Blog, Cleanroom

Top 8 cleanroom frequently asked questions

1.Question: What is a clean room?

A cleanroom is a room with a HEPA filter to remove airborne particles. Cleanrooms are used for manufacturing that requires a high level of cleanliness and sterility. Common applications are pharmaceutical, food, medical device and semiconductor manufacturing. FDA is required to use clean rooms to build manufacturing plants that meet GMP standards.

2.What are clean rooms used for?

Cleanrooms are used for production in places that require a high level of cleanliness and sterility. Common applications are pharmaceutical, food, medical device and semiconductor manufacturing. Cleanrooms use HEPA filters to remove airborne particles. People often see pharmaceutical clean rooms, medical equipment clean rooms, semiconductor clean rooms, electronics clean rooms, aerospace clean rooms, food clean rooms, USP797 complex pharmaceutical clean rooms and technology clean rooms biology. Clean rooms are also used by the government as national laboratories, the defense industry, and R&D laboratories at universities.

3.How clean is the room?

Extremely clean. A class 100 cleanroom has 100 particles per cubic ft3. By comparison, your typical office space has between 500,000 and 1 million particles per cubic ft3. Clean rooms come in many different types from class 100 to class 100,000.

4.When is a Clean Room needed?

Manufacturing of medical and pharmaceutical equipment, microchips, and food requires a sterile environment to produce products. This clean room provides an ultra-clean, sterile production space that reduces the risk of contamination. Semiconductor manufacturers produce ultra-small, ultra-dense devices. For example computer chips for mobile phones or PCs. If dirt gets on the chips during manufacturing, they won’t work.

5,What does clean room ISO mean?

ISO is the International Standards Organization. It has created the ISO 4644-1 Cleanroom Standard that describes the number of particles allowed, the particle size allowed, and the change in HEPA filtered air flow per hour that meets ISO-4, ISO-5, ISO- 6, ISO-7 and ISO -8 standards. It is based on measurements per cubic meter. It corresponds to US Fed Standard 209E based on measurements per cubic foot. Fed Standard 209E has classes of 10, 100, 1000, 10,000, and 100,000, respectively.

6.What is a clean room in pharmaceuticals?

In the pharmaceutical industry, a cleanroom is a controlled environment using HEPA filters to minimize particulate contamination. Pharmaceutical manufacturers must obtain FDA clearance for their manufacturing process, which often specifies the use of clean rooms to ensure the quality of the pharmaceutical product produced. Sterility is the highest priority. Pharmaceutical cleanrooms focus on both non-living and living contamination. They often use a laser particle counter to measure the level of non-viable contamination and plate with culture medium to measure the level of non-viable contamination. Pharmaceutical cleanrooms use chemical cleaning techniques and strong ultraviolet light to maintain sterility.

7.How does a clean room work?

Cleanrooms rely on HEPA or ULPA filters to remove airborne particles and create an extremely clean environment. With sufficient air changes per hour and laminar airflow, it is possible to reduce particle counts from typical office spaces greater than 500,000/ft3 to as low as 100/ft3 (class 100 cleanroom). Air locks are used to prevent contamination from entering the cleanroom. People operating inside cleanrooms often wear cleanroom clothing such as clean boots and tights to prevent them from bringing contaminants into the room. Eating and drinking is never allowed in clean rooms.

LABONE’S CLEANROOM PRODUCTS

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II/ Sample Transfer Box – Passbox TECRA-PB

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III/ FFU fan filter equipment – TECRA.FFU

 

IV/ Cleanroom furniture

  • LABone designs and constructs clean room interiors such as laboratory tables, work shelves, fume hoods, biological safety cabinets, etc. to ensure optimal and effective operations in the clean room.
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