Cleanroom Standard ISO 14644-2:2015 Key Updates

Cleanroom Standard ISO 14644-2:2015 Key Updates

The prime function of ISO 14644-2 is to prove continued compliance with ISO 14644-1. The 2015 edition emphasises the need to consider a monitoring strategy in addition to the annual cleanroom revalidation or initial validation in order to gain a continuing flow of data over time and therefore providing a detailed view of the performance of the cleanroom.

Some benefits gained from monitoring include:

• Develop trends over time and therefore faster response to events
• Enhanced knowledge of the cleanroom performance which will allow for more effective risk assessment and therefore improved control of operational costs and product impact.

The expectation of this standard is for you to know and be able to demonstrate what parameters can affect the classification performance of your cleanroom relative to the risk of the purpose of the cleanroom, take into consideration how these parameters can influence each other, and to be able to show that your cleanroom is in a state of control.

The ISO 14644-2 key updates are listed in the attached document

ISO 14644 2 2015 Key Updates

Summary of steps involved in the Creation, Implementation & Maintenance of a Monitoring Plan

1. Risk Assessment Input (Ref Annex A for considerations)
2. Risk Assessment Outputs – Monitoring PlanParameters to be monitored

• Locations to be monitored
• Measurement methods
• Calibration of instrumentation
• Acceptance criteria (Ref AnnexB)
• Procedure if OOS occurs
• How data will be recorded
• Trending requirements
• Reporting requirements
• Frequency of review

3. Review & Approval
4. Implement Plan
5. Analyse trends & performance
6. Document any actions required
7. Review monitoring plan

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Submitted by our expert Cleanroom Tutor, Kevina O’Donoghue