISINTEGRATION
TEST
DISSOLUTION
TEST
MICROBIAL
TEST
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DIMENSION
CAPSULE
SHAPE
SOLUBILITY ODOUREQUIPMENT 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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