PHARMACEUTICAL CLEANROOM

Turnkey pharmaceutical cleanroom solutions - GMP, FDA, and GMP WHO compliant

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pharmaceutical cleanroom projects implemented

What are your business requirements?

Turnkey Cleanroom Solutions for the Pharmaceutical Industry

GMP-WHO & FDA Compliant Cleanroom Design

Optimized layout & production workflow: Ensures the movement of materials, products, and personnel follows a “one-way” flow principle to minimize cross-contamination.
Specialized materials with smooth surfaces, preventing microbial contamination and dust accumulation.
Pressure & clean airflow control: Utilizes AHU (Air Handling Unit) systems and HEPA/ULPA filtration to maintain positive/negative pressure, preventing cross-contamination.

Advanced Control of Air Cleanliness, Temperature & Humidity

Pharmaceutical-grade air filtration systems: Compliant with ISO 14644-1 and GMP standards, effectively removing ultra-fine particles and airborne microorganisms.
Precise humidity & temperature control: Minimizes the risk of microbial growth and ensures consistent product quality.

Ensuring Validation & Compliance with International Standards

GMP, FDA, WHO-GMP, EU-GMP, PIC/S-GMP, ISO 14644 standards: Compliant with stringent requirements for microbial control, particulate contamination, and airflow dynamics.
Strict validation procedures: Includes testing of room pressure, airflow velocity, particle counts, and microbial levels prior to operation.
Documentation support and system validation execution across IQ, OQ, and PQ stages.

Cleanroom Maintenance & Upgrades for Pharmaceuticals

Inspection and maintenance of cleanroom systems to ensure stable operation and full compliance with standards.
Cleanroom upgrades to meet evolving standards: Supporting businesses in adopting advanced technologies and upgrading to higher standards (WHO-GMP, EU-GMP, PIC/S-GMP).

Proven Credibility with 250+ 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 & Efficient Collaboration Process

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 a pharmaceutical cleanroom meet to ensure safety and product quality?

Pharmaceutical cleanrooms must comply with stringent international standards such as WHO-GMP, FDA, EU-GMP, and ISO 14644, ensuring proper control of microbial contamination, particulate matter, pressure, and airflow dynamics.

What makes the design process of pharmaceutical cleanrooms different from other cleanrooms?

Pharmaceutical cleanroom design is optimized based on a “one-way” flow principle for materials, products, and personnel. It utilizes antimicrobial materials, epoxy flooring, specialized wall panels, and automatic doors to minimize the risk of cross-contamination.

Can existing pharmaceutical cleanrooms be renovated or upgraded?

Yes, we provide renovation and upgrade services for existing cleanroom systems to meet updated standards without disrupting production operations. We also offer periodic maintenance services to ensure optimal performance.