Is this surface clean? Cleaning validation by direct spectroscopic surface analysis

American Laboratory

Volumn 38, Issue 17, 2006, Pages 16-18

  Melling, Peter ^a   Thomson, Mary ^a  

^a Remspec Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONTAMINATION; DRUG PRODUCTS; FLUORINE CONTAINING POLYMERS; MONOMERS; SPECTROMETERS; TRACE ANALYSIS;

ETHYLENE PROPYLENE DIENE MONOMER (EPDM); PEAK AREA MEASUREMENTS; SURFACE ANALYSIS;

SURFACE CLEANING;

EID: 33750904274     PISSN: 00447749     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (8)

1. Code of Fed. Reg. Title 21, Food and Drugs (General Services Administration, Washington, DC), Apr 1, 1973, Part 211.67.b.6.
2. Guide to Inspection of Validation of Cleaning Processes (U.S. Food and Drug Administration, Rockville, MD, 1993).
3. Yang, P.; Burson, K.; Feder, D.; Macdonald, F. Method development of swab sampling for cleaning validation. Pharm. Technol. Jan 2005, 1, 84-94.
4. Reddy, K.B.; Teelucksingh, N. Quantification of active pharmaceutical ingredients on metal surfaces using a mid-IR grazing-angle fiber optics probe - an in-situ cleaning verification process. Spectroscopy 2005, 20(10), 16-23.
5. Hamilton, M.L.; Perston, B.B.; Harland, P.W.; Williamson, B.E.; Thomson, M.A.; Melling, P.J. Fiberoptic IRRAS for trace analysis on surfaces of varying roughness: sodium dodecyl sulfate on stainless steel. Appl. Spectrosc., in press.
6. Hamilton, M.L.; Perston, B.B.; Harland, P.W.; Williamson, B.E.; Thomson, M.A.; Melling, P.J. Grazing-angle fiber-optic IR reflection-absorption spectrometry (IRRAS) for in situ cleaning validation. Org. Proc. Res. Devel. 2005, 9(3), 337-43.
7. Hamilton, M.L.; Perston, B.B.; Harland, P.W.; Williamson, B.E.; Thomson, M.A.; Melling, P.J. Grazing-angle fibre-optic FT-IRRAS for the in situ detection and quantitation of multiple organic residues on glass, in preparation.
8. Mehta, N.K.; Goenaga-Polo, J.; Hernandez-Rivera, S.P.; Hernandez, D.; Thomson, M.A.; Melling, P.J. Development of an in situ spectroscopic method for cleaning validation using mid-IR fiber-optics. BioPharm. 2002, 15(5), 36, 38-40, 42, 71.