Superheated water sterilizer for pharmaceutical applications
Ensure precise sterilization with real-time monitoring and state-of-the-art process control, crucial for pharmaceutical production lines needing compliance with regulatory benchmarks like 21CFR Part 11.
Sterilizes Pharmaceutical and Biopharmaceutical Products
The industrial autoclave from TRUKING Technology Limited excels in providing reliable sterilization for pharmaceutical and biopharmaceutical products, ensuring compliance with GMP and FDA standards. This autoclave features real-time F0 value processing, utilizing pressure and temperature data to maintain precise sterilization conditions. Its innovative jacketed chamber design accelerates cooling through PID programming, optimizing energy consumption and maintenance accessibility.
This equipment is engineered to handle a diverse range of products, such as vaccines, lyophilized antibiotics, and traditional herbal extracts. With its automated, continuous operation, the autoclave integrates seamlessly into high-speed production lines. It offers an industrial PC control system, ensuring data integrity and remote access, compliant with 21CFR Part 11.
Manufactured with advanced TIG welding and a mirror-finish chamber, the autoclave resists corrosion and supports various material options for enhanced chemical compatibility. The integrated online sterilization and integrity testing of sterile filters, alongside its unique chamber door sealing for pressure retention, make it a robust choice for high-stakes pharmaceutical manufacturing. TRUKING provides customization options and engineering support to tailor the autoclave to specific production requirements.
Benefits
- Ensures product safety and compliance with precise sterilization control.
- Reduces cooling time and energy use with innovative chamber design.
- Facilitates seamless integration into automated production lines.
- Enhances data security and traceability with 21CFR Part 11 compliance.
- Offers material versatility to withstand aggressive processing conditions.
- Applications
- Injectable products,Chinese traditional medicine,Lyophilized products,Soft bag containers,Ampoules,Biopharmaceuticals,Pre-filled syringes,Oral liquid formulations,Bfs containers,Pharmaceuticals
- End products
- Prefilled insulin syringes,Infusion soft bags,Vaccines,Freeze-dried vaccines,Ginseng extract formulations,Bfs saline solution,Insulin,Liquid herbal extracts,Antibiotics,Monoclonal antibodies,Cough syrups,Vitamin c ampoules,Iv fluids,Lyophilized antibiotics,Prefilled heparin syringes,Oral suspensions,Bfs eye drops
- Steps before
- Purification,Drying,Concentration,Extraction
- Steps after
- Sterilization,Packing,Inspection,Leakage Testing
- Input ingredients
- raw materials,glass ampoules,vials,soft bags,plastic bottles,glass bottles,pre-filled syringes,bioengineering components,diagnostic reagents
- Output ingredients
- sterile products,sterilized containers,lyophilized products,sealed ampoules,filled vials,packaged pharmaceuticals,treated oral liquid medicines,sterilized BFS products,purified solutions
- 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.
- Precision
- Real time F0 value processing
- Design
- Jacketed chamber
- Utility Consumption
- Efficient modular design
- Welding Technology
- Advanced TIG welding
- Chamber Finish
- Mirror finish at Ra 0.5um
- Sealing Device
- Unique chamber door sealing
- Control
- Industrial PC control
- Compliance
- 21CFR Part 11
- Audit Trail
- Available
- Sterilization Cycle Monitoring
- Online,real time feedback
- Sterile Filter Testing
- Online sterilization and integrity
- Real-time monitoring
- Temperature and pressure parameters
- Process control
- Online sterilization cycle feedback
- Cooling mechanism
- Jacketed chamber design with PID program
- Automation level
- Industrial PC control with remote access
- Batch vs. continuous operation
- Batch
- Pressure relief
- Air partition with steam pressure relief outlet
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine footprint
- Compact
- Chamber Design
- Jacketed
- Chamber Finish
- Mirror finish at Ra 0.5um
- Door Sealing Device
- Unique chamber door sealing
- Control Panel Type
- Industrial PC Control
- Cooling Method
- Pumping system for faster cooling
- Control panel type
- Industrial PC control
- Integration possibilities
- GAMP,cGMP,FDA compliance
- Cycle monitoring
- Real-time feedback
- Cooling design
- PID program-controlled
- Jacketed chamber design
- For faster cooling
- Door sealing device
- Pressure maintenance during power failure
- Data control
- Audit trail,data integrity,21CFR Part 11 compliance