microPHAZIR RX
Thermo Scientific microPHAZIR RX is a handheld NIR material analyzer designed for rapid on-site pharmaceutical material identification. The 2.75 lb (1.25 kg) analyzer is battery powered and completely self-contained for portable analysis. Take the power of NIR out of the laboratory and into the warehouse or manufacturing floor to save testing costs and ensure product quality through increased testing frequency, while also reducing supply chain risk.
Validation and qualification assistance is now available.
Contact us for details.
The microPHAZIR RX analyzer offers an unparalleled solution for rapid, accurate raw material identification:
- Rugged portable handheld solution
- Lightweight 2.75 lb (1.25 kg) device
- Intuitive Color LCD screen
- Rechargeable Li-Ion batteries
- Long battery operation
- Simple operation, no experience required
- Minimal training required
- Instantaneous (1-2 seconds) results
- Non-destructive measurement
- Results are logged in a on-board database
- Fully programmable via PC software
- Ready-to-use library with 100s of ingredients
- Integrated barcode scanner
- 21 CFR Part 11 compliant
- IQ/OQ/PQ qualification package
- USP 1119 & EP 2.2.40 compliant
- EMEA & PIC/S Compliant
- Traceable standards available
- Validation services available
For additional information, please contact sales.chemid@thermofisher.com.
| Principle of Operation | Non-destructive chemical analysis via Near Infrared Spectroscopy |
|---|---|
| Samples Mode | Diffuse reflectance, optional adapters for liquids |
| Weight | 2.75 lb (1.25 kg) |
| Light Source | Tungsten light bulb, safe for operators and sample integrity |
| Measurement time | Less than 3 seconds |
| Data Download | Data and Applications synchronization via PC USB connection |
| Security | Multiple security levels |
| Batteries | Interchangeable, rechargeable 5+ hours lithium-ion battery pack. AC battery charger included. Battery pack recharge time <2 hours. System includes 2 batteries |
| Housing | High-strength, dust proof/splash proof plastic housing |
| Calibration | Factory tested to rigorous standards and USP 1119 protocol using traceable wavelength and photometric standards, includes certificate of compliance |
| Compliance |
USP 34 Chapter 1119 JP 16 General Information EP 2.2.40 21 CFR Part 11 |
Options | |
| mPHZR-Holster | microPHAZIR™ Holster with battery compartment |
| mPHZR-BTRY | microPHAZIR™ spare battery |
| Polychromix Method Generation software | |
| Validation support services |
Qualification and Validation
We offer assistance with the deployment of microPHAZIR RX into good manufacturing practice (GMP) environments while complying with regulatory requirements.
Our applications team can help in all aspects of the validation cycle including:
- Method development
- Development and execution of validation protocols for raw material identifications
- Development of Standard Operating Procedures (SOPs)
- Assistance with regulatory filings
- Onsite Installation Qualification/Operational Qualification (IQ/OC)
For more information about qualification and validation services, contact us at sales.chemid@thermofisher.com