PHARMACEUTICAL FLUIDIZED BED GRANULATOR

DRYING, GRANULATION, COATING

PHARMACEUTICAL FLUIDIZED BED GRANULATOR

DRYING, GRANULATION, COATING

Fluidized Bed Granulator (also called Fluid Bed Granulator) designed for 3 different pharmaceutical processes:
■ Drying of wet granulate (dryer).
■ Granulation by top spraying (granulator).
■ Coating by bottom or tangential spraying (coater).

Innovative high-quality equipment certified by accredited entities.
Fully designed and built in Europe following regulatory requirements and GMP´s normative.

STE TECPHARM offers all range of services: installation “turnkey concept” in the client facilities, start-up, qualification, training, and production support.

FLUIDIZED BED GRANULATOR

MAIN FEATURES

■ From 30 L to 1.540 L. [Other dimensions on request].
■ In-wall design concept.
■ Built in AISI 316L, mirror polished Ra < 0,5.
■ Granulation by top spray system.
■ PCL + HMI in manual and automatic mode, with recipe editing.
■ 12 bar pressure-shock resistance.

EXPANSOR

■ Load valve to charge product by lance.
■ Sigh glass to see the internal process.
■ WIP washing lance and top spray housings.
■ Clamp connection for temperature probe.
■ LED iluminator.
■ Cleaning spray balls.

PRODUCT CONTAINER

■ Mobile container with 4 anti-static wheels and shock protection.
■ Double inflatable joint to ensure tightness.
■ Side valve for automatic loading from the high shear mixer granulator.
■ Clamp connection for temperature probe.
■ Sampling point for process control.
■ Longitudinal sigh glass to see the product process.
■ Container bottom with mesh of perforated plate (configurable).
■ Discharge valve.

INTERNAL FILTRATION

■ Mobile filter plate with motorized lift.
■ Peripheral inflatable joint to guarantee the tighness, with pneumatic connection.
■ Filters with quick change system without tools.
■ Cartridge or bag filters with cage (configurable).
■ Filter cleaning sectorized blown with countercurrent pharmaceutical compressd air.
■ Cleaning spray balls included.

OPTIONALS

■ Coating of micro granules by bottom spray system.
■ ATEX version.
■ Automatic cleaning system (WIP).
■ Dry conic mill.
■ Automatic loadind and discharge.
■ 21CFR part 11 compliance module: Batch report & Audit Trail.
■ Containment execution (OEB 5).
■ Bag-in bag-out system in outlet AHU, for high potency products.

PERIPHERALS

INLET AIR HANDLING UNIT (AHU)
■ Prefiltration stage G4 and F9.
■ Dehumidification unit by cold water.
■ Heating unit with steam battery or electric heaters.
■ HEPA 13 absolute filtration.
■ Inlet security valve 12 bars.

EXHAUST AIR TREATMENT (AHU or Dust Collector)
■ Prefiltration.
■ HEPA 13 absolute filtration.
■ Exhaust security valve 12 bars.

CENTRAL WIP UNIT
■ Cleaning fluids preparation skid.
■ Heat-insulated tank.
■ Plate heat exchanger.
■ Detergent tanks with dosing pumps.
■ Drive pumps.

CODE DESIGN AND CERTIFICATIONS

■ GMP, EHEDG and FDA validated.
■ Design according to ASME, DIN and EN (EN 12445:2015 and EN 13445).
■ Accordance with the VMP of our customers.
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

The top spray allows to carry out the granulation process in the Fluidized Bed Dryer Granulator.

The movement of the powder in a fluidized state is combined with the spraying of a binder solution. This combination allows increasing the particle sizing, generating a granulate.

In the Fluidized Bed Dryer, the drying process is carried out to reduce the humidity in the granule.

Hot air is introduced through a vacuum generated inside the equipment. The wet solids rise from the bottom and are suspended in a current of air, remaining in a fluidized state.

The heat transfer and the low humidity of the air in direct contact with the wet granule allow the evaporation of the water or solvents, reducing their humidity.

The coating process in the Fluidized Bed Dryer Coater is carried out by combining the spraying of the coating suspension on the microgranules in a fluid bed movement.

Spraying is done from the bottom and can be:
■ Vertical through tubular (wurster system).
■ Tangential rotation (tangential spray).