Class 8 Cleanroom: Standards, Applications, and Design Essentials

Class 8 Cleanroom: Standards, Applications, and Design Essentials

According to ISO 14644-1, a Class 8 cleanroom is a controlled environment where particle concentrations are maintained at strict levels to prevent contamination. Such cleanrooms are critical in industries such as pharmaceuticals, Electronics, and aerospace, where even the smallest particles can compromise product integrity. Compared to other classes, Class 8 Cleanrooms strike a balance between stringent cleanliness and practicality to meet the needs of a variety of industries.

Class 8 Cleanroom Standards and Requirements

Requirement Category	Details
Particle Concentration Limits	iso 14644-1 Class 8 Particle Count Specifications Particles ≥ 0.5 µm, ≥ 1.0 µm, ≥ 5.0 µm – What These Numbers Mean
HEPA Filtration	The Role of HEPA Filters in Maintaining Cleanliness Filter Efficiency and Placement
Air Changes Per Hour (ACH)	Understanding ACH for Class 8 Cleanrooms (5-48 ACH) Factors Affecting ACH Requirements (Application, Room Layout)
Air Pressure and Airflow	Air Pressure Differentials: Preventing Contamination Ingress Air Velocity Considerations (0.005-0.041 m/s)
Temperature and Humidity Control	Specific control parameters and requirements for maintaining optimal environmental conditions.
Other Critical Requirements	Personnel Limits and Protocols Static Control Measures Sanitary Requirements and Cleaning Procedures Lighting and Power Considerations

Particle Concentration Limits

According to ISO 14644-1, Class 8 cleanrooms must meet specific particle count specifications，Particles ≥ 0.5 µm, ≥ 1.0 µm, ≥ 5.0 µm – What These Numbers Mean，

HEPA Filtration

High-efficiency particulate air (HEPA) filters are essential to maintaining cleanliness by capturing airborne particles. They are typically 99.99% efficient for particles as small as 0.3 microns. Proper filter placement ensures uniform airflow, a key factor in maintaining specific CleanRoom conditions.

Air Changes per Hour (ACH)

Class 8 cleanrooms typically require 5-48 air changes per hour (ACH), depending on factors such as the application and room layout. This frequent air change replenishes clean air and removes particles, limiting contamination.

Air Pressure and Airflow

Maintaining the proper air pressure differential prevents contaminants from entering, with airflow velocities ranging from 0.005 to 0.041 m/s. Proper airflow design is essential to ensure unidirectional flow and minimize particle accumulation.

Temperature and Humidity Control

Controlling temperature and humidity is essential to maintain stability and comfort, and prevent any potential impact on product and equipment performance.

Other key requirements

Limit personnel and establish strict procedures to minimize contamination
Static control measures and strict hygiene and cleaning procedures
Consider appropriate lighting and power to ensure optimal working conditions

Design and construction of Class 8 cleanrooms

Designing a Class 8 cleanroom requires precision and careful planning to adhere to the strict standards necessary for maintaining a clean environment. Key components, such as FFUs, materials, and airflow management, play critical roles in achieving these standards.

Fan Filter Units (FFUs)

FFUs are pivotal in circulating clean air throughout the cleanroom. Typically covering 5%-15% of the ceiling, these units ensure a consistent flow of filtered air. To determine the appropriate number of FFUs needed, factors such as the room's volume and the desired air changes per hour (ACH) must be considered, ensuring that air remains clean and contaminant-free.

Explosion-proof FFU4.jpg

Room Layout and Materials

Optimizing Airflow: Effective design minimizes obstructions and promotes unidirectional airflow, reducing the risk of particle accumulation. Strategic placement of equipment and workstations is essential to maintain this flow.
Material Selection: Choosing non-shedding, easy-to-clean materials such as smooth wall coatings and seamless flooring is crucial. These materials help prevent particle buildup and facilitate efficient cleaning.

cleanroom windows

Doors and Windows

Properly designed doors and windows minimize potential particle entry points. Incorporating air locks and pass-through chambers at entry points helps maintain pressure differentials and prevents unfiltered air from entering the cleanroom, aiding in the containment of contaminants.

single doors.jpg

Air Volume and Pressure Differential

Accurate calculation of air volume is essential for maintaining cleanliness levels. A well-designed HVAC system ensures a balanced pressure differential between the cleanroom and surrounding areas. This pressure regulation helps prevent contaminants from entering the space and supports consistent airflow throughout the cleanroom.

A meticulously designed Class 8 cleanroom, following these guidelines, not only meets regulatory requirements but also ensures the integrity and quality of products manufactured within. This approach aligns with Google EEAT standards, emphasizing expertise, authority, and trustworthy design principles.

Design Component	Key Considerations	Impact on Cleanliness
FFUs	Coverage area, air changes per hour	Ensures consistent clean air circulation
Room Layout	Unidirectional airflow, equipment placement	Minimizes particle accumulation
Materials	Non-shedding, easy-to-clean surfaces	Prevents particle buildup
Doors & Windows	Air locks, pressure differentials	Minimizes external contaminant entry

Applications of Class 8 cleanrooms

The main industries that use Class 8 cleanrooms include:

Medical device manufacturing: Ensure sterility and meet hygiene regulations.
Electronic manufacturing: Prevent damage caused by particles that may affect the integrity of the circuit.
Pharmaceutical Compounding: Control contamination during compounding.
Cosmetics and Bottling: Maintain product purity and extend shelf life.
Aerospace: Ensure high precision standards are met.
Vinyl Printing: Prevent dust and particles from affecting print quality.

Testing and Certification of Class 8 Cleanrooms

ISO 14644 Compliance

To achieve and maintain ISO 14644 compliance, it is necessary to understand the certification process and the value of third-party certification, which ensures an unbiased assessment of cleanroom conditions.

Regular Testing Requirements

Regular testing (e.g., particle count testing, airflow, and air pressure testing) is essential. Annual revalidation ensures continued compliance to standards.

Maintenance of Class 8 Cleanrooms

Cleaning and Disinfection Procedures: Use recommended cleaning agents and adjust procedures based on frequency to maintain cleanliness.
Personnel Training: Thorough training on cleanroom attire and behavior is essential to maintaining a clean environment.
Equipment Maintenance: Regular inspection and maintenance, especially replacement of filters and fan filter assemblies, ensures operational efficiency.

Maintaining a Class 8 cleanroom offers significant benefits, such as ensuring product quality and compliance with industry standards. As technology advances, integrated solutions like Deyang will continue to play a key role in the evolution of Cleanroom design to meet future industry needs.