Sterilization and drying tunnel for glass bottles
Ensure aseptic integrity and regulatory compliance in injectable product lines with optimized pyrogen removal and validated sterilization intervals, crucial for maintaining product safety and efficacy.
Removes Pyrogens and Sterilizes Aseptic Products
The TRUKING Depyrogenization Tunnel is engineered to elevate aseptic fill finish lines for pharmaceutical and biotech industries. This equipment excels in pyrogen removal via advanced tunnel design, maintaining consistent pressure differentials in relation to cleanroom standards. Its unique CNC-designed mesh belt ensures longevity and efficient auto-cleaning, employing a state-of-the-art auto wash-in-place feature.
The tunnel is pivotal for producing vaccines, insulin, monoclonal antibodies, and more by providing a sterilized and depyrogenized environment integral to injectable and oral liquid formulations. It incorporates PLC controls under 21 CFR part 11 compliance, facilitating audit trails and data integrity.
Designed for energy efficiency, the tunnel optimizes utility usage and is available with HEPA filtration to prevent contamination. Compliance with cGMP and FDA standards assures users of its adherence to necessary regulations. Customization options are supported by TRUKING’s expert engineering team for tailored operational requirements.
Benefits
- Enhances product safety by consistently achieving effective pyrogen removal.
- Reduces cleaning time with an automated wash-in-place system.
- Ensures regulatory compliance with cGMP and FDA standards, safeguarding production quality.
- Minimizes operational expenses through optimized energy and utility consumption.
- Prevents contamination with advanced HEPA filtration systems.
- Applications
- Lyophilization products,Injectable,Biopharmaceuticals,Traditional chinese medicine,Oral liquid formulations,Aseptic fill finish lines,Diagnostic reagents,Pharmaceuticals
- End products
- Vaccines,Infusion solutions,Insulin,Monoclonal antibodies,Cough syrup,Pre-filled syringes,Antiviral tablets,Diagnostic kits,Herbal extracts,Freeze-dried plasma
- Steps before
- Washing,Pre-washing,Depyrogenization
- Steps after
- Sterilization,Filling,Stoppering,Capping
- Input ingredients
- glass bottles,plastic bottles,soft bags,ampoules,vials,diagnostic reagents,oral liquids,traditional Chinese medicine materials,injectables
- Output ingredients
- sterilized containers,lyophilized products,pre-filled syringes,BFS products,softbags,oral preparations,filled and sealed ampoules,depyrogenized glass bottles,processed Chinese medicine
- 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 time
- Shortest possible
- Pressure differential
- Adequate between zones
- Air auto balancing system
- Excellent design
- Temperature distribution
- Ensured laminarity
- Mesh belt type
- CNC design
- Mesh belt feature
- Auto wash in place
- Cooling zone SIP
- State of art
- Cooling method of blower bearing
- Unique water cooling
- Control system
- IPC
- Audit trail compliance
- 21 CFR part 11
- Troubleshooting feature
- Graphical
- Remote bugging function
- Standard
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Tunnel design
- State of art
- Conveyor belt
- CNC mesh belt with auto wash
- HEPA loading system
- Unique negative pressure diversion
- Airflow system
- Laminarity ensured
- Cooling system
- Unique water cooling of blower bearing
- Control panel type
- IPC (Industrial PC) Control
- HMI type
- Graphical interface with troubleshooting
- Integration possibilities
- GAMP,cGMP,FDA Compliance
- Cleaning method
- Auto wash in place
- Pressure management
- Pressure differential maintenance