ASTM Standards in Medical Device Cleaning Validation

G.J.C. Braithwaite, S.H. Spiegelberg
Cambridge Polymer Group, Inc.,
United States

Keywords: ASTM, cleaning validation, FDA


Cleaning processes have evolved over the last decades to cover a vast array of options, materials and techniques. However, in parallel with this evolution is a growing recognition that standardization of how to validate process is critical for patient safety. ASTM has therefore been active in developing standards for medical device cleaning activities for the past two decades. This activity was initiated by a single implant recall in the orthopedic industry that was ultimately associated with a cleaning issue. Since this recall, multiple standards have been developed. These standards are being used for single use devices (long-term implants, disposable devices) as well as re-usable devices (surgical tools, patient assist devices, personal protective equipment), to help companies design their devices with cleaning in mind, to test their devices to assess if cleaning levels have been attained, and to validate their cleaning processes. The standards are written for devices processed by more conventional methods of manufacturing, including metal machining and injection molding, as well as the increasing use of additive manufacturing techniques, such as powder bed fusion and fused filament fabrication. Pharmaceutical manufacturers are also making use of these standards, albeit for their manufacturing equipment rather than for the finished product. These ASTM Standards are also referenced in the standards of allied organizations, including AAMI and ISO documents and guidance documents authored by the U.S. FDA. This presentation delves into the current and upcoming standards that are available to assist in matters involving cleaning processes for the medical industry during the entire product lifecyle, from initial design to regulatory clearance, along with how the standards are being used in the industry.