No. 30 - Glatt

The identification of the main processes, together with a simulation of the
complete process flow, is a good basis for a successful project realization.
Technologies and their flexible interfaces
14
Milling
Classifying
Blending
Wet Mixing
Compacting
Compression
Raw materials
API’s
Identification
Humidity
Quantities
Delivery of
l Excipients
l Functional components
l Active ingredients
Providing for pharma-manufacturing
Weigh-in cycle
Product flow vertical
Handling
horizontal
Packaging
Warehouse / Shipment
Wet Granulation
Drying
Granulating
Coating
Extrusion
Spheronising
Capsule filling
Pellets
Drying
Granulation,
Coating,
Milling
Humidity,
Endpoint of Wetting and Drying
Pellet Agglomeration
Particle Size Control
Particle Size Distribution
(Fluid Bed, Milling)
Fluidization Control
Monitoring against Reference Batch
Blending
Weighing Systems:
Key Factor in Solid Dosage Fabrication
The weigh-in procedure as the first unit operation of the
fabrication process has a substantial influence on . . .
l Product quality
l Productivity
l Process validation
l Operator protection measures
Characteristics
l 1 . . . 10 discharge stations / dosage lines
l 1 dispensing station for active ingredients
l Dispensing inc. documentation generally automated
l Recipe management possible
l high productivity ( 2 . . . 4 bins per hour)
l low cleaning efforts, because of product-dedicated
stations
(regular cleaning only for dispensing of active ingredients)
l high investment costs
l Containment within all levels possible
The new pharmaceutical products will be more complex
and difficult to produce under higher containment requirements
and increased product quality control. The need
to control the quality at all the process steps is essential
for a successful manufacturing. The process equipment,
as well as the material handling equipment must be designed
for the new technologies.
Compressing
Homogenity Hardness,
Compression Rate
Coating
Coating Thickness,
Dissolution Profile
Times No. 30 · December 2010