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 p...
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....
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...
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...
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...
In highly controlled environments, ensuring that a cleanroom consistently meets its design and operational standards is critical. Cleanroom validation is a systematic process used to confirm that facilities, equipment, and environments function as intended, ensuring compliance with regulatory requirements and user specifications. For companies like Wonclean, providing professional cleanroom validation services helps clients achieve operational efficiency while maintaining long-term cleanroom compliance. Understanding the Basics A cleanroom is a modular environment in which key factors such as temperature, airborne particles, microbial load, relative humidity, pressure differentials, and airflow are strictly controlled. The primary purpose of cleanroom validation is to verify that facility designs meet intended use, that equipment and systems comply with user requirement specifications (URS), and that all regulatory standards are fully adhered to. Once validation is complete, cleanrooms are certified according to the selected ISO 14644-1 classification. Each ISO class has specific requirements, and facilities must meet these conditions to obtain the corresponding certification. The Lifecycle of Cleanroom Validation Validation for a new cleanroom follows a structured lifecycle comprising five stages, each designed to control and verify the performance of the modular environment. If equipment or control systems are modified, re-validation is required to maintain compliance. Design Qualification (DQ) Design qualification verifies, with objective evidence, that the facility’s design meets its intended purpose. The DQ protocol typically reviews: User Requirement Specification (URS) Supplier documentation and specifications Facility layout and design drawings Purchase orders and equipment datasheets Factory Acceptance Testing (FAT) The output of the DQ stage includes a DQ report and a Standard Document List (SDL), recording design requirements, procurement records, drawings, component lists, checklists, and FAT results. Approval of DQ is a prerequisite for starting Installation Qualification (IQ). Installation Qualification (IQ) Installation qualification confirms that installed equipment meets both user and design requirements. The IQ protocol usually covers: HVAC calibration P&ID loop verification HEPA filter integrity data review Critical equipment calibration status Site Acceptance Testing (SAT) Standard operating procedures and work manuals The IQ report documents all tests, calibrations, deviations, consumables, spare parts, and vendor certificates. IQ approval is required before Operational Qualification (OQ) can begin. Operational Qualification (OQ) OQ provides objective evidence that the cleanroom operates within specified parameters and consistently meets functional requirements. Testing generally includes: HVAC system performance Critical alarms and interlocks Airflow, pressure differentials, and filter integrity Worst-case scenario testi...
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