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Environmental Engineering Controls and Monitoring in Medical Device Manufacturing

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The trend toward an aging population in the highly developed countries of the world has the demand for innovative biomedical devices and tools at record levels. The products desired in this market are typically smaller and more portable than their predecessors, and require more sophisticated components and allied manufacturing technologies and automation techniques. In essence, similar to traditional consumer products, biomedical devices such as patient monitors, drug deliver systems, therapeutic devices, and life assisting devices have all shrunk in size yet still have market expectations of enhanced performance characteristics and features [1–35].

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References

  1. American Conference of Governmental Industrial Hygienists (2005) Threshold limit values for chemical substances and biological exposure indices. ACGIH, Cincinnati

    Google Scholar 

  2. American Conference of Governmental Industrial Hygienists (2001) Air sampling instruments 9th ed. ACGIH, Cincinnati, OH

    Google Scholar 

  3. American Conference of Governmental Industrial Hygienists (1995) Industrial ventilation: a manual of recommended practice 22nd ed. ACGIH, Cincinnati

    Google Scholar 

  4. Burgess WA et al. (1989) Ventilation for control of the work environment. John Wiley & Sons, New York

    Google Scholar 

  5. Burton DJ (2003) General methods for the control of airborne hazards. In The Occupational Environment: Its Evaluation, Control, and Management 2nd Ed. (S.R. DiNardi). AIHA, Fairfax, VA

    Google Scholar 

  6. Conviser S (2000) The future of ethylene oxide sterilization. Infection Control Today - 06/2000, http://infectioncontroltoday.com/articles/061feat.html

  7. Environmental Science and Technology Online (2005) It’s in the microwave popcorn, not the Teflon® pan. Science News report November 16th

    Google Scholar 

  8. European Agency for Safety and Health at Work (2006) Indicative Occupational Exposure Limit Values http://europa.eu.int/comm/employment_social/health_safety/docs/oels_en.pdf

  9. European Environmental Agency, http://www.eea.eu.int

  10. European Union (1996) Council directive 96/29/EURATOM. Official Journal L159 - 29/06/1996, pp 0001-0114

    Google Scholar 

  11. European Commission Guide to Good Manufacturing Practice Revision to Annex 1(2003) Manufacture of Sterile Medicinal Products, http://pharmacos. eudra.org

  12. Gaggeler HW et al. (1989) The epiphaniometer, a new device for continuous aerosol monitoring. J Aerosol Science 20(6):557-564

    Article  Google Scholar 

  13. George DK et al. (2003) An introduction to the design of local exhaust ventilation systems. In The Occupational Environment: Its Evaluation, Control, and Management 2nd Ed. (S.R. DiNardi). AIHA, Fairfax, VA

    Google Scholar 

  14. Institute of Occupational Medicine for Health & Safety Executive 2004 Research Report 274, http://www.hse.gov.uk/research/rrpdf/rr274.pdf

  15. International Commission on Non-Ionizing Radiation Protection (2002) General approach to protection against non-ionizing radiation. Health Physics 82(4): 540-548

    Google Scholar 

  16. International Organization for Standardization, http://www.iso.org

  17. International Organization for Standardization (2000) Cleanrooms and associated controlled environments-part 2: specifications for testing and monitoring to prove continued compliance with ISO 14644-1, ISO 14644-2:2000. ISO, Geneva

    Google Scholar 

  18. International Organization for Standardization (1999) Cleanrooms and associated controlled environments-part 1: classification of air cleanliness, ISO 14644-1:1999. ISO, Geneva

    Google Scholar 

  19. Heinsohn RJ (1991) Industrial ventilation: engineering principles. WileyInterscience, New York

    Google Scholar 

  20. Hitchock et al. (2003) Nonionizing radiation. In The Occupational Environment: Its Evaluation, Control, and Management 2nd Ed. (S.R. DiNardi). AIHA, Fairfax, VA

    Google Scholar 

  21. Kittleson DB (1998) Engines and nanoparticles: a review. J Aerosol Science 29(6):575-578

    Article  Google Scholar 

  22. Maslansky CJ, Maslansky SP (1993) Air monitoring instrumentation. Van Nostrand Reinhold, New York

    Google Scholar 

  23. Maynard AD (2004) Examining elemental surface enrichment in ultrafine aerosol particles using analytical scanning transmission electron microscopy. Aerosol Science & Technology 38(4):365-381

    Google Scholar 

  24. National Institute of Safety and Hygiene at Work, http://www.mtas.eu/insht/en/principal/insht_en.htm

  25. National Institute of Occupational Safety and Health (2005) Pocket guide to chemical hazards. US Dept. of Health and Human Resources, Washington, DC

    Google Scholar 

  26. Nickerson R, Sheu M (2000) Plasma cleaning of medical devices. Critical Cleaning in Precision Manufacturing

    Google Scholar 

  27. Reitz V (2004) Sterilization for beginners. Medical Design Magazine - 06/2004, http://www.medicaldesign.com/articles/ID/12003

  28. Ritter GW (2000) Using adhesives effectively in medical devices. Medical Device and Diagnostic Industry Magazine, http://devicelink.com

  29. Salditt P (2004) Trends in medical device design and manufacturing. J SMT 17 (3):19-24

    Google Scholar 

  30. SKC, Inc. (2004) Comprehensive catalog and sampling guide. SKC Inc., Eighty Four, PA

    Google Scholar 

  31. Soule RD (1991) Industrial hygiene engineering controls. In Patty’s Industrial Hygiene and Toxicology 4th ed. (Clayton and Clayton). John Wiley & Sons, New York

    Google Scholar 

  32. The InfoShop (2003) Biomedical applications of nanoscale devices. The InfoShop report September 12th

    Google Scholar 

  33. US Environmental Protection Agency, http://www.epa.gov

  34. US Occupational Safety and Health Administration, http://www.osha.gov

  35. Washington University-St. Louis, Missouri (December 2005) Dr. Da Ren Chen’s faculty webpage, http://mesun4.wnstl.edu/me/faculty/dc/dc_reseach.pdf

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(2007). Environmental Engineering Controls and Monitoring in Medical Device Manufacturing. In: Jackson, M.J., Ahmed, W. (eds) Surface Engineered Surgical Tools and Medical Devices. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-27028-9_10

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  • DOI: https://doi.org/10.1007/978-0-387-27028-9_10

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-387-27026-5

  • Online ISBN: 978-0-387-27028-9

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