創建
員工
年營業額(百萬)
合作國家
我們的工廠位於中國江甦的Kunshan。 它的建築工程廠關注的是設計和建造清潔室。為信息電子，藥品，食品，化妝品，軍事行業，化學工業等提供專業且經濟的合理建築計劃和服務。
超過17年的清潔室經驗專業和技術團隊。
“從事實，服務合作中尋求真相”業務哲學。做應該做的事情確保建立每個優質的項目。
商業範圍：清潔室。機電。 裝飾工程。
潔淨室產品：FFU天花板網格三明治面板、乾淨的房間門和Window -airShower、pashpassbox、comecover cover cover coper freate Quality Engineering並為客戶提供優質的產品。
2025
In modern high-standard production environments, maintaining stable, controlled, and verifiable cleanroom conditions is essential for ensuring product performance and process consistency. As industries demand greater environmental precision, the cleanroom monitoring system has become fundamental in pharmaceuticals, biotechnology, semiconductors, and precision manufacturing. It ensures key parameters remain compliant throughout production, providing reliable data support and consistent quality assurance. What is a Cleanroom Monitoring System? A cleanroom monitoring system is an intelligent platform designed to continuously monitor and record critical environmental parameters. Through a network of sensors, it collects real-time data on temperature, humidity, airborne particles, differential pressure, airflow velocity, and microbial levels, and then transmits this information to central monitoring software for traceable data management. Within the broader framework of cleanroom environmental monitoring, such systems play a central role by supporting compliance with standards like GMP and ISO 14644. As a company specializing in cleanroom solutions, WONCLEAN has extensive expertise in system integration and regulatory requirements, providing customized monitoring solutions tailored to different cleanroom applications. How does a Cleanroom Monitoring System Work? Real-Time Data Collection High-performance sensors continuously capture key environmental variables, enabling users to detect fluctuations and avoid potential contamination risks. Data Analysis and Trend Identification The monitoring platform analyzes data patterns, helping users identify anomalies such as sudden particle spikes or pressure drops. Alarm Mechanisms and Rapid Response When data exceeds predefined limits, the system triggers automated alarms, allowing operators to intervene early and prevent escalation. Compliance Records and Traceability Monitoring systems generate audit-ready documentation, supporting internal reviews and regulatory inspections—an essential function of cleanroom monitoring services. Why Cleanrooms must have Monitoring Systems? Cleanroom stability directly impacts product yield and process reliability. Even slight environmental deviations can affect production quality, such as: Excess particle concentration leading to contamination or reduced yield Pressure fluctuations allowing unfiltered air to enter controlled zones Temperature and humidity instability affecting material performance A well-structured monitoring system ensures stable cleanroom operation and enhances long-term product quality consistency. Industry Applications of Cleanroom Monitoring Systems Pharmaceutical & Sterile Manufacturing Ensures compliance with aseptic production standards and supports traceable batch release. Semiconductor & Electronics Manufacturing Particle control is critical for device integrity, making monitoring indispensable for wafer fabrication and precision assembly....
2025
Cleanroom HEPA filters are essential in modern laboratories and manufacturing facilities, where maintaining ultra-clean air is critical for product quality and process reliability. These filters efficiently capture airborne particles, including tiny contaminants that could compromise sensitive production processes, cause product defects, or trigger regulatory issues. By providing a controlled environment, cleanroom HEPA filters help facilities consistently meet strict cleanliness standards and ensure the integrity of products across pharmaceuticals, electronics, and biotechnology industries. What Are HEPA Filters and How Do They Work? Many people ask what is HEPA filter or what does HEPA stand for. HEPA stands for High-Efficiency Particulate Air, and its purpose is to capture extremely small particles that ordinary filters cannot trap. A HEPA filter is essentially a dense web of randomly arranged fibers, made from materials such as borosilicate glass or synthetic polymers like polypropylene. The filter’s efficiency depends on fiber diameter, density, and the overall thickness of the media. The physics behind particle capture is complex. Cleanroom HEPA filters rely on mechanisms such as interception, impaction, and diffusion to remove dust, microbes, chemical aerosols, and other contaminants from the airflow. These mechanisms work together to maintain cleanroom standards and protect sensitive processes, making HEPA filters indispensable in critical production and research environments. Why Are Cleanroom HEPA Filters Essential? Particle Control The main function of any filter is to remove airborne particles. In cleanrooms, even minimal dust, bacteria, or mold can compromise industries like pharmaceuticals, biotechnology, and semiconductor manufacturing. Cleanroom HEPA filters reduce contamination risks, ensuring stable processes and high product quality. Regulatory Compliance Many industries must manufacture products in controlled environments to meet regulatory standards. Compliance with ISO 14644, cGMP/GMP, and USP 797/800 is often mandatory in healthcare, biotech, and pharmaceutical sectors. HEPA filtration ensures consistent air quality, helping facilities pass audits and maintain certifications. Understanding hepa meaning reinforces the importance of these systems in regulated environments. Workplace Safety HEPA filters also protect cleanroom personnel. In pharmaceutical compounding or chemical processing, workers may be exposed to hazardous particles. Filters trap these materials, preventing circulation in the workspace. This is a key part of USP 800 compliance, reducing occupational exposure and improving safety. Types of HEPA Filters in Cleanrooms Different HEPA filter types suit varying applications and airflow requirements: Standard HEPA Filters: Capture ≥99.97% of particles ≥0.3 microns, suitable for general cleanroom environments. ULPA (Ultra-Low Penetration Air) Filters: Higher efficiency, used in critical areas where contamination mus...
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Maintaining proper pressure differentials is essential for meeting ISO 14644, USP 797/800, cGMP, and other regulatory requirements. Pressure control ensures that air flows in the correct direction—either to prevent external contaminants from entering the cleanroom or to keep hazardous substances from escaping. Depending on the application, a cleanroom may require positive pressure, negative pressure, or a multi-room pressure cascade. Importance of Cleanroom Pressure Differential Proper pressure differential control is vital for cleanroom stability, air cleanliness, and regulatory compliance. Correct pressure levels prevent external contaminants—such as dust, microbes, and chemical particles—from entering, while avoiding airflow reversal that could cause cross-contamination or product quality issues. Since pressure determines airflow direction, it plays a key role in preventing particles and microorganisms from spreading between rooms, which is essential in pharmaceuticals, biotech, medical device manufacturing, and semiconductor production. Pressure control is also a core requirement of ISO 14644, GMP, and USP 797/800. Even small deviations can affect cleanliness levels, increase contamination risks, or lead to compliance failures. Therefore, precise pressure control and continuous monitoring are indispensable for maintaining cleanroom performance and safety. Positive Pressure Cleanrooms Positive pressure is used when the goal is to keep contaminants out. Common industries include: Pharmaceuticals Semiconductors Electronics manufacturing Aerospace Medical device production When doors open, clean air flows outward, blocking contaminants from entering. Typical pressure differential: +0.03 to +0.05 in. w.g. (≈ +7.5 to +12.5 Pa) Multiple rooms often use a pressure cascade, where cleaner areas maintain higher pressure. Negative Pressure Cleanrooms Negative pressure is used when hazardous materials must be contained to prevent their escape. Common applications include: Cytotoxic drug handling areas (USP 800) Infectious pathogen laboratories (biosafety labs) Hazardous chemical processing areas Air always flows into the room, preventing contaminants from escaping. Typical differential: –0.01 to –0.03 in. w.g. (≈ –2.5 to –7.5 Pa) This ensures safe operation and regulatory compliance. Cleanroom Pressure Differential Requirements ISO 14644 & GMP Standards Between clean zones of different classifications: ≥ 5 Pa Between cleanroom and non-cleanroom areas: ≥ 10 Pa USP 797 / USP 800 Requirements USP 797 sterile compounding rooms: Positive pressure USP 800 hazardous drug rooms: Negative pressure (minimum –2.5 Pa) These standards ensure safe airflow direction and minimize cross-contamination risks. Air Volume Calculation for Pressure Differential To maintain stable pressure, leakage compensation airflow must be accurately calculated. Leakage Airflow Formulas LC = µP × AP × ΔP × ρ or LC = α × q × l Note： LC = required leakage compensation airflow AP = effectiv...
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In cleanroom environments, flooring is a critical element for contamination control, air cleanliness, product quality, and personnel safety. High-quality cleanroom flooring enhances cleanability, durability, and long-term compliance with industry standards. For pharmaceuticals, semiconductors, biotechnology, and life-science labs, selecting the right flooring for clean room helps reduce risks from particles, microbes, and static electricity while ensuring compliance with GMP and ISO 14644. Main Types of Cleanroom Flooring Rubber Flooring Rubber flooring is widely used in high-tech manufacturing and laboratory environments due to its exceptional durability, impact resistance, and superior ESD control. Brands such as Nora use 1 m² solid sheets installed with cold welding to create seamless surfaces that prevent particle accumulation. Rubber flooring is ideal for areas with heavy equipment movement and for ESD-sensitive environments such as electronics or medical device manufacturing. In pharmaceutical clean room flooring projects, rubber floors are often chosen for their longevity, ease of maintenance, and high cleaning efficiency. Seamless Vinyl Flooring This is a cost-effective solution for small cleanrooms or low-load areas. Vinyl flooring can extend up walls to form coved edges, eliminating cleaning dead corners. However, due to its lower resistance to heavy traffic and equipment loads, it is best suited for light-to-medium-duty cleanroom applications. Epoxy Coatings Epoxy flooring provides an attractive, low-porosity, and highly sealed surface, ideal for cleanrooms with well-prepared concrete substrates. With thicknesses ranging from 10–25 mils, epoxy can smooth out minor imperfections and offers excellent chemical resistance. While epoxy may be slightly less stain-resistant and wear-resistant than urethane systems, it remains a strong, cost-efficient cleanroom flooring option. MMA Flooring (Methyl Methacrylate) The standout advantage of MMA flooring is its ultra-fast cure time—typically less than one hour—and its ability to be installed even in low-temperature environments down to –20°C. MMA systems are highly durable, impact-resistant, antimicrobial, and low-glare, making them ideal for pharmaceutical facilities, cold-chain laboratories, and biosafety environments where downtime must be minimized. Urethane Flooring (Urethane Cement / PU Systems) Urethane flooring offers superior wear resistance, heavy-load tolerance, and outstanding resistance to a wide range of chemicals, including acids, alkalis, fuels, and hydraulic oils. It is well-suited for environments requiring frequent cleaning, heavy equipment movement, or exposure to corrosive substances. Anti-slip additives can be incorporated to enhance operator safety. VCT (Vinyl Composition Tile) VCT is commonly used in Class 7 & 8 cleanrooms in the electronics sector due to its low upfront cost and availability in ESD-safe versions. However, because it contains many seams and requires fre...
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