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WONCLEAN COMPANY LIMITEDโรงงานของเราตั้งอยู่ที่ Kunshan, Jiangsu, China เป็นโรงงานวิศวกรรมการก่อสร้างที่มุ่งเน้นการผลิตและการก่อสร้างห้องพักที่สะอาด จัดทำโครงการอาคารและบริการที่สมเหตุสมผลสำหรับมืออาชีพและประหยัดสำหรับอิเล็กทรอนิกส์ข้อมูลเวชภัณฑ์อาหารเครื่องสำอางอุตสาหกรรมทหารอุตสาหกรรมเคมีและอื่น ๆ
มากกว่า 17 ปีประสบการณ์การทำความสะอาดทีมงานมืออาชีพและเทคนิค
โดย "แสวงหาความจริงจากข้อเท็จจริงความร่วมมือการบริการ" ปรัชญา ทำในสิ่งที่ควรทำตรวจสอบให้แน่ใจว่าการสร้างโครงการที่มีคุณภาพยอดเยี่ยมทุกโครงการ
ขอบเขตธุรกิจ: Cleanroom เครื่องจักรกลไฟฟ้า วิศวกรรมการตกแต่ง
ผลิตภัณฑ์ทำความสะอาด: กริดเพดาน FFU 、แซนวิชแผง、สะอาดประตูห้องพักและหน้าต่างห้องอาบน้ำฝักบัวอากาศผ่านกล่องชั่งน้ำหนัก ฯลฯ สร้างวิศวกรรมคุณภาพและจัดหาผลิตภัณฑ์ที่มีคุณภาพสำหรับลูกค้า
2025
Planning a clean room project can feel overwhelming. From design to installation, many factors affect the clean room cost, and making sense of them can save both time and money. Whether you’re considering a traditional facility or a modular solution, understanding the key cost drivers is crucial to making informed decisions. What Factors Influence Clean Room Cost? Cleanliness Class (ISO Level) The first major factor in determining clean room cost is the required cleanliness level. Higher ISO classes (such as ISO 1–5) demand more precise air filtration, stricter materials, and advanced environmental controls, all of which increase the investment. Conversely, lower-grade clean rooms, like ISO 7–9, are easier and cheaper to build, suitable for basic manufacturing or storage. Space Size and Complexity The larger and more complex the space, the higher the cost. Multi-zone layouts, specialized areas, or multi-floor designs require more construction time, advanced HVAC systems, and additional equipment. Even within the same ISO class, a 500 m² room will cost significantly more than a 100 m² room. Construction Type: Modular vs Traditional Modular Clean Room: These prefabricated systems offer flexibility and faster deployment. While initial costs may be higher, modular solutions are ideal for projects that may expand or relocate in the future. Traditional Construction: Custom-built clean rooms can meet highly specific requirements and larger scale projects, but they require longer construction times and higher budgets. Material Selection Material choices also impact the clean room cost. Examples include: Walls: Soft partitions (lower cost) vs rigid panels (higher cost for high cleanliness) Flooring: Epoxy, PVC, stainless steel — each with different costs and maintenance requirements Ceiling & Lighting: Must be dust-resistant, easy to clean, and well-sealed for airflow integrity Equipment and Specialized Features Essential clean room equipment contributes significantly to the budget: HVAC systems with HEPA or ULPA filtration Pass-through chambers, air showers, and airlocks Clean benches, laminar flow units, and specialized furniture Compliance and Certification Meeting industry standards like ISO 14644, GMP, or FDA requirements often involves extra documentation, validation, and inspection costs. Failing to plan for this can lead to unexpected expenses later. How Much Does a Clean Room Typically Cost? While actual pricing varies by project specifics, here’s a rough guide to clean room cost per square foot: ISO Class Estimated Cost (USD/sq. ft) Typical Applications ISO 7–9 (Basic) $100–$300 Storage, basic production ISO 5–6 (Intermediate) $300–$600 Pharmaceutical, biotech labs ISO 1–4 (High) $600–$1,000+ Semiconductor, electronics, sterile formulations For companies exploring clean room installation, knowing these estimates helps in budgeting and planning. If you are considering buying a prebuilt solution, searching for clean room for sale or comparing ...
2025
In modern clean room operations for precision manufacturing and life sciences, ISO 14644-1 clean room standards, FED-STD-209E classifications, and GMP clean room regulations are the “guardians of quality.” But when engineers talk about a “Class 100 clean room,” the quality team requests “ISO 5,” and auditors review “GMP Grade A” documents, it’s easy to get confused. Don’t worry—this guide will explain the relationship between ISO clean room standards, FED-STD-209E, and GMP clean rooms, so you can confidently manage design, validation, and daily operations. Why Understanding These Standards Matters Mixing these terms can be headache-inducing. Think of them as different languages: some people speak American English, some British English, and some “legalese.” Without knowing how they relate, you could make mistakes during design, acceptance, or audits. In short: Practical problem: Engineers say “Class 100,” quality wants ISO, auditors look at GMP. Can they match? Historical context: FED-STD-209E is an old US standard, ISO is international, GMP is regulatory. Old and new terms coexist in practice. Value of this guide: Quickly build a framework to understand all three, and learn how to choose or convert standards for easier clean room management. Overview of the Three Major Standards ISO 14644-1 (International Standard) ISO 14644-1 is the global standard that tells you “how many particles are allowed in a clean room, and how to measure and test them.” Applicable industries: Semiconductors, aerospace, medical devices, pharmaceuticals… virtually any industry that needs contamination control. Core value: It’s the “universal language” for designing, constructing, and validating clean rooms—used in contracts, acceptance, and technical communication. FED-STD-209E (US Historical Standard) First issued in 1963, FED-STD-209E measured clean room classes in cubic feet. It was officially replaced by ISO standards in 2001. Current use: Although obsolete, the “Class X” terminology is still widely used, especially in North American semiconductor projects and legacy facilities. GMP (Good Manufacturing Practice) GMP is not just about particle counts—it’s a regulatory framework for pharmaceuticals and medical devices. Core content: Controls the full process—from personnel, facilities, and equipment to processes and documentation. Environmental requirements: Clean room levels often refer to ISO standards, but GMP emphasizes both dynamic and static conditions, microbial monitoring, and process control. ISO Classification Maximum Number of Particles in Air (Particles in each cubic meter = or>the specified size) >0.1 μm >0.2 μm >0.3 μm >0.5 μm >1.0 μm >5.0 μm ISO 1 10 - - - - - ISO 2 100 24 10 - - - ISO 3 1,000 237 102 35 - - ISO 4 10,000 2,370 1,020 352 83 - ISO 5 100,000 23,700 10,200 3,520 832 - ISO 6 1,000,000 237,000 102,000 35,200 8,320 298 ISO 7 - - - 352,000 83,200 2,930 ISO 8 - - - 3,520,000 832,000 29,300 ISO 9 - - - 35,200,000 8,320,000...
อ่านเพิ่มเติม2025
A particle counter for clean room is essential for measuring air quality in a cleanroom, helping manufacturers maintain regulatory compliance and protect product integrity. These devices allow precise monitoring of airborne particles, ensuring the facility consistently meets ISO standards. But how do particle counters work, and which type is best suited for your cleanroom? Why a Particle Counter for Cleanroom is Essential Using a cleanroom particle counter is critical for maintaining cleanliness levels in controlled environments. Most facilities require third-party certification at least once per year and rely on internal checks—monthly or weekly—to monitor particle counts. A particle counter measures both the number and size of particles in the air, providing key data to sustain a controlled environment. Without reliable particle counters, facilities risk non-compliance, reduced product quality, and potential contamination incidents How Particle Counters Work A typical particle counter for clean room works by drawing a fixed volume of air through a laser chamber, which counts particles across multiple size ranges. The accuracy of measurement improves with larger air samples. Standard devices usually measure particles in five size ranges to classify the cleanroom according to ISO standards. Types of Cleanroom Particle Counters There are three main types of particle counters used in cleanroom monitoring: Handheld Cleanroom Particle Counters Handheld units, often called portable air particle counters, cost between $1,000 and $3,000. They are useful for qualitative checks, such as identifying major particle sources in a facility. However, their readings can be inconsistent due to challenges in maintaining a fixed height and position during measurement. They are not recommended for formal certification purposes. Tabletop Cleanroom Particle Counters Tabletop cleanroom particle counters are the most common choice for modular cleanrooms, costing $6,000 to $11,000. Usually mounted on carts, they can be moved to multiple test points while maintaining a consistent height. These counters provide reliable and repeatable data for regular monitoring and internal quality assurance. Fixed Particle Counting Systems For large or pharmaceutical cleanrooms, fixed particle counting systems offer comprehensive monitoring. These systems, ranging from $20,000 to $100,000, use pumps and piping to collect air samples from multiple locations, providing real-time data for regulatory compliance. Fixed systems are increasingly popular in high-demand cleanroom environments due to their automation and accuracy. Choosing the Right Particle Counter Selecting the correct particle counter for clean room depends on the cleanroom’s ISO classification and size. For ISO7 and ISO8 cleanrooms, 0.1 cfm particle counters are generally adequate. For ISO5 and ISO6 cleanrooms, larger 1.0 cfm counters are necessary to ensure accurate measurements. Larger air samples provide...
อ่านเพิ่มเติม2025
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....
อ่านเพิ่มเติม
Room JT30151, Building 4, Area B, No. 925 Yecheng Road, Industrial Zone, Shanghai,China
info@wonclean.com
Allen@wonclean.com
Joy@wonclean.com
+8613671979988(Allen)+8615950938878(Joy)
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