What Are The Differences Between Pharmaceutical Cleanrooms And Electronic Cleanrooms?

In the pharmaceutical and electronics industries, cleanrooms serve as core production infrastructure, directly determining the stability and safety of product quality.  Detailed analysis follows:

I. Design Standards and Core Orientations

Pharmaceutical cleanrooms adhere to the Good Manufacturing Practice (GMP) standards. The core orientation is "preventing microbial contamination" and "ensuring drug safety and efficacy," emphasizing traceability and compliance throughout the entire production process. From design to operation, they must meet the contamination control requirements of the entire drug supply chain. Electronic cleanrooms, on the other hand, primarily follow the ISO 14644 series of standards. The core orientation is "controlling particulate contamination" and "ensuring the performance stability of electronic components," focusing on preventing physical damage to precision electronic components from dust and static electricity.

II. Key Points of Air Cleanliness Control

Both cleanrooms and electronic cleanrooms use air cleanliness as a core indicator, but their control targets and standards differ. Pharmaceutical cleanrooms need to control both particulate matter and microorganisms. The cleanliness level is typically required to reach ISO 5 (≤100 particles ≥0.5μm per cubic meter). Critical process areas (such as aseptic filling and freeze-drying) may even need to reach ISO 4. Strict control of settling and airborne bacteria (e.g., ≤1 CFU/plate) is required to prevent microbial growth that could lead to drug deterioration. Electronic cleanrooms, on the other hand, prioritize particulate control, with even stricter requirements on particle size. For example, the photolithography area in semiconductor manufacturing needs to reach ISO 1-2 (≤10-100 particles ≥0.1μm per cubic meter). The focus is on preventing the short-circuit and open-circuit effects of extremely small particles on electronic components. There are no mandatory requirements regarding microorganisms.

III. Temperature, Humidity, and Environmental Parameter Control

The temperature and humidity control in pharmaceutical cleanrooms is directly related to drug stability and requires greater precision: temperature is typically maintained at 20-24℃±1℃, and relative humidity at 45%-65%±5%. Fluctuations in temperature and humidity must be avoided to prevent drug degradation, abnormal crystallization, or deformation of packaging materials. Some biopharmaceutical workshops also require additional control of the pressure gradient to prevent cross-contamination.

The temperature and humidity control in electronic cleanrooms serves process requirements and electrostatic discharge (ESD) control. Temperature is generally 22-24℃±2℃, and relative humidity at 40%-60%±10%. While the precision requirements are slightly less stringent, adjustments are necessary based on component type—for example, semiconductor manufacturing requires lower humidity to reduce ESD, while LCD panel production requires higher humidity to ensure process stability.

IV. Personnel and Material Flow Control Logic

The core of personnel and material flow control in pharmaceutical cleanrooms is "full-process contamination prevention." Personnel must undergo multiple steps including changing clothes, handwashing and disinfection, and air showers, wearing sterile cleanroom garments. Materials must pass through by pass box or sterile transport carts, undergoing cleaning, disinfection, and sterility testing before entering, preventing the introduction of external contaminants.

The focus of control in electronic cleanrooms is "anti-static and prevention of particulate matter introduction." Personnel wear anti-static clothing and shoes, and enter after passing through an anti-static elimination device; material transfer must pass through an anti-static transfer window, focusing on cleaning surface particles and eliminating static electricity, without requiring sterile treatment; some areas are equipped with air showers to remove dust attached to personnel clothing.

In summary, the design differences between pharmaceutical cleanrooms and electronic cleanrooms are essentially extensions of differing industry needs—the pharmaceutical industry focuses on "biosafety and compliance," while the electronics industry focuses on "physical cleanliness and process compatibility."

Suzhou Pharma Machinery Co.,Ltd.

2026/02/02

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