Vial filling and stoppering system for aseptic production
Streamline aseptic production by integrating high-speed vial filling and stoppering to ensure precision dosing and contamination control, optimizing your pharmaceutical output.
Fills and Stopper Vials for Injectable Products
The TRUKING Vial Filling and Stoppering Machine is designed to streamline filling and stoppering processes for various injectable products, including vaccines, biologics, and parenteral nutrition solutions. This fully servo-driven system ensures accurate and consistent dosing using advanced volumetric and peristaltic pumps, maintaining dosing precision within ±0.5%–±1%. Engineered for high throughput, it processes up to 24,000 units per hour, accommodating vial sizes from 2 to 100 ml.
This equipment integrates seamlessly into your production line with compact, modular customization options to fit your cleanroom layout, and supports enhanced automation through an industrial PC control system that complies with 21 CFR Part 11 for data integrity and audit trails. The construction in superior SS 316L material ensures no dead angles and facilitates easy cleaning with integrated online CIP/SIP systems.
TRUKING further enhances operational safety by implementing in-house containment solutions up to OEL 5, offering O-RABS, C-RABS, and isolators. Additionally, it features a specialized head space oxygen reduction capability, reducing oxygen levels to 0.5% for oxygen-sensitive products. This machine is fully compliant with GMP, cGMP, and FDA standards, supporting rigorous pharmaceutical and biotech manufacturing environments.
Benefits
- Enhances production efficiency with high-speed processing of up to 24,000 vials per hour.
- Ensures precision and consistency with dosing accuracy maintained within ±0.5%–±1%.
- Optimizes cleanroom space with a compact, modular design tailored to your facility's layout.
- Improves product safety and compliance through robust containment and oxygen reduction features.
- Minimizes contamination risks with efficient CIP/SIP cleaning systems and high-grade material construction.
- Applications
- Lyophilized products,Oral preparations,Bfs (blow-fill-seal) products,Ampoules,Pre-filled syringes,Soft bags,Injectables,Oral liquid formulations,Diagnostic reagents
- End products
- Oral antibiotic suspensions,Biologics,Bfs-packaged eye drops,Vaccines,Cough syrup,Diagnostic test kits,Injectable insulin,Parenteral nutrition solutions,Collagen ampoules,Hormone pre-filled syringes,Sterile pharmaceutical solutions in soft bags,Freeze-dried antibiotics
- Steps before
- Washing,Purification,Concentration,Extraction
- Steps after
- Sterilization,Packing,Inspection,Capping
- Input ingredients
- vials,bulk product,lyophilized substances,liquid pharmaceuticals,diagnostic reagents,containers,ampoules,PFS (pre-filled syringes),bottles,oral liquid formulas,traditional Chinese medicine ingredients
- Output ingredients
- filled vials,aseptic fill-finished products,lyophilized products,softbag products,BFS (blow-fill-seal) products,oral preparations,ampoule productions,pre-filled syringes,sterilized containers,processed traditional Chinese medicines
- Market info
- Truking is known for manufacturing engineered-to-order pharmaceutical equipment, specializing in liquid and solid preparation systems. They have a strong reputation for innovation and quality in the pharmaceutical machinery sector.
- Filling Speed
- Up to 24,000 units per hour
- Application range
- 2 to 100 ml
- Accuracy
- ±0.5% to ±1%
- Containment Level
- OEL 5
- Automation
- Fully Servo Driven
- Data Integrity
- 21 CFR Part 11 compliance
- Dosing System
- Volumetric / Peristaltic pumps
- Product Contact Material
- SS 316L
- Oxygen Reduction
- 0.5% headspace
- CIP/SIP
- Online CIP-SIP with temperature controlled buffer tanks
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- CIP/SIP
- CIP 121°C / SIP 135°C
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Automation and Control
- Fully Servo / PLC and Industrial PC
- In-process control
- 100% statistical control
- Compact footprint design
- Modular Customization
- Containment Levels
- OEL 5,O-RABS,C-RABS,Isolators
- High accuracy dosing system
- ± 0.5%-± 1%
- Head space oxygen reduction
- 0.5%
- Cleaning method
- Online CIP-SIP
- Corrosive resistance (e.g. acids)
- Stainless Steel 316L
- Cleanability
- Designed for CIP/SIP
- Density/particle size
- 0.5–2.5 g/cm³
- Biological compatibility
- FDA compliant materials
- Compact footprint
- Compact ergonomic design
- Machine footprint
- Modular customization to match floor plan
- Contact material
- SS 316L design
- Discharge method
- SOP standard design
- Control panel type
- Industrial PC control with state of art features
- Foot print
- Space-saving design
- Control panel type
- Industrial PC control
- Integration possibilities
- O-RABS,C-RABS,Isolators
- Compact footprint design
- Modular customization
- Head space oxygen reduction
- 0.5%
- Dosing system customization
- Volumetric to Peristaltic pumps
- Containment levels
- Up to OEL 5
- Cleaning method
- Online CIP-SIP
- Temperature controlled buffer tanks
- Automatic