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Cleanroom Gowning Requirements
Cleanroom Gowning Requirements
Cleanrooms are designed to provide controlled environments for many stringent applications. Often used in electronics manufacturing, food production, medical research, or scientific laboratories, cleanrooms require a high-purity environment, as debris and other particles can be destructive to processes. To prevent cross-contamination or the entry of debris and particles, gowning in protective gear reduces the introduction of dust, skin cells, hair, or other particulates. The ISO class and industrial application of the cleanroom determine proper cleanroom gowning requirements.
Contact us to discuss your cleanroom requirements, and we will happily answer any questions you may have. Cleanrooms by United proudly serves various industries with cleanroom solutions.
ISO Class Gowning Protection Levels
Depending on the cleanroom classification level and operating processes, gowning requirements vary. A lower, more comfortable level of cleanroom garments is required in lower classified cleanrooms to maintain particulate levels. In higher classifications, more extensive coverage is necessary.
ISO Class 5 Gowning Requirements
Class 100 or ISO Class 5 cleanrooms must maintain air cleanliness levels with a maximum of 100 particles (≥0.5 µm) per cubic meter of air. They include purification systems that provide filter coverage of 60-70% and a minimum of 300 air changes per hour, with an airflow rate of 36-65 CFM per square foot. ISO Class 5 gowning requirements are more stringent, requiring nonwoven materials, such as Goretex, and the use of apparel, including:
- Beard Cover/Face Mask
- Booties
- Coverall
- Gloves
- Hair Cover and Hood
ISO Class 6 Gowning Requirements
Similar to Class 100, Class 1000 or ISO Class 6 cleanrooms require higher levels of protective gowning. This classification maintains air cleanliness levels with a maximum of 1,000 particles (≥0.5 µm) per cubic meter of air, with filter coverage of 20-30%, a minimum of 180 air changes per hour, and an airflow rate of 18-32 CFM per square foot. The use of the following nonwoven apparel is necessary to meet ISO Class 6 gowning requirements:
- Beard Cover
- Booties
- Coverall
- Gloves
- Hair Cover
ISO Class 7 Gowning Requirements
With less strict particulate contamination requirements, Class 10,000 or ISO Class 7 cleanrooms meet air cleanliness levels with a maximum of 10,000 particles (≥0.5 µm) per cubic foot. Their filtration systems must provide filter coverage of 15-25% with a minimum of 60 air changes per hour and an airflow rate of 9-16 CFM per square foot. Featuring a lower purity classification, ISO Class 7 gowning requirements include the following apparel:
- Beard Cover
- Hair Cover
- Lab Coat
ISO Class 8 Gowning Requirements
ISO Class 8 cleanrooms, or Class 100,000, have a maximum particle count requirement of 100,000 particles (≥0.5µm) per cubic foot of air. In this class, air filtration systems provide 4-5% coverage with a minimum of 20 air changes per hour and airflow rates of 4-8 CFM per square foot. Similar to ISO Class 7, ISO Class 8 gowning requirements are less extensive and feature the following protective apparel:
- Beard Cover
- Hair Cover
- Lab Coat
Proper Cleanroom Gowning Procedure
To reduce contamination entering the cleanroom, it may feature a gowning room or anteroom for proper gowning procedures. It’s essential to begin with thorough handwashing and removing dirt and debris from shoes by stepping on a sticky mat at least 3 times. Starting from the head down, the cleanroom gowning procedure is as follows:
- If called for, put on donning gloves or glove liners, then don a bouffant cap and beard cover, if necessary.
- Put on a hood if required by the cleanroom classification, making sure only to touch the inside of the hood.
- Attach a face mask, ensuring to bend the nosepiece so it fits properly. If a shield or goggles are required, add them.
- Use a shoe brush cleaner to remove any excess debris, then put on overshoes, booties, or overboots.
- Put on a coverall, making sure that sleeves and upper garment don’t touch any surfaces or objects. Tuck the hood panels inside the coverall before zipping.
- Apply an alcohol solution to the glove liners and add gloves. Double-check that booties and gloves overlap the coveralls for complete coverage.
- Wipe down the gowning bench with sterile wipes, and ensure proper garment fit by checking a mirror before entering the cleanroom.
Gowning Materials and Material Features
There are a variety of materials used for cleanroom garments, including washable and disposable. Cleanroom gowning materials are chosen depending on the level of protection required, ranging from easy-to-tear fabrics in lower classes to non-woven, non-shedding, protective options in higher classes. Materials used for compliance with cleanroom gowning requirements include:
- SMS: Providing the highest protection and durability, SMS materials offer exceptional liquid and dust protection. This material features excellent particle retention and water vapor transmission for a comfortable temperature.
- Microporous: For medium-level protection, microporous materials are cloth-like with waterproof barrier protection that allows water vapor to escape to keep users cool.
- PE-Coated Polypropylene: Offering basic protection, PE-coated polypropylene materials feature light liquid splash protection for less stringent cleanroom gowning requirements.
- Spun-bound Polypropylene: A cost-effective gowning solution, spun-bound polypropylene materials are lightweight with basic protection features.
- Polyethylene: This material offers light and temporary protection, making it ideal for short-term use. Polyethylene does not provide sufficient protection from liquids and is easy to tear.
Cleanroom Apparel Removal or “Doffing”
Protective garments can be removed once cleanroom processes are finished, and you have exited the cleanroom. Removing cleanroom apparel, also known as doffing, begins with the last item put on. Work through the gowning procedure backward until all protective wear is removed, taking care to place reusable apparel in laundry facilities and dispose of one-use garments.