Iso5 modular cleanroom for aseptic manufacturing of semiconductors and biopharmaceuticals.

Cleanliness standards

● According to international standard ISO 14644-1, ISO Class 5 cleanrooms require a concentration of ≤3520 particles ≥0.5μm per cubic meter of air, ≤10000 particles ≥0.1μm per m³, and ≤29 particles ≥1μm per m³. The US Federal Standard 209E Class 100 standard is equivalent, specifying ≤100 particles ≥0.5μm per cubic foot of air (approximately 3530 particles/m³).

HVAC System Parameters:

● Temperature and Humidity Control: Temperature is generally controlled at 22±2℃, with some processes in the semiconductor industry requiring ±0.5℃. Humidity is typically controlled at 45±5% RH, with some biopharmaceutical processes requiring 30-50% RH.

●Filtration System: A three-stage filtration system is used. The pre-filter (G4 grade) filters particles ≥5μm with an efficiency of 80%@1μm; the medium-efficiency filter (F8-F9 grade) filters particles ≥1μm with an efficiency of 90-95%; and the terminal high-efficiency filter (H13-H14 grade) has an MPPS (most penetrating particle size) efficiency ≥99.95-99.995%.

●Air Change Rate: The air change rate is 50-60 times/hour in non-unidirectional flow areas and even higher in unidirectional flow areas to ensure air cleanliness.

Construction and Acceptance Standards:

●Construction Process: All materials must undergo cleanroom packaging removal and testing before arrival (particle count ≤ ISO 8); welding operations must be equipped with local fume extraction devices, and the surface roughness Ra after welding must be ≤ 0.8μm; a "top-down, inside-out" construction sequence should be adopted, with physical barriers set up between different trades.

●Acceptance Testing: Includes suspended particle testing: ≥0.5μm particles ≤ 3520/m³, ≥5μm particles ≤ 29/m³ (static test); microbial limit testing: settling bacteria ≤ 1 CFU/plate (φ90mm, 4 hours); airflow pattern visualization testing, using a fume generator to verify the absence of eddy zones; self-cleaning time testing: recovery from ISO 8 to ISO 5 must be ≤ 15 minutes.

Application Compatibility in the Semiconductor and Biopharmaceutical Industries:

●Semiconductor Industry: In semiconductor manufacturing processes, critical steps such as chip lithography and etching are extremely sensitive to particle contamination. Even tiny particles can cause short circuits or malfunctions. ISO Class 5 modular cleanrooms can strictly control particle concentrations ≥0.1μm, while also controlling vibration, static electricity, and gaseous molecular contaminants to meet the extremely high environmental requirements of semiconductor production.

●Biopharmaceutical Industry: In aseptic production processes in biopharmaceuticals, such as aseptic filling, cell therapy, and vaccine production, strict control of microbial and particle contamination is necessary to ensure the safety and efficacy of drugs. The microbial limit standards and high cleanliness environment of ISO Class 5 cleanrooms effectively prevent product contamination and comply with GMP and other relevant regulations.

Commonly used equipment in cleanrooms