Professional Cleanroom Design – Meeting GMP, ISO Standards

Professional Cleanroom Design Service – GMP, ISO Standard Solutions

In modern production environments, cleanrooms play a crucial role in ensuring product quality and production safety. A standard cleanroom design not only helps control microbes and dust but also meets GMP, ISO 14644-1, EU-GMP, FDA, HACCP standards, helping enterprises optimize production processes and minimize risks. Enterprises can refer to our Cleanroom Design and Construction for comprehensive solutions.

Anh Khang Cleanroom's cleanroom design service offers comprehensive A-Z solutions, helping enterprises optimize investment costs while ensuring an effectively operating, high-quality cleanroom.

Main Customer Groups for Cleanroom Design Service

• Pharmaceutical & Medical Enterprises: Drug, vaccine, and medical device manufacturing facilities require a germ-free environment to ensure product quality. Enterprises in this field can contact our Pharmaceutical Cleanroom Construction for detailed consultation.

• Food & Beverage Factories: Food, food additive, and beverage production requires a sterile environment meeting HACCP, ISO 22000 standards. Additionally, enterprises can learn more via our Food Cleanroom Construction.

• Electronics & High-Tech Companies: Semiconductor, OLED display, and electronic component manufacturing requires a dust-free environment to avoid production errors. Enterprises in this sector should refer to our Electronics Cleanroom Construction.

• Cosmetics Factories: Cosmetics and perfume production requires a GMP-standard environment to avoid contamination.

• Chemical & Advanced Materials Companies: Polymer, composite, and special chemical research require cleanrooms with strict environmental control.

So what does a standard cleanroom design look like? What standards must be followed? Let's explore the details in the article below.

What is Cleanroom Design? Why is it Important?

Definition of a Cleanroom

A Cleanroom is a space that is strictly controlled for dust, microbes, pressure, temperature, and humidity to meet specific production or research requirements. A standard cleanroom design must ensure critical criteria such as:

• Air Cleanliness: Measured by the number of particles per unit volume of air, in accordance with the ISO 14644 standard.

• Positive or Negative Pressure: To control airflow movement and prevent cross-contamination between areas.

• Temperature & Humidity Control: Maintaining appropriate levels for each industry to protect products.

• Air Filtration Systems (HVAC, HEPA, ULPA): Removing bacteria, fine dust, ensuring air quality.

Cleanliness Levels in Cleanrooms According to ISO 14644-1

• ISO 1: Particle count ≤ 10 – Application: Ultra-microchip component production.

• ISO 5: Particle count ≤ 100,000 – Application: Medical cleanrooms, sterile pharmaceutical production.

• ISO 7: Particle count ≤ 352 million – Application: Cosmetics, food, electronics factories.

• ISO 8: Particle count ≤ 3.5 billion – Application: Non-sterile food and pharmaceutical production.

Note: Industries such as microelectronics and sterile pharmaceutical production typically require ISO Class 5 or lower.

Applications of Cleanrooms in Industries

Cleanrooms are widely applied in many important industries:

• Pharmaceutical & Medical:

  • ✔ Drug, vaccine, and medical device manufacturing facilities require bacteria-free environments to avoid cross-contamination.

  • ✔ Meets GMP-WHO, EU-GMP, FDA standards for export drug production.

• Food & Beverage:

  • ✔ Ensures food safety in accordance with HACCP, ISO 22000 standards.

  • ✔ Prevents contamination, protecting products during processing and packaging.

• Electronics & High-Tech:

  • ✔ Semiconductor, component, OLED, LED manufacturing requires dust-free and static-controlled environments.

  • ✔ Common standard: ISO 14644-1 Class 5-7.

• Cosmetics:

  • ✔ Cosmetics and perfume production require microbial control environments to avoid contamination.

  • ✔ Required standards: GMP, ISO 22716.

• Chemical & Advanced Materials:

  • ✔ Polymer, composite, and special chemical research require environments with stable temperature and humidity.

  • ✔ Standards required: ISO Class 6-8, depending on the material.

Anh Khang Cleanroom's Cleanroom Design Service – Comprehensive Cleanroom Solutions

With over 15 years of experience, Anh Khang Cleanroom is a specialist in designing and constructing cleanrooms that meet GMP, ISO 14644-1, EU-GMP, HACCP standards for the pharmaceutical, food, electronics, cosmetics, and high-tech industries. We provide turnkey solutions from consultation, design, construction to inspection and maintenance, helping enterprises ensure international-standard production environments.

Standard Cleanroom Design Process

To ensure effective operation of cleanroom systems, Anh Khang Cleanroom's design process follows 5 strict steps, fully complying with ISO 14644-1, GMP, EU-GMP, FDA standards.

Step 1: Survey & Design Consultation

• ✅ Assess the area, technical requirements, and specific production characteristics of the enterprise.

• ✅ Propose the appropriate cleanliness level according to ISO 14644-1, GMP-WHO, EU-GMP, FDA standards.

• ✅ Advise on optimal control systems for pressure, temperature, humidity, and air filtration.

Step 2: Cleanroom Design Drafting

• ✅ Design an optimal cleanroom layout, ensuring proper segregation of clean and contaminated areas.

• ✅ Integrate HVAC, AHU, FFU, Air Shower, Pass Box systems to control bacteria and dust.

• ✅ Ensure control of pressure, temperature, and humidity as per each industry's requirements.

Step 3: Material Selection & Construction Solutions

• ✅ Choose wall, ceiling, and floor materials that meet GMP, FDA, ISO standards.

• ✅ Install HEPA, ULPA air filtration systems to ensure the required clean air quality.

• ✅ Advise on energy-saving solutions to optimize operating costs.

Step 4: Construction & System Installation

• ✅ Cleanroom Construction according to design drafts, ensuring timely completion and standard compliance.

• ✅ Install and inspect HVAC, AHU, Pass Box, Air Shower systems.

• ✅ Run system tests, measure air filtration performance.

Step 5: Inspection, Evaluation & Handover

• ✅ Validate the cleanroom according to ISO 14644-1, GMP, EU-GMP standards.

• ✅ Evaluate parameters: air cleanliness, microbial control, pressure, temperature.

• ✅ Handover the cleanroom along with inspection documentation, supporting enterprises in obtaining GMP, ISO certification.

Standards Applied in Cleanroom Design

A cleanroom that meets international standards must comply with strict regulations and standards. Anh Khang Cleanroom designs cleanrooms according to the latest standards, helping enterprises meet export and stringent inspection requirements.

International Standards & Vietnamese Regulations

• ISO 14644-1: Classification of cleanliness levels by particle count.

• WHO GMP: Cleanroom standard for the pharmaceutical and medical industry.

• EU-GMP: European standard for export pharmaceutical production.

• FDA & HACCP: Food safety control, contamination prevention.

• TCVN 8664-1:2011: Vietnamese cleanroom standard, equivalent to ISO 14644-1.

Benefits of Partnering with Anh Khang Cleanroom

• High Expertise & Practical Experience:

  • ✅ Over 15 years of experience in cleanroom design and construction.

  • ✅ A team of experienced engineers and experts, having implemented over 500 projects.

  • ✅ In-depth knowledge of GMP, ISO 14644-1, EU-GMP, HACCP standards in various fields: pharmaceuticals, food, electronics, cosmetics.

• Optimal Design Solutions – Cost Savings:

  • ✅ Design consultation tailored to budget, optimizing costs while meeting standards.

  • ✅ Application of energy-saving technologies, reducing operating costs.

  • ✅ Maintenance and upgrade of cleanrooms as per enterprise needs.

• Commitment to Standards – Ensured Certification:

  • ✅ Fully meets GMP, ISO, HACCP, FDA standards.

  • ✅ Support for inspection and cleanroom certification upon completion.

  • ✅ Long-term warranty policy, 24/7 technical support.

Cleanroom Design Quote – Contact Now for Consultation

Cleanroom design costs depend on:

•  Area & required cleanliness level (ISO Class 5, 6, 7, 8, etc.).

•  Applicable standards (GMP, EU-GMP, HACCP).

•  HVAC systems, air filtration equipment, construction materials.

     Contact now 0902.051.222 to receive a detailed quote!

Frequently Asked Questions about Cleanroom Design

How Long Does Cleanroom Design Take?

On average, 2 - 4 months, depending on scale and specific requirements.

How Should a Cleanroom be Maintained After Commissioning?

Regularly inspect HVAC, AHU, and HEPA filter membranes. Check pressure, microbial levels, and air cleanliness annually.

Does the Company Support GMP, ISO Certification?

Yes, we support inspection, evaluation, and completion of certification documentation.

Professional Cleanroom Design Solutions for Enterprises

Anh Khang Cleanroom is a trusted partner in cleanroom design and construction, committed to:

• ✅ International-standard quality (GMP, ISO 14644-1, EU-GMP, HACCP).

• ✅ Cost-optimized, energy-saving solutions.

• ✅ Turnkey services from consultation, design, construction to inspection.

ANH KHANG sincerely values and looks forward to a long-term partnership with Your Enterprise

Designing and constructing a cleanroom to standard helps enterprises increase production efficiency, optimize costs, and meet strict inspection requirements. ANH KHANG CLEANROOM is proud to be a leading provider in cleanroom consultation, design, and construction in Vietnam.

Công ty Cổ phần Cơ điện Phòng sạch Anh Khang Hotline: 1900 636 814 Email: info@akme.com.vn Website: akme.com.vn Add: Lô B7 Xuân Phương Garden, Đường Trịnh Văn Bô, Phường Phương Canh, Quận Nam Từ Liêm, Hà Nội.