Sterilizing and depyrogenization tunnel for ampoules
Ensure sterile and pyrogen-free ampoules with precision control in depyrogenization and sterilization, crucial for maintaining drug safety and efficacy in pharmaceutical production.
Removes Pyrogens and Sterilizes Containers
The TRUKING Depyrogenization Tunnel is an essential solution for aseptic processing needs, leveraging advanced sterilization expertise to ensure optimal pyrogen removal. This cutting-edge tunnel utilizes state-of-the-art sterilization techniques, including a validated pressure differential system to maintain sterile conditions throughout the process. Designed to support biopharmaceutical and pharmaceutical tablet production, it ensures sterile manufacture of products like prefilled syringes, ampoules, and intravenous therapy bags.
Featuring a unique CNC-designed mesh belt and an auto wash-in-place system, it offers automatic cleaning and long-term operational reliability. With precise HEPA filter loading and negative pressure diversion technology, contaminant prevention is guaranteed. The tunnel supports automation and integration through IPC control, enabling audit trails and data integrity features compliant with 21 CFR Part 11.
Engineered for energy efficiency, the tunnel minimizes utility usage while maintaining strict compliance with GAMP, cGMP, and FDA regulations. It comes ready for customization with various material options, suited for diverse chemical processing environments, ensuring long-lasting performance and reducing maintenance downtime.
Benefits
- Ensures pyrogen-free sterile environments, safeguarding product quality and patient safety.
- Reduces utility costs through efficient energy consumption and innovative tunnel design.
- Complies with global regulatory standards, ensuring reliable and market-ready production.
- Minimizes contamination risk with advanced air balancing and negative pressure technologies.
- Streamlines cleaning and maintenance, maximizing operational uptime and reducing labor efforts.
- Applications
- Injectable,Pharmaceutical tablets,Oral liquid,Softbag production,Lyophilization production,Biopharmaceuticals,Diagnostic reagent,Bfs production,Pre-filled syringe production,Ampoule production,Chinese traditional medicine,Oral preparation
- End products
- Anti-cancer drugs,Sterile ampoules,Freeze-dried vaccines,Blow-fill-seal containers,Intravenous therapy bags,Diagnostic test kits,Iv fluids,Liquid cough syrup,Biotech drugs,Prefilled syringes,Herbal medicine extracts,Antibiotics tablets
- Steps before
- Extraction,Purification,Drying,Concentration,Reaction Tank Operation
- Steps after
- Sterilization,Packing,Inspection,Sealing,Leakage Testing
- Input ingredients
- ampoule,vial,soft bag,glass bottle,plastic bottle,biological ingredients,water system
- Output ingredients
- sterilized vials,filled ampoules,packaged soft bags,processed glass bottles,finished plastic bottles,purified biological products,depyrogenated equipment
- 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.
- Pyrogen removal
- Logarithmic reduction
- Pressure differential
- Adequate between zones
- Air auto balancing system
- Ensures laminarity
- Temperature distribution
- Uniform
- Mesh conveyor belt
- Auto wash in place
- Cooling zone SIP
- Standard
- Cooling of blower bearing
- Water cooling
- Automation
- IPC controlled
- Data integrity
- 21 CFR part 11 compliance
- Troubleshooting functions
- Graphical and remote bugging
- Automation level
- IPC / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- Automatic washing system / Auto wash in place
- Tunnel design
- Laminar airflow / Pyrogen removal
- HEPA loading system
- Negative pressure diversion
- Energy efficiency
- Minimum utilities
- Pressure differential maintenance
- Between cleanroom zones
- Temperature control
- Temperature distribution / Water cooling
- Belt type
- CNC design mesh belt
- Control panel type
- IPC (Industrial PC) with Audit trail,data integrity
- Integration possibilities
- Remote bugging functions,SIP,Auto wash in place
- Loading system
- Unique HEPA loading system with negative pressure diversion
- Pressure management
- Adequate pressure differential with cleanroom reference
- Machine design
- Unique flow sharing technology for laminarity
- Mesh belt design
- CNC design ensuring long life
- Cooling features
- Water cooling of blower bearing