Cleanrooms Simply Explained

Cleanrooms contribute to our everyday lives in countless ways. From the electronic devices we use every day, to medical breakthroughs that prolong our lives, cleanrooms are an essential part of good manufacturing practices (GMP). This helps ensure that products are consistently produced and controlled according to quality standards.[1]

What is a Cleanroom?

The Lawrence Berkeley National Laboratory cites the following ISO standard 14644-1 definition. A cleanroom is defined as “a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g., temperature, humidity, and pressure, are controlled as necessary.” Cleanrooms are sometimes referred to as sterile chambers.

Cleanroom Classifications

ISO7 clean room diagram showing airlock system

Image source: mecart-cleanrooms.com

ISO standard 14644-1 also defines nine classes of cleanrooms: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9. These classes are determined by the quantity and size of the particles allowed in the room. The cleanest class is ISO 1. These facilities are extremely rare and are used for highly specialized tasks that require absolute pristine conditions. For example, the European Space Agency uses an ISO 1 cleanroom to examine temperature sensors destined for the surface of Mars. Conversely, a typical medical office or lab is usually class ISO 9. These rooms are well-ventilated and cleaned, but are not held to the same strict standards that true cleanrooms are held to.

The most common classes of cleanrooms are ISO 7 and ISO 8. These classes are commonly used for electronics and medical device manufacturing. Depending on its use, an ISO 8 cleanroom may require a separate gowning room, but not airlocked entry. An ISO 7 cleanroom will likely require an ISO 8 gowning room with an airlock before entry into the ISO 7 area, as shown in the diagram.

How Do Cleanrooms Stay Clean?

Cleanrooms utilize a variety of methods to prevent air particles, bacteria, and other contaminants from entering the work area. This may include employee gowning and washing techniques, airlocks, and specific cleaning standards and protocols.[1]

One of the greatest potentials for contamination in these areas comes directly from the personnel who work with in them.[2] Skin-shedding and breathing are primary risks and are of particular concern in the healthcare and pharmaceutical sectors. Gowning and masking help mitigate these risks.

Additionally, cleanrooms use air filters as the primary method of maintaining optimal levels of particulate matter. ULPA (i.e., ultra-low particulate air) and HEPA (i.e., high efficiency particulate air) filters remove approximately 99.9% of particulates from the air using either a laminar or turbulent air flow technique. Laminar air flow moves air in a straight downward direction into a ULPA or HEPA filter. Turbulent air flow moves air in a non-directional. Cleanrooms often used a combination of air flow techniques to move particulates through the air filters.[3]

Whatever contaminants remain in the cleanroom must be removed by regular and strict cleaning protocols. At Commercial Building Maintenance LLC, our meticulous janitorial team carries a biolab cleaning certification. From cleanrooms to offices and labs, CBM will help you maintain a safe and clean environment for your staff to work in and for your clients to visit.

Contact us today for a free cleanroom cleaning estimate. We look forward to serving you!