Description
The US FDA, Office of the Chief Scientist (OCS), San Juan Medical Products Laboratory (SJNLMP) is seeking a Mettler Toledo HX204 Halogen Moisture Analyzer, or an equivalent instrument, to replace the current manual balance to oven method for loss on drying (moisture content) analysis. The required instrument should have high-performance moisture analysis capabilities, real-time monitoring, reporting, user management, and method storage. It must also meet cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the lab’s current accreditation.
The scope of work includes delivery, installation, qualification test, and training for the instrument. The contractor will be responsible for providing all necessary hardware, software, and labor for the installation and qualification of the instrument.
Some key requirements for the instrument include:
• High-performance moisture analysis
• Readability of at least 0.001% MC (0.1mg)
• Maximum capacity of at least 200g
• Programmable user roles
• Real-time drying curve
• Storage for 300 methods and 3000 results
• Control charts
• Four drying programs
• Motorized lid
• Automated export and print functionality
• Current instrument controller software with features such as easy monitoring, data collection, and reporting.