Clean Room Commissioning

Cleanrooms are used in a wide variety of industries such as Pharmaceutical, Biotech, and Medical Device. Each Cleanroom play critical roles in maintaining contamination free production environments for critical processes. To ensure your cleanroom is working as designed it is essential that a well planned and executed cleanroom testing and certification and maintenance program is undertaken for operation and regulatory compliance. APT cleanroom testing offers clean room testing and clean room commissioning certification.

Clean Room Environment


It is imperative that companies know if any airborne contaminants put products at risk. It is also very important to understand what the contaminants are, and their origin. Important environmental measurements, like airborne viable particle measurements, assist with keeping processes in control and with helping to find the root cause of unwanted events such as the ingress of filter pollutants such as microbes, dust, and chemical vapours. With so many hazards to contend with it is essential to monitor cleanrooms for viable particles and other potential contaminants to ensure a clean environment is maintained at all times.

These controlled environments when used in conjunction with the correct protective clothing, equipment, and practices, keep people safe while allowing manufacturing, research, and even medical procedures to be performed consistently and with minimum downtime.

Clean Room Commissioning
To ensure this consistency, standards have been created by the International Standards Organization. With the implementation of ISO 14664-1: 2015 and ISO 14644-2: 2015 through to 10 as well as ISO14698-1 through 3. These documents outline terminology and measurement units, compliance testing standards, surface and air contamination definitions, and more referenced when undertaking clean room commissioning and validation testing.

Cleanroom Technology

Cleanroom technology has been greatly refined over the last 20 years. Improved HEPA filtration along with HVAC efficiencyand construction technology is improving efficiency. HVAC and filtration is especially important in cleanroom design, as the air-change rate ranges help determine a cleanroom’s classification. The ACR is how many times per hour the volume of air in the room is replaced. In a normal home, the ACR is a maximum of 2, but cleanrooms can reach over 700 – the higher ACR the higher the ISO standard for the cleanroom.

According to the latest ISO standards, there are 8 classes of cleanrooms, with different standards required for various applications. Each of the eight ISO classes is determined by how much particulate of specific sizes exist per cubic meter.

The corresponding ISO standards necessary for each particular class of cleanroom should remain consistent across all equipment to ensure full protection. Without ISO adherence, contamination can cause equipment breakdown and quality degradation. Considering most cleanrooms are a company’s main critical it is essential that they are maintained in-line with relevant ISO standard.

Each classification also has different testing requirements to ensure standards are being met. The following chart lists mandatory tests and frequency to maintain ISO compliance

In addition to the Particulate Count Testing and HEPA filter testing you can also undertake containment leakage, recovery, and airflow visualisation. These additional tests aren’t required for compliance but can help proactively maintain a cleanroom environment, especially in high-risk environments with stringent ISO standards.

APT has your Clean Room Commissioning Covered.

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464 or email at info@aptcleanroomtesting.co.uk

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