PILOT PLANT SCALE UP
PILOT PLANT
SCALE UP FOR CAPSULES
HGC are filled with - dry powder blend / granule mix/pellets
The processed powder blend:
·
Sufficient cohesiveness
·
Particle size distribution
·
Bulk density
·
Compressibility
·
Promote good flow characteristics
·
Formation of compacts of the right size
Capsule
filling methods
Indirect filling
Dosing disk
Dosator
Capsule filling machine – Zanasi
Dosator
Dosator- hollow tube with plunger to eject the capsule plug
Dosator Dosing
tube and Piston
Dosing Disk
Dosing Disk- tamping pins form compacts on the die plate uses
a disk with holes and tamping pins to form a plug
Problems
encountered in scale up
With both the systems the common issues are
• Bulk density
• Powder flow
• Compressibility
• Lubricant distribution
Inadequate
lubrication Ã
Plugs stick to dosator, plunger surfaces / die walls à Weight variation
Over lubrication à Soft plugs will not be
completely transferred to capsule body Ã
Weight variation
Over lubrication à Delays capsule
disintegration and dissolution Ã
Reduced bioavailability
• Size and type of
equipment used in blending, granulating, drying, sizing and lubrication of
capsule granules or powder mixtures
• Environmental
conditions inside the production unit
Environmental
conditions?????
• Humidity has a significant effect on the moisture content
of granules and on empty gelatin capsules
• Problems often occur in encapsulation rooms as humidity is
not adequately controlled
Granulation moisture
content à influences à Chemical and physical
stability of the finished product
Granulation moisture
content à If not controlled à Machine problems of
flow
à Sticking during
material transfer and filling
Empty gelatin
capsules à influences à Storage conditions of
15-25 oC Relative humidity between 35-65%
Empty gelatin
capsules à If not controlled à Changes in physical dimensions
of capsule shells- Problems in filling
Processing room
humidity Ã
influences à between
45-55%
Processing room
humidity Ã
If not controlled Ã
High humidity- capsules swell because of moisture absorption
è
Low humidity- capsules become brittle
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