what is a class 7 cleanroom

What is a Class 7 ?

When it comes to manufacturing and high-tech industries, cleanliness is of the utmost importance. Even the smallest speck of dust or particle can cause contamination and ruin sensitive pharma machinery or products. Thats where cleanrooms come in. Cleanrooms are specially designed environments where the concentration of airborne particles is controlled to meet specified limits. These controlled environments are essential in industries such as pharmaceuticals, medical device manufacturing, electronics, aerospace, and many more. One type of cleanroom is a Class 7 pharma clean room. But what exactly is a Class 7 pharma clean room, and what goes into creating one?

Subheading: Understanding Classification

Before we dive into what a Class 7 cleanroom is, its important to understand the classification system that is used to determine cleanroom standards. Cleanrooms are classified based on the concentration of particles allowed in the air. The standard used for classifying cleanrooms is ISO 14644-1, which is set by the International Organization for Standardization (ISO). Each cleanroom classification has a corresponding maximum allowable concentration of particles per cubic meter of air.

Cleanrooms are classified as follows:

Class 1: Maximum allowable concentration of particles is 10 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 2: Maximum allowable concentration of particles is 100 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 3: Maximum allowable concentration of particles is 1,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 4: Maximum allowable concentration of particles is 10,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 5: Maximum allowable concentration of particles is 100,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 6: Maximum allowable concentration of particles is 1,000,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 7: Maximum allowable concentration of particles is 10,000,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Class 8: Maximum allowable concentration of particles is 100,000,000 particles per cubic meter of air of a size of 0.1 micrometers or larger.

Subheading: Characteristics of a Class 7

A Class 7 cleanroom has a maximum allowable concentration of particles of 10,000,000 per cubic meter of air of a size of 0.1 micrometers or larger. This cleanroom classification is suitable for industries such as electronics, pharmaceuticals, and medical device manufacturing. In a Class 7 cleanroom, the temperature and humidity are tightly controlled, and air pressure is maintained at a slight positive pressure to prevent outside air from entering the cleanroom. The cleanroom also uses high-efficiency particulate air (HEPA) filters that capture particles as small as 0.3 micrometers. The filters are designed to remove 99.97% of all airborne particles.

Subheading: Creating a Class 7

Creating a Class 7 cleanroom is a complex process that requires the expertise of professionals. The first step in creating a Class 7 cleanroom is designing the layout. The cleanroom layout is critical because it determines the flow of people and materials and can help prevent contamination. The next step is selecting the appropriate materials for the cleanroom, such as flooring, walls, and ceilings. The materials used in a cleanroom must be easy to clean, non-porous, and resistant to chemicals.

Once the design and materials are selected, the cleanroom is constructed. The construction process must follow strict protocols to prevent contamination during construction. After construction is complete, the cleanroom is tested to ensure that it meets the requirements of a Class 7 cleanroom. This testing includes particle count testing, air pressure testing, and airflow velocity testing. The cleanroom is then certified and monitored regularly to ensure that it continues to meet the standards of a Class 7 cleanroom.

Subheading: Benefits of a Class 7

A Class 7 cleanroom provides numerous benefits for industries that require a clean environment. One of the most significant benefits is the prevention of contamination. By controlling the concentration of particles in the air, the cleanroom ensures that products and pharma machinery are not contaminated, resulting in higher quality products and fewer product recalls. A cleanroom also reduces the risk of infection in medical environments by preventing the spread of airborne pathogens.

In addition to preventing contamination, a Class 7 cleanroom can also increase efficiency and productivity. By providing an environment free of distractions and interruptions, workers can focus on their tasks and complete them more efficiently. The cleanroom may also have a positive impact on employee morale by providing a clean and well-maintained workspace.

Subheading: Conclusion

In conclusion, a Class 7 cleanroom is an essential tool for industries that require a controlled environment. By controlling the concentration of particles in the air, a Class 7 cleanroom prevents contamination and ensures the quality of products and equipment. Creating a Class 7 cleanroom is a complex process that requires the expertise of professionals. However, the benefits of a Class 7 pharma clean room make it a worthwhile investment for industries that require a clean environment.

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