Cleanroom Manufacturer
As a leading cleanroom manufacturer in China, KINROM is specialized in designing and manufacturing high-performance cleanroom systems that meet the stringent cleanliness and environmental control requirements of various industries. With decades of expertise and a commitment to excellence, we provide a full range of cleanroom system solutions, including traditional cleanrooms, modular cleanrooms (hardwall cleanroom and softwall cleanroom), to suit your specific operational needs.
Whether you’re in pharmaceuticals, biotechnology, electronics, healthcare, laboratory, or food processing, our cleanrooms are meticulously engineered to create controlled environments that ensure optimal productivity and compliance with international standards. By integrating advanced technology, innovative design, and superior materials, we are proud to deliver world-class cleanroom solutions to clients worldwide.
Stick-Built Cleanroom
Traditional stick-built cleanrooms are permanent controlled environment designed to meet the most stringent cleanliness standards, which are constructed by cleanroom partitions, ceilings, doors, windows, and other cleanroom components, ensuring an airtight and contamination free environment.
Features:
- High durability and structural integrity.
- Lower construction cost per sqm.
- Easy modification on site during installation.
- Fully compliant with industry standards.
Our hardwall cleanrooms offer flexibility, speed, and cost-effectiveness without compromising on quality or performance. These prefabricated systems are easy to assemble, expand, or reconfigure, making them perfect for dynamic production requirements.
Features:
- Quick installation and scalability.
- Easy operation and maintenance.
- Recyclable and high cost performance.
- No air and noise pollution during installation.
- Smart control and monitoring.
Softwall cleanrooms, also known as clean booths, provide a versatile solution for applications requiring temporary or mobile contamination control. These cleanrooms are lightweight, cost-effective, and designed for easy relocation or deployment.
Features:
- Ligh weight and easy to move.
- Quick installation and scalability.
- No air and noise pollution during installation.
- Easy operation and maintenance.
- Recyclable and high cost performance.
Cleanroom Manufacturer for All Industries
Pharmaceutical
Food Processing
Semiconductor
Medical Device
Laboratory
Hospital
Cleanroom Components We Manufacture
Cleanroom components are mainly consist of partitions, ceilings, doors, windows, and equipment, etc. KINROM offers a comprehensive range of cleanroom components to meet the diverse requirements of industries relying on controlled environments, such as pharmaceutical, biotechnology, semiconductor, electronics, laboratory, etc.
More Than Your Cleanroom Manufacturer
KINROM is not only your trusted cleanroom manufacturer, but also your end-to-end cleanroom solution provider. Our services extend beyond manufacturing to include cleanroom design, engineering, installation, construction. With a holistic approach, we ensure that every phase of your cleanroom project is meticulously planned and executed to meet your unique requirements and industry standards.
Cleanroom Manufacturer-The Complete FAQ Guide
Learn more about the clean rooms with this guide. We prepare some questions and answers for you.
- What Is A Cleanroom?
- How Does Cleanroom Work?
- What Are The Different Types Of Cleanrooms Based On Structure?
- What Are The Main Types Of Cleanrooms Based On Their Application Fields?
- What Are The Types Of Cleanrooms Based On Airflow?
- How Are Cleanrooms Classified By Cleanliness Grade?
- What Are The Main Components Of A Cleanroom?
- Why Is Cleanroom Pressure Differential So Critical?
- How Is A Cleanroom Installed?
What Is A Cleanroom?
A cleanroom is a specially designed enclosed space that removes airborne particles, harmful gases, microorganisms, and other pollutants from the indoor air. It maintains parameters such as temperature, humidity, cleanliness, indoor pressure, airflow velocity and distribution, noise, vibration, lighting, and static electricity within predefined requirements to meet specific operational or environmental standards.
Picture 1 Cleanroom
How Does Cleanroom Work?
A cleanroom operates on the principle of controlled air circulation, multistage filtration, and precise pressure management to maintain a contaminant-free environment. Its core function is to continuously remove airborne particles, microorganisms, and chemical pollutants to meet specific cleanliness standards required in industries such as pharmaceuticals, electronics, and biotechnology.
Key mechanisms include:
Airflow Circulation and Control
Air is continuously drawn into the air handling system (AHU), where it undergoes conditioning before being supplied into the cleanroom through ceiling-mounted or raised-floor vents. The air then moves in a controlled pattern—either unidirectional (laminar flow) or non-unidirectional (turbulent flow)—to sweep away contaminants and ensure consistent cleanliness levels.
Multistage Filtration
Cleanrooms utilize a series of filters: pre-filters, intermediate filters, and high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters. These filters progressively remove particles down to 0.3 microns (for HEPA, with 99.97% efficiency) or even smaller. This ensures the air entering the cleanroom meets target purity levels.
Pressure Differential Control
To prevent infiltration of external contaminants, cleanrooms maintain pressure differentials relative to adjacent areas:
Positive Pressure: Used in most cleanrooms to force clean air out and block unfiltered air from entering.
Negative Pressure: Applied in biohazard or toxic material handling areas to contain pollutants within the room.
Supplemental Contamination Control Measures
Additional equipment such as airlocks, pass-through chambers, and air showers minimize particle introduction during personnel or material transfer. Air showers use high-velocity HEPA-filtered air to remove particles from surfaces before entry.
Continuous Monitoring and Control Systems
Sensors and automated control systems constantly monitor critical parameters including particle count, temperature, humidity, and pressure. Data are often displayed and recorded in real time to ensure compliance with standards such as ISO 14644 or GMP.
In summary, cleanrooms function through integrated design and engineering strategies that include directed airflow, advanced filtration, pressure management, and strict operational protocols—all working together to sustain a ultra-clean environment essential for high-precision manufacturing and research.
What Are The Different Types Of Cleanrooms Based On Structure?
Cleanrooms can be broadly classified into two main categories: stick-built cleanrooms and modular cleanrooms. Modular cleanrooms are further divided into hardwall cleanrooms and softwall cleanrooms. Each type offers distinct features, advantages, and limitations, making them suitable for different applications.
1. Stick Built Cleanrooms
Description: These are permanent structures built directly into a facility, using traditional construction materials such as drywall, metal panels, and integrated HVAC systems, etc.
Advantages:
High structural durability and long-term stability.
Customizable to complex layouts and stringent requirements.
Ideal for high-vibration environments or processes requiring heavy infrastructure.
Disadvantages:
Long installation time and significant disruption to ongoing operations.
High initial cost and difficult to modify or expand.
Applications: Suitable for large-scale, permanent installations with fixed cleanroom standards, such as semiconductor fabs, pharmaceutical production lines, and biomedical research facilities.
Picture 2 Traditional Stick-Built Cleanroom
2. Modular Cleanrooms
Modular cleanrooms are prefabricated structures that can be quickly assembled and reconfigured. They provide flexibility and are ideal for dynamic environments.
2.1 Hardwall Cleanrooms
Description: Constructed with rigid solid panels (e.g., acrylic, tempered glass, or composite panels), these offer a permanent-like structure while maintaining modularity.
Advantages:
Excellent cleanliness control (can achieve ISO Class 1-8), durability, and noise reduction.
Full climate control capability (temperature, humidity).
Can be expanded, reconfigured, or relocated with minimal disruption.
Disadvantages:
Higher cost than softwall options.
Requires more time to install compared to softwall units.
Applications: Ideal for industries requiring stringent environmental controls such as medical device manufacturing, aerospace, and advanced electronics assembly.
Picture 3 Hardwall Cleanroom
2.2 Softwall Cleanrooms
Description: Made from clear vinyl or PVC curtain walls suspended from a metal frame, these provide a cost-effective and flexible clean environment.
Advantages:
Lower cost, lightweight, and easy to install or modify.
Portable and suitable for temporary or space-limited applications.
Disadvantages:
Limited physical isolation and inferior acoustic performance.
Less effective for controlling temperature/humidity and not suitable for processes requiring strict pressurization.
Applications: Often used in laboratories, packaging areas, medical compounding, and light-duty industrial applications where full environmental control is not critical.
Picture 4 Softwall Cleanroom
Summary
Traditional stick-built cleanrooms offer permanence and high performance but involve high cost and long installation cycles.
Modular hardwall cleanrooms balance flexibility with robust performance, suitable for expanding operations and mid-to-high classification uses.
Modular softwall cleanrooms provide an affordable, adaptable solution for lower-classification environments and temporary needs.
At KINROM, we specialize in designing and delivering cleanroom solutions tailored to your specific requirements—whether you need a traditional, hardwall, or softwall system. Our experts ensure compliance, scalability, and cost-efficiency to support your operational goals.
What Are The Main Types Of Cleanrooms Based On Their Application Fields?
Based on their application, cleanrooms are primarily categorized into the following types:
Pharmaceutical Cleanrooms: These are critical for the manufacturing of drugs, vaccines, and sterile products. They prevent microbial (bacterial, viral) and particulate contamination to ensure product safety, efficacy, and compliance with strict regulatory standards (e.g., FDA, GMP).
Picture 5 Pharmaceutical Cleanrooms
Semiconductor & Electronics Cleanrooms: The production of microchips, circuit boards, and nanotechnology requires environments with extremely low levels of airborne particles. Even a single microscopic dust particle can damage a microscopic circuit, leading to product failure.
Picture 6 Semiconductor & Electronics Cleanrooms
Biotechnology & Life Sciences Cleanrooms: Essential for genetic research, cell culture, and working with sensitive biological agents. They provide a controlled, contaminant-free environment to ensure the integrity of experiments, protect samples, and maintain reproducible results.
Medical Device Manufacturing Cleanrooms: Used for producing and packaging surgical implants, devices, and diagnostic kits. A sterile environment is mandatory to prevent patient infection and ensure that devices function as intended without any particulate or biological interference.
Hospital & Healthcare Cleanrooms: Specifically designed for operating rooms, pharmaceutical compounding, and isolation rooms. They control airborne pathogens to protect vulnerable patients during surgery, prevent infections, and ensure the sterility of compounded medications.
Picture 7 Modular Operating Rooms
Aerospace Cleanrooms: The assembly of satellites, spacecraft, and precision optical systems requires ultra-clean conditions. Particulate contamination can interfere with sensitive instrumentation and lead to critical system failures in space.
Food & Beverage Cleanrooms: Used in processing environments for ready-to-eat foods, dairy products, and beverages. They inhibit the growth of spoilage microorganisms and pathogens (like Listeria or E. coli), significantly extending shelf life and ensuring consumer safety.
Research Laboratory Cleanrooms: Found in universities and R&D facilities for advanced physics, chemistry, and materials science experiments. They provide a stable environment where variables like particulates, vibration, and temperature are minimized to not interfere with sensitive measurements.
At KINROM, we understand that each industry has unique contamination control challenges. Our expertise lies in designing and building tailored cleanroom solutions that meet the specific standards and operational demands of your application. From ISO-classified environments to stringent cGMP-compliant facilities, we partner with you to create a space that ensures your product quality, safety, and success.
What Are The Types Of Cleanrooms Based On Airflow?
Cleanrooms can be classified into four main types based on their airflow patterns. Each type is designed to meet specific cleanliness levels and operational requirements, ranging from ISO Class 1 to ISO Class 9 environments.
1. Unidirectional Flow Cleanrooms (Vertical / Horizontal Laminar Flow)
Description: Airflows in a single direction (vertical or horizontal) at a consistent velocity (typically 0.3–0.5 m/s), passing through HEPA/ULPA filters that cover the entire ceiling or wall.
Working Principle: Uses a “piston effect” to push contaminants toward returns, preventing mixing and ensuring minimal particle retention.
Applications: Ideal for highest cleanliness levels (ISO Class 1–5), such as semiconductor manufacturing, biotechnology, and sterile compounding.
Advantages: Exceptional contamination control; stable and predictable airflow.
Disadvantages: High initial investment and operational costs.
2. Non-Unidirectional Flow Cleanrooms (Turbulent Flow)
Description: Air enters through diffusers or filter units and forms irregular turbulent flows, mixing with indoor air while gradually diluting contaminants.
Working Principle: Relies on dilution and repeated air exchanges to reduce particle concentration.
Applications: Suitable for ISO Class 6–8 environments (e.g., packaging, medical devices, certain pharmaceuticals).
Advantages: Lower construction and operating costs; flexible layout.
Disadvantages: Higher risk of turbulence-induced contamination; not suitable for ultra-clean processes.
3. Mixed Flow Cleanrooms (Combination)
Description: Integrates both unidirectional and non-unidirectional airflow within the same cleanroom. Critical zones use laminar flow, while surrounding areas use turbulent flow.
Working Principle: Combines contamination removal and dilution strategies for efficiency.
Applications: Useful where high cleanliness is needed only in specific areas (e.g., filling lines in pharma, assembly stations in electronics).
Advantages: Bal performance with cost-effectiveness; optimizes energy usage.
Disadvantages: Requires careful zoning and control system design.
4. Vector Flow Cleanrooms (Radial Flow / Sidestream)
Description: Uses HEPA filters in fan-shaped arrangement to create a diagonal, non-crossing “vector” airflow that pushes particles toward returns in a sweeping motion.
Working Principle: Directed diagonal airflow removes contaminants with relatively low air volume.
Applications: Less common; used in specific applications in Europe and the US for ISO Class 6–8 environments with energy-saving goals.
Advantages: Energy-efficient; suitable where space or budget limits full laminar flow.
Disadvantages: Limited real-world data and adoption; requires precise engineering.
Conclusion:
The choice of airflow type depends on cleanliness requirements, process sensitivity, energy considerations, and budget. Unidirectional flow offers the highest purity, non-unidirectional is cost-effective for lower classes, mixed flow provides a hybrid solution, and vector flow remains a niche yet efficient option.
How Are Cleanrooms Classified By Cleanliness Grade?
Cleanrooms are classified based on the concentration of airborne particles per cubic meter of air. The most widely recognized standard is ISO 14644-1, which defines classes from ISO 1 (cleanest) to ISO 9 (least clean). Another common system, especially in pharmaceutical and biotechnology sectors, is the GMP classification (A, B, C, D) used in regulatory environments.
| Class | Max. Particles/m³ | FED STD 209 Equivalent |
|||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | ||
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class 1 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class 10 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | Room Air | |||
Table 1 Cleanroom Cleanliness Classifications
1. ISO 14644-1 Classification
This international standard measures the maximum allowable number of particles (≥0.1µm to ≥5µm) per cubic meter:
ISO Class 1 – ISO Class 3:
Ultra-clean environments with extremely low particle counts. Used in nanotech, advanced semiconductor manufacturing, and fundamental research.
ISO Class 4 – ISO Class 5:
Equivalent to former Federal Standard Class 10 and Class 100. Common in pharmaceuticals (aseptic filling), biotechnology, and microelectronics.
ISO Class 6 – ISO Class 7:
Suitable for less critical stages in medical device manufacturing, optics, and certain lab environments.
ISO Class 8 – ISO Class 9: Used for assembly, packaging, or support areas where lower contamination control is acceptable.
2. GMP A/B/C/D Grades
Good Manufacturing Practice (GMP) guidelines are common in health-related industries:
Grade A (ISO 5): High-risk operations like sterile filling, open container handling. Requires unidirectional airflow.
Grade B (ISO 5 background): Background environment for Grade A zones, e.g., in sterile manufacturing.
Grade C (ISO 7) & Grade D (ISO 8): Used for less critical stages such as solution preparation or component handling.
Key Factors in Classification:
Particle size and count
Air change rates
Airflow type (unidirectional vs. non-unidirectional)
Monitoring requirements (continuous vs. periodic)
Selecting the right cleanliness class depends on your process sensitivity, regulatory requirements, and risk assessment. At KINROM, we help you determine and achieve the optimal cleanroom grade for quality, compliance, and cost-effectiveness.
What Are The Main Components Of A Cleanroom?
A cleanroom is a complex engineered system designed to achieve precise control over environmental parameters such as particles, temperature, humidity, and pressure through the integration of multiple specialized systems. Its main components can be summarized into the following core systems:
The enclosure forms the airtight shell of the cleanroom, consisting of partitions, ceilings, floors, as well as doors, windows, and covings. It defines the physical boundaries of the clean space and maintains positive or negative pressure through high-integrity construction, effectively preventing the ingress of external contaminants and providing a stable barrier for the controlled environment.
Air Purification and HVAC System
This is the core functional system of the cleanroom, primarily including air handling units (AHUs), ductwork, primary/medium/high-efficiency particulate air (HEPA/ULPA) filters, fan filter unit (FFU) and temperature/humidity control devices. It performs multi-stage air filtration, manages airflow patterns, and regulates temperature, humidity, and fresh air exchange. This system is essential for maintaining cleanliness levels, thermal and moisture conditions, and pressure differentials.
Electrical and Lighting System
This system covers power supply, lighting, and low-voltage systems (such as monitoring and communication). Cleanroom lighting requires specialized sealed fixtures to minimize dust accumulation and allow easy cleaning. Electrical design must also address electrostatic discharge (ESD) protection and electromagnetic compatibility (EMC) to prevent interference with sensitive equipment.
Control and Automation System
Serving as the “brain” of the cleanroom, this system uses sensors, PLCs, and computers to monitor environmental parameters (e.g., temperature, humidity, pressure differentials, and cleanliness). It enables automatic adjustment, operational logic control, and fault alarm functions, ensuring a continuous, stable, reliable, and compliant environment.
Fire Protection and Safety System
This includes fire detection, sprinkler systems, gas suppression, and emergency evacuation systems. Given the enclosed nature and high value of equipment in cleanrooms, the fire protection system must balance effective suppression with minimal secondary contamination, prioritizing personnel safety and asset protection.
Water, Drainage, and Specialty Gas Systems
These systems comprise process water, gas supply, and drainage pipelines. Material selection and installation must meet non-shedding and corrosion-resistant requirements. Pipeline layout should avoid dead legs to prevent microbial growth and ensure media purity.
Dedicated Purification Equipment
Auxiliary devices such as weighing booth, air showers, pass boxes, biosafety cabinets, laminar air flow (LAF), and ozone or UV sanitization units are configured based on specific use cases. These provide an additional layer of contamination control and protect critical process areas.
Environmental Monitoring System (essential for bio-cleanrooms)
Used for real-time monitoring of airborne particles and microbial contamination, this system may integrate active air samplers, particle counters, and other sensors to ensure continuous compliance with standards such as GMP and ISO 14644.
Other Equipment
Cleanroom furniture, such as cleanroom locker, cleanroom bench, cleanroom shelving, cleanroom stool, cleanroom gowning rack, cleanroom tables, cleanroom trolley, cleanroom sink, etc.
Why Is Cleanroom Pressure Differential So Critical?
Cleanroom pressure differential refers to the controlled difference in air pressure between a cleanroom and its adjacent, less-clean areas. It is a fundamental control mechanism for preventing cross-contamination, protecting products and processes, and ensuring personnel safety.
Core Functions of Pressure Control:
Contamination Prevention
A positive pressure (higher pressure inside than outside) ensures that air flows out of the cleanroom when doors are opened or through small leaks. This prevents unfiltered external air—carrying particles, microbes, or aerosols—from entering and contaminating the critical environment.
Containment of Hazardous Materials
Rooms handling toxic substances, pathogens, highly potent compounds (e.g., penicillin), or volatile chemicals require negative pressure (lower pressure inside). This contains dangerous materials within space, preventing their escape and protecting surrounding areas and personnel.
Directional Airflow Assurance
A well-maintained pressure gradient ensures consistent and predictable airflow patterns from cleaner zones to less clean ones, effectively sweeping contaminants away from critical areas.
Environmental Stability
Pressure control supports the stability of other environmental parameters such as temperature and humidity by minimizing uncontrolled air exchange with outside environments.
Key Requirements & Standards:
Standards such as ISO 14644 and GMP require a minimum pressure differential of ≥5 Pa between different cleanliness grade zones, and ≥10 Pa between clean and non-clean areas.
In practice, many facilities maintain higher differentials (e.g., 10–15 Pa) to account for door openings, personnel movement, and system fluctuations.
How Pressure Differential is Achieved:
Pressure control is achieved by balancing the HVAC system’s air volumes:
For positive pressure: Supply air volume > return air + exhaust air + leakage air.
For negative pressure: Exhaust air volume > supply air + return air.
Control methods include adjusting return air dampers, using automated pressure sensors and variable frequency drives (VFDs) on fans, and installing excess air relief valves.
Consequences of Pressure Failure:
Loss of positive pressure can lead to influx of contaminants, resulting in batch failure in pharmaceuticals or yield loss in microelectronics.
Loss of negative pressure in biohazard labs can cause leakage of hazardous agents, posing serious safety risks.
In summary, pressure differential is not just a technical indicator—it is a primary engineering defense for cleanroom integrity, product quality, and safety. Regular monitoring, validation, and system adjustments are essential to maintain this critical barrier.
How Is A Cleanroom Installed?
The installation of a cleanroom is a meticulous, phase-driven process that follows a precise sequence to ensure integrity and performance. The core construction steps typically proceed as follows:
1. Layout Marking-Out
The installation begins with accurately transferring the design layouts to the physical site. Benchmark lines are established for walls, partitions, and key equipment locations to guide all subsequent work.
2. HVAC Rough-In (Ductwork & Systems)
Prior to enclosing the space, all primary ventilation ductwork, pipes, and mechanical services are installed. This stage excludes terminal filters to prevent contamination during construction.
3. Clean Enclosure Construction
The physical shell of the cleanroom is assembled, including:
Wall and ceiling panels mounted onto a dedicated structural framework.
Windows, doors, and aluminum profiles designed for airtightness.
Precise cutting and sealing of all necessary panel penetrations for utilities or pass-throughs.
4. Electrical Systems & Terminal Air Devices
Electrical Infrastructure: Wiring, conduits, control cabinets, switches, and cleanroom-grade sealed lighting fixtures are installed.
Air Termination Units: HEPA/ULPA filters, diffusers, and return air grilles are mounted and securely sealed into the ceiling or wall panels.
5. Flooring & Final Finishes
Specialized flooring (e.g., conductive vinyl, epoxy resin) is applied to create a seamless, durable, and easy-to-clean surface.
6. Auxiliary Purification Equipment Installation
Final placement and connection of equipment such as air showers, pass-through chambers, laminar flow hoods, and biosafety cabinets.
7. System Commissioning & Certification
This critical final phase includes:
Testing: Checking for leaks, verifying airflow patterns (velocity, uniformity), and measuring particle counts.
Balancing: Adjusting the HVAC system to achieve specified pressure differentials, air changes, and environmental conditions (temperature, humidity).
Certification: Formal validation (e.g., IQ/OQ/PQ) against standards like ISO 14644 to ensure the cleanroom meets its classified performance level.
At KINROM, we expertly manage this entire installation lifecycle, ensuring your facility is built efficiently on schedule, and to the highest standards of quality and compliance.
