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Benefits
| Features
| Description
System Benefits
Titan Scan's On-Site System provides medical device manufacturers with an in-house solution to sterilization challenges. The system is designed as an in-line or end-of-line sterilization system housed within the manufacturer's facility. In-line application includes sterilization of individual items directly on a production line prior to packaging or inclusion in a kit. End-of-line configuration places the Titan Scan On-Site unit at the end of the production and packaging process and sterilizes the product in its final shipping case configuration.
Overall Best Value -- In-house sterilization eliminates costs associated with the transportation and handling to and from the sterilization contractor as well as the associated reduction in paperwork, staff time, and inventory carrying costs. Labor costs are dramatically reduced for handling, counting, auditing, exception reporting, and disposition connected with the movement of the product in the sterilization process. In addition, same day processing capability of unique or limited life products reduces losses from obsolete inventory. Titan Scan Technologies systems provide a very attractive economic payback.
Just-In-Time Sterilization -- Supply management goals and emergency shipments are easily addressed with the ability to convert goods from raw materials to released sterile goods in the same day. A sterilization lot can be released in as little as 30 minutes after the goods have been processed and the dosimetry results read to confirm the delivered dose. The On-Site System can change over from one sterilization lot to the next within 5 minutes, thus providing maximum flexibility in production scheduling.
New Product Introduction -- New product development and "time-to-market" are greatly facilitated by in-house sterilization capabilities, allowing for high priority testing and product validation to be within the complete control of the manufacturer.
Easy Installation -- The Titan Scan On-Site is literally a go-anywhere system that can be quickly installed in any manufacturing location with minimal facility modifications or improvements. The overall space requirements are less than 750 square feet (70 square meters).
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Safety -- Electron beam is the safest method of sterilization available today for your facility, staff and environment. There are no radioactive isotopes or materials to handle, transport, or store.
System Features
Self Contained -- The Titan Scan On-Site system is delivered to your site fully operational. All that is required for operation is minimal facility interface requirements for ventilation, cooling water, and electrical power making this system portable should your future needs change. Once the facility hookups are in place, the system is ready for validation and use.
Conformal Shielding -- The Titan Scan On-Site system is self-shielded by steel encased lead components that are designed as part of the overall structure of the system Radiation monitors and fail-safe interlocks continually check all operating parameters to ensure the complete safety of the staff and facility.
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Process Integrity -- The Titan Scan On-Site system has been designed from inception exclusively as a medical product sterilization system. The SureTrack® Control Subsystem ensures that the product is accurately controlled throughout the process and provides a validated process interrupt procedure in the event of any system fault, thereby assuring the sterility and protection of your products.
Processing Flexibility -- The Titan Scan On-Site systems is upgradable in power and processing speed capabilities and easily interfaces with upstream and downstream automated packaging, loading, and unloading equipment.
Single or Double Sided Processing -- The Titan Scan On-Site system employs the Titan patented horizontal beam process with a precision controlled process conveyor system. Dependent on product dose configuration requirements, either single or double sided product irradiation processing is available. During double sided processing, the product is automatically rotated 180 degrees without the need for human interaction and without the opportunity for products to shift within the packaging.
Complete System -- This is a complete operating system validated to ISO 11137 regulations and delivered with all required training, documentation, dosimetry system, and process certification.
Service & Support -- The Titan Scan On-Site system has been designed to operate more than 7,400 hours per year utilizing commonly available components and materials. Support services include maintenance programs, inventory supply and service contracts, and process and product validation. Service is provided by Titan Scan Technologies and Varian Associates worldwide.
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Subsystems Description
Performance
- Reliability >95% annual uptime
- 7,400+ hours per year duty cycle
- 24 hours per day operation
- ISO 11137 and EN 552 standards compliance
System Warranty -- twelve (12) month full system warranty provided
Production Throughput
Dose Range
- Nominal range 10 to 50 kGy
- Meets ISO Standards for dose auditing and dose setting
Annual Capacity
- Single Products -- possible multi-million units per year
- Bulk Case -- up to 500,000 cubic feet per year
Technical
Linear Accelerator Subsystem -- An industrial grade RF linear accelerator provides the radiation source for the On-Site System
- Energy 10 MeV
- Power 4 to 6 kW
- Multiple Beam Scan Height -- User Selectable
Material Handling Subsystem -- Products are loaded onto specially designed carriers which are guided through the radiation shield and onto the process conveyor.
- Process conveyor controls product speed through the beam within +0.5% accuracy.
- Programmable Logic Controller (PLC) based real-time control system monitors and controls the flow of products throughout the system.
Safety Subsystem -- A safety control system continually monitors and controls the safety devices and support equipment.
- Hard wired, fail-safe safety alarms, radiation monitors, emergency stops and fire and smoke detection.
- Monitors electrical, ozone ventilation, air handling, and water cooling equipment.
SureTrack® Control Subsystem -- The SureTrack® is the overall information system that manages and coordinates the resources required to process products in conformance with AAMI/ISO and CEN regulations.
- Provides a graphical user interface for ease and simplicity of operator use
- Sequences and controls complex tasks
- Provides real-time error detection and recovery
- Archives the overall processing data
- Manages the flow of data and information
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