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Transforming Osmolality Testing in Quality Control

Ensure regulatory compliance with accurate and consistent measurements of a variety of samples

The OsmoTECH XT support 21 CFR Part 11, EU Annex 11, and Pharmacopeia compliance

Ensure regulatory compliance with accurate and consistent measurements of a variety of samples

Q: Can you reliably measure the osmolality of highly viscous samples with freezing point depression technology?

The increasing use of subcutaneous injections has created a need for smaller injection volumes with higher concentrations of proteins and excipients to alleviate pain and increase compliance among patients. Various drug formulations can also create viscous samples. These highly concentrated and viscous samples can pose analytical issues, and create challenges for older freezing point depression technologies. It is critical to have an instrument that provides optimal performance and reliability when measuring these types of samples while also ensuring data integrity and compliance.

A:Accurately and consistently measure the osmolality of high concentration samples and viscous matrices using powerful, intelligent freezing technology with the OsmoTECH® XT SingleSample Micro-Osmometer.

The OsmoTECH XT measures the widest variety of sample types with the ability to accurately and consistently measure high concentration and high viscosity samples across bioprocessing and cell and gene therapy workflows. Using only a small sample volume of 20 µl for testing avoids unnecessarily wasting your valuable product. Furthermore, the OsmoTECH XT is designed to make your work as streamlined and comfortable as possible with powerful and robust data integrity and management features that support 21 CFR Part 11, EU Annex 11, and Pharmacopeia compliance to meet your GMP requirements and match your digital environment.

To learn more visit aicompanies.com/OsmoTECHXTLab