Biotechnology and Pharmaceutical Cleanroom Testing

Biotechnology and Pharmaceutical Cleanroom Testing

There are many different types of industries that use cleanrooms, so what makes a cleanroom in one industry different than another? It’s quite a common question. Let’s have a look at the different cleanroom industries in more detail along with varying ISO requirements.

Many biotechnology and pharmaceutical cleanrooms are specified at ISO Class 5 to ISO Class 8 and apply to a large portion of the cleanroom standards. If you’re not familiar, ISO classes and standards are set by the International Organisation for Standardisation.

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The many ISO standards provide various requirements, specifications, guidelines and characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their intended purpose.

In all cleanrooms, particulate matter is a great concern. Specifically, viable particulate contamination should receive careful consideration and attention. Viable particulate contamination refers to the ability to keep the room clean by typically using modular or stick-built components with integral cove bases and corners, as well as coved ceilings in order to maintain a cleanable surface condition. This high grade finish is crucial for biotechnology and pharmaceutical cleanroom standards.

In all instances concealed areas may allow for bacterial growth which is unacceptable. These clean rooms typically use cleanroom technology that keeps the seal unbroken during sanitation and filter changes. Biotechnology and pharmaceutical cleanrooms typically have a heavy focus on pressurisation control, the elimination of cross contamination and the ongoing filtration of outdoor air and indoor air.

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

  1. 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.
  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. 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– 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. 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.
  6. 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.

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APT Cleanroom 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:  info@airpressuretesting.net