The introduction of micro-organisms and other contaminants into the human body may prove harmful to patients, making sterilization control of medical devices a critical part of the manufacturing process.
Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and clinics. The micro-organism-controlled environment keeps room pressure, temperature, humidity and contamination levels within the limits required in the standard.
Each clean room is equipped with High-Efficiency Particulate Air (HEPA) filters to prevent the spread of airborne and viral organisms. They also feature a positive pressure design that keeps unfiltered air out of the room while air-showers remove particulates from workers and products before they enter. The audit clean room maintenance process includes a micro-organisms count to ensure compliance of cleanliness and bio-burden levels. The medical-grade, surgical and non-surgical cables are used in a wide variety of applications including ablation, arthroscopy, coblation, cosmetic, dental, electro-surgery, endoscopy, gastro, laparoscopy, lasers, ophthalmic, power tools, surgical catheters, robotics and video endoscopy.
For more information about the Class 100,000 clean-room facility from Molex please visit www.molex.com/link/cleanroomgrademedicalcables.html.
Molex, LLC
www.molex.com
