High quality sterile filling system

Experience unparalleled precision in aseptic filling with this advanced system, designed to enhance sterility, reduce manual intervention, and optimize high-speed operations across multiple product types like vials, syringes, and bags, ensuring seamless integration into your processing line.

Fills, Assembles, and Sterilizes Pharmaceutical Products

The SuperTrak PHARMA8™ from Comecer and ATS is an engineered-to-order sterile filling and aseptic isolator system that stands out for its integration of advanced asynchronous linear motion technology. This system excels in aseptic filling and assembly, efficiently processing pharmaceutical vials, prefilled syringes, IV infusion bags, and more, while complying with cGMP, FDA, CE, and UL standards. Utilizing a state-of-the-art isolator with Grade A air quality, it reduces particle generation and eliminates manual intervention, achieving speeds up to 2.5 m/s. Its automation level includes minimized moving parts to enhance reliability and energy efficiency. The system’s versatility supports a wide range of applications across industries like pharmaceuticals, biotech, radiopharma, and cell and gene therapy, making it an ideal choice for high-speed, continuous manufacturing. Comprehensive engineering support ensures seamless integration and customization, meeting the specific production line requirements of pharmaceutical manufacturers and related sectors.

Benefits

  • Ensures product sterility and operator safety with integrated aseptic isolator.
  • Cuts operational costs by minimizing manual intervention through automated processes.
  • Increases production speed with asynchronous conveyance technology yielding up to 2.5 m/s.
  • Complies with stringent regulatory standards, guaranteeing legal manufacturing practices.
  • Adapts to diverse pharmaceutical applications, enhancing production line flexibility.

General


Applications
Syringes,Vials,Combination products,Ampules,Dry powder processing,Cartridges,Pills,Bags
End products
Vitamin pills,Drug-device combination kits,Glass ampoules,Cartridge injectors,Pharmaceutical vials,Prefilled syringes,Iv infusion bags,Antibiotic dry powder
Steps before
Emulsification,Purification,Drying,Grinding
Steps after
Sterilization,Packing,Coating
Input ingredients
vials,syringes,bags,cartridges,combination products,ampules,dry powder,pills
Output ingredients
sterile filled vials,sterile filled syringes,sterile filled bags,sterile filled cartridges,sterile filled combination products,sterile filled ampules,packaged dry powder,packaged pills
Market info
Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.

Technical Specifications


Automation
Automated manufacturing
Speed
Up to 2.5 m/s (8.2 ft/s)
Acceleration
Up to 30 m/s²
Filling Purpose
Sterile filling of vials,syringes,bags,cartridges,combination products,ampules,dry powder processing,pills
Air Quality Compliance
Grade A in Operation (EEC-cGMP conforms)
Particle Generation
Reduced due to minimal moving components
Conveyor Type
Asynchronous sterile filling system
Airflow
Laminar airflow over the entire area

Operating Characteristics


Batch vs. continuous operation
Batch / Inline Continuous
Automation level
PLC / SCADA
CIP/SIP
CIP 121°C / SIP 135°C
Cleaning method
CIP / Manual
Energy efficiency
0.5–2 kWh/kg moisture
Working mechanism
Asynchronous conveyance,linear motion technology
Integrated steps
Ready-to-mix filling and assembly
Compliance with grade
Air quality Grade A in Operation (EEC-cGMP)

Material Compatibility


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


GMP Compliance
cGMP
FDA Compliance
Yes
CE Marking
Yes
UL Certification
Yes

Physical Characteristics


Machine Footprint
Compact
System Type
Asynchronous filling system