The Importance of Validating your Cleanroom

18th Jan 2017 Regular cleanroom validation can help detect and identify any harmful contamination sources, as well as assuring regulatory bodies and clients that your controlled environment continues to meet its ISO Class parameters. In short, it ensures your critical process remains protected. If a cleanroom does not have a current validation certificate to prove it meets the particle concentration limits set out in ISO 14644-1:2015 then it will not be compliant to ISO 14644-2:2015. What is the risk to your business if you don’t regularly validate your Cleanroom? Although guidance is in place for validating your controlled environment, the scope and frequency of your validations should be defined by your businesses individual risk assessment. Intervals should be assigned in-line with each risk identified. Failure to do so could result in high maintenance costs and loss of operational time.

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