The principles, methods, and results of air filtration applications in pharmaceutical and medical device manufacturing systems. In this sector, air filtration is a core element in ensuring product quality, safety, and regulatory compliance, far exceeding the importance of general industrial or residential environments.    Why Use Air Filtration?  In pharmaceutical and medical device manufacturing, the core principle of air filtration systems is strict contamination control. The goal is to create and maintain a controlled environment that meets specific cleanliness levels to prevent product contamination from various airborne sources.    Specific principles and motivations include:    Preventing microbial contamination: This is a critical goal, especially in the production of sterile pharmaceuticals (such as injectables and eye drops) and implantable/sterile medical devices. Airborne microorganisms such as bacteria, fungal spores, and viruses can cause product failure, lead to patient infection, or even be life-threatening if they land on product or contact surfaces. Air filtration (particularly HEPA/ULPA grades) is the primary means of removing airborne microorganisms and their carriers (such as dust particles).   Preventing Particulate Contamination: Non-viable particles in the air, such as dust, fibers, metal shavings, and skin flakes, are also serious contaminants for pharmaceuticals (especially injectables, which can cause blood vessel blockage) and precision medical devices (which can affect performance or trigger foreign body reactions in the body). High-efficiency filtration can keep the number of airborne particles to extremely low levels.   Preventing Cross-Contamination: In workshops producing different types of pharmaceuticals or active ingredients, air filtration helps coordinate airflow design to prevent powder or active ingredients from previous batches from spreading through the air and contaminating subsequent products.      II. How is Air Filtration Implemented?    Air filtration in pharmaceutical and medical device production is a complex and sophisticated systems engineering process, primarily manifesting in the following aspects:    Cleanroom HVAC System:    Core Support: Air filtration functions are primarily integrated into HVAC systems designed specifically for cleanrooms.   Multi-stage Filtration Strategy: Air handling units (AHUs) typically have multiple stages of filtration:   Pre-filter: Typically rated G4/MERV 8/ISO Coarse, removes large particles and protects the medium-efficiency filter.   Medium/High-Medium Filter: Typically rated F7-F9/MERV 13-15/ePM1, ePM2.5, further purifies the air and reduces the burden on the final HEPA filter.   Terminal Filtration: This is the most critical step in ensuring cleanroom quality. These filters are installed at the very end of the air supply system, directly supplying air into the cleanroom.   Filter Type: HEPA (High-Efficiency Particulate Air) filters (H13, H14) or ULPA (Ultra-Low Penetration Air) filters (U15 or higher) are commonly used. The specific cleanliness level to choose depends on the required cleanliness level of the area (for example, an ISO 8/GMP Grade D area might use H13, an ISO 7/GMP Grade C area uses H14, and an ISO 5/GMP Grade A/B core area must use H14 or higher, combined with unidirectional airflow).      Installation Type:    High-efficiency air inlets: HEPA/ULPA filters are installed in a custom-designed air inlet housing, with air delivered through diffusers (often used in areas with non-unidirectional airflow).   Fan filter units (FFUs): Fans and HEPA/ULPA filters are integrated into a modular unit. These units are densely mounted in the ceiling to create vertical, unidirectional (laminar) airflow over a large area. They are the primary method for achieving an ISO 5/GMP Grade A environment.   Airflow pattern: This works closely with filtration to control the direction of air flow to remove contaminants.   Unidirectional Flow (Laminar Flow): In critical operating areas (such as aseptic filling and areas directly exposed to product, corresponding to GMP Grade A), HEPA/ULPA-filtered air flows through the work area in uniform, parallel streams (typically vertically downward) at a specific velocity (e.g., 0.36-0.54 m/s). This quickly "blows away" generated particles and prevents them from settling above the product or on critical surfaces.   Non-Unidirectional Flow (Turbulent Flow): In areas with lower cleanliness requirements (such as GMP Grades C and D), filtered air is introduced through supply vents, mixed with room air to dilute contaminants, and exhausted through return vents. Maintaining cleanliness relies on a sufficiently high air changes per hour (ACH).    Localized Protection & Containment Systems:    Laminar Flow Hoods / Biological Safety Cabinets (BSCs): These provide a small, unidirectional, clean environment to protect products or personnel.   Isolators / Restricted Access Barrier Systems (RABS): These provide highly enclosed physical barriers, maintaining a GMP Grade A environment and separating personnel from the core aseptic processing area. They are a key technology in modern aseptic production, relying on HEPA/ULPA filtration for both internal air circulation and exchange with the external environment.   Exhaust Air Filtration: For operating rooms or equipment generating hazardous dusts (such as highly active pharmaceutical powders), aerosols, or biohazardous materials, exhaust air must be filtered through HEPA filtration (sometimes even two stages of HEPA) before discharge to protect personnel and the environment. A bag-in/bag-out (BIBO) filter replacement system is often used to ensure that operators do not come into contact with contaminated filters when replacing used filters.    III. Application Outcomes (What are the Outcomes?)  The successful application of air filtration systems in the pharmaceutical and medical device sectors is crucial: Major Pros (Pros):   Ensuring Product Safety and Quality: Minimizing the risk of microbial and particulate contamination ensures the safety and effectiveness of finished drugs and medical devices, which is directly related to patient health and life.   Meeting Regulatory Compliance: This is a prerequisite for companies to obtain production licenses and market their products. Compliance with standards such as GMP and ISO 14644 is mandatory. Failure to comply can result in serious consequences such as warning letters, product recalls, production suspension, and even license revocation.   Improving Production Reliability and Consistency: A stable, clean production environment reduces process fluctuations and deviations caused by environmental factors, helping to ensure consistent quality between product batches.   Reduce Batch Rejection Due to Contamination: Effective contamination control significantly reduces the risk of products failing quality inspection due to microbial or particulate contamination, thereby mitigating significant economic losses.   Ensure Operator Safety: Exhaust air filtration and isolation technologies protect employee health in processes handling highly active or toxic substances.   Improve Corporate Reputation and Market Competitiveness: Strict adherence to high-standard production practices is the cornerstone of the credibility of pharmaceutical and medical device companies.    Summary:  Air filtration plays an absolutely core role in pharmaceutical and medical device manufacturing. It is a cornerstone technology for ensuring product sterility and the absence of particulate contamination, thereby safeguarding patient safety and meeting regulatory requirements. Its application is highly systematic and sophisticated, closely integrated with HVAC systems, air flow management, and isolation technologies. While costly and maintenance-intensive, the resulting product safety, regulatory compliance, and production reliability are fundamental to the survival and growth of this industry.

The Battery Show and Electric & Hybrid Vehicle Technology Expo 2025, a highly anticipated annual event for the global new energy industry, was successfully held in the United States on October 9th. As a leading company in air filtration and cleanroom solutions, KLC participated in the exhibition, showcasing cutting-edge technology, professional solutions, and in-depth industry insights. We worked with global customers and partners to successfully demonstrate our key value in supporting the electric vehicle and battery manufacturing supply chain.   High-precision battery workshop air filters: We showcased HEPA/ULPA high-efficiency filters for controlling the battery production environment. These products effectively remove fine dust and metal particles from the air, ensuring extremely clean battery production, and guaranteeing consistent and safe battery performance from the source, attracting significant attention from battery manufacturers.      Professional Exchanges, Insights into the Industry  The KLC booth was bustling with visitors throughout the exhibition. We engaged in hundreds of high-quality, in-depth discussions with representatives from battery manufacturers, electric vehicle OEMs, component suppliers, and research institutions from North America and around the world.     This exhibition was not only a successful brand showcase, but also a valuable journey of learning and insight. We deeply feel that with the rapid development of the electric vehicle industry and the continuous iteration of battery technology, the requirements for "purity" and "precision control" in the production environment are becoming more stringent than ever before.     KLC will use this exhibition as a new starting point to continuously increase R&D investment and continuously optimize our products and technologies, striving to provide safer, more efficient, and more economical air filtration and cleanroom solutions for the global new energy industry chain. We look forward to transforming the sparks generated during the exhibition into fruitful future collaborations and working with industry colleagues to contribute the "pure power of KLC" to driving the future of green mobility.

In modern industrial and commercial environments, air quality management has become a critical consideration for business operations. Chemical air filters, as a key component of air purification technology, have been used across multiple industries for decades. They effectively remove odors, corrosive gases, and harmful or toxic gases from the air, protecting personnel health and optimizing the production environment.    The Development of Chemical Filtration Technology    Activated carbon, one of the primary materials used in chemical filtration technology, has been used as far back as 3750 BC. Egyptians first used charcoal to smelt ore to create bronze. By 1500 BC, activated carbon's uses had expanded to treating intestinal ailments, absorbing odors, and for papyrus writing. By 400 BC, ancient Indian and Phoenician civilizations had discovered activated carbon's antiseptic properties and used it for water purification.   Today, activated carbon is widely used in air filtration technology. For more detailed information on the classification and filtration mechanisms of chemical filters, please refer to "AMC Pollutant Control - Filter Media."   In addition to activated carbon, chemical filtration materials also include coconut shell activated carbon, ion exchange resins, and other adsorbent media, providing highly effective purification in diverse environments.      Wide Application of Chemical Filters    With the acceleration of industrialization, air pollution, particularly chemical pollution in the industrial sector, has become increasingly prominent. Unlike conventional cleanroom methods for controlling particulate and microbial contamination, the molecular size of chemical pollutants is often too small to be effectively captured by traditional particle filters. Therefore, chemical filtration technology has become essential for air pollution control, with applications across a wide range of industries.      Air Molecular Contamination Control (AMC)  In high-tech industries such as semiconductor, microelectronics, and photovoltaic manufacturing, even the slightest change in air quality can impact product yield. Consequently, these industries place extremely high demands on chemical filters, requiring the removal of acids, alkalinity, volatile organic compounds (VOCs), refractory compounds (RCs), oxidants, dopants, and ozone to ensure a stable production environment.

  From September 11th to 13th, 2025, KLC participated in RHVAC & CLEANFACT 2025 in Vietnam. As a leading brand in China's air purification and cleanroom solutions sector, KLC showcased its cutting-edge high-efficiency filters and innovative cleanroom technologies. With its superior product performance and professional solutions, KLC served as a vital bridge between the Vietnamese and Southeast Asian markets, further strengthening exchanges and cooperation within the cleanroom technology industry.   The Vietnam HVAC & Refrigeration & Cleanroom & High-Tech Factory Facilities Exhibition, which has undergone multiple iterations, has attracted participants from countries including Japan, South Korea, the European Union, Singapore, China, and India, including investors, general contractors, engineers, and representatives from manufacturing, cleanroom, and HVAC/Refrigeration industry associations. Notably, this exhibition was held concurrently with the Vietnam International Industrial Exhibition 2025 (VIET INDUSTRY 2025), which encompassed sectors such as machinery manufacturing, automation, pharmaceutical technology, and the construction industry. Together, they fostered a diverse exhibition ecosystem, strengthened industry collaboration and cooperation in modern infrastructure development, and provided exhibitors, sponsors, and partners with an excellent opportunity to explore business prospects and establish connections within the industry.      Technical Interaction and Exchange    At the booth, KLC's team of technical experts engaged in in-depth and fruitful exchanges with visitors and industry experts from Vietnam, surrounding regions, and around the world. Through product sample dissections, performance demonstrations, and case studies, the KLC team thoroughly addressed specific questions regarding product compatibility, energy-saving optimization, and maintenance cycles.      A Successful Ending: Fruitful Harvest, Looking Forward to the Future    The KLC booth remained bustling with visitors and a lively atmosphere throughout the multi-day exhibition. This RHVAC & CLEANFACT 2025 journey was not only a successful brand showcase and product promotion, but also a platform for profound market insights and industry exchange. KLC will continue to deepen its presence in the Southeast Asian market, continuously increasing R&D investment, launching products that better meet regional needs, and continuously improving its sales and service network. KLC is committed to becoming a "Clean Air Gold Partner" that supports industrial upgrading in Vietnam and Southeast Asia, working with customers to build a clean, healthy, and efficient industrial environment for the future.