class100 cleanroom

I. Basic Definitions & Standard Correspondence

Class Rating Source: US Federal Standard FS 209E (industry-standard, though superseded by ISO), Class 100 refers to ≤100 particles ≥0.5μm per cubic foot;

International Correspondence: ISO 14644-1 ISO Class 5 (≤3520 particles ≥0.5μm per cubic meter);

Additional Biological Scenario: Pharmaceutical/Medical microorganisms requiring control (e.g., GMP Grade A area: airborne bacteria ≤1~5 CFU/m³, settling bacteria ≤1 CFU/plate);

Compliance Basis: ISO 14644 series, FDA cGMP, EU GMP, GB 50073 (domestic).

II. Core Technical Requirements (Hard Specifications)

Airflow Organization: Vertical unidirectional flow (entire room) / local laminar flow hood, fixed air velocity 0.45±0.1m/s, no eddies, no dead zones;

Filtration System: MAU + pre-filter + medium-efficiency filter + H14 grade HEPA filter (terminal, 0.3μm filtration efficiency 99.997%), ULPA if necessary; PAO leak testing must be performed after installation/replacement;

Environmental Parameters: Positive pressure ≥10Pa in adjacent lower-level areas; temperature 22±2℃, humidity 45%~60% RH (anti-static, antimicrobial);

Materials/Personnel: Multi-level clean changing room + forced air shower; materials pass through transfer windows (interlocked + UV/chemical disinfection) to prevent cross-contamination.

III. Typical Application Scenarios

Focusing on core processes requiring high precision and sterility, avoiding full-room Class 100 coverage (high cost), most applications utilize localized Class 100 areas in core zones:

Semiconductor/Optoelectronics: Advanced process lithography, wafer bonding, high-end sensor assembly;

Pharmaceuticals: Sterile injection filling, freeze-drying dispensing, aseptic handling of biological agents;

Medical: Organ transplant operating rooms, IVF embryo laboratories, high-risk implantable device assembly;

Precision Manufacturing: High-end optical lenses, aerospace precision component assembly.

IV. Acceptance & Maintenance Key Points

Acceptance Conditions: Full testing in empty, static, and dynamic (actual production/operation) states, with dynamic testing as the core quality control standard;

Regular Monitoring: Particle count, air velocity, pressure differential, temperature and humidity, microorganisms, with full data traceability;

Filter Management: Replace filters based on pressure differential/usage time, with at least one PAO leak test per year;

Cost Optimization: Minimize the Class 100 core area, replacing full-room Class 100 with laminar flow hoods/FFU microenvironments to reduce maintenance costs.

V. Clarification of Common Misconceptions

Not “Zero Particles”: This only means that the particle concentration is strictly limited, not that there are no particles;

Class Classes Are Not Confusing: Class 100 = ISO 5, ≠ ISO 1 (ISO 1 has much higher particle requirements);

Dynamic Performance Is More Important: Static compliance does not mean dynamic compliance. Personnel/equipment operation is a key factor affecting cleanliness.