Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

If you are stakeholder in regards to a clean room facility it is worth noting that Part 2, 14644-2:2015 has also been updated, it is now much more focussed on customers deciding what is standards need to be rehired via risk assessments and monitoring plans.

Clean Room Validation and Testing


The updated ISO 14644-2:2015 – requires cleanroom stakeholders undertake careful monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration and recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.

The updates standard 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 these guides are in place for validating your controlled environment you may need to undertake more frequent testing to comply with the scope of your validation as defined by your process specific risk assessment.

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing


We undertake a wide range of clean room testing service for all types of industries from the Pharmaceutical through to the automotive industries. Our full range of services includes:

  1. Differential pressure– Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas, with your clean room having a higher pressure than adjacent less clean areas.
  2. Particulate testing – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process
  3. HEPA Filter Integrity Testing– Your ventilation system’s high efficiency particulate air (HEPA) filter, and its housing will be tested with DOP (Dispersed Oil Particulate) to ensure their integrity.
  4. Air supply and extract quantities– If your air supply is unidirectional we will measure and record the air velocity, while for non-unidirectional systems we will measure air supply.
  5. Air movement control– Studying the movement of the air within your clean room we will check that there is sufficient air movement to dilute or remove pollutants, preventing any contamination build-up.
  6. Containment leak testing– We will check the construction of your clean room to ensure that no airborne contamination can occur via leaks from higher pressure work areas adjacent to it.

APT Clean Room Testing offers peace of mind from a UKAS accredited test laboratory.

If you have a cleanroom and you need to discuss the changes to ISO 14644-01 & ISO 14644-02, and/or you wish to discuss your cleanroom monitoring and testing validation requirements, please contact Darren Helliwell on 07775623464 or email