ISO 14644-1:2015 Compliant Cleanroom Monitoring
ISO 14644-1 specifies the classification of air cleanliness in terms of the concentration of airborne particles in cleanrooms and clean zones. It details sampling procedures and monitoring plans, as well as defining how validation sampling plans and data evaluation should be conducted.
A statistical approach is taken for the selection and number of sampling locations, and the evaluation of the data collected. This approach allows each location to be treated independently with at least a 95% level of confidence that at least 90% of the cleanroom or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness.
ISO 14644-1:2015 - Classification of air cleanliness by particle concentration
To ensure that your cleanroom continues to perform efficiently and your critical processes remain protected, it needs to be validated to prove it complies with ISO 14644-1.
Each sampling location is to be evaluated separately and all sampling locations must pass for a cleanroom/zone to comply.
ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-2 recommends customers complete risk assessments and monitoring plans to determine the frequency of testing and validation to their processes.
ISO 14644-2 states the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months, and ISO class 6 and above is 12 months.
Although this guidance is provided for validating your controlled environment, the scope and frequency of your validations should be defined by your process-specific risk assessment.
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Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
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