GMP Modular Class 100 Clean Room OEM ODM Portable Dust Free Safety Cleanroom System

Class 100 OEM ODM Dust Free Clean Room Safety Cleanroom System Portable GMP Modular

Feature

Clean room with temperature and humidity requirements for production process: determined according to the requirements of production process

Clean room without temperature and humidity requirements for production process: 24 C–26 C in summer; 20 to 22 DEG C in win;

Room for personal purification and living: 26 C–30 C in summer; 16 to 20 DEG C in win;

The amount of fresh air in the clean room shall be the maximum of the following two:

1. The sum of the amount of fresh air required to compensate the indoor exhaust volume and maintain the indoor positive pressure value.

2. Ensure the supply of clean indoor fresh air per person per hour is not less than 40 m .

Clean Room Classifications

• Clean rooms are classified based on the number and size of particles allowed in the air. The most common standards for classification are the ISO 14644-1 (international standard for clean rooms) and Federal Standard 209E (outdated but still referenced in some regions).
• ISO Classifications range from ISO 1 (the cleanest) to ISO 9 (the least clean). For instance, an ISO 1 clean room has fewer than 12 particles per cubic meter of air, while an ISO 9 clean room allows up to 35,200,000 particles.

Surface Cleanliness

• Smooth, Non-porous Surfaces: Surfaces inside a clean room are typically made from smooth, non-porous materials like stainless steel or epoxy-coated surfaces, which are easier to clean and less likely to harbor contaminants.
• Frequent Cleaning: Clean rooms are regularly cleaned using specific cleaning agents that do not leave residues, and all items entering the room are often sterilized or sanitized.

Monitoring and Documentation

• Continuous Monitoring: Clean rooms are equipped with sensors to monitor particle counts, airflow, temperature, and humidity. These readings are often logged continuously and checked against standards to ensure the room’s performance.
• Environmental Control Systems: Advanced monitoring systems can also track air quality, contamination sources, and any deviations from standard protocols to ensure compliance with stringent requirements.

Technical Data