ISO 14644 – Revision to Parts 1 and 2

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 #1

• ISO 14644-1:2015 – Part 1: Classification of air cleanliness
• ISO 14644-2:2015 – Part 2: Specifications for testing and monitoring to prove continued compliance with
  ISO 14644
•  ISO 14644-3:2005 – Part 3: Test methods
•  ISO 14644-4:2001 – Part 4: Design, construction and start-up
• ISO 14644-5:2004 – Part 5: Operations
  

  ISO 14644 – parts #2

• ISO 14644-6: 2004 – Vocabulary
• ISO 14644-7:2004 – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
•  ISO 14644-8:2013 – Part 8: Classification of air cleanliness by chemical
  concentration (ACC)
•  ISO 14644-9:2012 – Part 9: Classification of surface cleanliness by particle
  concentration
•  ISO 14644-10:2013 – Part 10: Classification of surface cleanliness by chemical
  concentration
•  No part 11 in draft
•  ISO 14644-12:draft – Part 12: Classification of air cleanliness by nanoscale
  particle concentration
•  ISO 14644-13:draft – Part 13: Cleaning of surfaces to achieve defined levels of
  cleanliness in terms of particle and chemical classifications
• ISO 14644-14:draft – Part 14: Assessment of suitability for use of equipment by
  airborne particle concentration

Cleanrooms

• Cleanrooms
– Design
• Air
– Filtration (HEPA)
– Pressure differentials
– Air changes
– Clean-up times
– UDAF: air velocity
– Personnel
– Gowning
– Behaviours
– Cleaning and disinfection

ISO 14644

• Became live in December 2015:
•  ISO 14644-1 – Classification of air cleanliness
• ISO 14644-2 – Specifications for testing and monitoring to prove continued compliance by ACP.
• Both parts deal with particles only

ISO 14644 Part 1 – purpose

Classification is the process of qualifying the cleanroom environment by the number of particles using a standard method.

• Determine classification of cleanroom according to standards e.g. Room x is ISO class y.
•  Distinct from routine environmental monitoring.
• Distinct from process monitoring e.g. ongoing assessment of aseptic filling.