METTLER TOLEDO Tablex2 Pharmaceutical-Grade Metal Detector

Overview

The METTLER TOLEDO Tablex2 is a high-integrity, pharmaceutical-grade metal detection system engineered for inline inspection of solid dosage forms—including tablets, capsules, and granules—during final packaging or post-compression stages. It operates on the principle of balanced coil electromagnetic induction: a high-frequency alternating current generates a stable magnetic field across the detection aperture; the presence of ferrous, non-ferrous, or stainless steel contaminants disrupts this field, inducing measurable phase and amplitude shifts in the receiver coils. These deviations are processed in real time by the embedded Signature™ control platform to trigger precise rejection events. Designed explicitly for compliance with global pharmaceutical quality frameworks, the Tablex2 meets the physical construction, operational traceability, and validation requirements mandated by FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 22000–aligned hygiene principles. Its fully sealed, mirror-polished 316L stainless steel housing achieves IP65 ingress protection and supports CIP/SIP-compatible cleaning protocols—critical for minimizing cross-contamination risk in multiproduct facilities.

Key Features

• Pharmaceutical-optimized mechanical architecture: seamless welds, zero-stagnation-zone product pathways, and tool-free disassembly for rapid cleaning and changeover
• Dual-rejection configuration: configurable top/bottom or left/right pneumatic reject mechanisms, each validated for >99.9% ejection reliability under dynamic line-speed conditions
• Signature™ software interface: membrane-keypad control with intuitive parameter navigation, multilingual support, and audit-trail-enabled user access levels
• Advanced electromagnetic sensing: optimized high-Q coil geometry coupled with adaptive digital filtering to suppress vibration-induced noise and ambient EMI without compromising sensitivity
• Integrated performance verification: built-in reject confirmation circuitry monitors actuator response time and mechanical stroke; automatic alarm triggers if rejection fails within programmable latency windows
• Full regulatory alignment: preconfigured electronic signatures, timestamped event logs, and encrypted data storage compliant with FDA 21 CFR Part 11 and EU Annex 11 data integrity expectations

Sample Compatibility & Compliance

The Tablex2 accommodates standard tablet diameters from 4 mm to 25 mm and capsule sizes ranging from 00 to 5, with adjustable belt speeds up to 120 m/min. It detects ferrous particles ≥0.3 mm, non-ferrous ≥0.4 mm, and austenitic stainless steel ≥0.6 mm—performance verified per ASTM F2781-22 test methodology. All wetted surfaces conform to USP <661.1> and EP 3.1.1 material specifications. The unit ships with EQ Pac™ Validation Package, including IQ/OQ/PQ protocols, equipment qualification records, and calibration certificates traceable to NIST standards. Design documentation satisfies MHRA, PMDA, and Health Canada pre-approval review criteria for automated quality control systems.

Software & Data Management

Signature™ software provides role-based access control (administrator, operator, QA), real-time graphical trend monitoring of signal-to-noise ratio and baseline drift, and exportable CSV/Excel reports for statistical process control (SPC). Optional Ethernet connectivity enables integration into MES/SCADA environments via OPC UA or Modbus TCP. All electronic records—including rejection logs, calibration histories, and user actions—are digitally signed, time-stamped, and stored with immutable audit trails. The system supports periodic performance qualification (PQ) prompts aligned with ICH Q5A and WHO TRS 986 Annex 6 timelines, guiding QA personnel through standardized test-kit challenges and acceptance criteria verification.

Applications

• In-line final inspection of compressed tablets prior to blister packaging
• Capsule batch release screening in high-speed rotary fillers
• Post-granulation powder stream verification before encapsulation
• API intermediate transfer point monitoring in containment suites
• Supporting root cause analysis during OOS investigations per ICH Q9 principles
• Enabling continuous process verification (CPV) as defined in FDA Guidance for Industry (2019)

FAQ

What regulatory standards does the Tablex2 comply with?

The system meets FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485:2016, and ASTM F2781-22 for pharmaceutical metal detection.
Can the Tablex2 be integrated into an existing SCADA system?

Yes—via optional industrial Ethernet module supporting OPC UA, Modbus TCP, or EtherNet/IP protocols for real-time status and event data exchange.
Is validation documentation included out-of-the-box?

Yes—the EQ Pac™ package contains pre-written IQ/OQ/PQ protocols, equipment specification sheets, and calibration certificates compliant with ALCOA+ data integrity principles.
How often must performance qualification be performed?

Per ICH Q5A and internal quality procedures, PQ is recommended at installation, after major maintenance, and at least annually—guided by the system’s built-in PQ scheduler.
Does the Tablex2 support multi-language operator interfaces?

Yes—interface languages include English, German, French, Spanish, Chinese, and Japanese, configurable via the Signature™ menu system.