FDA 21 Part 11 Compliant

The THS/PH21 Metal Detector Series is a high-sensitivity, high-precision 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.

Real-time embedded self-calibration control

The Self-Calibration control allows 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.

Exclusive auto-learn system

The 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.

Continuous auto-test function

Special 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.

CEIA automatic calibration test

To comply with the daily Metal detection and ejection verification requirements, the CEIA Metal Detectors THS 21 Seriesprovide:

• A full digital internal structure, completely free from internal trimmers to be calibrated, as the analog processing has been replaced by digital numerical analysis.
• An automatic, wide dynamics, antenna balance tracking system to maintain in-range performances in all installation environments.
• A continuous embedded Self-Calibration control.
• A continuous Auto-Test function which generates stimuli corresponding to the manual metal samples transits.
• A calibration test in automatic mode. During the automatic test, the Metal Detector generates a stimulus equivalent to the same excitation signal of the last manual test, verifying the correct activation of the alarm and the ejector. All test results are recorded into the Events buffer and are available for data traceability. The THS 21 Series provides the possibility to determine and program the mix of manual and automatic test operation in a wide ratio range, depending on the User Quality procedures, through the MTI parameter.

Increases in productivity and cost savings

• Increased detection sensitivity
• Reduced product waste
• Fewer operator interventions
• Fewer product acquisition procedures
• Reduction in line stoppages
• No periodic calibration

Modern, rugged and user friendly interface

• Industrial rate design
• Rapid data entry with extended keyboard
• Easy to read, high-contrast graphic display
• Rugged, antivandalic stainless steel keyboard. Organic graph display with extremely high contrast (3000:1) and a viewing angle up to 180°, and an extended alphanumeric keypad for quick keystrokes.
• Protection degree: Power Supply Box: IP65 (IEC60529); Antenna & Ejection System: IP67
• 40 users available (including administrator)
• Quick access function. A new function, activated simply by pressing a dedicated key, allows the most frequently-used functions to be directly recalled. These functions are programmable by the operator.

Ejection system specifications

• Monolithic AISI 316L Stainless Steel Body
• Advanced mechanical and electronic solutions guarantee the integrity of the inspected product
• Extremely quick response time provides full safety in the ejection of contaminated product
• Double confirmation system carefully monitors and controls the complete opening and closing of the ejection flap
• Bin full sensor kit (on request)

BT Connectivity

In 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 BT 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.

THS Production Plus

THS Production Plus software provides acquisition and report capability for the THS Metal Detector.

• Connects and Acquires Data from Multiple THS Detectors via Ethernet LAN
• Provides Connection to an External Database and Definition of a Programmable Block of SQL Instructions for each Metal Detector Event
• Enables Data Base Management and Back-Up of Metal Detector events
• Report Data Exportable in HTML, CSV format and PDF
• Provides User Authentication and Manages Electronic Signatures and Records
• Allows Data Integrity and Operator Auditing
• FDA Requirements Compliant, Title 21 of the Code of Federal Regulations (CFR)
• E-mail sender
• OPC-UA protocol API for Metal Detector Monitor and Control
• High performance 64-bit database that handles more than 500 millions events
• Compatible with standard SCADA Systems
• Integrated Web-Server Appliance for real-time monitoring for HMI and touch panel
• CEIA-ERP API interface for communication to the factory management software
• Batch management
• Data Inspector Tool for signal and product analysis (optional)

MD-SCOPE

Software Diagnostic Package complete with connector cable and hardware key:

• Remote programming
• Signal input/output
• Alarm threshold and amplitude of the signal
• Oscilloscope functionalities

Network communication capabilities

The Metal Detector can be linked to an Ethernet network (optional IXC module required).

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.