In January 2016, ISO introduced an update to standards ISO 14644-1:2015 – Classification of air cleanliness by particle concentration and ISO 14644-2:2015 and Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
APT Cleanroom Testing have received many questions in regards to what impact the updated standard has on validation and testing frequency. To try and help our clients we have tried to answer those questions here.
It is essential that your undertake clean room particle testing to prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process,
Within ISO 14644-2:2015 – Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration; recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.
It states the maximum time interval between airborne particle concentration testing for cleanrooms of ISO class 5 and below at six months and ISO class 6 and above at 12 months. Here is a quick table showing this in more details.
|Test Parameter||Class||Maximum Time Interval|
|Airborne particle concentration||ISO Class 5 and below||6 months|
|ISO Class 5 and above
|Schedule of additional tests|
|Airflow velocities in unidirectional airflow||All classes>||6 months|
|Airflow volume supply in non-unidirectional airflow||All classes||12 months|
|Pressure differentials||All classes||Continuously monitored|
Using our vast technical knowledge along with our commitment to quality we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time.
If you would like more information on our clean room testing please contact APT Cleanroom Services at firstname.lastname@example.org or call Darren direct on 07775623464.