VIETNAM’S LEADING COMPANY

A cleanroom is a controlled environment designed and operated to minimize the introduction, generation, and retention of airborne particles, while also regulating other parameters such as temperature, humidity, and pressure as required.

Comprehensive control of these factors helps significantly reduce the risk of contamination or cross-contamination during research and manufacturing processes, thereby ensuring aseptic conditions.

Today, cleanrooms are increasingly prevalent and widely applied across industries such as pharmaceuticals, food processing, cosmetics, and biotechnology - sectors that require stringent control over particulate levels and airborne contaminants.

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• Food Industry
• Healthcare Facilities (Operating Rooms, Laboratories)
• Pharmaceutical Industry
• Electronics Industry

Cleanroom construction refers to the process of building and installing an enclosed controlled environment where critical parameters—including particulate concentration, microbial levels, temperature, humidity, and differential pressure—are strictly maintained in accordance with specified standards.

This process requires a significantly higher level of technical expertise compared to conventional construction and typically consists of three core components:

• Architectural Envelope System: Installation of ceilings and wall panels (sandwich panels), antimicrobial flooring systems (Epoxy or Vinyl), and airtight door systems to create a fully sealed enclosure isolated from external environments.
• Mechanical, Electrical, and Plumbing (MEP) & HVAC System: Installation of ductwork networks, air handling units (AHUs), supply air fans, and high-efficiency filtration systems such as HEPA/ULPA filters. This system ensures continuous air circulation, filtration, and maintenance of pressure differentials between clean zones.
• Utility Systems: Implementation of compressed air systems, ultrapure water systems (RO), power supply systems, lighting, and fire protection systems.

The primary objective of cleanroom construction is to establish a sterile production environment, effectively eliminating the risk of cross-contamination.

As a result, the facility can comply with stringent international standards such as ISO 14644, GMP (for pharmaceuticals), and HACCP (for food industry).

Cleanroom construction must comply with international standards governing the concentration of airborne particles and microbial contamination. Below are the four core standards that have been and are currently applied:

• Federal Standard 209 (1963) (*): The first cleanroom standard in the world, issued by the U.S. Department of Defense. This standard classifies cleanliness levels based on the number of particles ≥0.5 µm per cubic foot of air (ft³). Common classifications include: Class 100, Class 10,000, Class 100,000.
• Federal Standard 209E (1992) (*): An updated version of FS 209, incorporating the metric measurement system alongside the imperial system. Cleanliness levels are designated from M1 to M7. Although officially withdrawn in 2001, the terminology and classification system of this standard are still widely used in engineering practice and manufacturing facilities.
• ISO 14644-1 Standard: The current and most widely adopted international standard, fully replacing FS 209E. It classifies cleanrooms into nine classes, ranging from ISO Class 1 (highest level of cleanliness) to ISO Class 9 (lowest level of cleanliness).
  Classification is based on the allowable concentration of airborne particles per cubic meter of air (m³).
• GMP (Good Manufacturing Practice) Cleanroom Standard: A mandatory standard system applied in the pharmaceutical, food, and medical device industries.
  Guidelines such as EU-GMP and WHO-GMP classify cleanrooms into four grades: A, B, C, and D. The key distinction between GMP and ISO standards lies in the simultaneous evaluation of non-viable particles (airborne particulates) and viable particles (microbial contamination) under two conditions At rest or In operation.

(*) These standards were officially withdrawn in 2001 and replaced by ISO 14644-1:1999.

Cleanroom standards vary depending on the required level of control over airborne particles (non-viable particles) and microbial contamination (viable particles) in each industry.

• Pharmaceutical Industry:
  • Standard: Strict compliance with GMP (WHO-GMP, EU-GMP, PIC/S).
  • Characteristics: Cleanliness levels are classified into Grades A, B, C, and D based on both particulate count and microbial limits under “at rest” and “in operation” conditions.
  • Objective: To ensure absolute sterility and prevent cross-contamination in the production of injectables, solid dosage forms, and vaccines.
• Electronics & Semiconductor Industry:
  • Standard: ISO 14644-1 is the primary standard.
  • Characteristics: Focus on the concentration and size of airborne particles (as small as 0.1 µm). Electrostatic discharge (ESD) control is critical.
  • Objective: To prevent microscopic particles from damaging integrated circuits, chips, and microelectronic components, while controlling humidity to minimize product impact.
• Food & Beverage Industry:
  • Standard: HACCP, ISO 22000, FSSC 22000.
  • Characteristics: Facility design strictly follows unidirectional flow, with separation between High Care Zones and Low Risk Zones.
  • Objective: To prevent the growth of mold and bacteria, and avoid cross-contamination between raw materials and finished products.
• Healthcare Sector:
  • Standard: Typically ISO Class 5 to Class 7 (for operating rooms, intensive care units, and laboratories).
  • Characteristics: Strict control of air changes per hour (ACH) and positive pressure differentials to prevent contaminated air from entering sterile areas.

Objective: To provide aseptic environments for surgical procedures and for treating immunocompromised patients.

Many businesses face significant cost inefficiencies due to the following common mistakes:

• Incorrect Panel Selection: Using standard EPS panels in areas that require high fire resistance instead of PU panels or Rockwool panels, leading to non-compliance with safety requirements.
• Uncoordinated HVAC System Design: Poorly integrated HVAC systems can result in thermal losses and failure to maintain required pressure differentials, increasing the risk of cross-contamination.
• Lack of Process Flow Planning: Improper layout of personnel and material flows (Man/Material Flow), causing cross-over and failing to meet international audit requirements.

Neglecting Maintenance Strategy: Selecting low-cost equipment that consumes 1.5-2 times more energy compared to optimized systems, resulting in higher long-term operational costs.

Selecting the right cleanroom contractor from the outset not only affects compliance with required standards but also determines operational efficiency and overall project cost.

In this context, Intech E&C is recognized as one of the most comprehensive cleanroom contractors in Vietnam.

• The only company in Vietnam to have successfully designed and constructed an ISO Class 1 cleanroom – the highest level of cleanliness globally.
• Certified in accordance with NEBB (National Environmental Balancing Bureau, USA) standards and honored as one of the Top 10 outstanding science and technology achievements in Vietnam (2022).
• Recognized as a pioneering enterprise in the cleanroom sector (2023) by the Ministry of Planning and Investment in collaboration with the U.S. Agency for International Development (USAID) under the IPSC Project.

The cost of cleanroom construction depends on the complexity and specific technical requirements of each project. The following key factors directly influence the total investment:

• Cleanroom Classification (Cleanroom Class): Higher cleanliness requirements (e.g., from ISO Class 9 to ISO Class 5, or GMP Grades A/B) demand higher air change rates (ACH) and denser HEPA filtration systems, resulting in increased equipment and operational costs.
• Industry Application and Applicable Standards: Stringent standards such as GMP (pharmaceuticals) or food safety standards (HACCP, ISO 22000) require more complex validation processes compared to conventional cleanrooms. Activities such as DQ, IQ, OQ validation and regulatory documentation contribute significantly to the total cost.
• HVAC System (Heating, Ventilation, and Air Conditioning): The HVAC system typically represents the largest portion of the project budget. Costs increase with system complexity, including high positive/negative pressure differentials, strict temperature and humidity control, and multi-stage air filtration.
• Finishing Materials: Costs vary depending on material selection. For example:
  • PU fire-retardant panels are more expensive than EPS panels
  • Antibacterial vinyl flooring or self-leveling epoxy flooring differs in cost compared to standard industrial flooring
• Equipment and Supporting Systems: Integrated equipment such as Pass Boxes, Air Showers, cleanroom lighting systems, laboratory furniture, and centralized environmental monitoring systems add to the overall cost.
• Area and Layout Design: Larger construction areas may optimize fixed costs (e.g., mobilization of equipment and engineering resources). However, complex layouts with multiple zones and strict unidirectional workflow requirements will increase material and construction costs.

For further information, please contact Intech E&C for free site survey, design consultation, and detailed quotation tailored to your project requirements.

Foreign Direct Investment (FDI) in 2026 is showing a strong shift toward high-tech and strategic industries. This transition is setting more stringent standards for manufacturing infrastructure, where conventional cleanroom solutions are no longer sufficient:

• Lithium Battery Manufacturing and Clean Energy: This sector is emerging as a key market driver, requiring the implementation of ultra-low humidity environments (Dry Rooms). The critical technical requirement lies in precise humidity control, with dew points ranging from -40°C to -60°C. Maintaining such conditions presents significant challenges and demands a sophisticated integration of advanced dehumidification technologies and airtight design.
• Semiconductor and Microelectronics Industry: As component sizes shrink to the nanometer scale, even ultra-fine particles can cause short circuits or product failure. Therefore, upgrading air filtration systems to ISO Class 1 levels and controlling Airborne Molecular Contamination (AMC) have become mandatory to ensure product integrity throughout the fabrication process.
• Biopharmaceuticals and Regenerative Medicine: The advancement of personalized medicine and stem cell technologies requires manufacturing environments integrated with aseptic isolator systems. These infrastructures go beyond air filtration, providing absolute biosafety barriers to prevent any contamination risks from both the environment and human operators.