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Practical experiences in particle deposition monitoring

Abstract The rate of deposition of airborne particles determines the risk of product contamination and demonstrates the operational quality of a cleanroom. The particle deposition rate at a particular location and time depends on the deposition velocity and the concentration of articles. The concentration of particles larger than 10 μm cannot be measured easily; therefore […]
  • author: Koos Agricola
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ISO 14644 – Revision to Parts 1 and 2

Actions and implications of the changes in the International cleanroom standard. ISO 14644 ISO 14644 International cleanroom standard  Part 1 in 1999 12 part standard Electronics, healthcare, biotechnology, pharmaceuticals Replaced FS 209E in 2001 Accepted by EU GMP in 2003 for classification but not monitoring FDA aseptic filling guide in 2004. ISO 14644 – parts […]
  • author: Sandle Tim
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Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding
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