THS/PH21N-FB Detection of very tiny metal particles on tablets with automatic rejection

• Ultra high sensitivity to all magnetic and non-magnetic metals, including stainless steel
  
• AISI 316L stainless steel construction
• Integrated controls for line speed and rejection
• High immunity to environmental interference
• Automatic learning & tracking of product effect
• AUTOTEST function
• AUTO-QC function
• Easy to maintain and inspect
• Digitally adjustable belt speed
• Automatic ejection management with synchronization of the product transit
• Verification of the successful ejection of the contaminated product

Applications: effervescent tablets

Flat conveyor inspection system

• Integrated controls for line speed and rejection
• High immunity to environmental interference
• Automatic learning & tracking of product effect
• Easy to maintain and inspect
• Digitally adjustable belt speed
• Automatic ejection management with synchronization of the product transit
• Verification of the successful ejection of the contaminated product

CEIA THS/PH21 and THS/PH210 Metal Detection Systems offer design, construction and reliability characteristics that make them the most effective solution for the automatic elimination of metal contaminants. These systems are compliant with the applicable parts of the 21 PART 11 and 21 CFR 210 FDA Standards and deliver advanced control features and extremely high detection sensitivity for metal contaminants - whether ferrous, non-ferrous, or stainless steel - on pharmaceutical products such as powders, capsules, tablets, and liquids.

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

 Download Brochure of pharmaceutical metal detector CEIA THS/PH21NFB