Our cleanroom validation services assess and ensure compliance with applicable regulatory requirements and ISO 14644-1, maintaining the required environmental conditions and cleanliness levels within cleanroom facilities.
Five tests confirm that the cleanroom's air supply, filters and cleanliness level meet its specified classification under ISO 14644-1.
The results are documented and compiled into a comprehensive validation report, providing supporting evidence of the facility's compliance with its specified cleanroom classification and applicable requirements.
A 360 smoke study, also called a multi-angle smoke study, uses a fogger and a multiple-camera recording system to visualise and assess airflow patterns within sterile areas. The generated smoke follows the airflow pattern, including the downward movement of air under laminar airflow conditions, so the direction and behaviour of the airflow can be seen.
Recording simultaneously from cameras at different positions gives a comprehensive visual assessment of airflow patterns, supporting the evaluation of airflow uniformity and of potential turbulence or airflow disruptions.
We assess the quality of utility gases used in cleanroom environments and their suitability for applications involving potential product contact. Testing evaluates critical parameters against applicable quality specifications and contamination control requirements, and helps identify potential sources of contamination.
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