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Contaminant Analysis

Chapter

Abstract

The identification of contaminants is the third area in which microscopy makes a major impact on pharmaceutical development. Interestingly, it may be the least published field in pharmaceutical microscopy and yet there are many high profile cases of particulate contamination and the resultant product recalls. The rapid identification of contaminants is critical to development and manufacturing success. The microscopist may not be able to solve the entire problem in the sense that he or she can point a finger at the exact source of failure and contamination, but the microscopist nearly always can point the industrial engineers in the right direction. In some cases, it may be as important to know what the contaminant is not as what it is.

Keywords

Carbon Black Activate Charcoal Drug Substance Polarize Light Microscopy Glass Fragment 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Reference

  1. Palenik SJ (1979) The Determination of Geographical Origin of Dust Samples. In: The Particle Atlas. 2nd Edition. Ann Arbor Science Publishers, Ann Arbor USAGoogle Scholar

General References

  1. Adrich DS, Smith MA (1995) Practical Applications of Infrared Microspectroscopy. Humecki HJ ed. Practical Guide to Infrared Microspectroscopy. Marcel Dekkar, Inc New York, pp 323–375 [Also reprinted in Applied Spectroscopy Reviews, (1999) 34(4):275–327]Google Scholar
  2. Barber TA (2000) Control of Particulate Matter Contamination in Healthcare Manufacturing. Interpharm Press, Englewood CO USAGoogle Scholar
  3. Blanchard J, Coleman J, Hayling, CD, Ghaderi R, Haeberlin B, Hart J, Jensen S, Malcolmson R, Mittelman S and Nagao LM, et al. (2004) Foreign Particles Testing in Orally Inhaled and Nasal Drug Products. Pharm Res 21(12):2137–47CrossRefGoogle Scholar
  4. Li G, Torraca G, Jing W, Wen ZQ (2009) Applications of FTIR in Identification of Foreign Materials for Biopharmaceutical Clinical Manufacturing. Vibrational Spectroscopy, 50:152–9CrossRefGoogle Scholar
  5. McCrone WC, Delly JG, Palenik, SJ et al. Ed. (1979) The Particle Atlas. 2nd Edition. Vol. V: Light Microscopy Atlas and Techniques, Ed: Ann Arbor Science Publishers, Ann Arbor USA; Volume I – Principles and Techniques; Volume II – Light Microscopy Atlas; Volume III – Electron Microscopy Atlas; Volume IV – The Particle Analyst’s Handbook; Volume V – Light Microscopy Atlas and Techniques; Volume VI – Electron-Optical Atlas and Techniques. The Particle Atlas is a necessary collection to have if you are doing contaminant and particulate analysis. I refer to it routinely. There is an electronic version available as well from McCrone Associates. Google Scholar

Internet References

  1. McCrone Research Institute: http://www.mcri.org/home/

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.GlaxoSmithKline Pharmaceuticals Physical PropertiesKing of PrussiaUSA

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