Robotic filler for aseptic pharmaceutical production
Streamline your aseptic filling process with high-speed robotic precision, ensuring sterility and versatility for a wide range of pharmaceutical products, from gene therapies to monoclonal antibodies.
Performs Aseptic Filling and Sealing Operations
The Flex-Line Robotic Filler from ATS Life Sciences Group is a state-of-the-art solution engineered for aseptic filling in the pharmaceutical and biotech industries. This robotic filler excels with its seamless integration of Scientific Products’ precision filling with Comecer isolation technologies, ensuring sterility and reliability.
Capable of handling diverse applications such as injectables, biologics, and advanced therapy medicinal products, it produces critical end-products like monoclonal antibodies and mRNA vaccines with precision. Its throughput ranges from 15 to 200 units per minute, accommodating microvials to large parenterals, supported by a robust servo-driven transport system.
Utilizing Stäubli robotics, it maintains high cleanliness and precision, while optional modes minimize material wastage, boosting efficiency and reducing costs. Made from premium stainless steel, it adheres to cGMP, Annex 1, and FDA compliance standards.
Processing integration is simplified with its capacity for upstream de-bagging and downstream operations like labeling, capping, and freeze-drying, all coordinated via a single project management team for streamlined project execution and validation. The equipment supports rapid changeover and customization to meet unique production demands.
Benefits
- Enhances production efficiency with rapid, aseptic filling capabilities.
- Minimizes material waste, supporting cost-effective production.
- Ensures regulatory compliance with cGMP and FDA standards.
- Reduces contamination risk through advanced isolation technologies.
- Simplifies integration into existing lines with convenient modular connectivity.
- Applications
- Maps,Biologics,Protein-based therapeutics,Compounded sterile preparations,Adc,Lyophilized products,Large volume parenterals (lvps),Nutritional formulations,Biosimilars,Small volume parenterals (svps),Biopharmaceuticals,Advanced therapy medicinal products (atmps),Injectable pharmaceuticals,Injectables,Hormones,Gene therapies,Cell therapies
- End products
- Chemotherapy solutions,Stem cell suspensions,Total parenteral nutrition (tpn) bags,Gene therapy vectors,Liposomal doxorubicin,Intravenous antibiotics,Reconstituted lyophilized drugs,Monoclonal antibodies,Covid-19 vaccines,Immunoglobulin preparations,Mrna vaccines,Serum albumin,Vitamin d injections,Insulin injections,Enzyme replacement therapies
- Steps before
- Debagging,Delidding
- Steps after
- Sterilization,Plunger Insertion,Label Insertion,Freeze Drying,Capping,External Vial Washing,Tray Loading
- Input ingredients
- RTU vials,syringes,cartridges,microvials,pre-sterilized vials,Active Pharmaceutical Ingredients (API)
- Output ingredients
- filled vials,filled syringes,filled cartridges,sealed vials,sealed syringes,sealed cartridges
- Market info
- SP Scientific is known for manufacturing high-quality freeze dryers, laboratory thermal control systems, and aseptic processing equipment, catering primarily to the pharmaceutical, biotech, and life sciences sectors with reputation for precision engineering and reliable performance.
- Production Output
- 15–200 units per minute (upm)
- Container Format
- RTU vials,syringes,cartridges
- Material
- Premium stainless steel
- Compliance
- cGMP,Annex 1,21 CFR Part 11,GAMP5
- Robotics
- Stäubli Stericlean
- Filling Nozzles
- Two,five,six,or ten
- Automation
- Siemens or Allen Bradley PLC-controlled
- Gas Flushing
- Available at multiple stages
- Servo Motors
- PLC-controlled
- Isolation Technology
- Comecer
- Decontamination Requirement
- Vaporized Hydrogen Peroxide (VPHP)
- Integration
- Full integration with upstream and downstream machinery
- Container Handling
- Servo-driven robotic transport
- Particle Monitoring System
- Optional
- Vacuum Insertion
- Available for stoppers,tips,and caps
- Working mechanism
- Servo-driven robotic transport
- Integrated steps
- Filling,capping,and stoppering
- Batch vs. continuous operation
- Batch / Continuous
- Automation level
- PLC-controlled
- Changeover time
- Minimal
- Containment integration
- RABs or Isolator
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Control panel type
- HMI
- Material
- Stainless steel AISI-316
- Customization
- Siemens or Allen Bradley PLC-controlled
- Integration possibilities
- Upstream/de-bagging,downstream/cappers
- Control panel type
- Siemens or Allen Bradley PLC
- Compact footprint
- Minimal disruption to existing space
- Discharge method
- Servo-driven robotic transport
- Nozzle configuration
- Two,five,six,or ten filling nozzles
- Container compatibility
- RTU vials,syringes,cartridges
- Environmental control
- Stäubli Stericlean robotics for VPHP decontamination