FDA 21 Part 11 Compliance

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® and THS/PH210® 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 fulfilled.

All events relevant to the THS/PH21® and THS/PH210® Metal Detectors 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 calibration tests using standard test samples or the AUTO-QC function. A proprietary checksum algorithm ensures data integrity and prevents any tampering of the logged data records.

FDA 21 CFR 210 Compliance

The regulations set forth in 21 CFR 210 FDA Standard concern the good manufacturing practice, the methods and the controls to be used for the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety and meets the quality and purity characteristics that it purports or is represented to possess.

The THS/PH21® and THS/PH210® Metal Detector Series are high-sensitivity, high-precision, measuring instruments. The output from the devices directly drives the ejection of the contaminated products while dedicated sensors perform closed-loop verification that they have in fact been eliminated.

In terms of detection of metal contaminants and confinement of the contaminated drugs, CEIA THS/PH21® and THS/PH210® are state-of-the-art solutions with high and consistent performances in time and automatic compensation of all thermal, mechanical and electromagnetic environmental changes.

Validation Solutions Available:

• Calibration Standards
• Validation Manuals
• Comprehensive Service & Support
• Compliance Tools
• On-line Production Data Validation

Compliance exceeding the quality standards

To comply with and exceed the current pharmaceutical Quality Standards CEIA THS 21® and 210® Metal Detector Series provide:

• A fully digital internal structure, free from trimmers to be calibrated, as analog processing has been completely replaced by digital numerical processing;
• An automatic, wide dynamic, antenna balance tracking system to maintain in-range performances in all installation environments;
• A continuous auto-diagnostic system, signaling detected faults in a fraction of a second;
• A continuous embedded AUTOTEST function to lock performances stability and consistency;
• An AUTO-QC function for the automatic verification of the calibration;
• A full FDA Code 21 Part 11 compliant Data Recording and Traceability capability

Continuous AUTOTEST Function

Calibrated reference signals are continuously injected into the transmission and reception chain of the THS/PH21® and THS/PH210® Series Metal Detector, generating corresponding multi-spectrum amplitude and phase changes which are compared with the reference values stored in the memory of the Metal Detector at the time of the FAT (factory acceptance test).

This internal function allows to correct any drift of the emission/reception chain in real-time, providing maximum repeatability and performance consistency over time and with environmental changes. The final result for the User is system stability and consistency in detection performance and product effect neutralization.

AUTO-QC Function

The AUTO-QC function generates automatic stimuli corresponding to the manual metal samples transits, verifying the correct activation of the alarm and of the ejector. The mix of manual and automatic test operations can be programmed in a wide ratio range (from full manual up to one manual to full automatic), depending on the User Quality procedures.

Exclusive Auto-Learn System

The Multi-Point Auto-Learn System provides simultaneous maximum sensitivity to all metals starting from a single learning transit. The THS/PH21® and THS/PH210® Series employ 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.

ISO 9001 Compliance

CEIA THS/PH21® and THS/PH210® Metal Detection Systems are manufactured under CEIA ISO 9001 Certified Quality Management System, ensuring consistent delivery of products and services that meet Customers and Regulatory requirements.THS/PH21® & THS/PH210® productivity and cost savings

• Increased detection sensitivity
• Reduced product waste
• Fewer operator interventions
• Fewer product acquisition procedures
• Line downtime reduction
• Minimization of manual periodic calibration

THS Production 4.0

• CEIA-ERP API interface for communication to the factory management software (Microsoft Dynamics NAV, SAP, ORACLE ERP)
• OPC-UA protocol API for Metal Detector Monitor and Control
• Connection to an External Database and Definition of a Programmable Block of SQL Instructions for each Metal Detector Event
• Compatible with standard SCADA Systems
• E-mail sender for Metal Detector events
• Integrated Web-Server Appliance for real-time monitoring for HMI and touch panel
• Data Inspector Tool for signal and production analysis (enhanced option)
• Early Metal Explosion identification
• Batch management for defective product traceability
• Connects and Acquires Data from Multiple THS Detectors via wired or wireless LAN (requires IXC module for the THS/PH21 series)
• Enables Data Base Management and Back-Up of Metal Detector events
• Report Data Exportable in HTML, CSV and PDF formats
• 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)
• High performance 64-bit database that handles more than 500 millions events

Network communication

The Metal Detector can be linked to an Ethernet network (optional IXC module required for THS/PH21 series).

In association with the THS Production 4.0 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.

MD-Scope software

Software Diagnostic Package complete with connector cable and hardware key:

• Remote programming
• Input/output signals
• Detected and alarm signals
• Oscilloscope functionalities

BT connectivity

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.