What is a clean room? Clean room system according to standards

Tuesday March 15th, 2022
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In 1963, for the first time, “clean room standards” were regulated in the US. Since then, this standard has been gradually improved, perfected and become a common standard for the whole world, applied in many different fields. Cleanrooms are usually specified and classified according to Federal Standard 209 E, ISO 14644-1 and national standards TCVN 8664-1:2011. So, what is a clean room? Classified clean room? And clean room standards? Let’s find out and contact us immediately when you have a need!

1. What is a clean room? Clean room concept

A cleanroom is a room that is built and used to minimize the entry and retention of airborne particles, and to control other relevant room parameters such as temperature, humidity, and pressure. when needed. When all factors in the room are controlled, it will help minimize the risk of bacterial contamination or cross-contamination of products during research and production, ensuring sterility.

Currently, “clean room” is increasingly popular and is applied in many fields such as pharmaceutical industry, food, cosmetics, biotechnology… industries that require control of dust levels and components. in the air.

2. Clean room standards
2.1 Fundamentals

Cleanroom standards is one of the requirements that should be met for any clean room. To be assessed as a clean room, it is necessary to ensure the following parameters:

Clean rooms, in addition to regulated temperature and pressure like conventional air-conditioned rooms, also need stricter requirements on pressure, cleanliness and cross-contamination.

Because the air moves from a place of high pressure to a place of low pressure, controlling the pressure helps to prevent air, dust, organisms… from another area to the cleanroom area.

Room cleanliness is determined by the number of air and filter exchanges. The larger the number of wind exchanges, the lower the concentration of dust particles, reducing pollutants generated in the room. Therefore, with each different level of cleanliness, the number of air and filter exchanges is also different.

For clean rooms, cross-contamination is quite complicated and difficult to control because it can be caused by many causes both from inside and outside. Setting standards on cross-contamination helps to minimize the appearance of impurities and foreign ingredients that will destroy or reduce product quality.

Among them, the parameter of dust content is the most important. Based on the parameter of the number of dust particles within a certain size range, people are classified into different  cleanroom levels .

2.2 Cleanroom status

In addition, in the inspection and evaluation of the clean room system , it is necessary to consider the activities carried out in the clean area. Due to the movement of materials, goods, the movement of employees or production process activities that can lead to dust contamination or dust disturbances in the clean room system. There are three states that can affect the cleanroom grade  rating in any cleanroom classification:

Setup status: clean room is built but no equipment yet.
Idle state: the clean room has been installed and put into operation, but no employees are working.
Operation status: the equipment and machinery in the clean room are being operated according to the production process and the operator’s staff is present as required.
3. Clean room classification
3.1 According to FEDERAL STANDARD 209 E (1992)

The Federal Standard 209 E cleanroom standard sets forth the evaluation criteria for the  cleanroom level, the tests required to demonstrate compliance, and the frequency with which the tests must be conducted for evaluation.

This cleanroom standard was deprecated on November 29, 2001 by the United States General Services Administration (GSA), but it is still widely adopted globally.

The cleanroom standard according to ISO 14644-1 adds three new levels of cleanliness compared to Federal standard 209 E: two levels cleaner than the cleanest level in Federal standard 209 E and one level less clean than the lowest level in the Federal standard 209 E. Federal standard 209 E. The addition of these new cleanroom levels will help with more efficient control and evaluation especially in emerging industries.

The two cleaner levels are applied in areas that require strict control cleanroom such as the microelectronics industry. The lowest  clean room level  standard is applied to industries that are just beginning to control the number of dust particles such as the plastic industry or facilities that produce food, beverages, consumer goods…

Clean rooms are increasingly popular and receive the attention of organizations and individuals in many fields. The clean room system meeting cleanroom standards will help ensure quality and improve the efficiency of the production process.