what is a class 10 cleanroom

What is a Class 10 ?

If you work in industries such as electronics, pharmaceuticals, medical devices, or semiconductors, you may have heard of a 'cleanroom.' A cleanroom is an enclosed and controlled environment that minimizes the level of contaminants such as dust, bacteria, and airborne particles that could compromise the manufacturing process.

Cleanrooms are classified according to how clean they are, with the lowest classification being Class 1 and the highest being Class 9. In this article, we will focus on the highest classification level, Class 10 cleanrooms.

What is a Class 10 ?

A Class 10 cleanroom is a controlled environment that has no more than 10 particles per cubic foot of a size greater than or equal to 0.5 micrometers. This level of cleanliness is achieved through a combination of air filtration, positive pressure, and strict cleanliness protocols.

A Class 10 cleanroom is used in industries that require the highest level of cleanliness, such as the semiconductor industry, where even a tiny dust particle can cause irreparable damage to the circuits. In a Class 10 cleanroom, personnel must wear specialized clothing, including gloves, head coverings, and face masks, to prevent shedding skin particles or other contaminants.

Design and Construction

A Class 10 cleanroom is designed and constructed with several essential elements to maintain the desired level of cleanliness. These elements include:

1. Air Filtration System: The most critical component of a Class 10 pharma clean room is its air filtration system. The air inside the pharma clean room is actively filtered through HEPA filters, which capture particles down to 0.3 micrometers in size. The cleanroom air is also circulated and cleaned continuously to maintain a positive pressure.

2. Walls and Flooring: walls and flooring are made of smooth and non-porous materials, such as stainless steel or polyvinyl chloride (PVC), which are easy to clean and maintain. The walls and flooring must be sealed to prevent any air leaks or contamination from outside the cleanroom.

3. Lighting: Lighting in a Class 10 cleanroom is designed to provide clean and shadow-free illumination while minimizing heat generation. The lighting fixtures are sealed and located to prevent any possible contamination from dust or particles.

4. Personnel Entry and Exit: Personnel come in and out of the pharma clean room through airlocks or gowning rooms. These areas are specially designed to minimize the entry of contaminants into the cleanroom.

5. : All pharma machinery used in a Class 10 cleanroom must be designed and constructed to minimize particle generation. must be easy to clean and maintain, and all surfaces must be smooth.

Protocols and Operations

In addition to design and construction, a Class 10 cleanroom must be operated according to strict cleanliness protocols. These protocols include:

1. Personnel Training: All personnel who work in the cleanroom must receive specialized training on cleanroom procedures, gowning, and behavior.

2. Gowning: All personnel entering the cleanroom must gown in a designated area and follow specific procedures for donning, removing, and storing cleanroom attire.

3. Behavior: Personnel who work in a Class 10 cleanroom must follow specific behavior protocols to minimize the shedding of particles or other contaminants. For example, they must move slowly and deliberately to minimize air turbulence.

4. Cleaning: A Class 10 cleanroom must be cleaned regularly using specialized cleaning protocols and pharma machinery. All cleaning materials must be non-shedding and non-contaminating.

5. Monitoring: A Class 10 cleanroom is continuously monitored for particles, temperature, humidity, and other environmental factors. The monitoring data is logged and analyzed to ensure that the cleanroom remains within its specified parameters.

Final Thoughts

A Class 10 cleanroom is a highly specialized and controlled environment that requires careful design, construction, and operation. The cost of building and maintaining a Class 10 cleanroom can be significant, but it is necessary for industries that require the highest level of cleanliness. With proper protocols and procedures in place, a Class 10 cleanroom can help ensure the quality and reliability of critical manufacturing processes.

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