Softgel Capsule Pulverizer Machine | GMP-Compliant Fill Material & Shell Separation

The Challenge of Defective Softgel Capsules

Every softgel production line generates a percentage of defective capsules - misshaped shells, weight deviations, seal failures, and cosmetic rejects. For pharmaceutical manufacturers, handling these rejects presents two competing priorities:
• Regulatory compliance: Defective product must be managed under controlled conditions with documented disposition - no uncontrolled rework that could compromise product identity, purity, or quality
• Material value: Rejected capsules contain both expensive active pharmaceutical ingredients (API) - destroying them represents significant raw material loss

Our Softgel Capsule Pulverizer Machine provides a controlled, GMP-aligned method for separating fill material from gelatin shells - allowing both streams to be properly evaluated for qualified reintroduction into production, under your quality system's approved reprocessing procedures.

How the Separation Process Works

Vitol's Softgel Capsule Pulverizer Machine uses a patented cutting and centrifugal filtration system to process defective softgels in three continuous stages - all within a fully enclosed chamber:

Step 1 - Capsule Cutting

Defective capsules are fed through the top hopper into the cutting assembly. Precision blades slice open each capsule, releasing the fill material while shearing the gelatin shell. Blade size is matched to capsule dimensions: small blades for 4–6 mm capsules, standard blades for 6–8 mm capsules, and custom configurations for other sizes.

Step 2 - Centrifugal Filtration & Separation

The mixture of liquid fill and shell fragments enters the centrifugal filtration chamber. Rotating at 960 RPM, the centrifugal force drives liquid fill through the filtration screen, while gelatin shell fragments are retained on the screen surface and conveyed upward. This mechanical separation ensures clean division of the two material streams.

Step 3 - Dual-Point Discharge

The two separated material streams exit through dedicated, physically isolated outlets:
• Upper discharge port: Recovered gelatin shell fragments
• Lower discharge port: Filtered liquid fill material
This separate discharge design eliminates cross-contamination between the two recovered streams - critical for pharmaceutical reprocessing where material identity must be maintained.

Liquid Material Recovery Value

Fill Material Recovery
• Oily fills: ≥90% recovery rate - ideal for lipid-based, vitamin, and oil-solution formulations
• Suspension fills: ~80% recovery rate - for suspended-particle formulations
• Centrifugal filtration produces clean, particle-free recovered liquid
• Recovered fill can be evaluated for reintroduction per approved quality procedures
Directly reduces API and excipient waste costs

GMP Compliance & Hygienic Design

Every aspect of the Softgel Capsule Pulverizer Machine is designed to support cGMP pharmaceutical manufacturing requirements:

Enclosed Processing & Cross-Contamination Prevention

• Fully enclosed processing chamber - internal and external isolation throughout the cycle
• Separate dedicated discharge ports for fill material and gelatin shells - no cross-mixing of recovered streams
• Single-product batch processing - complete product changeover with full cleaning between formulations

Materials of Construction

• SS316L stainless steel for all product-contact surfaces - pharmaceutical-grade corrosion resistance
• Smooth, polished internal surfaces resist product buildup and support cleaning validation
• All materials compatible with typical pharmaceutical cleaning agents and disinfectants

Cleanability & Changeover

• Tool-free disassembly of product-contact components for thorough cleaning
• No dead legs or crevices in the product flow path
• Open access to all wetted surfaces for visual inspection
• Supports cleaning validation protocols required for multi-product facilities

Operational Control

• Simple start/stop operation with consistent process parameters - no operator variability
• Fixed speed and feed conditions ensure reproducible separation performance batch after batch
• Compact footprint fits within standard production room layouts

Applications & Capsule Compatibility

Suitable Capsule Types

Standard oval and oblong softgel capsules
Oily fill formulations (vitamins, lipid-based APIs, essential oils)
Suspension fill formulations (powder-in-oil suspensions)

Capsule Size Range

Capsule Size	Blade Configuration	Availability
4 – 6 mm	Small blade assembly	Standard option
6 – 8 mm	Standard blade assembly	Standard configuration
Other sizes / special shapes	Custom blade design	Available on request

Typical Use Cases

Recovery of misshaped, mis-weight, and seal-defective capsules from production
Reclaim of fill material from stability and QC test samples (per quality procedures)
Processing of start-up and shut-off capsules from encapsulation line changeovers
Recovery of off-spec batches where fill material remains within specification

Technical Specifications

Parameter	Model-SCPM
Processing Capacity	60 kg/hour
Fill Recovery Rate - Oily Formulations	≥ 90%
Fill Recovery Rate - Suspension Formulations	~ 80%
Motor Power	1.1 kW
Separation Speed	960 RPM
Product Contact Material	SS316L stainless steel
Standard Capsule Size	6 – 8 mm (4–6 mm and custom sizes available)
Discharge Points	Dual: upper (shells) + lower (fill liquid)
Diameter × Height	Ø510 × 1,200 mm
Net Weight	80 kg
Electrical Supply	Configurable to local standards

Standard & Optional Configurations

Standard Configuration

• Patented capsule cutting and centrifugal separation mechanism
• SS316L stainless steel product-contact surfaces
• Standard blade assembly for 6–8 mm capsules
• Top feed hopper
• Dual dedicated discharge ports (fill liquid + shell fragments)
• 1.1 kW motor, 960 RPM
• Integrated control panel with start/stop and safety interlock
• Adjustable leveling feet

Optional Upgrades

• Small Blade Assembly: For 4–6 mm capsule sizes
• Custom Blade Design: Engineered for non-standard capsule sizes or special shapes
• Interchangeable Filter Screens: Different mesh sizes for varying fill viscosity and particle content
• Mobile Cart Version: Casters with brakes for flexible positioning between production rooms
• Enclosed Discharge Adapters: Sanitary clamp connections for closed transfer to collection containers
• CIP-Compatible Design: Spray ports and drain configuration for clean-in-place wash cycles

Compliance, Documentation & Support

Regulatory Alignment

• SS316L product-contact materials compatible with FDA 21 CFR Part 211 requirements
• Hygienic design supports EU GMP expectations for pharmaceutical processing equipment
• CE marking available for European market installations
• Material Test Reports (MTR) available for all SS316L product-contact components

Documentation Package

• Operation and maintenance manual
• Electrical schematics
• Spare parts list
• Recommended cleaning procedures
• IQ/OQ documentation available on request for pharmaceutical validation

Service & Support

• 12-month comprehensive warranty
• Installation supervision and operator training available
• Technical support for formulation-specific recovery optimization
• Compatible with all major softgel encapsulation machine brands

Note: Reprocessing of recovered fill material must be performed under your facility's approved quality procedures and in compliance with applicable regulatory requirements. Our equipment provides the mechanical separation capability - final disposition of recovered material is determined by your quality assurance system.

Questions about recovery rates for your specific formulation? Send us your capsule size and fill type, and we'll provide estimated recovery performance and equipment configuration recommendations.

Our Factory

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