What is a Class 100 Laboratory: The Highest Standard for Cell Culture Safety

The Significance of Class 100 Labs in Regenerative Medicine

In the process of cultivating stem cells and immune cells for medical use, environmental purity is the most critical factor. A Class 100 laboratory, also known as a high-level cleanroom, is specifically designed to minimize airborne particles and contaminants. It restricts particles sized 0.5 microns to no more than 100 per cubic foot of air, a standard much stricter than conventional operating rooms.

At EHL BIO, we prioritize quality control at the highest level. Our Class 100 facilities are an integral part of our GMP-certified centers in Korea. This sterile environment ensures that cell viability and proliferation are maximized, providing clients with the confidence that they are receiving high-quality, safe cells based on EHL team assessments in every step.

Advanced Airflow and Filtration Technology

To achieve Class 100 standards, EHL BIO's Cell Centers are equipped with Air Handling Units (AHU) combined with high-efficiency HEPA filters, which accurately trap dust particles and micro-organisms. Furthermore, Biological Safety Cabinets (BSC) are installed within the labs to create a bio-secure workspace, preventing cross-contamination during the isolation and cultivation of cells.

These innovations work in tandem with optimal air pressure management systems to ensure the air within the laboratory remains pristine at all times, even during active operations. EHL BIO's stable technology in isolating and culturing adipose-derived stem cells yields up to 1,000 times more cells than standard, all within this strictly controlled environment to support the goal of recovery and enhanced quality of life through standardized care.

The Class 100 laboratory standard is the core that allows EHL BIO to deliver high-quality, safe cells for a sustainable future in regenerative medicine.

GMP Standards and Quality Recognition

EHL BIO does not only feature Class 100 laboratories but also operates comprehensive GMP production systems across our first and second centers, capable of handling 6,000 lots per year. We were the first in Korea to be licensed as a Human Cell Management Business, solidifying our credibility.

Additionally, our cell storage system utilizes liquid nitrogen tanks at -196°C to preserve the youthfulness and biological properties of the cells. By integrating cleanroom technology with advanced storage systems, EHL BIO leads in regenerative medicine, ready to serve through a network of partner hospitals in Korea and Thailand, ensuring the goal of recovery and sustainable quality of life for clients.

Commitment to R&D and Cell Therapy Innovation

Within this excellently controlled environment, EHL BIO’s research team of over 85 specialists continuously develops innovative cell therapies, such as ADSTEM for atopic dermatitis and KDSTEM for chronic kidney disease, which are currently in medical development and various testing phases. The Class 100 laboratory standard ensures that these biologics are produced consistently with high safety.

We are committed to merging medical and pharmaceutical technologies to address age-related degeneration and hard-to-treat diseases. EHL BIO's goal is to improve the quality of life through transparent research and protected patented technologies, such as SVF cell isolation and specialized cultivation. This ensures that every client receives positive outcomes based on EHL team assessments from the innovations we develop.