Fourier Transform Infrared Spectrophotometer (FTIR)

HEALTH AND HUMAN SERVICES, DEPARTMENT OF — FOOD AND DRUG ADMINISTRATIO·San Juan, PR·RFP·Federal

Scope

Statement of Work (SOW) Fourier Transform Infrared Spectrometer (FTIR) for the San Juan Medical Products Laboratory Background The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) needs to replace an existing Fourier Transform Infrared Spectrometer (FTIR) system used for routine sample identification analysis with a new Fourier Transform Infrared Spectrometer (FTIR System. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by USP, internal FDA, DOD SLEP, and the FCC program. As a Medical Product Specialty Laboratory, the laboratory uses FTIR technology to analyze and provide specific identification to a variety of drug samples. The San…

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