Micro-organism-controlled environment ensures full conformance to industry standards and regulatory requirements
US company Molex, a supplier of electronic components and solutions, is not able to deliver ISO-compliant, medical-grade surgical cables from its class 100,000 cleanroom facility. The Class 8-certified cleanroom, located in Thailand, manufactures a variety of ISO 13485-compliant medical cables and surgical cables, which are used in operating theatres, hospitals, laboratories and clinics. The micro-organism-controlled environment keeps room pressure, temperature, humidity and contamination levels within the limits defined by the standard.
‘The introduction of micro-organisms and other contaminants into the human body may prove harmful to patients, making the sterilisation of medical devices a critical part of the manufacturing process,’ said Seann Kwan, Product Marketing Manager, Molex. ‘Our ISO-compliant Class 100,000 cleanroom 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,’ he added.
Each cleanroom 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 cleanroom maintenance process includes a microbial count to ensure compliance with cleanliness and bioburden levels. The medical-grade, surgical and non-surgical cables are used in a wide variety of applications, including ablation, arthroscopy, coblation, cosmetic, dental, electrosurgery, endoscopy, gastro, laparoscopy, lasers, ophthalmic, power tools, surgical catheters, robotics and video endoscopy.