The Role of Cleanrooms for Businesses

For products that require a safe production environment for consumer safety, cleanroom design is one of the mandatory elements. Along with this need, many reputable cleanroom contractors have emerged. Cleanrooms play an essential role across many fields such as healthcare, material science and engineering, electronics, physics, chemistry, biology, food preservation, and pharmaceuticals. Specifically:

1.1. Cleanrooms in the Electronics Industry

In electronic device manufacturing, especially in semiconductor, chip, and microcircuit production, precision and safety are critical. Even a tiny dust particle can damage the production process. Therefore, cleanrooms are indispensable to meet strict standards such as absolute dust control, stable environmental temperature, and anti-static protection. These conditions greatly support the manufacturing and assembly of precision cleanroom equipment, electrical devices, and electronic components.

1.2. Cleanrooms in Medical Equipment Manufacturing

In medical equipment manufacturing plants, cleanrooms are vital. A sterile and controlled environment ensures products are not contaminated, guaranteeing user safety.

1.3. Cleanrooms in Food Processing Plants

With today&rsquos diverse consumer demands, food products must meet freshness and hygiene standards before reaching the market. Cleanrooms play an increasingly important role in food processing, especially for perishable items like confectionery, dairy, and beverages. A clean, bacteria-free environment is necessary to prevent spoilage and ensure consumer safety.

1.4. Cleanrooms in Pharmaceutical Manufacturing

Pharmaceuticals directly affect human health, requiring strict control of safety and quality from the production stage.

Environmental conditions have the most significant impact on product quality. Therefore, all processes involving direct product exposure must be strictly controlled. In pharmaceutical cleanrooms, cleanliness levels are maintained to the appropriate standards, air is filtered through high-performance filters, and personnel, machinery, and raw materials must pass through airlocks. These factors ensure sterile pharmaceutical production.

Thus, cleanrooms are mandatory in pharmaceutical plant design. During inspections, cleanrooms are also decisive for achieving GMP certification.

Key Considerations in Cleanroom Design

2.1. Principles and Standards for Cleanroom Design

• Air Pressure Differentials
  Air pressure management is critical because air contains countless microscopic particles. In cleanrooms, air pressure is usually maintained lower than surrounding areas, requiring careful calculation and coordination to ensure stability.

• Airflow Direction
  Airflow orientation is crucial for classifying cleanliness levels between rooms and preventing contamination. Proper airflow control helps establish the required clean environment for each business purpose.

• Air Balance Between Zones
  Balancing airflow creates sealed environments without unwanted inflows or outflows, ensuring stability. Monitoring and adjusting pressure differences is critical during construction.

• Ventilation
  Cleanrooms must be properly ventilated with air control systems (including filters to prevent contamination and cross-contamination while regulating temperature and humidity) suitable for the products, processes, and external environment.

• Design and Layout
  Cleanrooms must be designed for logical, sequential workflows aligned with production processes.

• Working Space
  Adequate space is needed to organize equipment and materials systematically, minimizing risks of product mix-ups, cross-contamination, or procedural errors.

• Surface Requirements
  Surfaces in direct contact with exposed products must be smooth, crack-free, and sealed. They must not generate or accumulate particles and should allow easy and effective cleaning and disinfection.

• Hard-to-Clean Areas
  Ducts, lighting fixtures, vents, and services should be designed to avoid inaccessible crevices. Maintenance should be possible from outside production zones.

• Drainage
  Drains must be large enough and designed to prevent backflow. Open drains should be avoided, but if necessary, they should be shallow for easier cleaning and disinfection.

2.2. Cleanroom Classification Levels

Cleanrooms are widely applied in different industries, each with unique cleanliness requirements. Cleanroom classes are categorized into Grades A, B, C, and D, but larger international standards such as ISO 14644-1 and US FED-STD 209E are commonly used.

ISO 14644-1 Cleanroom Standards

Cleanroom Design Services

3.1. Cleanroom Design Process

Stage 1: Conceptual Design

• General site plan and functional zoning.

• Process layout for production lines (soft capsules, tablets, syrups, herbal medicines, etc.).

• Equipment layout drawings with full technical specifications (dimensions, height, power, utilities).

• Preliminary budget estimation for project investment planning.

Stage 2: Technical Design

• System calculations (HVAC, electrical, water, etc.).

• Detailed system design based on calculation data.

• Detailed cost estimation for each system based on preliminary estimates.

Stage 3: Construction Design

• 3D modeling of integrated systems for a clear project visualization.

• Detailed construction drawings (shop drawings) for implementation.

3.2. Scope of Cleanroom Design and Construction

Cleanroom design is part of a comprehensive cleanroom solution package, including:

Process Design

• Concept design.

• Process layout planning.

• Equipment installation layout.

• Production equipment consulting.

System Design

• Panel system (walls, ceilings, doors, windows).

• HVAC system (AHU, FCU, ducts, filters, diffusers).

• Electrical system (power, control, lighting).

• Utility systems (compressed air, RO water, purified water, steam, etc.).

Unlike most contractors that only handle limited stages, GMP Groups stands out by providing end-to-end cleanroom solutions &mdash from process layouts and equipment installation to complete cleanroom construction.