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Research ArticleRESEARCH

Some Observations on Airborne Particles in the Critical Areas of a Blow-Fill-Seal Machine

Stefan Sundström, Bengt Ljungqvist and Berit Reinmüller
PDA Journal of Pharmaceutical Science and Technology January 2009, 63 (1) 71-80;
Stefan Sundström
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  • For correspondence: stefan.sundstroem@astrazeneca.com
Bengt Ljungqvist
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Berit Reinmüller
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References

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    1. Bradley A.,
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    3. Sinclair C. S.,
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    Airborne microbial challenges of Blow/Fill/Seal equipment: a case study. J. Parenter. Sci. Technol. 1991, 45 ( 4), 187– 192.
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    1. Jones D.,
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    Environmental microbial challenges to an aseptic blow-fill-seal process—a practical study. PDA J. Pharm. Sci. Technol. 1995, 49 ( 5), 226– 234.
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    1. Price J.
    Blow-fill-seal technology: Part I. A design for particulate control. Pharm. Technol. 1998, 22 ( 2), 62– 72.
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    1. Leo F.,
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    Design, development and qualification of a microbiological challenge facility to assess the effectiveness of BFS aseptic processing. PDA J. Pharm. Sci. Technol. 2005, 59 ( 1), 33– 48.
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  5. 5.↵
    1. Leo F.,
    2. Poisson P.,
    3. Sinclair C. S.,
    4. Tallentire A.
    Impact of Blow/Fill/Seal process variables in determining rate of vial contamination by air dispersed microorganisms. PDA J. Pharm. Sci. Technol. 2005, 59 ( 5), 320– 331.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Price J.
    Blow-fill-seal technology: Part II. Design optimization of a particulate control system. Pharm. Technol. 1999, 23, 42– 52.
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  7. 7.↵
    1. Whyte W.,
    2. Matheis W.,
    3. Dean-Netcher M.,
    4. Edwards A.
    Airborne contamination during blow-fill-seal pharmaceutical production. PDA J. Pharm. Sci. Technol. 1998, 52 ( 3), 89– 99.
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  8. 8.↵
    1. Ljungqvist B.,
    2. Reinmüller B.,
    3. Löfgren A.,
    4. Dewhurst E.
    Current practice in the operation and validation of aseptic blow-fill-seal processes. PDA J. Pharm. Sci. Technol. 2006, 60 ( 4), 254– 258.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Sundström S.,
    2. Ljungqvist B.,
    3. Reinmüller B.
    Some observations on airborne particles in blow-fill-seal filling rooms. PDA J. Pharm. Sci. Technol. 2007, 61 ( 3), 147– 153.
    OpenUrlAbstract/FREE Full Text
  10. 10.↵
    ISO 14644-1. Cleanrooms and associated controlled environments. Part 1: Classification of air cleanliness. International Organization for Standardization: Geneva, 1999.
  11. 11.↵
    Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice; Rockville, MD, 2004.
  12. 12.↵
    1. Ljungqvist B.,
    2. Reinmüller B.
    Practical Safety Ventilation in Pharmaceutical and Biotech Cleanrooms. PDA: Bethesda, MD; DHI Publishing LLC: River Grove, IL, 2006.
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PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 1
January/February 2009
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Some Observations on Airborne Particles in the Critical Areas of a Blow-Fill-Seal Machine
Stefan Sundström, Bengt Ljungqvist, Berit Reinmüller
PDA Journal of Pharmaceutical Science and Technology Jan 2009, 63 (1) 71-80;

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Some Observations on Airborne Particles in the Critical Areas of a Blow-Fill-Seal Machine
Stefan Sundström, Bengt Ljungqvist, Berit Reinmüller
PDA Journal of Pharmaceutical Science and Technology Jan 2009, 63 (1) 71-80;
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