🔬 Operation and Calibration of FTIR Spectrophotometer

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🔬 Operation and Calibration of FTIR Spectrophotometer

1. Purpose

To define a standardized procedure for the operation, calibration, and maintenance of the Fourier Transform Infrared (FTIR) Spectrophotometer to ensure accurate qualitative and quantitative analysis in compliance with GMP and regulatory requirements.

2. Scope

  • Quality Control laboratories
  • Research and Development laboratories
  • Stability testing laboratories
  • Any department performing FTIR analysis

3. Definitions

  • FTIR: Fourier Transform Infrared Spectrophotometer used to identify functional groups in substances.
  • Background Scan: Reference scan recorded without sample.
  • Resolution: Ability of the instrument to distinguish between close spectral peaks.
  • Wavenumber: Reciprocal of wavelength, expressed in cm⁻¹.
  • Calibration: Verification of wavelength accuracy and performance against standards.

4. Precautions

  • Operate the instrument only by trained personnel.
  • Ensure the sample compartment is clean and dry.
  • Do not touch optical components with bare hands.
  • Use clean and dry ATR crystal or sample holders.
  • Protect instrument from moisture and vibration.
  • Use appropriate PPE (lab coat, gloves, safety glasses).

5. Responsibilities

Role Responsibility
Analyst Sample analysis, cleaning, and documentation
QC Supervisor Review data and logbooks
Quality Assurance Ensure compliance and handle deviations
Engineering / Calibration Calibration and preventive maintenance

6. Equipment & Materials

  • FTIR Spectrophotometer with ATR accessory
  • Certified Polystyrene film (wavelength calibration)
  • Computer system with validated FTIR software
  • Lint-free tissue and approved cleaning solvent
  • Authorized logbooks

7. Operation Procedure

  • Switch ON the FTIR instrument and allow warm-up as per manufacturer instructions.
  • Ensure ATR crystal or sample holder is clean.
  • Open FTIR software and create a new method or select an approved method.
  • Perform background scan without sample.
  • Place the sample on ATR crystal or sample holder.
  • Apply uniform pressure if required.
  • Scan the sample over the defined wavenumber range.
  • Save and label spectra appropriately.
  • Compare spectra with reference or library spectra.
  • Record analysis details in the logbook.

8. Calibration Procedure

8.1 Frequency

  • Once every 6 or 12 months
  • After major maintenance or software upgrade

8.2 Wavenumber Accuracy

  • Scan certified polystyrene film.
  • Verify characteristic peaks (e.g., 1601, 1583, 1154 cm⁻¹).
  • Compare observed peaks with certified values.

8.3 Resolution Check

  • Verify resolution using polystyrene film peaks.
  • Ensure peak separation meets specification.

8.4 Acceptance Criteria

  • Wavenumber deviation: ±1 cm⁻¹ (or as per manufacturer).
  • Resolution: As specified in instrument manual.

8.5 Post-Calibration

  • Affix calibration status label with due date.
  • Document calibration results.
  • If out of limits, label instrument as OUT OF CALIBRATION and inform QA.

9. Cleaning & Maintenance

  • Clean ATR crystal after each analysis.
  • Use approved solvent and lint-free tissue.
  • Do not scratch or damage optical surfaces.
  • Perform preventive maintenance as per manufacturer schedule.

10. References

  • ICH Q2 (R1) – Validation of Analytical Procedures
  • ICH Q7 – GMP for APIs
  • USP <854> Mid-Infrared Spectroscopy
  • USP <1058> Analytical Instrument Qualification
  • WHO GMP Guidelines
  • Manufacturer’s FTIR Instruction Manual

© 2026 sopnest.blogspot.com. All rights reserved. This content is independently written and intended for educational purposes. References to regulatory guidelines are for compliance guidance only.

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