Pharmaceutical refractometer

Abbemat Pharma Pharmaceutical Refractometer - Tengyi Technology

This pharmaceutical refractometer is designed to exceed the requirements of pharmaceutical regulations and other regulated environments: 21 CFR Part 11, GAMP 5, and EU GMP Vol. 4 Annex 11. It provides secure data management, audit traceability, electronic signatures, and access control, ensuring audit readiness at all times, integration into processes, and secure storage of measurement results and metadata. The AISQ+ qualification package accelerates qualification by 70% and provides risk analysis, SOPs, and traceability documentation for rapid deployment in regulated environments.

Completely validate your pharmaceutical refractometer
Qualification and routine monitoring of your measuring equipment goes beyond verifying refractive index. Anton Paar also ensures the accuracy of a second critical parameter: temperature.

Anton Paar service engineers verify precise temperature measurements using the patented T-Check system, providing:

• Traceable temperature verification and adjustment on-site
• The most accurate prism surface temperature measurement
• Prevention of temperature-related measurement errors
• Comprehensive documentation and certification
• Error prevention through user guidance

User rights management ensures that operators only have access to the functions required for their tasks.

Only users with appropriate permissions can change settings. User profiles can be seamlessly integrated from Active Directory.

Routine measurements can be structured according to SOPs with predefined pass/fail criteria. Check intervals can be set to enforce system suitability testing and ensure compliance with measurement equipment control regulations.

Secure data management options

The automated refractometer can be used standalone and export file-based data to your network. Alternatively, data can be managed via Anton Paar Connect: an encrypted SQL database, resistant to manipulation, ensures secure data storage, straightforward backup and restore, and easy access throughout the entire retention period.

Digital AISQ+ Certification Program

Comprehensive Analytical Instrument and System Qualification (AISQ+) significantly reduces the effort required to use a new pharmaceutical refractometer. Printable or fully digital with electronic signatures, it expedites review and approval during the qualification process.

Durable sapphire prisms are scratch-resistant and come with a 25-year warranty.

The high-quality optics of the automated pharmaceutical refractometer are meticulously designed for durability, ensuring excellent resilience and long life.

• Can withstand cleaning with scrapers and other lab tools.
• Features a Mohs hardness rating of 9, close to diamond-grade.
• Prisms are covered by a 25-year warranty.