GMP and ISO Standard Cleanroom Construction

Complete Cleanroom Construction Service - ANH KHANG: Optimal Cleanroom Solution

In an environment where industries such as pharmaceuticals, food, electronics, healthcare... are increasingly focusing on production environments, aseptic processing and stringent quality control, cleanrooms play a key role. ANH KHANG, with many years of experience in the field of Cleanroom Design and Construction, is proud to offer your enterprise comprehensive solutions that meet the strictest standards such as CGMP, ISO 14644 and US FED STD 209E. Additionally, the WHO GMP standards are also referenced to affirm global manufacturing standards.

What is a Cleanroom? Why Do Enterprises Need Cleanrooms?

A cleanroom is a space that is specially controlled for contamination levels such as dust, airborne microorganisms, aerosol particles, and chemical vapors. The basic operating principle of a cleanroom is to strictly control factors such as the ventilation and air conditioning (HVAC) system, air filtration, temperature, humidity, and pressure to maintain a sterile or extremely low contamination working environment.

So, why should enterprises invest in cleanrooms?

• Ensure product quality: In industries such as pharmaceuticals and food, cleanrooms help prevent contamination and mold, ensuring that products are safe and meet the highest quality standards. In the electronics industry, cleanrooms help eliminate dust and static electricity, increasing precision and the lifespan of components.
• Compliance with regulations and standards: Many industries require enterprises to have standardized cleanrooms to meet legal regulations and international standards such as GMP and ISO.
• Enhance brand reputation: Owning a modern cleanroom demonstrates an enterprise's professionalism and commitment to quality, thereby boosting market reputation.
• Protect employee health: A clean working environment helps reduce the risk of respiratory and skin diseases among staff.

For the pharmaceutical industry, your enterprise should consider the Pharmaceutical Cleanroom Construction service to ensure that production processes meet standards.

In the electronics field, the application of Electronic Cleanroom Construction contributes to improving product efficiency and reliability.

In the food industry, implementing Food Cleanroom Construction is a key factor in ensuring food safety and hygiene.

For the healthcare sector, implementing Medical Cleanroom Construction will enhance service quality and ensure patient safety.

Common Classifications of Cleanrooms

Cleanrooms are classified according to various criteria; below are some common classifications:

By Cleanliness Level (based on ISO 14644-1)

• ISO Class 1 - ISO Class 5: Very high cleanliness levels, typically used in semiconductor manufacturing and nanotechnology.
• ISO Class 6 - ISO Class 8: Moderate cleanliness levels, common in the pharmaceutical, food, and healthcare industries.
• ISO Class 9: Cleanliness equivalent to a controlled conventional environment.

By Airflow

• Laminar Flow Cleanroom: Air flows in a single, uniform direction, typically used in areas requiring extremely high cleanliness.
• Turbulent Flow Cleanroom: Air flows in multiple directions, typically used in areas with lower cleanliness requirements.

By Pressure

• Positive Pressure Cleanroom: The room’s internal pressure is higher than the outside, preventing the ingress of external contaminants.
• Negative Pressure Cleanroom: The room’s internal pressure is lower than the outside, preventing the spread of contaminants outside (commonly used in biological laboratories).

Professional Cleanroom Construction Process at ANH KHANG

At ANH KHANG, we employ a professional cleanroom construction process, ensuring quality and project timelines:

1. Consultation and Survey: The expert team at ANH KHANG will carefully listen to your enterprise's requirements and conduct an on-site survey to provide the most suitable solution.
2. Detailed Design (Cleanroom Design): Using specialized design software, we create detailed drawings for layout, HVAC systems, air filtration systems (employing high-performance filters such as HEPA, ULPA with a 99.97% efficiency for 0.3 micron particles), lighting, electrical systems, monitoring systems, and other technical requirements. The experienced engineering team at ANH KHANG always ensures precision and optimization in every design detail.
3. Material Selection: ANH KHANG is committed to using high-quality materials with clear provenance that meet cleanroom standards. Some typical materials include:
   • Insulation panels: EPS panels, PU panels, Rockwool panels with excellent thermal insulation, soundproofing, and fire resistance.
   • Toughened glass: Ensures durability and load-bearing capacity.
   • Antibacterial vinyl flooring: Easy to clean, dust, and bacteria resistant.
   • HVAC system materials: Air ducts, control valves, air diffusers, central air conditioning units... from reputable brands.
   • Air filtration system materials: Pre-filters, fine filters, HEPA/ULPA filters...

4. Installation (Cleanroom Construction): The skilled technical team at ANH KHANG carries out the installation of the system in accordance with the detailed design and technical standards. We strictly adhere to quality control processes throughout the construction phase.
5. Inspection and Acceptance: After installation, ANH KHANG conducts comprehensive checks on all components, including integrity, pressure, airflow, and particle count (using specialized measuring equipment), ensuring the cleanroom meets the committed standards. The acceptance process is carried out with the participation of your enterprise's representatives.
6. Maintenance and Servicing: ANH KHANG provides regular maintenance and servicing for the cleanroom system, helping to ensure stable performance and prolong the system's lifespan.

Why Should Your Enterprise Choose ANH KHANG as Your Cleanroom Construction Partner?

• Experience and Reputation: With many years in cleanroom construction, ANH KHANG has successfully completed hundreds of projects for major partners in various industries.
• Expert Team: ANH KHANG has a team of highly skilled and experienced engineers and architects who continually update with the latest technologies in the cleanroom field.
• Comprehensive Solutions: We provide turnkey services from consultation, design, construction, inspection to maintenance and servicing, saving your enterprise time and costs.
• Quality Materials: ANH KHANG only uses genuine, certified materials with clear provenance.
• Advanced Technology: We apply modern construction technologies, ensuring project timelines and quality.
• Competitive Pricing: ANH KHANG is committed to offering your enterprise the most competitive pricing in the market, along with superior service quality.
• Thoughtful After-Sales Service: We are always ready to support and resolve any issues that arise after project completion.

Cleanroom Construction Quotation

To receive a detailed quotation and free consultation for your enterprise's cleanroom project, please contact ANH KHANG using the following information:

ANH KHANG Cleanroom Electromechanical Joint Stock Company Hotline: 1900 636 814 Email: info@akme.com.vn Website: akme.com.vn Address: Lot B7 Xuan Phuong Garden, Trinh Van Bo Street, Phuong Canh Ward, Nam Tu Liem District, Hanoi.

Don't miss the opportunity to own a standard cleanroom, enhancing product quality and brand reputation. Call 0902.051.222 now for dedicated consultation!

ANH KHANG is confident as your enterprise's reliable partner in cleanroom construction. We are committed to delivering optimal, high-quality solutions that meet the most stringent requirements. Let ANH KHANG accompany your enterprise's sustainable development.