latest company case about Guangzhou Cleanroom Construction Co., Ltd. Certifications

Cleanroom classification is a critical step in cleanroom design. It defines the maximum allowable airborne particles and ensures compliance with ISO 14644-1 and GMP standards, protecting product quality, process reliability, and regulatory compliance.

A cleanroom class specifies the maximum number of airborne particles per cubic meter at defined particle sizes. Different industries require different levels of cleanliness:

• Pharmaceuticals & biotechnology
• Microelectronics & semiconductors
• Food & beverage processing

Higher classes demand stricter airflow control, filtration, and monitoring.

ISO 14644-1 defines cleanrooms by particle counts. Common classes include:

• ISO 5: Pharmaceutical aseptic areas, operating rooms
• ISO 6–7: Clean assembly, background areas
• ISO 8: Packaging and preparation zones
• ISO 9: Non-controlled environments

Testing uses particle counters at defined locations to verify compliance.

GMP focuses on product safety and process control, complementing ISO standards:

GMP also includes microbial limits, personnel discipline, and process validation.

Factors to consider:

• Product sensitivity (e.g., sterile drugs vs. packaging)
• Process risk (open vs. closed handling)
• Regulatory requirements
• Cost and energy efficiency

Proper classification balances compliance, performance, and cost.

Cleanroom classification is verified through:

• Particle count tests
• Airflow velocity and uniformity
• Pressure differential checks
• Temperature and humidity monitoring

Testing ensures compliance during commissioning, requalification, and after modifications.

Cleanroom classification is the foundation of effective contamination control. Applying ISO 14644-1 standards and GMP grades ensures product safety, regulatory compliance, and operational efficiency.