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Cleanroom Measurement and Sampling Equipment – The Foundation for a Sterile Environment

 

At Filterfine Vietnam, we understand that maintaining a certified cleanroom environment is a crucial factor for many industries, from pharmaceuticals and healthcare to electronics. To ensure this, equipping accurate and efficient measurement, monitoring, and sampling devices is essential. These devices not only help control contamination but also ensure strict adherence to international standards.

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1. Particle Counters

 

Particle counters are core instruments used to assess air cleanliness in cleanrooms by quantifying the number and size of suspended dust particles.

Key Functions:

• Counts and classifies the number of particles in the air according to different sizes.
• Monitors particle concentration continuously or periodically to detect sources of contamination.
• Ensures cleanroom compliance with international standards such as ISO 14644-1 and EU GMP Annex 1.
• Supports determining the performance of air filtration systems (HEPA/ULPA).

Typical Specifications:

• Measurable Particle Sizes: Commonly from 0.3 µm, 0.5 µm, 1 µm, 3 µm, 5 µm to 10 µm. Some advanced devices can detect particles as small as 0.1 µm.
• Sampling Flow Rate: Typically from 2.83 L/min (0.1 CFM) to 100 L/min, allowing for quick and efficient sampling.
• Connectivity: Supports USB, Ethernet, Wi-Fi, or RS-485 ports for data transfer and integration into monitoring systems.
• Sampling Volume: Usually 1 cubic meter (1000 liters) of air per measurement.

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2. Microbial Air Samplers

 

Microbial air samplers are used to control microbial quality in cleanroom environments, ensuring the air is free from biological contaminants.

Key Functions:

• Collects airborne microorganisms onto agar plates (Petri dishes or contact plates) for culturing and quantification.
• Assesses the risk of microbial contamination and identifies sources of pollution.
• Verifies the effectiveness of HVAC systems and ensures compliance with regulations such as EU GMP Annex 1, ISO 14698.
• Provides quantitative data for environmental control.

Typical Specifications:

• Sampling Method: Primarily impaction, where air is drawn through small holes and microorganisms impact onto the agar surface.
• Airflow Rate: Usually 100 liters/minute.
• Sampling Volume: Typically 1000 liters (1 cubic meter) per sample.
• Compatible Agar Plates: Often uses standard 90mm Petri dishes or 55mm contact plates.
• Material: Device casing is typically made from stainless steel (SUS316), allowing for easy autoclaving and disinfection.
• Physical Cut-off Efficiency (d50): For example, d50 = 1.6 µm, indicating the particle size at which 50% of the particles are retained.
• Features: Touch screen, HEPA exhaust filter, data storage, connectivity (USB, RS-485, Bluetooth), and sample traceability capabilities.

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Investing in high-quality cleanroom measurement and sampling equipment is a strategic step to protect products, processes, and human health. Filterfine Vietnam is proud to offer comprehensive solutions to help our customers maintain optimal production environments and comply with all the strictest requirements.