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High-capacity 500 kg fluid bed processor with Wurster bottom-spray pellet coating, top-spray granulating, and nitrogen closed-loop recovery.
Batch Capacity: 500 kg (Bowl Volume: 1,350 Liters)
The FBG-500 Granulation Suite is our largest fluid bed processing platform, engineered for continuous commercial granulation and Wurster pellet coating. Operating with 500 kg batch capacity, the system features automated through-the-wall product loading and direct vacuum discharge to sizing mills.
| Bowl Volume | 1,350 LSource: SAMPLE datasheet — replace with approved datasheet |
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| Airflow | Up to 8,000 m³/hrSource: SAMPLE datasheet — replace with approved datasheet |
| Working capacity | 40-75% of gross volumeSource: SAMPLE datasheet — replace with approved datasheet |
| Impeller / rotor speed | Variable via VFDSource: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L stainless steelSource: SAMPLE datasheet — replace with approved datasheet |
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| Contact surface finish | ≤ 0.8, mechanically polished µm RaSource: SAMPLE datasheet — replace with approved datasheet |
| Non-contact structure | AISI 304, bead-blasted satin finishSource: SAMPLE datasheet — replace with approved datasheet |
| Elastomers | Silicone / EPDM to FDA 21 CFR 177.2600 and USP Class VISource: SAMPLE datasheet — replace with approved datasheet |
| Steam Rating | 350 kg/hr @ 4 barSource: SAMPLE datasheet — replace with approved datasheet |
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| Blower Power | 37 kWSource: SAMPLE datasheet — replace with approved datasheet |
| Chilled water | 20 L/min at 7-10 °C for jacket coolingSource: SAMPLE datasheet — replace with approved datasheet |
| Supply voltage | 415 V ±10%, 3-phase + N + PE, 50 Hz (60 Hz option)Source: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 4,400 × 2,000 × 3,000 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 6,400 kgSource: SAMPLE datasheet — replace with approved datasheet |
| Service clearance | 1,000 mm on operator and maintenance sidesSource: SAMPLE datasheet — replace with approved datasheet |
| Noise level | < 78 dB(A) at 1 mSource: SAMPLE datasheet — replace with approved datasheet |
* Specifications may vary by model. Contact us for exact configuration.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Evidence: ISO 9001:2015 Quality Management System Certificate (PDF · 2 KB)World Health Organization guidance on good manufacturing practice, widely used as the reference for export markets and WHO prequalification.
United States current Good Manufacturing Practice regulation for finished pharmaceuticals, including equipment design, cleaning and maintenance requirements (21 CFR 211.63 and 211.67).
US regulation setting the controls under which electronic records and signatures are considered trustworthy and equivalent to paper records.
Evidence: Computerised System Validation & 21 CFR Part 11 Assessment Template (on request)Industry guidance for a risk-based approach to validating GxP computerised systems, used to scope the CSV deliverables supplied with the machine.
EU directive and international certification scheme for equipment intended for use in potentially explosive atmospheres, including solvent vapour and combustible dust zones.
All configurations
Confirms that the FBG-500 design, as specified, meets the user requirement specification before manufacture begins.
GMP configurations
Documents that the machine is installed to drawing, connected to the specified utilities and calibrated.
GMP configurations
Challenges the machine across its operating ranges, alarms and interlocks to show it performs as specified.
Customer-executed; product-specific acceptance criteria
Executed by the customer with our support: three consecutive batches with granule size distribution, loss on drying and blend uniformity within limits.
All configurations; customer witnessing optional
Witnessed at our works before dispatch, so defects are corrected where the parts, tools and engineers are.
All configurations
Repeats the critical FAT checks at the customer site after installation and utility connection.
Machines with the PLC/HMI control package
Validation of the PLC/HMI control system to GAMP 5, including the 21 CFR Part 11 controls for electronic records.
| Model | StandardFBG-500 Aqueous | FBG-500 Flameproof | FBG-500 CIP |
|---|---|---|---|
| Output | Batch Capacity: 500 kg (Bowl Volume: 1,350 Liters) | Batch Capacity: 500 kg (Bowl Volume: 1,350 Liters) | Batch Capacity: 500 kg (Bowl Volume: 1,350 Liters) |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | Ex-rated PLC panel outside the hazardous zone, intrinsically safe field devices | PLC with integrated CIP recipes and cycle records |
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| Notes | Not specified | Required for solvent granulation; cannot be retrofitted to a standard build. | Not specified |
| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
|---|---|---|---|---|---|
| Impeller shaft seal kit | GP-GR-IMPS-FBG500-01 | Service kit | 2 kits | 12 months | 4 weeks |
| Chopper blade set | GP-GR-CHOP-FBG500-02 | Wear part | 1 set | 12 months | 4 weeks |
| Filter bag set | GP-GR-FBAG-FBG500-03 | Consumable | 2 sets | 6 months | 2 weeks |
| Sizing screen, round hole | GP-GR-SCRN-FBG500-04 | Change part | 1 per aperture | Per wear inspection | 3 weeks |
| Discharge valve gasket | GP-GR-DVGS-FBG500-05 | Wear part | 2 nos | 6 months | 2 weeks |
| Temperature transmitter (PT100) | GP-GR-PT10-FBG500-06 | Electrical | 1 no | On failure | 2 weeks |
Models, typical specification, utilities and materials of construction for the granulation & blending range. Sample content for staging; replace with the approved controlled document before go-live.
Front elevation and plan view with overall dimensions, service clearances and the utility connection schedule. Sample content for staging; replace with the approved controlled document before go-live.
Safety, installation, operation, cleaning, preventive maintenance and troubleshooting for the granulation & blending range. Sample content for staging; replace with the approved controlled document before go-live.
Protocol structure, prerequisites, test case tables and acceptance criteria for installation and operational qualification. Sample content for staging; replace with the approved controlled document before go-live.
Document review, mechanical, electrical, functional and performance checks witnessed at our works before dispatch. Sample content for staging; replace with the approved controlled document before go-live.
Installation verification, utility connection, re-test of critical FAT items and production trial at the customer site. Sample content for staging; replace with the approved controlled document before go-live.
GAMP 5 categorisation, 21 CFR Part 11 controls checklist, audit trail review and user access matrix for PLC/HMI control systems. Sample content for staging; replace with the approved controlled document before go-live.
Overview of the full range: capsule filling, tablet compression, blister packing, granulation, coating, washing, liquid filling and utilities. Sample content for staging; replace with the approved controlled document before go-live.
Checklist for DQ, IQ, OQ and PQ of solid oral dosage equipment, including surface finish, calibration and cleaning checks. Sample content for staging; replace with the approved controlled document before go-live.
Guide to electronic records, electronic signatures, audit trails and access control on machine control systems. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
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