American Cleanroom Systems® Presents Cleanroom Classifications

A: Medical device and pharmaceutical manufacturing requires sterile environments to produce their products. Cleanrooms provide this sterile super clean manufacturing space which reduces the chance of contamination getting in your medicine. Semiconductor manufacturers produce devices with ultra small super dense features. Examples are computer chips for your cell phone or PC. If contamination were to get on the chip during manufacturing, they would not work.

A: ISO is the International Standards Organization. It has created the ISO 4644-1 Cleanroom Standards that describe the allowed number of particles, the allowed size of particles and HEPA filtered air flow changes per hour meet ISO-4, ISO-5, ISO-6, ISO-7, and ISO-8 standard. It relies on measurements per cubic meter. It corresponds to the USA based Fed Standard 209E which relies on measurements per cubic foot. Fed Standard 209E corresponding classes are 10, 100, 1000, 10k and 100k.

A: In pharma a clean room is a controlled environment using HEPA filtration to minimize particulate contamination. Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharma cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

A: A data cleanroom is a secure isolation virtual platform that typically stores anonymized marketing data from multiple sources. It is used to protect privacy and share data from multiple sources. It is very different from physical cleanrooms used for manufacturing.

A: Cleanrooms rely on HEPA or ULPA filtration to remove particles from the air and create an ultra clean environment. With sufficient air changes per hour and laminar air flow it is possible to reduce particulate count from greater then 500k/ft3in typical office space to as low as 100/ft3(class 100 cleanroom). Airlocks are used to prevent contamination from entering the cleanroom. Workers inside cleanrooms typically wear cleanroom garments such as booties and bunny suits to prevent them from bringing contamination into the room. Eating and drinking are never allowed in cleanrooms.

A: Industries such as pharmaceutical, medical device and USP797 compounding pharmacies are required by the government to manufacture in sterile environment and must use cleanrooms. Other industries such as semiconductor, electronics, aerospace and optics find the ultra-clean environments in cleanrooms are the only way to cost effectively manufacture their products. Other industries that use cleanrooms include food, beverage, e-liquid, CBD and vitamins.

A: Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharmaceutical cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

A: A class 1 cleanroom refers to ISO standard allowing less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 1 cleanroom typically has from 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the cleanest classification.

A: A class 2 cleanroom refers to ISO standard allowing less than 11 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 2 cleanroom typically has 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 2nd most clean classification.

A: The most common type cleanrooms are modular cleanrooms, stick-built cleanrooms (or standard), and softwall cleanrooms. Modular cleanrooms utilize prefabricated modular wall systems which allow for faster installation, easy modification(s) and reasonable cost. Stick built or standard cleanrooms rely on conventional steel stud(s) drywall construction. It can be slightly cheaper. Softwall cleanrooms use clear vinyl curtains suspended from metal frames. Small softwall cleanrooms are often mounted on casters so they can be easily moved around.

A: A class 4 cleanroom refers to ISO standard allowing less than 1020 particles greater than 0.3 microns and less than 2 particles greater than 5.0 microns per cubic meter. A class 5 cleanroom requires from 500-600 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 4th most clean classification.

A: If you need an ISO-7 cleanroom you should prepare your facility for the modular cleanroom installation. Check that area is free and clear up to height of cleanroom. Frequently existing electrical conduit, lighting, sprinklers, and HVAC ducting need to be relocated. When installing new cleanroom flooring make sure the existing concrete is in good shape. Have any cracks and depressions filled to level the floor.

• Do wipe down all surfaces on a regular basis to remove contamination.
• Do make sure doors are always closed to maintain positive pressure.
• Do always have all staff were cleanroom suits over their street clothes to prevent bringing contamination into the cleanroom.