14644 Parts 1 & 2: What does this really mean for users?

Following January 2016, the revised ISO 14644 Parts 1 and 2 replaced all previous standards. Part 1 deals with revised particle counting standards and the cleanroom classification whilst Part 2 refers to the monitoring of compliance with Part 2 using a risk based assessment procedure.

Although these are not pieces of legislation, most clean room production contracts and activities require compliance with the most recent standards. As a result of these changes the MHRA has given up to 12 months for users to revise their activities in order to comply with the most recent standards. The FDA has not given any formal indication of any transitional “period of grace.”

As the second half of 2016 has fast approached leaving only 50% of the MHRA’s grace period left, it is vital that all cleanroom users ensure that their practices are compliant with Parts 1 and 2. In regards to Part 3 of the standard “Test Methods,” this is still under revision and is expected to be published in 2017.

What does this mean?

Whilst important, Part 1 sets out revised particle counting standards leaving little room for imaginative interpretation! Classification by equation is replaced by table, definitive guidance is delivered for working plane, sample points, numbers and location and averaging methodology are all clearly stated.

Part 2 on the other hand is a more difficult proposition moving the goal posts by two principle means:

  1. It moves compliance to a risk assessment (RA) based process where you are responsible for drawing up the RA, ensuring it is fit for the intended application
  2. It requires “demonstration of control”

However, in some instances (for example testing frequency), it sets out minimum standards and is up to you to determine if these are consistent with your RA and whether frequency should be increased. This shift in responsibility is further compounded by the approach leading to differences in RA between rooms, and also between products in the same room. It also requires a complete view to be taken incorporating secondary containment within the clean room (fume cupboards, safety cabinets, LAF’s etc.) into the overall room RA.

Various elements set out in Annex A suggests what users should consider as part of an RA: identification of risks, the relationship between risk and monitoring position, alert and alarm policies, it falls short of settling out a complete framework for what should and what doesn’t need to be contained within a competent RA.

How can Crowthorne help?

Development of a proper RA may require an independent view from outside your organisation which Crowthorne is able to provide. With great expertise in the field, our team is well acquainted with developing a compliant RA for your business.

Items that will  be considered are:

  • Room morphology
  • Critical parameters relevant to product and process
  • Annex A risk
  • Monitoring processes
  • Alert and alarm policies and justification of tolerances
  • Frequency of testing, number and location of sample points
  • Data collection, spot and trend analysis
  • Amendment of current compliance to the new standard
  • Amendment of GMP practice to the new standard
  • Reconciliation with historic data
  • Development of a pathway for compliance with Parts 1 & 2 and preparation for Part 3

In looking at Part 2 compliance, cleanroom personnel use of common/shared pathways should be avoided, as any differences between current and proposed practice will need to be strongly supported against close review with compliance guidelines.


For further information, please contact Kevin Beauchamp at kevinb@chts.co.uk.


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