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What is a cleanroom?

Defining the Controlled Environments of Modern Technology | Product Designer: Jason.peng

Cleanrooms function as strictly controlled work environments, where every core operational indicator is kept within precise, predefined ranges. Monitored metrics cover particle counts — including aerosols, microorganisms, viruses and airborne bacteria — alongside temperature, humidity, air pressure, airflow volume, air change rates and lighting levels.

Enterprises deploy cleanroom facilities primarily to create consistent, stable environments for manufacturing, which is critical for boosting production yield and sustaining high-quality product standards. This versatile purification solution serves a wide spectrum of fields, ranging from food and beverage production, pharmaceuticals, semiconductors and electronics to optics, new energy, hospital operating rooms and scientific laboratories.

Every cleanroom site enforces clear access protocols for staff, raw materials and test samples, with customized standards adapting to unique industry demands. GMP-compliant pharmaceutical manufacturing facilities and medical operating rooms apply rigorous control measures, managing not only indoor airborne particle concentrations but also the entire flow of personnel and materials. In comparison, electronics and optics manufacturing sectors, whose products pose no risks to human health, adopt far looser regulations for entry and internal circulation.

Cleanroom construction materials stand out from conventional building materials due to specialized functional requirements. All applied materials must be non-shedding, easily maintainable for routine cleaning and fully airtight to meet purification criteria. For special industrial application scenarios, the materials are also required to deliver extra functionalities, including antistatic performance, corrosion resistance and explosion-proof features.

With 20 years of dedicated experience in the cleanroom industry, Deiiang boasts professional design capabilities and experienced construction teams. We serve global clients across multiple continents and maintain long-term partnerships with leading enterprises in various sectors. We welcome all business inquiries and project collaborations.Contact Us



Why Cleanrooms Are Essential - Applications & Necessity

Instead of just listing why cleanrooms are essential, let me share a recent Deiiang success story. We recently commissioned an ISO Class 6 modular cleanroom for a high-precision aerospace component manufacturer (Project "Aero-Precision"). The challenge was unique: the client required 99.99% removal of particles >0.3 microns while managing a high heat load from their CNC machinery.

Deiiang Market Solutions & Case Context

Our Project Portfolio

Industry Breakdown

  •                                    Semiconductor (35%)

  •                                    Biotechnology & Pharmaceuticals (20%)

  •                                    Medical Devices (15%)

  •                                    Aerospace (15%)

  •                                    Other Industries (15%)

Alt Text: Cleanroom application industry distribution chart showing semiconductor, biotechnology & pharmaceuticals, medical devices, aerospace, and other industries as the main application areas.

Cleanroom Classification & Standards

Deiiang cleanrooms are classified according to the number and size of particles permitted per volume of air. While many vendors quote older standards, we strictly adhere to the latest ISO 14644-1:2015 series. For the "Aero-Precision" project mentioned above, achieving ISO Class 6 meant strictly limiting particles ≥0.5μm to 35,200 per cubic meter.

International Standard: ISO 14644 Series

ISO 14644 is the most widely accepted global standard for cleanroom air cleanliness classification. Its core principle is defining the maximum allowable number of airborne particles per cubic meter of air based on particle size (such as 0.1μm, 0.3μm, 0.5μm). Deiiang uses laser particle counters to verify these counts during the "At-Rest" and "Operational" states.

ISO 14644-1 Cleanliness Classification Quick Reference

ISO Class≥0.1μm (particles/m³)≥0.2μm (particles/m³)≥0.3μm (particles/m³)≥0.5μm (particles/m³)≥1μm (particles/m³)≥5μm (particles/m³)
ISO 1102----
ISO 210024104--
ISO 31,000237102358-
ISO 410,0002,3701,02035283-
ISO 5100,00023,70010,2003,52083229
ISO 61,000,000237,000102,00035,2008,320293
ISO 7---352,00083,2002,930
ISO 8---3,520,000832,00029,300
ISO 9---35,200,0008,320,000293,000

ISO 1

≥0.1μm: 10 particles/m³

≥0.2μm: 2 particles/m³

Applications: Ultra-precision manufacturing, nanotechnology research

ISO 2

≥0.1μm: 100 particles/m³

≥0.2μm: 24 particles/m³

≥0.3μm: 10 particles/m³

Applications: Advanced semiconductor manufacturing

ISO 3

≥0.1μm: 1,000 particles/m³

≥0.2μm: 237 particles/m³

≥0.3μm: 102 particles/m³

Applications: Pharmaceutical sterile filling, microelectronics

ISO 4

≥0.1μm: 10,000 particles/m³

≥0.2μm: 2,370 particles/m³

≥0.3μm: 1,020 particles/m³

Applications: Optics manufacturing, advanced medical devices

ISO 5

≥0.1μm: 100,000 particles/m³

≥0.2μm: 23,700 particles/m³

≥0.3μm: 10,200 particles/m³

Applications: Pharmaceutical aseptic processing, biotechnology

ISO 6

≥0.1μm: 1,000,000 particles/m³

≥0.2μm: 237,000 particles/m³

≥0.3μm: 102,000 particles/m³

Applications: Medical device manufacturing, hospital pharmacies

ISO 7

≥0.5μm: 352,000 particles/m³

≥1μm: 83,200 particles/m³

Applications: Food processing, electronics assembly

ISO 8

≥0.5μm: 3,520,000 particles/m³

≥1μm: 832,000 particles/m³

Applications: Plastic injection molding, packaging areas

ISO 9

≥0.5μm: 35,200,000 particles/m³

≥1μm: 8,320,000 particles/m³

Applications: Warehousing, general manufacturing areas

Table Explanation: Lower ISO classes indicate higher cleanliness requirements. The "-" symbol indicates that particle count for that size is not restricted or is too high to be meaningful at that classification level. ISO 1-4 are considered ultra-clean environments, ISO 5-6 are clean environments, and ISO 7-9 are controlled environments.

How does a cleanroom work?

Principle 1: High-Efficiency Air Filtration System

Air filtration is typically the first line of defense against particulate contamination and in the Aero-Precision case study Deiiang™ specialists implemented a 4-stage filtration bank to deal with the heavy industrial dust load.

Cleanroom air is filtered through multiple stages of filtration to remove a variety of sizes of particles from the air to achieve the highest level of purification.

Our Configuration for this Project

  • Pre-filters (G4 Grade): Captured 90% of coarse dust (10μm+) protecting the expensive HEPA units.

  • Medium-efficiency (F8 Grade): Removed fine pollen and industrial smoke.

  • HEPA H14 Filters: Deiiang's core technology, capturing 99.995% of particles at 0.3μm.

HEPA and ULPA filters operate by Diffusion, Interception and Inertial Impaction. These filters are Deiiang™ certified and are among the highest filtration efficiency products on the market. They are suitable for use in various cleanliness applications.

Keywords: HEPA filter, ULPA filter, air purification, filtration efficiency


Air Filtration System Schematic

Principle 2: Airflow Organization and Pattern Control

The “Aero-Precision” project has encountered large numbers of “dead zones” with the very large CNC machines used for the project. The direction and velocity of air within a cleanroom is a critical factor in controlling contamination – a principle perfected by Deiiang™ design engineers such as Jason.peng.

Clean air flow around the work area is used to remove contaminants from the air and to prevent them from settling on the work surface.

The Solution: Hybrid Airflow

  • Unidirectional (Laminar): Utilized as a specialized airflow pattern to directly blow off particulate from the exposed optical sensors. Initial test velocities of 0.45m/s are noted to immediately remove any loose particles from the sensor face.

  • Non-unidirectional (Turbulent): Used on the general walking aisles in order to conserve 30% of energy while maintaining a background classification of ISO 7.

All the airflow patterns have their special characteristics, strengths and possibilities. Air Changes Per Hour (ACH) is an important concept. For this project 60 ACH where calculated to deal with the expected heat load.

Keywords:Laminar flow, turbulent flow, airflow organization, air exchange rate


Unidirectional (Laminar) Flow&

Non-unidirectional (Turbulent) Flow

Unidirectional (Laminar) Flow& Non-unidirectional (Turbulent) Flow

Principle 3: Pressure Differential Control and Airlock Technology

Maintaining controlled pressure differentials between areas in a cleanroom prevents contamination infiltration. In our Case Study we kept up a cascading pressure regime of +30Pa in the core, +15Pa in the gowing area and 0Pa in the corridor.

Maintaining controlled pressure differentials allows a cleanroom to contain or exclude contaminants.

Pressure Types

  • Positive Pressure (+): Standard for Electronics/Aerospace. Higher pressure inside than outside to prevent contamination by outside agents.

  • Negative Pressure (-): Bio-Safety Standard. The inside pressure is kept lower than the outside pressure in order to contain any pathogens inside.

There are various types of pressure and each have their specific applications. Airlocks and pass-throughs are critical Deiiang™ components that allow the maintenance of pressure differentials while controlling contamination during personnel and material transfer.

Keywords: Differential pressure, positive pressure, negative pressure, airlock, pass-through box

Pressure Differential Control Schematic

High-Efficiency Air Filtration System

Principle 4: Personnel and Material Control

For the majority of particles that contaminate a clean environment, humans are the greatest cause of contamination with up to 80% of particles coming from the people in the environment and from the materials introduced into the environment by those people. Therefore, controlling the people and the materials entering a clean environment is critical to the success of any cleanroom, including Deiiang™ cleanrooms.

The Cleanroom Contamination Control Measures for human and material introduction into the environment of Deiiang™ cleanrooms are comprehensive in nature to minimize the risk of introducing contamination.


Control Measures

  • Gowning Protocols:Specialized cleanroom garments, shoe covers, masks

  • Personnel Behavior Protocols: Training, restricted movement, air showers

  • Material Transfer Management: Pass-throughs, surface cleaning, packaging control

  • Equipment Selection & Maintenance: Low-particle generating equipment, regular cleaning

All the equipment in the clean room is of low-particle generating type and is cleaned and maintained on a regular basis.

Each of the controls has a specific role in maintaining the cleanroom in a state of integrity. Deiiang™ strongly believes that a cleanroom requires a comprehensive training course and adherence to a set of protocols that have been developed by experts such as Jason.peng.

Keywords: Personnel management, cleanroom garments, air showersmaterial contamination control

Personnel & Material Control Process

1
Preparation Area
                                   Remove outer clothing and jewelry
2
Gowning Room
                                   Don cleanroom garments following Deiiang™ protocols
3
Air Shower
                                   Remove surface particles before entry
4
Cleanroom Entry
                                   Access controlled environment

Jason’s Field Note: “Laminar Flow is generally perceived to be better than Turbulent Flow. From my 15 or so years of design experience, for most general ISO 8 assembly areas, I would advocate to go with the more energy efficient and cost effective option of Turbulent Flow – unless your process is extremely sensitive.”

Frequently Asked Questions (FAQ)

What are the core requirements for cleanroom operation and management?

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What is positive pressure in a cleanroom?

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What do people wear in a cleanroom?

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WWhat kind of equipment is typically found in a cleanroom?

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What are cleanroom classifications (e.g., ISO, Federal Standard)?

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Why are cleanrooms important?

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