OsmoTECH® Single-Sample Micro-Osmometer
The OsmoTECH is specifically designed to meet the demanding needs of the biotech industry. Uniquely positioned in the market, OsmoTECH leads the industry with its data-management features that support 21 CFR Part 11 compliance. And, its gold-standard testing method uses freezing point depression to provide the accuracy and precision you need to optimize your process and quality control program.
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One-step direct sampling
Simply aspirate sample and load the sampler in the OsmoTECH. Go-to osmometer for slightly viscous samples.
Touchscreen user interface
The OsmoTECH is easy-to-use with an intuitive, color-coded menu-driven operating system, with multi-language capability.
Small sample size
Requiring only 20 µL of sample, OsmoTECH is ideal for sample limited applications.
Embedded web server
Easily and securely view, print and download results remotely from a network web browser.
Integrated barcode scanner
The built-in proximity sensor allows for traceable sample identification and reduces transcription errors.
Dot-matrix printer (optional)
With a simple USB connection, OsmoTECH allows for easy printing and archiving of test results.
21 CFR Part 11 features
Security features of OsmoTECH enable labs to satisfy 21 CFR Part 11 compliance requirements. User accounts are password protected with the ability to link sample ID and user ID to test results for improved traceability. The system requires strong passwords, includes a time stamped audit trail and user passwords are suitably encrypted for data storage.
The OsmoTECH provides secure data transfer to LIS and data management systems via Ethernet and TCP/IP communication protocol. Multiple USB ports provide the ability to easily export data in .PDF or .CSV format. Download of data can be disabled as well.
Industry leading accuracy and precision
OsmoTECH utilizes the industry-preferred freezing point depression method to accurately and precisely determine osmolality.
Time stamp synchronization
Synchronize time on the OsmoTECH to network clock to ensure accurate time stamp and alignment of records.
Built-in quality control
OsmoTECH calculates sample statistics instantly, can issue warnings when quality control is out of range, and allows tracking of quality control data over time with an exportable chart for controls monitoring.
The system is factory calibrated and ready to test. Recalibration is only required if quality control is out of specification, or after maintenance.
Plastic corrugate package
TECH500 micro-sample test kit provides product in plastic corrugate to support clean room compatibility.
OsmoTECH is not for patient diagnostic use. Advanced Instruments certifies that the technical features needed for 21 CFR Part 11 compliance are built into OsmoTECH. It is your responsibility to implement the necessary controls in your laboratory to comply with 21 CFR Part 11 requirements.
Products & Supplies
Osmometer Calibration Standards and Reference Solutions
Supplies and Accessories
|TECH500||Micro-Sample Test Kit: 2 boxes of 250 chamber cleaners, 250 sampler tips, 1 plunger wire|
|3M0828A||Plunger Wire, 1 per order (Replaces 3M0828- Plunger Wires, set of 2. Please note: A plunger wire is included in every 133800 and TECH500 Micro-Sample Test Kit box.)|
|3M0825||Ease-Eject 20-Microliter Sampler||View|
|3M0827||Sampler Calibration Key|
|135022||Epson Dot Matrix Printer (sold-separately)|
|AN2TP5||Dot Matrix Printer Paper|
Optimizing Process Development
You need robust process development—where you can create reproducible processes at each stage—so you can have confidence you’re developing a quality therapeutic. Testing osmolality gives you that confidence. At key points during processing, osmolality testing is critical—during upstream, downstream and as part of the quality check during formulation and fill.