Sterile robotic filling for ready-to-use vials and syringes

Achieve precise and contamination-free filling for biopharmaceutical vials and syringes with this advanced system, ensuring product integrity through seamless isolator integration and versatile container handling.

Fills and Stoppers Sterile Vials and Syringes

The Flex-Line™ from Comecer integrates cutting-edge robotic technology with modular isolator systems to deliver an unparalleled aseptic filling solution. Designed for biopharmaceuticals, vaccines, and advanced therapies, the machine excels in precise filling and stoppering of sterile vials and syringes. It employs a robotic handling system to eliminate glass-to-glass contact and incorporates peristaltic or piston pump fillers based on specific production needs. Capable of seamlessly aligning with existing production lines, Flex-Line™ supports both semi-automatic and automatic operations, catering to capacities of up to 2,500 syringes or 2,000 vials per hour. Its integrated VPHP decontamination and ISO 5/Grade A laminar flow ensure rigorous compliance with cGMP standards. With PLC and HMI controls, the system also offers real-time monitoring, facilitating rapid adjustments and operational efficiency. The compact design is engineered for minimized footprint and maximum precision, reducing contamination risks and enhancing overall productivity of pilot-scale and research production environments. Flex-Line™ not only meets but often exceeds industry benchmarks for quality and safety, offering extensive customization options to adapt to diverse processing requirements.

Benefits

  • Enhances aseptic conditions, minimizing contamination risks in pharmaceutical production.
  • Increases operational efficiency with automation that handles up to 2,500 units per hour.
  • Reduces human intervention, thereby lowering labor costs and manual error.
  • Ensures regulatory compliance with cGMP standards and ISO 5 air quality.
  • Allows flexible production with fast changeovers between different container types and sizes.

General


Applications
Gene therapy products,Liquid formulations,Vaccines,Cell,Pharmaceutical syringes,Biopharmaceuticals,Pharmaceutical vials
End products
Monoclonal antibody vials,Biopharmaceutical suspensions,Pre-filled insulin syringes,Lyophilized drug vials,Gene therapy vector vials,Antiviral pharmaceutical syringes,Sterile injectable vaccines,Cell-based therapy doses,Biologic drug products,Chemotherapy drug vials
Steps before
Decontamination,Aseptic Preparation,Material Loading
Steps after
Stoppering,Check Weighing,Sterilization,Nitrogen Purging,Sealing
Input ingredients
ready-to-use vials,prefilled syringes,nested syringes,nested vials,liquid products,lyophilized products,nests,tubs
Output ingredients
sterile filled vials,sterile prefilled syringes,aseptic vials,aseptic pre-filled syringes
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
Fully automatic or semi-automatic
Capacity
2500 syringes/hour,2000 vials/hour
Filling accuracy
High filling accuracy by peristaltic pump
Filling method
Peristaltic or Volumetric piston pumps
Control System
Panel PC HMI compliant with CFR21 Part11 and Data Integrity
Air Quality
ISO5 / Grade A (EU-GMP)
Compact footprint
Yes
Decontamination system
Integrated VPHP system
Air Flow
Full Laminar Air Flow
Nitrogen purging
Before,After filling
Container type
Nested vials and Pre-filled Syringes
Particle counter
Included
Microbiological sampler
Included
Leak Test
Automatic for Chambers
HEPA Filtration
HEPA H14 absolute filter

Operating Characteristics


Automation level
Fully Automatic / Semi-Automatic
Batch vs. continuous operation
Batch / Semi-Batch
Changeover time
Minimal
Cleaning method
VPHP Decontamination
CIP/SIP
VPHP Sterilization
Energy efficiency
Optimized for minimal human intervention

Material Compatibility


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


CGMP Standards
Compliant
ISO 10648-2
Class 3
ISO 9001
Compliant
ISO 13485
Compliant
ISO 45001
Compliant
ISO 14001
Compliant
ISO 50001
Compliant

Physical Characteristics


Machine footprint
Compact footprint
Control panel type
Panel PC HMI Control System

Custom Options


Control panel type
Panel PC HMI Control System compliant with CFR21 Part11
Integration possibilities
Integrated with isolator
Filling system type
Peristaltic or Volumetric piston pumps
Robotic handling configurations
Multiple possible configurations for different production needs
Decontamination system
Integrated VPHP generator with distribution pipes
Process control and documentation
HMI with SCADA interface available
Sterile Transfer Ports
RTP Rapid Transfer Port or Sterile Liquid Transfer port
Glove Testing
Speedy Glove– Automatic glove tester