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(Singapore – August 26, 2015) Molex operates a clean room that is fully compliant with ISO 146441-1:1999 Class 8 certification and meets the stringent particle contamination standards set by ISO requirements. Located in Thailand, the facility contains less than 100,000 (30.5 mm) particles per cubic foot of air, making it possible to manufacture a wide range of ISO 13485 compliant medical cables and surgical cables for use in operating rooms, hospitals, and laboratories. Room and clinic. Its microbiologically controlled environment maintains indoor pressure, temperature, humidity, and pollution levels within the limits required by standards.
Seann Kwan, product marketing manager at Molex, said: “The introduction of microbes and other contaminants into the body can cause harm to patients, making disinfection control of medical devices a key component of the manufacturing process. ISO certified 100,000 Level Cleanroom facilities allow us to provide medical device designers with cable assemblies that meet various international standards and regulatory requirements for medical devices used outside or in vivo."
Each clean room is equipped with a High Efficiency Air Particulate (HEPA) filter to prevent the spread of airborne organisms and viral organisms. The filter also features a positive pressure design that isolates unfiltered air from the outside of the room, while the air shower removes contaminated particles before the worker and product enter the room. The clean room audit maintenance process includes counting microorganisms to ensure compliance with cleanliness and bioburden levels. Medical grade surgical cables and non-surgical medical cables for a variety of applications including ablation, arthroscopy, cryoablation, cosmetic, dental, electrosurgical, endoscopy, gastritis, laparoscopy, laser , ophthalmology, power tools, surgical catheters, robots, and endoscopes.
About Molex, LLC
Molex not only manufactures connectors, but also provides complete interconnect solutions for many areas. The markets we serve include: data communications, telecommunications, consumer electronics, industrial, automotive, commercial vehicles, aerospace and defense, medical, and lighting. Molex is a global company founded in 1938 and currently operates in more than 40 countries.
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.