CEIA, a global leader in industrial and in 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 the security of operations.
Additionally, all events, including metal detections, ejections, program operations, and calibration tests, are logged to 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 to eliminate metal contaminants in pharmaceutical products, ensuring that drugs meet the highest quality and purity standards. These systems utilize 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:
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
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.
About CEIA
Heat and Control has been a proud long-term partner with 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.
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