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CEIA, a global leader in industrial and pharmaceutical inspection technologies, is pleased to introduce its latest advancements in metal detection: the THS/PH210® Series Metal Detectors. These cutting-edge systems are fully compliant with FDA 21 CFR Part 11 and FDA 21 CFR 210, delivering unparalleled performance, security, and traceability in pharmaceutical applications.

FDA 21 CFR Part 11 Compliance for Data Integrity and Traceability

The THS/PH210® Series Metal Detectors meet the stringent criteria outlined in FDA 21 CFR Part 11, ensuring that user access, data protection, and traceability are maintained at the highest standard. User access is secured through a User Name and Password login system, managed by a System Administrator who controls individual user profiles. This ensures only authorized personnel can access the system, safeguarding the integrity and security of operations.
Additionally, all events, including metal detections, ejections, program operations, and calibration tests, are logged assist with compliance and root cause analysis. This comprehensive logging mechanism is protected by a proprietary checksum algorithm to guarantee data integrity and prevent tampering, ensuring a robust solution for regulated environments.

FDA 21 CFR 210 Compliance for Good Manufacturing Practices (GMP)

The THS/PH210® Series are also fully compliant with FDA 21 CFR 210, adhering to stringent Good Manufacturing Practices (GMP). These systems are designed to detect and eliminate metal contaminants in pharmaceutical products, ensuring that drugs meet the highest quality and purity standards. The system utilizes advanced sensors to verify the successful ejection of contaminated products, offering a reliable and traceable solution for pharmaceutical manufacturing.

State-of-the-Art Features for Maximum Performance

CEIA’s THS/PH210® Metal Detectors provide an array of innovative features, enabling pharmaceutical manufacturers to achieve the highest levels of performance and compliance:

• Fully Digital Structure: The systems employ a fully digital internal structure, replacing analog processing with numerical digital processing, eliminating the need for manual trimmer calibrations.
• Automatic Antenna Balance: A dynamic balance tracking system ensures optimal detection performance, regardless of environmental changes.
• Continuous AUTOTEST Function: Embedded in the system is a continuous AUTOTEST function, which verifies performance stability and consistency by comparing real-time data to reference values stored during the Factory Acceptance Test (FAT).
• AUTO-QC Function: The AUTO-QC function automates quality control processes, verifying the activation of alarms and ejectors through automatic and manual test stimuli, customizable according to user quality procedures.
• Multi-Point Auto-Learn System: This proprietary feature optimizes detection sensitivity to all metals, significantly reducing the time required for learning transits while improving precision.

Ensuring Compliance and Flexibility in a Changing Environment

CEIA’s THS/PH210® Metal Detectors are designed to maintain optimal performance across varying environmental conditions, thanks to their continuous auto-diagnostic capabilities. These systems can signal detected faults within fractions of a second, reducing downtime and improving operational efficiency.Moreover, the systems support a wide range of communication protocols, including EtherNetIP, Profinet, Profibus, Ethercat, ModBus/TCP, and Profinet-OPC-UA, allowing seamless integration into existing pharmaceutical production lines. An optional embedded field-bus controller enables OEM system integration, maximizing configurability and ensuring the metal detectors meet the specific needs of each user.

ISO 9001 Certified Quality

Manufactured under CEIA’s ISO 9001 Certified Quality Management System, the THS/PH210® Metal Detection Systems consistently deliver products and services that meet or exceed customer and regulatory requirements. This certification further underscores CEIA’s commitment to delivering high-quality, reliable, and compliant metal detection solutions.Key Benefits and Features

• +50% sensitivity improvement in detectable metal volume
• 500 product profiles for easy, flexible programming
• Full AISI 316L stainless steel construction for maximum durability and sanitation
• 1,000,000 storable events with data integrity verification
• Optional Level Sensor on Reject Bin, with alerts for full and absent bins

Revolutionizing Pharmaceutical Inspection

With the launch of the THS/PH210® Series, CEIA continues to set the standard for pharmaceutical metal detection technology. These systems offer maximum sensitivity, ease of use, and full regulatory compliance, empowering manufacturers to safeguard their products and maintain the highest quality standards.
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About CEIA

CEIA is a world leader in the design and production of industrial and pharmaceutical inspection technologies, delivering high-performance, compliant solutions that support manufacturers in meeting regulatory standards and achieving operational excellence.

CEIA, a leader in pharmaceutical metal detection solutions, is proud to announce the launch of its cutting-edge valve system, the THS/PH210-FFV, designed specifically for pharmaceutical powder inspection. This new system offers advanced functionality to meet the stringent sanitation and performance standards required in modern pharmaceutical manufacturing.

Meeting the Unique Challenges of the Pharmaceutical Industry

Pharmaceutical production frequently involves small batches and multiple raw materials, necessitating regular and thorough equipment cleaning. The THS/PH210-FFV metal detector with valve system has been designed to optimize these processes by offering superior inspection and sanitation capabilities, ensuring compliance with hygiene standards and enhancing production efficiency.

Key Features of the THS/PH210-FFV Valve System:

1. Separate Flow Paths for Good and Contaminated Product
   The valve system features dual surfaces for product flow, with distinct paths for good and contaminated product, ensuring there is no cross-contamination during the switching process. This design innovation addresses a critical gap in existing market offerings.
2. Monolithic Rotor Design
   Made without welds or joints, the rotor provides unmatched resistance and durability. This design also improves precision and facilitates better sanitation, ensuring high operational reliability.
3. Open Semicircular Rotor Chambers
   The rotor’s unique design includes open, semicircular sections that simplify cleaning and inspection, enhancing the overall hygiene of the system.
4. AISI 316L Stainless Steel Construction
   Both the rotor and casing are constructed from high-quality AISI 316L stainless steel, featuring a mirror-polished finish. This material choice ensures durability, resistance to corrosion, and optimal sanitation for pharmaceutical applications.
5. Streamlined, Compact Design
   The valve’s compact structure eliminates changes in section between the product inlet and outlet, promoting smooth material flow and reducing potential product accumulation points.
6. Tool-Free Disassembly
   With Tri-Clamp connections, the THS/PH210-FFV offers easy, tool-free disassembly and reassembly, allowing quick sanitization between production batches, which is essential for processes involving frequent raw material changes.
7. Contamination Prevention
   By eliminating cavities, holes, and threads in product-passage areas and avoiding bolts in critical regions, the system prevents accumulation of processed material and reduces the risk of cross-contamination.
8. No Sealing Gaskets in Product Path
   The absence of sealing gaskets between the rotor and the nozzles ensures no product waste accumulates, reducing the risk of wear and contamination while extending the system’s lifespan.
9. Quick Product Expulsion
   With a rotor rotation angle of just 55°, the system ensures rapid and efficient expulsion of contaminated product, speeding up production cycles without compromising accuracy or safety.
10. Minimal Surface Contact
    The design minimizes the surface area between static and moving parts, reducing the risk of product buildup and ensuring smooth, continuous operation.

Revolutionizing Pharmaceutical Production

The THS/PH210-FFV valve system sets a new standard for pharmaceutical inspection by addressing key pain points in the industry, such as cross-contamination, sanitation, and equipment efficiency. Designed to meet the most rigorous standards, it offers pharmaceutical manufacturers a reliable, easy-to-clean, and efficient solution that enhances overall production quality.For more information about the THS/PH210-FFV or to schedule a product demonstration, please visit www.ceia.net.

About CEIA

CEIA is a leading innovator in pharmaceutical inspection technologies, committed to delivering solutions that enhance product quality, safety, and compliance in pharmaceutical production.

The Pharmaceutical division includes several state-of-the-art Quality Control Metal Detectors that offer full compliance with FDA requirements Part 210 and Part 211. The THS/PH21N provides superior metal detection in the manufacturing process of this strictly regulated industry. The highly reliable proprietary digital technology delivers a consistent detection far metal contaminants in tablets, capsules and powders. All models feature a mirror finish on the 316L Stainless Steel that offers the best level of sanitation achievement.

Superior Detection Capability
CElA THS/PH21N Metal Detection Systems feature extremely high detection sensitivity towards contaminating metals, whether ferrous, non-ferrous or stainless steel. Once a contamination is detected, the system rejects the identified material. The system's fail safe operation monitors the opening and closing of the ejection flap through a redundant confirmation sensor.

Continuous embedded Self-Calibration
CElA THS/PH21N introduces a continuous embedded Self-Calibration function for maximum repeatability and performance consistency over time. Proprietary signals are sent to the metal detector transmission and reception chain that provides constant monitoring of the detection characteristics. Constant regulation of algorithms supplies compensation for any variations caused by environmental factors. The result is system with stability, consistency in performance and effect product assurance.

FDA 21 Part 11 Compliant
CElA THS/PH21N Metal Detection Systems satisfy the standards of Security, Integrity and Traceability of production data as required by Part 11 of Title 21 of the CFR - Electronic Records - Electronic Signatures.

CEIA USA is pleased to announce the addition of Pharmaceutical Metal Detection to their extensive catalog of capabilities. For over 45 years, CEIA has established itself as a world leader in metal detection and has focused on providing only the highest quality products to their clients. Previously only available through distributors, CEIA Pharmaceutical Metal Detectors have been installed at countless companies throughout the US and have maintained a successful reputation. By adding this division to our US Headquarters, CEIA can now provide USA direct manufacturer sales support and technical assistance along with a fully stocked warehouse of products and spare parts.

Product Highlights
The CEIA THS/PH21 Metal Detection Systems offer detection, construction quality and reliability characteristics that make them the most suitable and effective solution to automatic elimination of metal contaminants whether ferrous, non-ferrous or stainless steel and even in very small quantities.

Main features are:

• Very High Throughput Rate
• Superior Detection Capabilities
• Maximum Configurability
• FDA Title 21CFR Part 11 Compliant
• Data Security, Data Integrity, Data Traceability
• Design and Construction compliant with 21 CFR Parts 210 and 211

For more information about CEIA Pharmaceutical Metal Detectors please contact Scott Larsen, North American Pharmaceutical Sales Manager, at 888-532-2342 and visit www.ceia-usa.com.

About CEIA USA
For over 45 years, CEIA has provided high quality threat detection solutions for security and ground search applications such as walk-through and hand-held metal detectors, loss prevention systems, cargo screening devices, bottled liquid scanners, shoe analyzers and ground search metal detectors for military and humanitarian use. CEIA metal detectors are deployed at airports, distribution centers, federal buildings, military bases and sports facilities throughout the world.
ISO 9001 Certified – GSA Contract Holder.