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Clean rooms are essential environments where controlled levels of airborne particulates, temperature, humidity, and air pressure are maintained to ensure the quality of products in industries such as pharmaceuticals, Semiconductors, and biotechnology. The design of these environments requires careful attention to several critical factors to maintain operational efficiency and compliance with stringent industry standards.
ISO Cleanliness Standards
Cleanroom design must comply with international cleanliness standards to ensure effective contamination control.
ISO 14644-1: This standard defines the classification of air cleanliness in cleanrooms based on particle concentration. Cleanrooms are rated from ISO Class 1 (highest cleanliness) to ISO Class 9 (lowest). The cleanroom’s design must meet these standards to ensure a controlled environment.
| Class | Particle Count per Cubic Meter (≥0.5 µm) |
|---|---|
| ISO 1 | ≤ 10 |
| ISO 5 | ≤ 3,520 |
| ISO 7 | ≤ 352,000 |
| ISO 9 | ≥ 35,200,000 |
GMP Standards: Good Manufacturing Practice (GMP) guidelines dictate that cleanrooms in pharmaceutical production must maintain specific cleanliness levels and environmental controls to ensure product safety. They require strict monitoring and validation protocols to meet regulatory compliance.
Ensure equipment and facilities are properly maintained.
Regularly monitor air quality, temperature, and humidity.
Adhere to specific airflow and pressure requirements.
Airflow Organization and Air Changes per Hour
A CleanRoom's airflow design is critical for maintaining air quality and preventing contamination.
Unidirectional Flow (Laminar Flow): This method ensures that air flows in a single direction, typically from the ceiling to the floor. Laminar flow reduces the risk of contamination by providing a consistent and clean airflow, which is vital in industries like semiconductor manufacturing.
Non-Unidirectional Flow (Turbulent Flow): In contrast to laminar flow, turbulent flow allows for more variable air movement, often used in less stringent cleanroom applications. Here, air is mixed in all directions, which may not guarantee as much contamination control as unidirectional systems.
Air changes per hour (ACH) should meet industry standards.
A turbulent system is often used for lower-level cleanrooms.
Unidirectional flow is required for ISO Class 1-5 environments.
Key Considerations:
Airflow Pattern: Cleanroom air patterns are commonly designed with top-down airflow and floor return systems to ensure a continuous air circulation loop.
Temperature and Humidity Control
Maintaining consistent temperature and humidity levels is critical for product quality in sensitive industries.
Semiconductor: In Semiconductor cleanrooms, temperature must be precisely controlled to within ±0.1°C. This tight control helps prevent product defects during manufacturing processes, such as wafer processing.
Pharmaceutical Industry: Humidity levels in pharmaceutical cleanrooms are typically maintained at 45±5% RH to prevent product degradation and ensure drug efficacy. It is essential for stability testing and overall product quality.
Temperature must be controlled based on the specific product.
Humidity impacts both the physical properties of the product and the environment.
Materials and Surface Treatment
The materials used in cleanroom design play an essential role in maintaining cleanliness and durability.
Wall Panels and Ceiling: The use of smooth, non-porous materials helps minimize particle accumulation and facilitates cleaning.
Flooring: Cleanroom floors should be made from seamless materials that can resist wear and are easy to clean.
Vinyl flooring for ease of cleaning.
Epoxy flooring for durability and chemical resistance.
Key Options:
Ductwork: Ducts should be designed with smooth internal surfaces to reduce particle buildup.
Lighting Fixtures: Lighting must be recessed and flush with the ceiling to prevent dust accumulation.
HVAC Systems: Cleanrooms must have specially designed HVAC systems to control air pressure, humidity, and temperature.
Personnel and Material Management
Controlling the movement of personnel and materials into and out of the cleanroom is essential to maintaining its integrity.
Personnel Access: Entry into the cleanroom requires strict protocols, including the use of gowns, gloves, and face protection to minimize contamination.
Material Transfer Windows: Material transfer windows are used to prevent contamination during the transfer of materials into the cleanroom. These windows often feature automated systems that reduce human error.
Testing and Acceptance: DQ/IQ/OQ/PQ Process
The Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) process is critical for verifying cleanroom functionality.
DQ ensures that the cleanroom design meets all specified requirements.
IQ verifies that equipment and systems are installed correctly.
OQ tests the operational performance under normal conditions.
PQ assesses the cleanroom’s performance during actual operations.
Conclusion
Mastering cleanroom design requires careful consideration of numerous factors including ISO standards, airflow systems, environmental controls, materials, and strict protocols for personnel and material management. By following established guidelines and using quality equipment, such as that offered by Deiiang™ and designed by experts like Deiiang Jason.peng and tested by Deiiang joebo.Wang, companies can ensure the integrity of their cleanroom environments. With a strong foundation in these design elements, businesses can operate efficiently while adhering to regulatory standards and industry best practices.
