Barely larger than a smartphone, the Mira P is one of the fastest and most compact Raman spectrometers on the market. With the Mira P, you will be able to ensure smooth and efficient processes, as you will get a reliable "Pass" or "Fail" result in 15 to 20 seconds on average. The instrument and dedicated MiraCal P software is compliant with 21 CFR Part 11 regulations, making the Mira P the ideal instrument for material verification in regulated industries.
Ensure regulatory compliance (FDA 21 CFR Part 11) and Pharmacopeia conformity (USP and EP) The Mira Cal P software provided with the Mira P instrument offers many features that help you to ensure secure and well-documented procedures in compliance with FDA 21 CFR Part 11 regulations: Multilevel access control, including three predefined access levels and optional password ageing and complexity requirements Audit trails to log all actions on the instruments Secure electronic records that are synced to a secure database on a PC Reports containing all required information (instrument info, parameters, electronic signatures) are generated at the push of the button Mira P handheld Raman analyzer for FDA-compliant materials verification in pharmaceutical industry The new Calibrate/Verify Accessory now provides a two-part verification of the system. First, the ASTM method E1840 for Toluene-Acetonitrile is used to achieve the best possible wavenumber calibration across the entire range. Second, NIST-Traceable polystyrene is used to verify the wavenumber accuracy. Using polystyrene allows worry-free conformity with USP 1120 and EP 2.2.48.
