Ultra-clean environments for sensitive medical implants
A rigorous specification for assembly and sterile packaging of sensitive electronic medical implants was issued by a world market leader in the field. The specification called for a number of AS/NZS ISO 14644-1 Class 5 ultra-clean work enclosures to be installed in a cleanroom. The enclosures specified were vertical laminar flow units to be located at a number of work locations. Stainless steel construction was required, as well as specific features to be compatible with process equipment and procedures. Vilair-AAF installed DFM Series downflow modules, supported by purpose-designed floor stands. Special clear anti-static plastics panels were fitted to enclose the ultra-clean work zones. Noise level of < 58 dB(A) together with low vibration provide an appropriate environment for the sensitive process operations. AAF HEPA filters were also installed to provide required air cleanliness in the cleanroom. DFM Series modules provide an economical means of achieving ISO Class 5 (AS 1386 Class 3.5) air cleanliness in a wide range of industrial and research applications. Modules are self-contained, laminar flow HEPA filter/ fan units that operate independently of other air-handling systems. When installed with flexible curtains or rigid panels, modules form an ultra-clean zone in which a high degree of product protection is maintained.