Continuous manufacturing for pharmaceuticals

Achieve precision in oral solid dosage production with seamless continuous processes that enhance product uniformity and quality while reducing development time and material usage.

Enables Precise Dosing and Continuous Production

The Xelum Continuous Manufacturing Platform from Syntegon is a transformative solution for the pharmaceutical and nutraceutical industries, offering seamless integration of precise dosing and continuous production for oral solid dosage forms. By leveraging discrete mass dosing, the Xelum platform eliminates the need for traditional scale-up, ensuring high content uniformity even for APIs below 1%. This system is ideal for producing a variety of products such as antibiotic tablets and antiviral capsules, thanks to its robust fluid bed processors that handle granulation and drying in a single chamber, avoiding wet granulate transfer and enhancing reliability. With throughput capacities ranging from 10 to 100 kg/h, Xelum supports rapid production cycles and maintains exact standards in API concentration.

The platform is fully automated, featuring PLC-controlled operations with direct process parameter transfers from R&D to production, allowing for efficient pilot and clinical trials without the constraints of scaling up. It accommodates complex formulations with contained capabilities for OEB4 materials and integrated WIP systems. Xelum’s design prioritizes energy efficiency, reducing production costs while maintaining flexibility for both tablets and capsules. Engineered to meet stringent GMP and FDA standards, it offers a clean-in-place (CIP) system ensuring fast, contamination-free cleaning, perfect for high-potent API development. Customization support allows for tailored configurations to suit specific manufacturing requirements, making Xelum a cornerstone for forward-looking production strategies.

Benefits

  • Streamlines R&D to production transfer, eliminating time-consuming scale-up.
  • Ensures high content uniformity in low API concentrations, enhancing product quality.
  • Minimizes operational costs with reduced energy consumption and efficient process integration.
  • Offers high flexibility with seamless transition between tablet and capsule production.
  • Promotes regulatory compliance with GMP and FDA standards for safe manufacturing.

General


Applications
Nutraceuticals,Granules,Pellets,Oral solid dosage forms,Tablets,Capsules,Pharmaceuticals
End products
Multivitamin pellets,Pain relief capsules,Energy supplement tablets,Calcium supplement granules,Antibiotic tablets,Iron supplement capsules,Probiotic tablets,Antiviral capsules,Chemotherapy granules,Antifungal granules
Steps before
API dosing,Blending,Encapsulation preparation,Granulation preparation
Steps after
Tablet pressing,Capsule filling,Inspection,Packaging
Input ingredients
active pharmaceutical ingredients (APIs),excipients,raw materials,powder,granules
Output ingredients
granules,tablets,capsules,sachets,mini tablets
Market info
Syntegon is known for its expertise in processing and packaging technology, offering innovative solutions for the food and pharmaceutical industries. It has a strong reputation for advanced equipment, sustainability, and customer-oriented service.

Technical Specifications


Accuracy
Precisely dosed less than 1% API
Automation
Automated DoE support
Batch Size
Starting from 250 g
Throughput
10 kg/h to 50-100 kg/h
Continuous Granulation
Up to 30 kg/h
API Concentration Precision
Down to 0.25%
Containment Capabilities
OEB4 with WIP
Scalability
Direct 1
Granulation Yields
High granulation yields
Particle Size Distribution
Unimodal distribution
Cleaning Process
Automated cleaning in one shift
Blending and Granulation
Same machine for both processes
Compression and Encapsulation
Seamless continuous process
Content Uniformity
High content uniformity
Product Quality Control
Easy and reliable quality control
Traceability
Integrated traceability
Footprint Reduction
Up to 50% reduction

Operating Characteristics


Working Mechanism
Continuous direct compression and encapsulation
Integrated Steps
Dosing,mixing,granulation
Automation Level
PLC-controlled with automated DoE support
Batch vs. Continuous Operation
Continuous
CIP/SIP
Integrated WIP (washing in place)
Energy Efficiency
Lower due to minimized losses
Changeover Time
Direct transfer from R,D to production without scale-up

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Control panel type
Automated / User-friendly interface
Discharge method
Continuous / Intermittent

Custom Options


Control panel type
HMI touch screen
Integration possibilities
PLC / SCADA integration
Discharge method
Continuous / Direct
Compact footprint
Yes
Containment capabilities
OEB4 with WIP