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FAQs About Cleanroom Classifications

  • 2022-03-02
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Q: What Is a Cleanroom?

A: A cleanroom (or clean room) is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. The FDA mandates the use of cleanrooms to create GMP manufacturing factories.

Q: What Are Cleanrooms Used For?

A: Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. Cleanrooms use HEPA filters to remove particles from the air.

Q: How Clean Is a Cleanroom?

A: Very clean. A class 100 cleanroom has 100 particles per cubic foot. By comparison your typical office space has between 500,000 and 1 million particles per cubic foot. Cleanrooms come in different classes from class 100 to 100,000.

Q: When Is a Cleanroom Required?

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.

Q: What Does ISO Stand For?

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.

Q: What is Clean Room in Pharma?

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.

Q: What Are Cleanrooms Used For?

A: Cleanrooms are used in any industry that wants to control contamination in their facility. It is common to see pharmaceutical cleanrooms, medical device cleanrooms, semiconductor cleanrooms, electronic cleanrooms, aerospace cleanrooms, food cleanrooms, USP797 compounding pharmacy cleanrooms and biotech cleanrooms. Cleanrooms are also used by the government such as national labs, defense industries, and R&D labs at universities.

Q: What is a Data Cleanroom?

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.

Q: How Do Cleanrooms Work?

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.

Q: Who Needs a Cleanroom?

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.

Q: What is a Pharmaceutical Cleanroom?

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.

Q: What is a Class 1 Cleanroom?

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.

Q: What is a Class 2 Cleanroom?

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.

Q: How Many Types of Cleanrooms Are There?

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.

Q: What is a Class 4 Cleanroom?

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.

Q: How Do You Prepare For Cleanroon / Installations?

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.

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