Molex 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 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.
“The introduction of micro-organisms and other contaminants into the human body may prove harmful to patients, making sterilisation control of medical devices a critical part of the manufacturing process,” said Seann Kwan, Product Marketing Manager, Molex. “Our ISO-compliant Class 100,000 clean room facility allows us to provide device designers with cable assemblies that meet the international standards and regulatory requirements for medical devices used on or within patients.”
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.