Die Systeme CEIA THS/PH21N bieten selbst beim Vorkommen einer geringen Menge eine ausgesprochen hohe Erfassungsempfindlichkeit gegenüber der verunreinigenden eisenhaltigen und nicht-eisenhaltigen und Edelstahl-Metalle
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.
Antistatische einlaufrutsche - Set
Dieses Set unterbindet elektrostatische Aufladung während des Produktdurchlaufs. Besonders effizient ist diese Einlaufrutsche bei der Detektion von Tabletten und Kapseln.
Produktcode: 90x25 Part #60214
100x40 Part #64270
Antistatische einlaufrutsche – Set für Dust Tight (DT) Ausführung
Staubdichte Einlaufrutsche, die elektrostatische Aufladung während des Produktdurchlaufs verhindert. Besonders effizient ist diese Einlaufrutsche bei der Detektion von Tabletten und Kapseln.
Produktcode: 100x40 Part #68105
Antistatische einlaufrutsche – Set für Wash In Place (WIP) Ausführung
WIP-Einlaufrutsche, die elektrostatische Aufladung während des Produktdurchlaufs verhindert. Besonders effizient ist diese Einlaufrutsche bei der Detektion von Tabletten und Kapseln.
Produktcode: 100x40 Part #70744
EtherNet/IP FIELD BUS FUNCTION
IXC-Karte mit internem USB-anschluss
Zusätzliche Karte, die dem Metalldetektor die Einbindung in ein Netzwerk ermöglicht. Zudem bietet sie Ethernet oder WLAN sowie eine USB-Schnittstelle. Die Karte verfügt über einen internen Speicher für die Ablage von bis zu 100.000 Ereignissen.
Produktcode: Part #57194
Set für externen USB-anschluss
Set zum anbringen des USB-Anschlusses der IXC-Karte außerhalb des Schaltschranks.
Produktcode: Part #55613
Testobjekte zur Qualitätskontrolle
TSDU (Test Sample Distributor Unit) Prüfkörper-Verteilsystem – Set für Dust Tight (DT) Ausführung
Durch die Installation des Sets bei einem Metalldetektor vom Typ THS/PH21, der mit einer doppelten Auswurfeinheit ausgestattet ist, kann ein Test mit zertifizierten Prüfkörpern im normalen Betrieb durchgeführt werden, ohne den Produktfluss zu stören. Inbegriffen sind neun Prüfkörper pro TSDU (3x Eisen / 3x Nichteisen / 3x AISI316).
Produktcode: Part #87150
MD-SCOPE
Technische Software, welche es dem Bediener ermöglicht, eine Diagnose des CEIA-Metalldetektors während der Installation und Wartung durchzuführen. Im Lieferumfang enthalten ist ein Handbuch, ein Anschlusskabel sowie ein USB-Stick.
Produktcode: Part #MD-SCOPE2
Rejected Product Containers
- 500 ml - STANDARD
- 950 ml - STANDARD
Rejected Product Containers
- 500 ml - TRICLAMP/DT/WIP
- 950 ml - TRICLAMP/DT/WIP
Technische Dokumentation (Digital Document)
Technische Dokumente, die über einen Link von CEIA heruntergeladen werden können.
Produktcode: Part #90674
THS Produktion Software
Vorraussetzung: IXC Karte
Software für ein separates und übersichtliches Datenmanagement der CEIA-Metalldetektoren.
Produktcode: Part #33908
Validierungsdokument
Wird für die Prozessvalidierung des MD verwendet.
Produktcode: Part #30839
Part #51698
Validierungsdokument (Digital Document)
Validierungsunterlagen, die über einen Link von CEIA heruntergeladen werden können.
Produktcode: Part #90672
Part #90673
Wartungs-set Kit
- Feststellschraube für Auswurfklappe
- Einlaufrutsche
- Zwischenförderer
Produktcode: 90x25 Part #48967
100x40 Part #48966