which two areas comprise the cleanroom
Cleanrooms are an essential part of many industries, including semiconductor manufacturing, biotechnology, and pharmaceuticals. They provide a controlled environment that is free from contaminants, including dust, microbes, and other particles that can harm sensitive pharma machinery or compromise the quality of products.
Cleanrooms are divided into two areas: the clean zone and the support zone. Each area has its own unique requirements and specifications that ensure the integrity of the cleanroom as a whole.
The Clean Zone
The clean zone is the primary area in the cleanroom where manufacturing processes take place. It is the heart of the entire operation and must be controlled carefully to maintain the desired level of cleanliness.
The clean zone is typically equipped with high-efficiency particulate air (HEPA) filters that remove particles as small as 0.3 microns from the air. These filters are placed in the ceiling and walls of the cleanroom and are designed to provide laminar airflow, which means that air moves in a uniform direction from top to bottom.
The air in the clean zone moves slowly and steadily to prevent turbulence, which can cause particles to become airborne and contaminate the environment. The floors in the clean zone are also designed to minimize particle generation and accumulation, with seamless, easily cleanable surfaces that are free from cracks and crevices.
The clean zone is further divided into different classifications based on the level of cleanliness required for specific processes. The classification system ranges from ISO Class 1, which is the cleanest, to ISO Class 9, which is the least clean. The specific classification required depends on the type of product being manufactured and the industry standards that apply.
The Support Zone
The support zone is the area surrounding the clean zone and provides the necessary support functions for the pharma clean room. It includes changing rooms, gowning areas, storage areas, and utilities that support the cleanroom's operations. The support zone is designed to be less clean than the clean zone since it does not directly affect the manufacturing processes.
The changing rooms and gowning areas are crucial in preventing contamination from entering the clean zone. Employees entering the pharma clean room must change into special cleanroom garments, including coveralls, gloves, and face masks, and follow strict protocols for donning and doffing the garments.
The storage areas in the support zone are used to keep pharma clean room materials and pharma machinery, including raw materials, supplies, and tools. These areas must be kept clean and organized to prevent cross-contamination and to ensure that the materials and pharma machinery are easily accessible when needed.
The utilities in the support zone include the heating, ventilation, and air conditioning (HVAC) system that provides the cleanroom with the necessary air changes and temperature control. The support zone also includes electrical systems and water supplies.
Conclusion
Cleanrooms are essential in many industries where the quality of the products depends on the cleanliness of the manufacturing environment. The cleanroom is divided into two areas, the clean zone and the support zone, each with its own specific requirements and specifications. The clean zone is where the manufacturing processes take place, and it must be kept clean and free from contaminants. The support zone provides the necessary support functions for the cleanroom and includes changing rooms, gowning areas, storage areas, and utilities. Understanding the two areas that comprise the cleanroom is essential in maintaining a clean and controlled environment that meets industry standards and produces high-quality products.
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