What is a Class iso 5 Cleanroom?

An ISO Class 5 Cleanroom is a controlled space. It follows strict cleanliness rules set by the International Organization for Standardization (ISO). Specifically, it allows a maximum of 3,520 particles per cubic meter for particles measuring 0.5 micrometers and larger. This type of cleanroom is made to reduce contamination. It is often used in industries like pharmaceuticals, biotechnology, electronics, and aerospace. In these fields, even tiny amounts of pollutants can harm product quality. 

The cleanroom's design and operation are critical for ensuring compliance with regulatory requirements and maintaining the quality of sensitive processes and products.

Cleanroom ISO Classification

CleanRoom Classifications are based

• ISO Class 1

• ISO Class 2

• ISO Class 3

• ISO Class 4

• ISO Class 5

• ISO Class 6

• ISO Class 7

• ISO Class 8

• ISO Class 9

Core Parameters of

ISO Class 5 Cleanrooms have specific core parameters that govern their operation. According to ISO 14644 standards, the maximum allowable particle count per cubic meter of air must not exceed 3,520 particles of 0.5 micrometers or larger.

Maintaining air flow and filtration is crucial in ISO Class 5 Cleanrooms. HEPA or

Construction

The architectural design of an ISO Class 5 cleanroom is fundamental to achieving stringent cleanliness standards. Key structural elements include:

• Double-layer Return Air Wall Panels: These enhance isolation and reduce airflow impact on cleanliness.

• Suspended Ceiling: Facilitates the installation of essential lighting and HVAC systems while maintaining cleanliness.

• Raised Aluminum flooring: Provides an easy access point for utilities while allowing for clean airflow underneath.

• Purification Steel Doors: Designed to minimize contamination during entry and exit.

• Double-glazed Hollow Windows: Ensures visibility without compromising air quality.

Each of these components contributes to a cleanroom environment that meets the rigorous standards set by international guidelines.

Industry Applications of ISO Class 5 Cleanroom

ISO Class

• Pharmaceutical manufacturing

• Biotechnology research

• Semiconductor production

These environments ensure that products are free from contamination, which is crucial for maintaining safety and efficacy.

Cost of Building an ISO Class 5 Cleanroom

Building an ISO Class 5 cleanroom involves significant investment. Factors influencing the cost include:

• Size of the cleanroom

• Complexity of the design

• Required materials and technologies

1. Size of the Cleanroom

The size of the cleanroom is one of the primary determinants of the construction cost. Typically, the cost per square foot for an ISO Class 5 cleanroom ranges from $250 to $600, depending on the specific requirements and regional construction costs. For instance, a 1,000 square foot cleanroom could cost between $250,000 and $600,000. Larger cleanrooms may benefit from economies of scale, potentially reducing the per-square-foot cost.

2. Complexity of the Design

The complexity of the Cleanroom design significantly impacts the cost. More intricate designs that require advanced HVAC systems, specialized wall materials, or unique layouts will increase expenses. For example, a simple cleanroom with basic requirements may cost around $250 per square foot, while a more complex design with advanced control systems can escalate costs to $600 per square foot or more.

3. Required Materials and Technologies

The choice of materials and technologies also plays a critical role in the overall expenditure. Cleanroom environments require high-quality materials that meet stringent cleanliness standards. For instance, the use of stainless steel, specialized wall panels, and HEPA or ULPA filtration systems adds to the cost. High-efficiency particulate air (HEPA) filters can cost between $300 and $1,500 each, depending on their size and efficiency ratings. Additionally, advanced monitoring and control systems that ensure compliance with ISO standards further contribute to the construction costs.

Conclusion

ISO Class 5 cleanrooms play an essential role in various industries by providing a controlled environment that meets strict cleanliness and sterility standards. Their construction involves specific materials and designs that help maintain the required conditions effectively.

Relevant International Standards

• ISO 14644: Cleanrooms and Associated Controlled Environments

• ISO 9001: Quality Management Systems

• GMP (Good Manufacturing Practice) Guidelines

Frequently Asked Questions

• What is an ISO 5 Cleanroom?
  A controlled environment with minimal airborne particles.

• What industries use ISO 5 Cleanrooms?
  Pharmaceuticals, biotechnology, and semiconductors.

• How is cleanliness measured?
  By the number of particles per cubic meter of air.

• What is the maximum particle count for ISO 5?
  ≤ 3,520 particles (0.5μm) per cubic meter.

• Why are HEPA filters used?
  They effectively remove airborne particles.

• What is the typical temperature in an ISO 5 cleanroom?
  20°C ± 2°C.

• How often should air be changed?
  At least 240 times per hour.

• What materials are used in cleanroom construction?
  Steel, aluminum, and specialized wall panels.

• What benefits do cleanrooms provide in surgeries?
  They reduce infection and enhance patient safety.

• Are cleanrooms expensive to build?
  Yes, costs vary based on size and complexity.