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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleRESEARCH

Cleanroom Airborne Particulate Limits and 70% Isopropyl Alcohol: A Lingering Problem for Pharmaceutical Manufacturing?

Tim Eaton
PDA Journal of Pharmaceutical Science and Technology November 2009, 63 (6) 559-567;
Tim Eaton
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References

  1. ↵
    Annex 1, Manufacture of Sterile Medicinal Products, European Union GMPs; European Commission, 2003.
  2. ↵
    Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice; US Food and Drug Administration, 2004.
  3. ↵
    Particle Measuring Systems (PMS) Inc., Application Note No. 15, Particle loss in transport tubing, 1997.
  4. ↵
    1. Hinds W.
    Aerosol Technology; John Wiley and Sons: New York, 1999; pp 278– 304.
  5. ↵
    1. Whyte W.
    Cleanroom Technology, Fundamentals of Design, Testing and Operation; John Wiley and Sons: Chichester, UK, 2001; p 56.
  6. ↵
    EN ISO 146441. Cleanrooms and Associated Controlled Environments Part 1: Classification of air cleanliness. Geneva, International Organization for Standardization, ISO, 1999.
  7. ↵
    1. Veysey S.
    Best Practice for Continuous Particle Monitoring to EU GMP Annex 1. The Pharmaceutical and Healthcare Sciences Society, Autumn Conference. Nottingham, England. October, 2008.
  8. ↵
    1. Hargreaves P.
    Revised EU GMP Annex 1. Parenteral Drug Association, Manufacture of Sterile Medicinal Products EU/PICS revised GMP Annex 1, Workshop. Geneva. November, 2008.
  9. ↵
    1. Eaton T.
    Annex 1 of the EC Guide to Good Manufacturing Practice (EC GGMP) and continuous particle monitoring—help or hindrance of cleanroom manufacturing? European Journal of Parenteral and Pharmaceutical Sciences 2007, 12 ( 2), 3– 7.
    OpenUrl
  10. ↵
    1. Whyte W.,
    2. Eaton T.,
    3. Farquharson G.,
    4. Ljungqvist B.,
    5. Reinmüller B.
    Letter to the Editor. European Journal of Parenteral and Pharmaceutical Sciences 2007, 12 ( 2), 47– 49.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 63 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 6
November/December 2009
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Cleanroom Airborne Particulate Limits and 70% Isopropyl Alcohol: A Lingering Problem for Pharmaceutical Manufacturing?
Tim Eaton
PDA Journal of Pharmaceutical Science and Technology Nov 2009, 63 (6) 559-567;

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Cleanroom Airborne Particulate Limits and 70% Isopropyl Alcohol: A Lingering Problem for Pharmaceutical Manufacturing?
Tim Eaton
PDA Journal of Pharmaceutical Science and Technology Nov 2009, 63 (6) 559-567;
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