Low-Dose Radiation Sterilization

I期研究和最近的结果表明：(1)聚丙烯（PP）单丝和聚乙二醇（PG）编织缝合线在密封包装中，在微量辐射控制的甲醛（CH2O）前体存在下，可以用5和7.5 kGy的伽马射线消毒；(2)在1中描述的放射化学灭菌（RC-S）条件下，PP和PG的体外和体内缝合性能没有明显受损；(3)在典型的RC-S循环中，几分钟不稳定的Celcon-M90可以放射性地产生足够的CH20来消毒被污染和未被污染的缝合线和孢子条对照；(4) Celcon power可以作为灭菌甲醛的来源和包装中多余CH20的缓慢吸收剂，使灭菌后的包装中残留的CH20数量微不足道。II期的目标是：(1)优化RC-S条件，以在小于或等于5kgy的剂量下实现设备和孢子条的无菌，同时在包装中获得几乎不含ch2o的气体环境；(2)与封装开发一起开发RC-S工艺，以广泛应用于包括可吸收和不可吸收辐射敏感部件的几种形式的设备；(3)进行研究，以支持在第三阶段安装独立（或共享）合同RC-S设施。II期计划包括：(1)优化RC-S工艺，使其与可吸收缝合线和相关设备一起使用，以小于或等于5kgy的速度选择Celcon重量和设备支架的实际组合；(2)将RC-S应用扩展到可吸收骨科器械；(3)对典型的商业和选定的实验缝合线、骨科和相关产品验证RC-S工艺；(4)与辐射技术合作伙伴制定计划，建设一个独立的（或共享的）RC- S设施，以便在第三阶段向预先包装的产品精确输送小于或等于5kgy的辐射。拟议的商业应用：II期结果将提供关键数据，以最终确定建设（或共享）多客户RC-S设施的计划，用于在III期对可吸收缝合线和骨科内固定装置以及其他辐射敏感医疗设备进行低剂量伽马辐射灭菌。

Phase I study and recent results demonstrated that (1) polypropylene (PP) monofilament and polyglycolide (PG) braided sutures can be sterilized by 5 and 7.5 kGy gamma radiation in sealed packages in the presence of minute amounts of radiolytically controlled formaldehyde (CH2O) precursors; (2) under radiochemical sterilization (RC-S) conditions described in 1, in vitro and in vivo suture properties of PP and PG are not significantly compromised; (3) in typical RC-S cycles, minutes amounts of unstabilized Celcon-M90 can radiolytically produce sufficient CH20 to sterilize contaminated and uncontaminated sutures and spore strip controls; and (4) Celcon power can be used as a source of sterilizing formaldehyde and a slow absorbent for excess CH20 in the package, resulting in insignificant quantities of residual CH20 in sterilized packages. Phase II objectives are to (1) optimize RC-S conditions to achieve device and spore strip sterility at a dose of less than or equal too 5 kGy, while attaining a practically CH2O-free gas environment in the package; (2) develop the RC-S process in concert with package development for broad application to several forms of devices comprising absorbable and non-absorbable radiation-sensitive parts; and (3) conduct studies to support installation of self standing (or shared) contract RC-S facilities in Phase III. Phase II plans entail (1) optimizing the RC-S process for use with absorbable sutures and allied devices at less then or equal too 5 kGy toward selecting a practical combination of Celcon weights and device holders; (2) extending RC-S applications to absorbable orthopedic devices; (3) validating the RC-S process for typical commercial and selected experimental sutures, orthopedic, and related products; and (4) developing plans with a radiation technology partner to construct a self-standing (or shared) RC- S facility for precise delivery of less than or equal too 5 kGy radiation to prepackaged products in Phase III. PROPOSED COMMERCIAL APPLICATIONS: Phase II results will provide critical data to finalize plans to construct a (or share) a multi-client RC-S facility for low-dose gamma radiation sterilization of absorbable sutures and orthopedic internal fixation devices as well as other radiation-sensitive medical devices in Phase III.