The Metrohm Raman Mira M-3 is fully compliant with FDA 21 CFR Part 11 providing multilevel access control, audit trails, secure electronic records and other features to exceed regulatory requirements.
High performance handheld Raman spectrometer: Mira M-3
The Metrohm Instant Raman Analyzer (MIRA) M-3 is a high performance, handheld Raman spectrometer used for rapid, nondestructive identification and verification of different material types, such as Pharmaceutical APIs and excipients. Despite the small size of the instrument, the M-3 has a ruggedized design and features a high-efficiency spectrograph design equipped with our unique Orbital-Raster-Scan (ORS) technology. The Mira M-3 is fully compliant with FDA 21 CFR Part 11 regulations.
Operating Procedures can be customized on the Mira M-3 to allow sampling flexibility. Routine users start their measurements at the push of a button to verify the identity of materials with a pass/fail result in a few seconds.
Dedicated sampling attachments such as a Vial Holder (for powders and liquids) and a Tablet Holder (for tablets and pills) are part of the Mira M-3 and can be used without any further laser protection (Laser Safety Class 1). Point-and-shoot attachments are also available for contact measurements through barriers (e. g., glass bottles).
The Mira M-3 is fully compliant with FDA 21 CFR Part 11 providing multilevel access control, audit trails, secure electronic records and other features to exceed regulatory requirements.