Superior and Consistent Detection
Enhanced Product Throughput Rate
Preventive Maintenance Not Required
Maximum Configurability / Integration
FDA 21 CFR Part 11 Compliant
Data Security • Data Integrity • Data Traceability
Design and Construction Compliant with FDA Title 21 CFR Parts 210 and 211

Tablets
Capsules
Gel Caps
Powders
Granular
Liquids
Syrups

State-of-the-Art Metal Detection Solution for Compliance with FDA Title 21 CFR 210-211 Requirements

CEIA THS/ PH21 Metal Detection Systems offer detection, construction quality and reliability characteristics that make them the most suitable and effective solution for the automatic elimination of metal contaminants.

FDA 21 Part 11 Compliant

The THS/PH21 Metal Detector Series is a high-sensitivity, high-precision measuring instrument. The device’s response is used to command the ejection of the contaminated product directly and verify that it has 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 Username 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 Control

Continuous embedded self-calibration control for maximum repeatability and performance consistency over time and with environmental changes

Specific signals sent to the metal detector’s transmission and reception chain constantly monitor the detection characteristics, consequently compensating 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 Safety

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 metal detector’s memory at the time of the factory calibration test. This produces an automatic certified check of the system’s sensitivity.

Quality Control Test Samples

We offer samples for quality assurance testing certified in composition, size, and electromagnetic response

New Auto-Learn System

A 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 Tools

The THS/PH21 Series introduces new tools for the installation and maintenance technician to measure the metal detector’s environmental compatibility. Functions that would otherwise have required the intervention of external instrumentation are now implemented in the device’s microcomputer control.

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. In addition, a new organic graphic display with extremely high contrast (13000:1) and a viewing angle up to 180° is included, 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. The operator can program these functions, which maintain the access protection criteria according to FDA Title 21 Part 11 requirements.

Ejection System Specifications

EASE OF MAINTENANCE

Maintenance is fast and does not require using tools to assemble or disassemble the components.

Monolithic AISI 316L Stainless Steel Body
Rapid response time ensures complete safety when ejecting contaminated products.
Advanced mechanical and electronic solutions guarantee the integrity of the inspected product.
The 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® conforms to ISO DN50 and is available as an option.

Bluetooth® 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 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 Capabilities

The THS/PH21 Metal Detector Series can be linked to an Ethernet network [optional module required, part # 571941. 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.

IXC Module Features

Gateway to THS Production Net Management System
Integrated Web-server
Dual 100base-T Ethernet
Dual Full Speed USB interface
Wi-Fi 802.11 b/g
100.000 events internal data logger

MD-SCOPE

Software Diagnostic Package complete with connector cable and hardware key:

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

THS PRODUCTION PLUS

Connects and Acquires Data from Multiple THS Detectors via Ethernet LAN
Provides Connection to an External Database (OLE DB) 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 and CSV format
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)

THS/PH21N

Ultra High Sensitivity Metal Detector

AISI 316L stainless steel construction
Control Power Box available according to UL 508A and CSA-C22.2 No. 14-05
500 product profiles, selectable by local programming or network software
10.000 storable events
High-contrast graphic display
Local programming: 16 stainless steel keys, 3 with double-function
Quick Access key for fast programming of user parameters

THS/PH21E

High Sensitivity Metal Detector

AISI 316L stainless steel construction
Control Power Box available according to UL 508A and CSA-C22.2 No. 14-05
250 product profiles, selectable by local programming or network software
1.000 storable events
4 x 20 character alphanumeric display
Local programming: 4 stainless steel keys, 3 with double function

THS/PH21N-DT & THS/PH21E-DT

Dust Tight Pharmaceutical Metal Detection System

Dust-tight transit pipe and ejection system prevent dispersion of the product.

The transit tunnel and ejection system are completely sealed
Easy integration with tablet press and deduster from the leading manufacturers
Rapid maintenance does not require the employment of tools to assemble and disassemble the components

THS/PH21N-WIP & THS/PH21E-WIP

Wash-in-Place Pharmaceutical Metal Detection System

A special built-in washing system allows the conduit to be cleaned completely after the completion of each production batch.

The transit tunnel and ejection system are completely sealed
Fitted with nozzles for washing water injection and decontamination
Easy integration with tablet press and deduster from the leading manufacturers

THS/PH21N-D25

Specific inspection against tiny metal particle contamination

Unsurpassed Detection
Best Product Quality
Round aperture
Applications:
R&D analysis
Rework confirmation
Root cause analysis assistance
New product specification

Mechanical Data

Integrated Systems for Granular, Liquid and Powder Products

THS/PH21N-FFV & THS/PH21E-FFV

Integrated System for Granular and Powder Products

The ejection system is fitted with an innovative deflector that features quick response, precise ejection of the contaminated product, and a high production flow rate

Ultra High Sensitivity to all metals
Very compact size
AISI 316L stainless steel construction
Control Power Box available according to UL 508A and CSA-C22.2 No. 14-05
ATEX ZONE 21 version (available on demand!)

Dimensions (mm)

THS/FFV 21 series

Large Aperture Integrated System for Granular and Powder Products

A wide range of standard pipe sizes is available to suit all applications
Enhanced product throughput rate
AISI 316L stainless steel construction
Compact size
Fast and efficient: achieve fast ejection speeds and accuracy with the minimum amount of rejected product
Pipe in antistatic material, certified for contact with food products

THS/PLV 21 series

Integrated System for Liquid and Viscous Products

A wide range of standard pipe sizes is available to suit all applications
Full compliance with HACCP criteria
AISI 316L stainless steel construction
Fast-acting reject device for a limited quantity of rejected product
Easy to clean and inspect

For more information, please email us at sales@worldpharmtech.com