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OsmoTouch 1 21 CFR Compliance Osmometer
The OsmoTouch 1 is an advanced 21 CFR Part 11 compliant freezing point osmometer designed for precise and secure osmolality measurement in clinical, pharmaceutical, and industrial laboratories. It provides accurate single-sample testing with advanced data management features, real-time analysis graphs, electronic signatures, and secure result storage for regulatory-compliant laboratory operations.
Equipped with a touchscreen interface, real-time temperature and freezing point monitoring, and intelligent data handling capabilities, the OsmoTouch 1 ensures efficient workflow and reliable analytical performance. Its advanced security features, password-controlled access, and unmodifiable electronic records make it ideal for laboratories requiring FDA 21 CFR Part 11 compliance.
Product Specifications
| Product Name | 21 CFR Compliance Osmotouch 1 Osmometer |
|---|---|
| Model | OsmoTouch 1 |
| Osmometer Type | Freezing Point |
| Sample Type | Urine, Industrial Fluid, Plasma, Serum |
| Sample Capacity | Single Sample |
| Measurement Range | 0 – 3000 mOsm/kg |
| Resolution | 1 mOsm/kg |
| Usage/Application | Measurement |
| Data Storage | Up to 4,000 Results |
| Calibration Memory | 3 Calibration Curves |
| Compliance | FDA 21 CFR Part 11 |
| Packaging | Box |
Key Features
- Freezing point osmometer with accurate single sample measurement
- Real-time graph display of sample temperature and freezing point
- FDA 21 CFR Part 11 compliant electronic data security system
- Two-level password protection for administrator and user access
- Stores up to 4,000 test results with date, time, and username
- USB data export and PC monitoring through CryoSoft Touch software
- Optional barcode reader support for fast sample identification
Applications
The OsmoTouch 1 Osmometer is widely used in clinical laboratories, hospitals, pharmaceutical industries, biotechnology research centers, and industrial laboratories for osmolality measurement of biological fluids and industrial samples. It is suitable for plasma, serum, urine analysis, drug development, quality control, and regulatory-compliant laboratory testing.
Working Principle
The OsmoTouch 1 determines osmolality using the freezing point depression method. When dissolved particles are added to a solvent, the freezing point decreases proportionally with the concentration of solutes. The instrument precisely measures the freezing point of the sample and calculates the total osmolality, providing accurate results independent of particle size or chemical properties.
