HEALTHCARE CLEANROOM

Turnkey solutions for healthcare cleanrooms - Compliant with ISO 14644, WHO-GMP, and TCVN standards

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successful projects delivered for FDI clients from South Korea, Japan, Europe, the US, and India

What are your business requirements?

Turnkey Cleanroom Solutions for Healthcare Facilities

Healthcare cleanroom design compliant with ISO standards and Ministry of Health regulations

Design and construction ensuring healthcare cleanroom standards in terms of air pressure, particle concentration (≤ 3 x 10⁶), chemical exhaust and volatile organic compounds (VOC), airflow rate and direction (15–20 air changes per hour), temperature and humidity (21–25°C / 60–70%), and microbial levels (<35 CFU/m³), etc.
Optimized layout & operational workflow: Ensures the movement of patients, personnel, equipment, pharmaceuticals, and contaminated materials follows a “one-way” flow principle, minimizing cross-contamination risks.
Specialized antimicrobial materials: Utilizes antibacterial panel walls, antimicrobial vinyl flooring, and automatic doors to limit bacterial growth and facilitate easy cleaning.
Pressure & clean airflow control: Applies AHU (Air Handling Unit) systems to maintain positive pressure, exhaust systems for negative pressure zones, and HEPA/ULPA filtration to control particle levels.

Advanced microbial & particulate contamination control technologies

Healthcare-grade air filtration systems: Compliant with ISO 14644-1 Class 5–8, ensuring ultra-clean environments for operating rooms, ICUs, and sterile areas.
Precise humidity & temperature control: Maintains optimal conditions to limit the growth of airborne bacteria and viruses.
Advanced sterilization systems: Utilizes UV-C technology to ensure maximum environmental cleanliness.

Ensuring validation & compliance with international standards

Compliance with stringent healthcare standards: ISO 14644, WHO-GMP, TCVN 8664-4:2011 (ISO 14644-4), TCVN 5687-2010, TCVN 4470:2012, Decision 3671/QĐ-BYT, and Decision 34/2005/QĐ-BYT for healthcare facilities, hospitals, and laboratories.
Strict validation procedures: Includes testing of air cleanliness, room pressure, airflow velocity, microbial control, and particle counts prior to operation.
Documentation & certification support: Provides SOPs, validation reports, and supports businesses in achieving ISO and GMP certifications efficiently.

Healthcare cleanroom maintenance & upgrade services

Inspection and maintenance of cleanroom systems to ensure stable operation and full compliance with standards.
Cleanroom upgrades to meet evolving standards: Supporting hospitals and healthcare facilities in upgrading operating rooms, ICUs, laboratories, and other areas to meet the latest international standards.

Proven Excellence with250+ Successful Projects

Pharvina Pharmaceutical Factory

Pharvina Pharmaceutical JSC is a reputable pharmaceutical company in Vietnam, established in 2013. Specializing in the production and distribution of high-quality pharmaceuticals, dietary supplements, and cosmetics, Pharvina meets the healthcare needs of the population.

Alina Eye Hospital

As a part of the global Alina Vision network, Alina Vision Vietnam offers a diverse range of high-quality eye care services at international standards. It is the top choice for residents in northern provinces and cities for their medical examinations and treatments related to eye health.

Biotech Pharmaceutical Factory

KONISHI BIOTECHNOLOGY VIETNAM is a reputable enterprise in the pharmaceutical manufacturing sector, with many years of experience in producing and supplying high-quality products.

Nano France Pharma Factory

The Nano France Healthcare Food Factory is a high-quality functional food manufacturing facility that operates on a closed-loop technology line, adhering to a one-way flow principle in compliance with high-quality standards. Established in 2015, the plant is dedicated to producing premium health protection supplements.

GSR Vina Factory

ICH CUBE Vietnam Co., Ltd. is a specialized brand in industrial tape manufacturing, headquartered in South Korea, with factories in Vietnam, China, and India.

FPT Project (Dell Vendor)

Simple & Effective Partnership Workflow

Consultation & Site Survey – Assess facility conditions and analyze project requirements

Solution Consulting – Propose optimal solutions and provide technical drawings

Construction & Validation – Install cleanroom systems and perform quality testing

Handover & Maintenance – Provide technical support and periodic maintenance

FAQs

What standards must healthcare cleanrooms meet to be put into operation?

Healthcare cleanrooms must comply with standards such as ISO 14644, WHO-GMP, FDA, and Vietnamese Ministry of Health regulations, ensuring proper control of microbial contamination, pressure, temperature, and air cleanliness.

Can existing pharmaceutical cleanrooms be renovated or upgraded?

Yes, we support the renovation and upgrading of existing cleanroom systems to meet updated standards without disrupting production operations. We also provide periodic maintenance services to ensure optimal performance.

Will certification and validation support be provided after project completion?

Yes, we provide complete documentation, validation reports, and SOPs, and support businesses throughout the certification process for GMP, FDA, and other international standards required for manufacturing and export.