Clean room

Our clean room facility provides a controlled environment essential for manufacturing sensitive products requiring high levels of cleanliness and precision.

Key features

• Positive Pressure Filter-Fan Unit (FFU): Equipped with an FFU system, our clean room maintains positive pressure to prevent contaminants from entering the environment, ensuring a pristine manufacturing, research, and sterile testing environment.
• ISO 5 & 7 classification: Our clean room is 12’ x 16’ space with a 6’ x 8’ gowning room (ISO 7 – Class 10,000) with a smaller 2’x4’ laminar flow assembly hood (ISO 5 – Class 100) inside. The larger part of the cleanroom can be segment into 4 quadrants, all adhering to ISO 7 certification standards, guaranteeing controlled levels of particulate and microbial contamination suitable for manufacturing medical devices and other sensitive products. Additionally, we offer an ISO 5 section within the clean room, providing and even higher level of cleanliness for specialized manufacturing processes.

Current application

Currently, the clean room is utilized for manufacturing a liquid embolic for aneurysm treatment, a balloon-mesh braided device, and an aspiration catheter system. The clean room can also accommodate electronic component development, chemical extractions and filtration, and biological sterile surgical setups.