If you are responsible for a cleanroom or a cleanroom environment then you need to know that ISO 14644-1 and -2 have reached Final Draft International Standard (FDIS) status and are out to the member states for final vote. According to some sources these new ISO standards could be contractually invoked as early as October 2015!

Are you Ready?

A few key changes include:

  • For ISO 14644-1 the main update is to include a two-method sampling scheme, where testing will need to include both a randomized sampling location selection and a risk-based location sampling technique.
  • For ISO 14644-2 in addition to performing initial and periodic testing to verify adequacy of the clean room environment, there is a new requirement for a monitoring strategy to provide a continuing flow of data to gain greater insight on the clean room performance.

For members of the life science industry, such as Pharmaceutical, Medical Device, API/Component suppliers, and Compounding Pharmacies (Outsourcing Facilities) now is the time to:

  • Obtain the new FDIS standards
  • Evaluate your current SOPs for cleanroom operation, monitoring, and maintenance against the requirements of the new standards
  • Update SOPs,
  • Train your staff on the SOPs and other changes resulting from these changes
  • Position yourself for implementation and meeting compliance requirements once the standards go live!
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