Washing machine for pharmaceutical rubber stoppers
Ensure sterile sealing and siliconization in rubber stopper processing with precision-controlled washing and sterilization equipment, vital for maintaining the integrity of injectable pharmaceutical products.
Processes and Sterilizes Rubber Stoppers and Caps
The Drum Type Stopper and Cap Processing Machine from TRUKING Technology is designed to meet the demands of aseptic processing in the pharmaceutical industry. This equipment is tailored for the rigorous cleaning, sterilization, and siliconization of rubber stoppers and caps, crucial in the production of vaccines, pre-filled syringes, and BFS containers. Operating with a high-capacity throughput of over 400,000 units per batch, it ensures efficient and precise processing.
The machine employs advanced vacuum-assisted loading, coupled with automatic transfer and bag making systems, for streamlined operations. Its construction features a high-quality TIG-welded chamber with a mirror-polished finish at an Ra ≤0.4µm, enhancing cleaning efficiency and product integrity. The siliconization process is expertly controlled to deliver a uniform layer, optimizing stopper performance in sealing applications.
Control is managed through an industrial PC system, compliant with 21 CFR Part 11, providing features such as audit trail, data integrity, remote access, and real-time monitoring of critical parameters like temperature and pressure. The equipment is constructed from materials compatible with GMP, cGMP, FDA, and other regulatory requirements, ensuring it meets the highest standards in pharmaceutical processing.
Integrated seamlessly into existing production lines, this machine offers a comprehensive solution for pharmaceutical manufacturers and biotech firms, reducing manual interventions and enhancing operational reliability.
Benefits
- Enhances productivity with automated processing and high-capacity throughput.
- Ensures product safety through compliance with GMP, cGMP, and FDA standards.
- Minimizes contamination risks with precise siliconization and advanced sterilization.
- Reduces operational costs by integrating seamlessly into existing production lines.
- Provides robust data integrity and traceability with advanced industrial PC controls.
- Applications
- Injectable,Oral liquid,Solid preparation,Softbag production,Lyophilization production,Traditional chinese medicine,Bfs production,Pre-filled syringe production,Ampoule production
- End products
- Blow-fill-seal (bfs) containers,Vaccines,Liquid dietary supplements,Tablet and capsule preparations,Biological injectable vials,Intravenous fluid bags,Pre-filled syringes,Freeze-dried pharmaceuticals,Herbal medicine extracts
- Steps before
- Extraction,Concentration,Purification and Separation,Reaction Tank Operation,Crystallization
- Steps after
- Pack sealing,Leakage Testing,Integrity Testing,Secondary Packaging,Inspection
- Input ingredients
- rubber stoppers,aluminum caps,liquid,vacuum,siliconization material
- Output ingredients
- washed stoppers,sterilized stoppers,sterilized caps,siliconized stoppers
- 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.
- Capacity
- 4,00,000+ per batch
- Automation
- Automatic vacuum assisted loading
- Siliconization technique
- Smart Siliconization
- TIG welding
- High quality with mirror polished chamber
- Chamber finish
- Ra ≦0.4µm
- Control System
- Industrial PC control
- Compliance
- 21 CFR Part 11
- Real-time Monitoring
- Temperature and pressure parameters
- Sealing Device
- Unique chamber door with pressure sealing
- Sterile Filter Integrity Testing
- Online sterilization and testing
- Cycle Customization
- Customized product recipes
- Pump Design
- Liquid ring pump with cavity
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP 121°C / SIP 135°C
- Smart Siliconization technique
- Uniform layer application
- Vacuum assisted loading
- Automatic
- Real time monitoring
- Temperature and pressure
- Online sterilization
- Sterile filter integrity testing
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Chamber size
- Accommodates 4,00,000+ stoppers and caps per batch
- Shape
- Vertical-Drum / Horizontal
- Basket
- Designed for maximum load
- Door sealing device
- Unique chamber door sealing
- Polish finish
- Mirror polished at Ra ≦0.4µm
- Feed method
- Automatic vacuum assisted loading
- Discharge method
- Auto transfer or bag making
- Control panel type
- Industrial PC control
- HMI integration possibilities
- Remote access,Audit trail,Data integrity
- Automation level
- Automatic vacuum assisted loading
- Product recipes customization
- Based on cycle requirements
- Siliconization technique
- Smart Siliconization for even layer application
- Chamber door sealing device
- Sealing pressure maintained during power failure
- Sterile filter integrity testing
- Online sterilization and integrity testing