Medical Device Cleanroom Testing

Cleanrooms for medical device technology typically fall under ISO Class 7 and ISO Class 8 range. As you can imagine the manufacturing process for these products ensures that the surface of the product does not have particulate contamination when it is completed. So, it is imperative that the cleanliness level inside the room is maintained both from a cleanroom standpoint.

In many cases people/personal is the major contaminator in most processes. This is why personnel are required to wear full gowns, booties, gloves, and hairnets in medical device manufacturing, as well as the biotech, pharmaceutical and semiconductor industries. While some medical device cleanrooms may not always adhere to the same stringent gowning practices as pharmaceutical cleanrooms, the protocol and cleaning process is just as important. The cleanroom environment for medical devices usually aims to eliminate surface contamination, or viable particulate, on their products.

We undertake a wide range of clean room testing service for the Biotechnology and Pharmaceutical industries such as:

1. Viable Particle Detection – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process.

2. HEPA Filter installation leak 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.

3. 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.

4. Differential pressure between cleanrooms – 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.

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 Sound Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at