ISO Class 6 Clean Room

What is an lSO class 6 cleanroom?

An ISO Class 6 cleanroom is a high-purity environment with stringent controls over particulate matter, air quality, and environmental conditions. By maintaining strict air filtration and high air change rates, these cleanrooms provide a critical setting for industries that require minimal contamination to ensure product quality and safety.

What is the lsO 6 limit?

Particle Concentration Limits,Maximum allowable concentration of particles per cubic meter:

≥ 0.1 microns: 1,000,000 particles

≥ 0.2 microns: 237,000 particles

≥ 0.3 microns: 102,000 particles

≥ 0.5 microns: 35,200 particles

≥ 1.0 microns: 8,320 particles

≥ 5.0 microns: 293 particles

What are the requirements for lSO 6 cleanroom gowning?

Initial Preparation: Personnel should remove all personal items such as jewelry and watches before entering the gowning area.

Hand Washing: Hands must be thoroughly washed and dried before gowning.

Gowning Sequence:

Don Hair Cover: A hairnet or hood to cover all hair.

Don Face Mask: A mask to cover the nose and mouth, preventing contamination from respiratory particles.

Don Beard Cover: If applicable, a beard cover for any facial hair.

Don Shoe Covers: Shoe covers to prevent contamination from footwear.

Don Coverall: A full-body coverall made from non-shedding material, such as Tyvek or similar fabric. The coverall should be zipped up completely.

Don Gloves: Gloves made of nitrile or latex, covering the wrists and fitting snugly over the sleeves of the coverall.

Don Goggles or Safety Glasses: Eye protection may be required to prevent contamination from skin flakes or hair.

Don Hood: A hood to cover the head and neck, ensuring no skin or hair is exposed.

Final Check: Ensure all gowning items are properly worn and securely in place, with no gaps where particles can escape.

What are the ISO guidelines for clean rooms?

The ISO (International Organization for Standardization) provides comprehensive guidelines for cleanrooms and controlled environments through the ISO 14644 series. The primary standard in this series is ISO 14644-1, which establishes the classification of air cleanliness by particle concentration. 

What is the difference between iso6 and iso7?

The main difference between ISO Class 6 and ISO Class 7 cleanrooms is the allowable concentration of airborne particles, with ISO Class 6 being significantly cleaner. This difference impacts various aspects of cleanroom design, operation, and usage, including air filtration, HVAC requirements, gowning protocols, and application suitability.

What is an lSO 7 clean room?

An ISO 7 cleanroom is a controlled environment classified under the ISO 14644-1 standard, which specifies the maximum allowable concentration of airborne particles per cubic meter. This classification defines the cleanliness level of the air within the cleanroom and is used in various industries to ensure that processes sensitive to contamination are carried out under stringent conditions.

What is an ISO-6 Cleanroom Classification?

ISO-6 cleanrooms are clean environments classified according to ISO 14644-1, where the concentration of particles in the air must be below specified limits. Specifically, the number of particles allowed per cubic meter of air is: no more than 35,200 particles greater than or equal to 0.5 microns, and no more than 8,320 particles greater than or equal to 1.0 microns. ISO-6 cleanrooms are often used in industries that require high air cleanliness, such as semiconductor manufacturing, biotechnology, and pharmaceutical fields.

ISO 6 Cleanroom Standards and Applications

An ISO 6 cleanroom, as defined by the ISO 14644-1 standard, is a controlled environment where the concentration of airborne particles is strictly regulated, allowing no more than 35,200 particles per cubic meter for particles ≥0.5 microns and no more than 8,320 particles per cubic meter for particles ≥1.0 microns. These cleanrooms are essential for industries requiring high levels of air cleanliness, such as semiconductor manufacturing, biotechnology, and pharmaceuticals, to ensure product quality and prevent contamination. The stringent standards necessitate advanced filtration systems, frequent air changes, and strict operational protocols, including specialized gowning and cleaning procedures.

What are the requirements for lSO Class 6 cleanroom?

An ISO Class 6 cleanroom, as per ISO 14644-1 standards, must maintain a controlled environment with strict limits on airborne particle concentrations, specifically allowing no more than 35,200 particles per cubic meter for particles ≥0.5 microns and no more than 8,320 particles per cubic meter for particles ≥1.0 microns. To meet these requirements, the cleanroom must implement advanced HEPA or ULPA filtration systems, maintain high air change rates typically around 150-240 air changes per hour, and follow stringent operational protocols. These protocols include rigorous gowning procedures, regular and thorough cleaning routines, and strict behavioral guidelines for personnel to minimize contamination risks.

What are the requirements for lSO 6 cleanroom gowning?

Gowning requirements for an ISO 6 cleanroom are stringent to ensure minimal contamination from personnel. Individuals must wear full-body coveralls, including hoods, face masks, gloves, and shoe covers made of low-shedding materials to prevent particles from entering the cleanroom environment. The gowning process typically includes a specific sequence to don the attire, starting with hand washing and application of gloves, followed by putting on the coverall, hood, mask, and finally the shoe covers, often in a designated gowning area to maintain cleanliness. These procedures are designed to minimize the introduction of contaminants from skin, hair, and personal clothing, thereby maintaining the strict particle limits required for an ISO 6 cleanroom.

ISO Class 6 Cleanroom Design and Build

Designing and building an ISO Class 6 cleanroom involves creating a controlled environment with strict limits on airborne particle concentrations, requiring advanced engineering and construction practices. The cleanroom must be equipped with HEPA or ULPA filtration systems to achieve high air purity, maintaining no more than 35,200 particles per cubic meter for particles ≥0.5 microns. The design includes high air change rates, typically 150-240 air changes per hour, to continuously remove contaminants. Surfaces and materials used in construction are smooth, non-shedding, and easy to clean. The layout includes airlocks and gowning areas to control personnel entry and prevent contamination. Additionally, the cleanroom is maintained under positive pressure to prevent the ingress of contaminants from adjacent areas, ensuring a consistently clean environment suitable for sensitive operations in industries like pharmaceuticals, biotechnology, and semiconductor manufacturing.