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A Class 7 cleanroom refers to a controlled environment that maintains a specific level of cleanliness in terms of airborne particles. According to ISO 14644-1, a Class 7 cleanroom must limit the concentration of airborne particles to a maximum of 352,000 particles per cubic meter of air at a size of 0.5 microns and above.
Pharmaceutical Manufacturing: For the production of non-sterile pharmaceuticals, where contamination control is important but the requirements are less stringent than for sterile drug manufacturing.
Medical Device Manufacturing: Production of medical devices such as surgical tools, implants, and diagnostic instruments, where particle contamination can affect product quality.
Biotechnology Research: Research labs working with genetically modified organisms, cell cultures, or other biological materials that need a controlled environment.
Electronics Manufacturing: Assembly of sensitive electronics such as semiconductors, microchips, and other electronic components that are highly susceptible to contamination from airborne particles.
Particle Count (per m³ of air):
Maximum of 352,000 particles of size 0.5 microns or larger.
Air Cleanliness: The air cleanliness is achieved through a high-efficiency filtration system, typically using HEPA (High-Efficiency Particulate Air) filters or ULPA (Ultra Low Penetration Air) filters.
Air Changes Per Hour (ACH): Typically, Class 7 cleanrooms require a minimum of 300 air changes per hour to maintain air quality.
Modular cleanrooms are built using pre-fabricated components, such as wall panels, ceiling grids, and flooring, that are designed to be quickly assembled or disassembled on-site. The modular approach allows for greater flexibility, scalability, and faster construction compared to traditional cleanrooms.
Modular Design: The components of the cleanroom, including walls, ceiling panels, and floor tiles, can be customized to fit the specific dimensions and needs of the facility. This allows for easy expansion, reconfiguration, or relocation.
HEPA/ULPA Filtration Systems: These systems ensure the cleanliness of the air by removing particulate contaminants. The cleanroom will typically have dedicated HVAC systems to provide filtered air and control temperature and humidity.
Controlled Access: Modular cleanrooms are designed with controlled entry and exit points to maintain contamination control, including airlocks and gowning areas for personnel.
Sealed Structure: The cleanroom is tightly sealed to prevent the ingress of external contaminants, and the HVAC systems are designed to handle the required air changes and filtration.
Modular cleanrooms offer several benefits over traditional fixed cleanrooms:
Flexibility:
Scalability: Modular cleanrooms can be expanded or reconfigured as needed, making them ideal for growing businesses or changing production requirements.
Customizability: They can be tailored to specific industry requirements, including size, layout, and the level of contamination control needed.
Cost-Efficiency:
Reduced Construction Time: Modular cleanrooms can be assembled much more quickly than traditional cleanrooms, reducing the overall project timeline and associated costs.
Lower Capital Investment: The ability to assemble modular cleanrooms from pre-fabricated parts reduces the capital investment compared to building a cleanroom from scratch.
Ease of Maintenance:
Modular Components: Individual components (such as filters or walls) can be easily replaced or upgraded as technology improves or requirements change.
Easier Maintenance and Repairs: Because modular systems are standardized, maintenance can often be carried out more efficiently, with minimal disruption to operations.
Compliance with Standards:
Class 7 cleanrooms are designed to meet ISO 14644-1 and other relevant standards (such as GMP, FDA, or EU regulations) to ensure compliance with industry-specific cleanliness and safety standards.
To ensure that a cleanroom maintains the required air quality and cleanliness, several key components are necessary:
Air Filtration Systems: High-efficiency filters (HEPA or ULPA) are used to remove particles from the air. The air filtration system is one of the most critical components of a modular cleanroom.
HVAC Systems: A well-designed HVAC system ensures that there is a constant flow of clean air into the room, with enough air changes to meet cleanliness standards. The system also controls temperature, humidity, and pressure.
Controlled Lighting: Cleanrooms require specialized lighting that does not produce particles or generate excessive heat.
Flooring and Wall Materials: Smooth, non-porous, and easy-to-clean materials are used for flooring and walls to reduce the risk of contamination.
Monitoring Systems: Cleanrooms typically feature environmental monitoring systems that track particle counts, temperature, humidity, and pressure in real time.
While Class 7 modular cleanrooms provide numerous advantages, there are also considerations to keep in mind:
Initial Cost: Although modular cleanrooms are generally more affordable than traditional cleanrooms, the initial setup cost can still be significant depending on the complexity of the design and the required level of cleanliness.
Ongoing Maintenance: Regular maintenance of air filters, HVAC systems, and monitoring equipment is required to ensure the cleanroom continues to meet the necessary standards.
Compliance and Certification: Ensuring that the cleanroom remains compliant with relevant standards (such as ISO, GMP, or FDA regulations) requires ongoing documentation, testing, and certification.
