Development of an in situ spectroscopic method for cleaning validation using mid-IR fiber optics

Spectroscopy (Santa Monica)

Volumn 18, Issue 4, 2003, Pages 14-19

  Mehta, Narinder K ^a   Goenaga Polo, Javier ^b   Hernández Rivera, Samuel P ^b   Hernández, David ^c   Thomson, Mary A ^d   Melling, Peter J ^a  

^a Department of Chemical Engineering ^*  (United States)

^b UNIVERSITY OF PUERTO RICO   (Puerto Rico)

^c PFIZER INC   (United States)

^d Remspec   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIBER OPTIC SPECTROSCOPY; IN-SITU METHOD; MID-IR SPECTROSCOPY; PERCENTAGE ERROR;

COMPUTATIONAL METHODS; DECONTAMINATION; ERROR ANALYSIS; ERRORS; FIBER OPTICS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INFRARED SPECTROSCOPY; LIGHT REFLECTION; METAL CLEANING; SOLVENTS; SURFACE TREATMENT; SURFACES;

SPECTROSCOPIC ANALYSIS;

EID: 23344435813     PISSN: 08876703     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (10)

1. "Current Good Manufacturing Practices for Finished Pharmaceuticals," Code of Federal Regulations, Food and Drugs, Title 21 Part 211.67 (U.S. Government Printing Office, Washington, DC), revised April 1990.
2. Office of Regulatory Affairs, Guide to Inspections of Validation of Cleaning Processes (FDA, Rockville, MD), 1993. Available at www.fda.gov/ora/ inspect_ref/igs/valid.html.
3. Office of Regulatory Affairs, Guide to Inspections of Bulk Pharmaceutical Chemicals (FDA, Rockville, MD), revised May 1994. Available at www.fda.gov/ora/inspect_ref/igs/bulk.html.
4. "Cleaning Procedures and Protocols in Focus," Gold Sheet 27 (1983).
5. G. Amer and P. Deshmane, "Ensuring Successful Validation: The Logical Steps to Efficient Cleaning Procedures," Bio-Pharm 14(3), 26-32 (2001).
6. P.R. Griffiths and J.A. De Haseth, Fourier-Transform Infrared Spectrometry (John Wiley, New York, 1986).
7. J.R. Berard et al., "Optical Fiber Coupled Devices for Remote Spectroscopy in the Infrared," U.S. Patent 5,170,056 (United States Patent and Trademark Office, Washington, DC).
8. P.J. Melling and P. Shelley, "Spectroscopic Accessory for Examining Films and Coatings on Solid Surfaces," U.S. Patent 6,310,348 (United States Patent and Trademark Office, Washington, DC).
9. P.J. Melling, unpublished work.
10. R. Kramer, Chemometric Techniques for Quantitative Analysis (Marcel Dekker, New York, 1998).