A special built-in washing system allows complete cleaning of the conduits after completion of each production batch
FDA 21 Part 11 CompliantThe THS/PH21 Metal Detector Series is a high-sensitivity, highprecision measuring instrument. The response from the device is used to directly command ejection of the contaminated product and to verify that it has in fact been eliminated.
FDA Code Title 21 Part 11 prescribes rigorous criteria for access to programming and computer data protection, which have been fully adopted in the CEIA THS/PH21 Series firmware. User access is only possible via a User Name and Password login under the control of the System Administrator, who programs and manages individual user profiles and user functions. As a result, the requirements for security, integrity and traceability are satisfied.
All events performed by the THS/PH21 Metal Detector are recorded in a data log to comply with FDA Part 11 protocol and assist in root cause analysis. The events include detection, ejection, program operations, passwords and periodic functional test phases using standard test samples.
Validation Solutions Available
- Calibration Standards
- Validation Manuals
- Comprehensive Service & Support
- Compliance Tools
- On-line Production Data Validation
Continuous Embedded Self-Calibration ControlContinuous embedded self-calibration control for maximum repeatability and performance consistency over time and with environmental changes.
By means of specific signals sent to the transmission and reception chain of the Metal Detector, constant monitoring of the detection characteristics is carried out, with consequent constant compensation for any variations caused by environmental factors. The result is system stability and constancy in detection performance and product effect neutralization.
Continuous Auto-Test Function Ensuring Maximum Production SafetySpecial electronic stimuli are sent to the transmission and reception chain of the THS/PH21 Series Metal Detector, causing variations in the detection signals which provide checks on detection characteristics.
These variations are compared with the reference values stored in the memory of the metal detector at the time of the factory calibration test. This produces an automatic certified check of the system’s sensitivity.
New Auto-Learn SystemA new Auto-Learn System provides simultaneous maximum sensitivity to all metals starting from a single learning transit. The THS/PH21 Series employs an exclusive Auto-Learn system for pharmaceutical products, which allows optimization of the detection sensitivity to all metals with the maximum speed and precision, equivalent to hundreds of conventional learning transits. This results in levels of precision and efficiency never before obtained.
New Diagnostic ToolsThe THS/PH21 Series introduces new tools for the installation and maintenance technician to measure the environmental compatibility of the metal detector. These are functions that would otherwise have required the intervention of external instrumentation, now implemented in the microcomputer control of the device itself. The measurements include general mechanical and electromagnetic environmental compatibility.
Modern, Rugged and User Friendly Interface
- Rugged, antivandalic stainless steel keyboard. The THS/PH21 Metal Detector Series maintains full compatibility with programming and parameter selection procedures already implemented in earlier versions of the THS/PH21. In addition, there is a new organic graphic display with extremely high contrast (3000:1) and a viewing angle up to 180°, along with an extended alphanumeric keypad for quick keystrokes.
- Industrial rate design.
- Rapid data entry with extended keyboard.
- Easy to read, high-contrast graphic display.
- Quick access function. A new function, simply activated by pressing a dedicated key, allows the most frequently-used functions to be directly recalled. These functions are programmable by the operator, and maintain the access protection criteria according to FDA Title 21 Part 11 requirements.
Ejection System Specifications
- Monolithic AISI 316L Stainless Steel Body
- Extremely quick response time provides full safety in the ejection of contaminated product
- Advanced mechanical and electronic solutions guarantee the integrity of the inspected product
- Double confirmation system carefully monitors and controls the complete opening and closing of the ejection flap
- Easy assembly and disassembly of the parts in contact with the product: no tools required
- Tri-Clamp® (Tri-Clamp® is a trademark registered by Alfa Laval Inc) conforms to ISO DN50 and is available as an option
Bluetooth® ConnectivityIn the THS/PH21 Series, local connection to the maintenance technician’s computer no longer requires physical access to the interior of the detector or the use of unwieldy connection cables. The Bluetooth connection can be used for programming, monitoring of the signals via the CEIA MD-Scope program and the transfer of the data contained in the Metal Detector’s events memory.
Sophisticated Network Communication CapabilitiesThe THS/PH21 Metal Detector Series can be linked to an Ethernet network (optional module required, part # 57194). In association with the THS Production Plus Software it enables remote management of production, collection of all technical and operational events, generation of statistical and traceability reports in compliance with FDA 21 CFR part 11 requirements.