Specification builder · Tier C
Fourier-transform infrared (FTIR) spectrophotometer, mid-infrared, with attenuated total reflectance (ATR) accessory and data-integrity software
An FTIR spectrophotometer shines infrared light through or onto a sample and records which wavelengths are absorbed, giving a fingerprint spectrum that identifies the substance. With an ATR accessory a powder, tablet, liquid or film is simply pressed on a crystal, so identification takes about a minute with no sample preparation. In Pakistan it is bought by pharma QC labs (raw material identification), drug testing labs, forensic and narcotics labs, universities and polymer or packaging industries; the key choices are signal-to-noise, ATR crystal, moisture protection of the optics, libraries and data-integrity software.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety requirements for laboratory equipment, including the spectrometer and its power supply.
- IEC 61326-1 Electromagnetic compatibility of laboratory equipment, so the instrument works near generators, UPS units and other lab equipment.
- IEC 60825-1 Safety of laser products; the internal reference laser must be classified, normally as an enclosed Class 1 product.
- USP <854> USP chapter on mid-infrared spectroscopy, including instrument qualification (wavenumber accuracy with polystyrene, resolution and performance checks).
- USP <197> USP spectroscopic identification tests (ATR, KBr disc and other sample methods) used in most USP monographs for identity testing.
- Ph. Eur. 2.2.24 European Pharmacopoeia chapter on infrared absorption spectrophotometry, with the polystyrene wavenumber and resolution tests used by BP-following labs in Pakistan.
- BP Appendix II A / JP 2.25 British and Japanese Pharmacopoeia infrared spectrophotometry requirements, aligned with Ph. Eur.
- USP <1058> Framework for analytical instrument qualification (DQ, IQ, OQ, PQ).
- 21 CFR Part 11 / EU GMP Annex 11 Electronic records, audit trail and electronic signature requirements for software in GMP and regulated labs.
- ISO 17034 / ISO/IEC 17025 Accreditation of the producer or calibration lab for the certified polystyrene reference film.
- ASTM E1421 Standard practice for describing and measuring performance of FT mid-infrared spectrometers (level zero and level one tests).
Common mistakes in tenders for this equipment
- Copying one brand's numbers exactly (for example a 0.45 cm-1 resolution, a 40,000:1 signal-to-noise figure or a 10-year interferometer guarantee) so only that model complies; specify the minimum performance the methods need.
- Asking for signal-to-noise without fixing the test conditions (peak-to-peak or RMS, scan time, resolution, wavenumber region), so bidders quote numbers that cannot be compared.
- Using proprietary names for interferometer designs, light sources or ATR accessories in the specification instead of measurable performance.
- Leaving out the certified polystyrene film, spare desiccant and IQ/OQ, so the instrument cannot be qualified and the optics are damaged by moisture in the first monsoon.
- Accepting a ZnSe ATR to cut cost for drug or forensic work; the crystal is scratched or etched within months and replacement costs more than the diamond option would have.
- Accepting 'Part 11 ready' without requiring audit trail, unique logins and e-signatures to be demonstrated at installation, or discovering later that the compliance software and libraries are separately priced licences.
- Asking for research features (MCT detector, near- or far-infrared extension, IR microscope) for a routine identification lab, which multiplies the price and narrows bidders without improving results.
- Ignoring post-warranty service and local engineer availability; a low bid followed by an expensive maintenance contract and weeks of waiting for a source or laser can cost more over 5 years.