Salı, Nisan 16, 2024

Osmometers / Supports 21 CFR Part 11 Compliance

Osmometers are used for the measurement of osmolality in fluids using freezing point depression principle. Osmolality is the concentration of the solids in an aqueous solution. Osmometers measure number of solids independent of the molecular weight or ion charges.

The following standard freezing curve shows the temperature of a sample in a freezing cycle, and also all steps of the cycle.

The main applications of the osmometers are as follows:

• Biotechnology and pharmaceuticals research and production,
• Clinical, emergency, and sports medicine,
• Industrial applications,
• Food&beverage production,
• Environmental research and control,
• Academic research,
• Medical research.

When an osmometer is operated by a trained staff in clinical applications, it helps to diagnose and find out proper treatment for patients having unbalanced water and electrolyte levels.

In clinical applications, osmolality of serum, plasma, urine, whole blood, faeces, saliva, cerebrospinal fluid, intraocular fluid, sweat, gastric fluid, synovial fluid, and all other body fluids can be measured.

Pharmaceuticals producers and researchers of biotechnology routinely use osmolality tests. During a drug development, osmometers are used to maintain stability in formula, monitoring production, maintain proper shelf life, and product stability. Osmolality tests can also help to formulise drugs to eliminate or minimize side effects.

In biotechology research, testing osmolality helps strengthening the cells, and by preventing cell cultures, saves production times, minimize production costs. Osmometers are key equipment in R&D to test new drugs.

Osmolality tests build a bridge between production and quality control, and are of great importance for the consistency and activity of the product.

Advanced Instruments has recently announced new osmometer models supporting 21 CFR Part 11 compliance.

Advanced Instruments Osmo1™ Single-Sample Micro-Osmometer

• For biotechnology, pharmaceuticals, industrial and clinical applications,
• 20 μl, single sample capacity,
• On-Board printer,
• Integrated barcode scanner,
• Touchscreen user interface,
• 90 seconds test time,
• Statistics calculations,
• Connectivity to LIS and data management systems.

 

 

Advanced Instruments OsmoPRO™ Multi-Sample Micro-Osmometer
• For biotechnology, pharmaceuticals, industrial and clinical applications,
• 20 μl, 20 sample capacity carousel design,
• On-Board printer,
• Integrated barcode scanner,
• Touchscreen user interface,
• 90 seconds test time,
• Statistics calculations,
• Connectivity to LIS and data management systems.

 

 

 

 

Advanced Instruments OsmoTECH™ Single-Sample Micro-Osmometer

• For biotechnology, pharmaceuticals, and industrial applications,
• 20 μl, single sample capacity,
• Dot-matrix printer (optional),
• Integrated barcode scanner,
• Embedded web server,
• Touchscreen user interface,
• 90 seconds test time,
• Statistics calculations,
• Connectivity to LIS and data management systems.

 

 

 


Mehmet Mutlu

Chemist
Sales & Application Specialist
Sümer Analitik ve Medikal
Teknolojiler San. ve Tic. A.Ş.

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