| Customization: | Available |
|---|---|
| After-sales Service: | Enginner Avaliable Overseas |
| Warranty: | 5 Years |
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Unlock unparalleled contaminant control and regulatory compliance with the VikingDetector™ High-Accuracy 35 mm Diameter Gravity-Feed Metal Detector, engineered specifically for the rigorous demands of pharmaceutical powder and granule processing. Boasting a precision-tuned 35 mm aperture, FDA- and EU-GMP-compliant stainless steel construction, and advanced digital signal processing, VikingDetector™ sets a new standard for metal detection in pharma.
Introduction
Industry Challenges & Regulatory Landscape
VikingDetector™ Overview
Key Technical Features
4.1 35 mm Precision Aperture
4.2 Advanced Multi-Frequency Detection
4.3 Food- and Pharma-Grade Construction
4.4 Intuitive Touchscreen Control
4.5 Modular, Gravity-Feed Design
4.6 Automatic Reject & Validation Systems
Compliance & Certification
Benefits to Pharmaceutical Manufacturers
Typical Applications in Pharma
Installation & Integration
Operation & Maintenance
Data Management & Traceability
Case Studies & Success Stories
Frequently Asked Questions
Conclusion & Call to Action
Appendix: Technical Specifications
In pharmaceutical manufacturing, product purity and patient safety are paramount. Minute metal contaminants-derived from milling equipment, packaging machinery, or raw-material handling-pose serious risks, potentially compromising drug efficacy or causing harm. To safeguard your brand's reputation and adhere to stringent regulatory standards, a reliable metal detection system is non-negotiable.
The VikingDetector™ 35 mm Gravity-Feed Metal Detector is meticulously designed to detect and reject metal contaminants as small as 0.3 mm, ensuring your powders, granules, and pellets remain free of ferrous, non-ferrous, and stainless-steel fragments. Its compact, gravity-fed configuration makes it ideal for inline integration with hoppers, tablet presses, and other vertical processing equipment.
Raw Material Variability - API powders and excipients may carry metal shards from upstream milling.
Equipment Wear - Prolonged use of blenders, granulators, and conveyors can shed microscopic metal fragments.
Cross-Contamination - Shared production lines increase the risk of unwanted metal intrusion.
FDA 21 CFR Part 11 - Electronic records and audit trails must be secure and retrievable.
EU GMP Annex 11 - Computerized system validation demands rigorous software qualification.
ICH Q7 & Q10 - Guidelines call for robust quality systems and contamination controls.
ISO 13485 - Medical device-related pharmaceuticals require strict risk mitigation.
Non-compliance not only invites costly FDA warning letters and import alerts but also jeopardizes patient safety. VikingDetector™ is built from the ground up to help you meet and exceed these demanding requirements.
The VikingDetector™ 35 mm Gravity-Feed Metal Detector comprises three major subsystems:
Detection Head - A precision 35 mm aperture detection coil encased in 316L stainless steel, optimized for true gravity-feed operation.
Control Console - A validated controller with a 7″ industrial-grade touchscreen, featuring role-based access, data logging, and recipe management.
Reject Mechanism - A high-speed pneumatic flap or diverter valve that isolates contaminated product in under 50 milliseconds.
Together, these modules deliver a turnkey solution for pharmaceutical lines that demand uncompromising detection sensitivity, cleanability, and regulatory compliance.
Optimized Throughput - The diameter balances maximum free-fall volume with enhanced sensitivity to detect 0.3 mm ferrous and 0.5 mm non-ferrous particles.
Uniform Detection Field - Engineered coil geometry ensures consistent sensitivity across the full aperture.
Dual- and Triple-Frequency Modes - Compensate for product effect (e.g., high-moisture or conductive powders like magnesium stearate).
Auto-Tune & Auto-Balance - Real-time adaptive algorithms maintain peak sensitivity despite temperature drift or product variation.
316L Stainless Steel - Electropolished finish to Ra ≤ 0.4 µm, eliminating microbial harborage points.
IP66 Protection - Dust tight and water resistant, capable of daily CIP spraydowns.
FDA & EC 1935/2004 Compliance - All wetted parts meet global food- and pharma-grade material requirements.
7″ Color TFT Display - High-resolution, glove-friendly interface.
Role-Based Access Control (RBAC) - Separate operator, supervisor, and QA levels with password protection and audit trails.
Multi-Language Support - English, German, Chinese, Japanese, and more.
Compact Footprint - Fits beneath hoppers, access panels, or within fume hoods.
Quick-Release Clamps - Tool-less removal of inspection head for rapid CIP cleaning.
Variable Inlet Angles - Adjustable 60°-90° configurations to match line geometry.
Pneumatic Flap Diverter - Closed-loop control minimizes false rejects and reduces waste.
In-Process Validation - Built-in standard test piece (STP) insert allows push-button validation without line shutdown.
Alarm Notification - Visual and audible alerts plus optional SCADA/PLC integration via 4-20 mA, Profibus, or Ethernet/IP.
The VikingDetector™ platform is designed and manufactured in an ISO 9001:2015 and ISO 13485:2016 facility, ensuring consistent quality controls. Key certifications include:
CE Marking - Meets EMC 2014/30/EU & Low Voltage Directive 2014/35/EU.
FDA GMP Conformity - System qualification IQ/OQ/PQ packages available.
EU GMP Annex 11 - Validated software modules with change control and electronic signature capability.
cGMP Documentation - Comprehensive validation documentation, including URS, DQ, FAT, SAT, and Trace Matrix.
Uncompromised Product Safety
Detects sub-0.3 mm ferrous particles and larger non-ferrous contaminants.
Eliminates costly recalls and protects patient health.
Regulatory Peace of Mind
Built-in 21 CFR Part 11 compliance for electronic records.
Validation-ready hardware and software accelerate regulatory submissions.
Enhanced Operational Efficiency
Gravity-feed design requires no additional mechanical conveyance.
High-speed reject minimizes downtime and product loss.
Lower Total Cost of Ownership
Modular construction simplifies maintenance, cutting service costs.
Long-life components and self-diagnostics extend mean time between failures (MTBF).
Seamless Data Traceability
Comprehensive audit trails with exportable CSV and PDF reports.
Integration with LIMS systems for end-to-end batch record management.
| Application | Key Considerations |
|---|---|
| Powder Fillers | Fine APIs and excipients with high fluidity |
| Granulation | Moist granules prone to bridging or moisture |
| Encapsulation | Pellets and beads through capsule lines |
| Blending | Multi-component batches with varying densities |
| Coating & Spray Drying | Aggressive CIP routines and moisture exposure |
Regardless of your process step-be it micro-powder conveyance or large-volume granule transfer-VikingDetector™ delivers consistent performance.
Mounting Structure - Stainless steel support frame or integrated into existing stands.
Power & Pneumatics - Single-phase 110/230 VAC, 50/60 Hz; 6-8 bar dry air.
Network Connectivity - Ethernet/IP or Profibus for SCADA/LIMS integration.
Factory Acceptance Testing (FAT) - Witnessed at our facility, demonstrating compliance with your URS.
Site Acceptance Testing (SAT) - On-site verification of performance with production materials.
Operator Training - Hands-on sessions covering line setup, validation routines, and troubleshooting.
Visual Inspection - Ensure inlet/outlet no blockages.
STP Validation - Push-button validation with built-in test piece.
Quarterly - Inspect pneumatic valves and clean sensor coils.
Annually - Full re-calibration and firmware updates; replace seals if worn.
Self-Diagnostic Alerts - On-screen guidance for sensor faults, coil imbalances, or pneumatic leaks.
Remote Support - Secure VPN access for real-time diagnostics by VikingDetector™ experts.
VikingDetector™ features a robust data architecture designed for pharma's exacting requirements:
Batch Record Integration - Automatically append metal detection logs to batch records.
Audit Trail - Immutable logs of all user actions and parameter changes.
Secure Data Export - Encrypted CSV/PDF reports for regulatory submission or QA review.
LIMS/SCADA Connectivity - OPC-UA, Ethernet/IP, and MQTT protocols supported.
Challenge - Frequent false rejects due to highly conductive magnesium stearate.
Solution - Multi-frequency VikingDetector™ auto-balanced to differentiate product signal from noise.
Result - 75% reduction in false rejects, saving 20 k USD annually in lost product.
Challenge - Intermittent metal shavings from upstream mixer.
Solution - Real-time data logging and rapid rejection minimized cross-contamination risk.
Result - Zero customer complaints over 18 consecutive months; audit ready for EU GMP.
Q1: What's the minimum detectable particle size?
Ferrous: 0.3 mm; Non-Ferrous/Stainless Steel: 0.5 mm.
Q2: Can the system handle high-moisture powders?
Yes-multi-frequency mode compensates for product effect in hygroscopic materials.
Q3: How is software validated?
Complete IQ/OQ/PQ protocols available; Annex 11-compliant electronic records.
Q4: Do I need compressed air?
Yes-6-8 bar dry air to operate the pneumatic reject.
Q5: What cleaning procedures are recommended?
Daily CIP spraydowns with neutral detergent; weekly rinse with 70% IPA.
For pharmaceutical manufacturers who demand zero-tolerance metal detection, regulatory peace of mind, and seamless integration, the VikingDetector™ 35 mm Gravity-Feed Metal Detector is the definitive choice. Elevate your quality assurance program, protect patient safety, and streamline compliance with an all-in-one solution built for the most demanding pharma environments.
Contact your VikingDetector™ representative today to:
Request a personalized quote
Schedule an on-site demo
Download detailed validation protocols
| Specification | Details |
|---|---|
| Aperture Diameter | 35 mm |
| Detection Sensitivity | Fe ≥ 0.3 mm; Non-Fe/Stainless ≥ 0.5 mm |
| Coil Frequencies | 25 kHz, 45 kHz, 65 kHz (auto-switching) |
| Construction Material | 316L Stainless Steel (Electropolished Ra ≤ 0.4 µm) |
| Finish Standard | FDA 21 CFR 175.300, EC 1935/2004 |
| Ingress Protection | IP66 |
| Operating Temperature | 5 °C - 40 °C |
| Humidity | 30 % - 85 % RH (non-condensing) |
| Power Supply | 110/230 VAC, 50/60 Hz |
| Compressed Air | 6-8 bar (dry, oil-free) |
| Display | 7″ Color TFT Touchscreen |
| Data Logging | 10 000+ event logs; CSV/PDF export |
| Communication Protocols | Ethernet/IP, Profibus, OPC-UA, MQTT |
| Validation Documentation | IQ/OQ/PQ packages, URS, FAT/SAT reports |
| Dimensions (L×W×H) | 400 × 200 × 350 mm |
| Weight | 18 kg |
| Certifications | CE, cGMP, FDA, EU GMP Annex 11, ISO 13485, ISO 9001 |
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