Thermo Scientific MicroPHAZIR 1624 RX Handheld Portable NIR Spectrometer

Thermo Scientific™ microPHAZIR™ RX Analyzer: Portable NIR Spectrometer for Raw Material Identification

Introduction: Revolutionizing Raw Material Identification in Pharmaceutical Manufacturing

In pharmaceutical manufacturing, verifying the quality and authenticity of raw materials is crucial for product safety, compliance, and efficiency. Traditionally, raw material analysis takes place in centralized laboratories, which often slows down the production process. However, with the Thermo Scientific™ microPHAZIR™ RX Analyzer, pharmaceutical manufacturers can now perform real-time, on-site identification of raw materials directly in the warehouse. This development significantly reduces waiting time, accelerating the production cycle and enhancing operational efficiency.

The microPHAZIR RX Analyzer is a battery-powered portable NIR (Near-Infrared) spectrometer that delivers fast, reliable material verification. By bringing on-the-spot testing to the warehouse, this tool helps manufacturers comply with global GMP (Good Manufacturing Practices), reduce supply chain risks, and streamline inventory management.

Key Benefits of the Thermo Scientific™ microPHAZIR™ RX Analyzer

1. Increase Operational Efficiency with Fast On-Site Analysis

The microPHAZIR RX Analyzer enables manufacturers to perform raw material analysis directly in the warehouse, removing the need to send samples to a centralized lab. As a result, operators can immediately test materials as they arrive, speeding up the entire inspection process. In doing so, manufacturers improve inspection throughput, ensuring faster decision-making and more efficient production workflows.

• With the handheld design, operators can easily carry out tests anywhere in the facility. This portability leads to shorter lead times and enhances productivity.

2. Non-Invasive, Non-Destructive Testing

Another key advantage of the microPHAZIR RX Analyzer is its ability to analyze materials without needing direct contact or sampling. It performs accurate measurements through plastic liners and glass containers, making it both safe and efficient. Moreover, this non-invasive analysis ensures that both operators and materials remain unaffected, improving operator safety and preserving the integrity of raw materials.

• The non-destructive approach minimizes contamination risks and eliminates potential degradation of materials during testing.

3. Comprehensive Container Inspection

Thanks to its unique design, the microPHAZIR RX Analyzer allows for 100% inspection of raw material containers. This capability helps manufacturers conduct thorough material verification at scale without incurring additional costs. As a result, testing can be performed for entire batches of materials, ensuring consistency and quality throughout the production process.

• By enabling complete material checks, the analyzer improves product consistency, reducing the chances of material-related issues later in production.

4. Enhanced Supply Chain Risk Management

The microPHAZIR RX Analyzer is a crucial tool in managing supply chain risks. By enabling rapid material verification, it allows manufacturers to assess raw materials before they enter the production line. This proactive approach helps reduce the likelihood of counterfeit or substandard materials entering the manufacturing process.

• Furthermore, the device ensures GMP compliance, improving inventory management and safeguarding against potential supply chain disruptions.

Applications of the Thermo Scientific™ microPHAZIR™ RX Analyzer

The microPHAZIR RX Analyzer proves useful across various stages of pharmaceutical manufacturing. Below are some of its key applications:

• Raw Material Identification: Quickly and accurately verify incoming raw materials to ensure they meet the necessary quality standards.

• Quality Control and Assurance: Monitor raw materials during production to maintain consistent product quality.

• Counterfeit Detection: Identify counterfeit raw materials, ensuring only authentic substances are used in the production process.

• At-Line Process Analytical Technology (PAT): Integrate the analyzer into your PAT system to perform real-time material verification and improve process control.

• Process Troubleshooting: Identify and address material discrepancies before they disrupt production.

• Quantitative Analysis: Use the analyzer for accurate quantification of raw material concentrations, ensuring proper formulation and compliance.

Thermo Scientific™ microPHAZIR™ RX Analyzer Specifications

1. Power and Battery

The microPHAZIR RX Analyzer is designed to be fully portable, featuring an interchangeable rechargeable lithium-ion battery that provides over 5 hours of continuous use. This ensures manufacturers can perform extended analysis without frequent recharging. Additionally, the included AC charger allows the batteries to recharge in under 2 hours, maximizing uptime.

• Battery Life: 5+ hours of continuous use

• Recharge Time: Less than 2 hours

• Two batteries included for continuous operation.

2. Compliance and Certifications

The microPHAZIR RX Analyzer meets all relevant industry standards, ensuring it’s suitable for use in regulated pharmaceutical environments. It is compliant with USP <1119>, EP 2.2.48, and 21 CFR Part 11. This ensures that manufacturers can rely on the analyzer for secure, traceable data and regulatory adherence.

• Certified for USP <1119> and EP 2.2.48

• Fully supports 21 CFR Part 11 compliance for electronic records.

3. Data Management and Connectivity

Data from the microPHAZIR RX Analyzer is stored in its internal memory and can be easily uploaded to a PC for analysis and reporting. Additionally, the device supports data synchronization via USB, making it convenient for manufacturers to store and access results.

• Data Storage: Internal memory, with easy PC data upload.

• Data Download: Via USB connection for seamless synchronization.

4. Design and Durability

The analyzer’s high-strength, dust-proof, and splash-proof plastic casing ensures durability in the warehouse or factory setting. It is designed to be ergonomic and lightweight, weighing only 2.75 lbs (1.2 kg), allowing operators to handle the device comfortably for long periods.

• Weight: 2.75 lbs (1.2 kg)

• Housing: Dust-proof and splash-proof for added durability.

What’s Included in the Package

Upon purchase, the microPHAZIR RX Analyzer comes with a complete set of accessories to help you get started:

• 1x microPHAZIR 1624 RX Analyzer

• 2x Rechargeable lithium-ion batteries

• 1x Battery charger

• 1x USB cable

• 1x Reference holder and white reference (Fluorilon)

• 1x CD or printed operating manual

• 1x Spare light bulb

• 1x Calibration certificate

Warranty and Support

The Thermo Scientific™ microPHAZIR™ RX Analyzer includes a 3-year warranty, ensuring your investment is protected. In addition, it comes with comprehensive customer support for troubleshooting, guidance, and maximizing the analyzer’s capabilities.