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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
Wonclean: A Heartfelt Thank You to Our Valued Clients This New Year As the final days of 2025 draw to a close, the entire team at Wonclean pauses to reflect on a year defined by partnership, trust, and shared success—and we owe it all to you. This past year, your confidence in our solutions fueled our drive to innovate, refine, and deliver results that exceed expectations. Whether you’ve been with us from the start or joined our journey recently, every collaboration has shaped who we are and where we’re headed. From the challenges we navigated side-by-side to the milestones we celebrated together, your support has been the cornerstone of our progress. As we step into 2026—a year brimming with new possibilities—we’re more committed than ever to earning your trust each day. We’re already working on exciting updates, tailored support, and solutions designed to grow with your needs, and we can’t wait to build even stronger connections with you in the months ahead. To our incredible clients: Thank you for choosing Wonclean. Here’s to a New Year filled with prosperity, positivity, and continued success—together. Warmest wishes, The Wonclean Team
2025
Let’s start by answering the question everyone asks first: “What exactly is USP 800?” In the cleanroom industry—especially pharmacy compounding and hospital pharmacy operations—it is both a safety rule and an engineering standard. As a cleanroom engineering and solution provider, Wonclean will break down the core concepts of usp 800 and the essential design requirements in a light yet rigorous way. What is USP 800? USP 800 is a standard specifically created to regulate the compounding, storage, and handling of Hazardous Drugs (HDs). Its primary goal is to protect healthcare workers, patients, and the environment. It works alongside USP 795 and USP 797, and in the U.S. healthcare system, it is considered a mandatory engineering and operational requirement. To make things clearer, USP 800 focuses on three major areas: Engineering controls (ventilation, cleanroom structure, exhaust, pressure control) Environmental controls (particle levels, temperature and humidity, ISO classification) Administrative controls (PPE, training, documentation) Key Requirements of USP 800 Engineering Control Essentials Below is a simplified version of the engineering requirements that Wonclean commonly uses when designing USP 800 facilities for hospitals and pharmacies: Area Pressure Air Changes (ACPH) Exhaust HD Storage Negative ≥12 ACPH External, no recirculation Non-Sterile HD Compounding Negative ≥12 ACPH External exhaust Sterile HD Buffer Room Negative, ISO 7 ≥30 ACPH Dedicated external exhaust Anteroom Positive, ISO 7 ≥30 ACPH Recirculation allowed The most critical point: All HD compounding must be done in externally exhausted equipment such as a pharmacy compounding hood (BSC or other externally vented C-PECs). What does USP 800 Compliance Require? USP 800 compliance is a system-level engineering effort—it is not “just buying a hood.” Wonclean typically plans a project with the following structure: Facility & Equipment Select Class II BSCs or isolators Equipment must be externally vented, never recirculated Position away from doors, vents, or airflow disturbances HVAC & Pressure Control Maintain -0.01 to -0.03 inH₂O in HD rooms 30 ACPH is required for ISO 7 sterile compounding rooms Exhaust points must be far from air intakes; buildings should reserve shaft space Administrative Controls USP 800 requires implementation of the following administrative measures: Annual training (HD handling, spill management, PPE donning/doffing) Continuous pressure monitoring and documentation Annual certification of containment devices (HEPA leak test, airflow testing) Updating HD inventory lists and performing risk assessments These administrative controls ensure engineering systems are properly used and remain stable. How to Design a USP 800 Space Based on years of cleanroom engineering experience, Wonclean usually follows a structured workflow during USP 800 projects: Needs Assessment This begins with detailed, checklist-style communication to determine: Compounding vol...
อ่านเพิ่มเติม2025
When people begin planning a cleanroom, the first question that usually comes to mind is: “Where do I even start?” This is exactly why a well-structured cleanroom checklist is so valuable—it breaks a large, complex project into a clear and understandable roadmap. At Wonclean, after supporting many clients with cleanroom design and engineering, our conclusion is simple: the clearer the checklist, the smoother the project. Why is a Cleanroom Checklist so Important? Unlike ordinary rooms, cleanrooms come with a lot of rules—particle control, airflow organization, pressure gradients, filtration efficiency… all tightly interconnected like gears in a precision machine. A good checklist helps you grasp the entire framework before diving into detailed design. But the question is: What exactly should a checklist include? What makes it “complete”? Let’s break it down from the most fundamental elements. Defining Requirements (More Important Than Design Itself) Every successful cleanroom project begins with clear requirements. These include the cleanroom’s purpose, product characteristics, and applicable regulatory standards. Whether you’re following cleanroom standards like ISO 14644 or compliance frameworks such as GMP/FDA, the foundation must be set first. Key requirements include: Cleanliness class (ISO 5–8 or GMP A–D) Temperature & humidity range Pressure gradients Airflow patterns Personnel/material flow routes Environmental monitoring needs Cleaning & maintenance procedures This serves as the project’s steering wheel—without it, every decision becomes guesswork. Layout & Process Flow Planning A good layout leads to a good cleanroom; a poor layout can never be fixed later. Your checklist should verify: Separation of personnel and material entry Adequate size of gowning rooms & airlocks Process flow designed to prevent cross-contamination Proper location for utility rooms Compliance of emergency exits If people and materials move inefficiently, even the most powerful filtration system cannot save the cleanroom’s performance. Building Materials & Surface Systems Cleanrooms must be easy to clean, corrosion-resistant, and free of dirt-trapping points. Checklist essentials: Wall materials (FRP panels, aluminum, stainless steel, etc.) Flooring (welded vinyl, epoxy, ESD flooring) Cove-radius corners instead of sharp angles Flush windows designed to prevent dust accumulation Proper sealing of doors and pass-throughs Materials may look simple—but they determine long-term durability and cleanliness. HVAC: The Heart and Soul of a Cleanroom This is where most people focus—the air system. But a cleanroom HVAC isn’t “just an air conditioner.” It is the engine of air quality. Checklist should include: Air changes per hour (ACH) HEPA/ULPA coverage and placement Airflow patterns (unidirectional, non-unidirectional, mixed flow) Temperature and humidity stability Pressure differentials (typically 10–15 Pa) Fresh air ratios and exhaust strategy Fan hea...
อ่านเพิ่มเติม2025
In the cleanroom industry, there is a common saying: “Air quality determines product quality.” And this is absolutely true. For any cleanroom, an hvac clean room system is far more than a device that delivers cooled or heated air—it is an integrated “air life-support system” responsible for particle control, pressure stability, airflow organization, and precise temperature and humidity uniformity. If you’ve ever wondered how cleanroom air is actually “calculated”—what determines air changes, airflow volume, or cooling load—this article will walk you through the fundamental principles and help you understand these seemingly complex calculations in a clear, practical way. Why is the HVAC System Considered the “Heart” of a Cleanroom? If an HVAC system in a conventional building is a hardworking assistant, then the cleanroom HVAC system is a true “all-in-one protagonist.” A cleanroom does not passively receive conditioned air—it actively creates its own air environment. The air must achieve: Stable particle concentration Tight temperature and humidity tolerance Defined pressure direction (positive or negative) Verifiable airflow patterns (unidirectional or non-unidirectional) All of this depends on continuous filtration, dilution, and replacement of air. Every calculation in the HVAC design directly affects whether a cleanroom can meet its classification, operate stably, and avoid energy waste over years of operation. As a cleanroom engineering company, Wonclean handles large volumes of design reviews every day and deeply understands the critical role of this system. What is an Air Exchange? For many newcomers, hearing “what is an air exchange” might sound like air simply “flowing around.” But in cleanroom engineering, the term has a very strict definition: It refers to how many times the entire room’s air is replaced within a specific period. The most common metric is ACH — Air Changes per Hour. How is ACH calculated? The formula is simple, as long as the units are consistent: ACH = Total Supply Air Volume (m³/h) ÷ Room Volume (m³) You might also wonder, “So is how to calculate air changes more complicated?” Not really—but the ACH requirement depends on the cleanroom class: ISO 8: 5–48 ACH ISO 7: 60–90 ACH ISO 6: 150–240 ACH ISO 5: 240–480 ACH (though airflow velocity is the real control point here) Higher ACH means faster contaminant removal, but also higher energy consumption. Reasonable—not excessive—air changes are the first principle of good design. How is Supply Air Volume Calculated? Once you know “how much air must be exchanged,” the next question is: “How much air should actually be supplied?” This directly relates to how do you calculate cfm for a room. CFM = ACH × Room Volume (ft³) ÷ 60 If you want to convert ACH to airflow volume, that’s where the term air change per hour to cfm applies—ACH and CFM are fully convertible as long as the room volume is constant. In cleanrooms, supply airflow is not determined only by air changes. Sometimes ...
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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