Abstract：
Past evaluation of particle contamination on packaged implants has typically been conducted using US Pharmacopeia (USP) 788, a 1970s pharmaceutical guideline created to evaluate contaminant particles in injectable fluids and syringes. Our objective was to reestablish relevant acceptance criteria for residual orthopedic and other implant debris, including smaller particles (i.e., <10 μm in diameter). Packaged total hip arthroplasty (THA) titanium (Ti6Al4V)-alloy femoral stems were used (hydroxyapatite [HA]-coated and non-coated stems). Short-term ultrasonication and longer-term 24-hour soak/agitation methods were used to elute surface-bound contaminant particles, and released particles were analyzed via scanning electron microscopy, energy-dispersive x-ray analysis, image analysis, and particle characterization. For HA-coated THA-stems, >99% of eluted particles were calcium phosphate. For plain non-coated THA-stems, >99% of eluted particles were titanium-alloy-based. The number-based median size of particles in both groups was approximately 1.5 μm in diameter despite being composed of different materials. The total volume of particulate removed from HA-coated stems was 0.037 mm3 (671 × 103 particles total), which was approximately >50-fold more volume than that on plain non-coated stems at 0.0006 mm3 (89 × 103 particles total). Only non-coated THA stems passed reestablished USP788 acceptance criteria, compared by using equivalent total volumes of contaminant particulate within new and legacy guideline ranges of >10 and >25 μm ECD, that is, <1.0 × 107 particles for <1 μm diameter in size, <600,000 for <1-10 μm, <6000 for 10-25 μm and <600 for >25 μm. These results fill a knowledge gap on how much residual debris can be expected to exist on packaged implants and can be used as a basis for updating acceptance criteria (i.e., termed USP788-Implant [USP788-I]). Residual implant particulate assessment is critical given the increasing implant complexity and new manufacturing techniques (e.g., additive manufacturing).
摘要：
过去通常使用美国药典（USP）788对包装植入物上的颗粒污染进行评估，这是1970年代的药物指南，旨在评估可注射流体和注射器中的污染物颗粒。我们的目标是重新建立残余骨科和其他植入物碎片的相关验收标准，包括较小的颗粒(即，直径<10μm)。使用包装的全髋关节置换术（THA）钛（Ti6Al4V）合金股骨柄（羟基磷灰石[HA]涂层和未涂层的柄）。短期超声处理和长期24小时浸泡/搅拌方法用于洗脱表面结合的污染物颗粒，并通过扫描电子显微镜分析释放的颗粒，能量色散X射线分析，图像分析,和颗粒表征。对于HA涂层的THA茎，>99%的洗脱颗粒是磷酸钙。对于无涂层的普通THA杆,>99%的洗脱颗粒是基于钛合金的。尽管由不同的材料组成,但两组中颗粒的基于数量的中值粒径为约1.5μm。从HA涂层的茎中去除的颗粒的总体积为0.037mm3（总共671×103个颗粒），在0.0006mm3（总共89×103个颗粒）下，其体积比普通的未涂覆茎上的体积大大约>50倍。只有未涂覆的THA茎通过了重新建立的USP788验收标准，通过在>10和>25μmECD的新指南范围内使用等效的污染物颗粒总体积进行比较，也就是说,<1.0×107个颗粒，直径<1μm，对于<1-10μm，<600,000，对于10-25μm，<6000，对于>25μm，<600。这些结果填补了有关包装植入物上预期存在多少残留碎片的知识空白，并可用作更新接受标准的基础（即，称为USP788-植入物[USP788-I])。考虑到不断增加的植入物复杂性和新的制造技术（例如，增材制造)。
