Low-Dose Radiation Sterilization

低剂量辐射灭菌

• 批准号: 6626078
• 负责人: SHALABY W SHALABY
• 金额: $ 36.84万
• 依托单位: POLY-MED, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2004-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6626078
• 关键词: antiseptic sterilization; biodegradable product; biomedical equipment development; gamma radiation; laboratory rat; orthopedics; polymers; polypropylenes; radiochemistry; surgery material /equipment; tensile strength

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.

I期研究和最近的结果表明，（1）聚丙烯（PP）单股和聚乙交酯（PG）编织缝线可在存在微量放射性受控甲醛（CH 2 O）前体的密封包装中接受5和7.5 kGy伽马辐照灭菌;（2）在1所述的放射化学灭菌（RC-S）条件下，PP和PG的体外和体内缝线性能未受到显著损害;（3）在典型的RC-S循环中，微量的未稳定化Celcon-M90可放射性地产生足够的CH 20，以消毒污染和未污染的缝线和孢子条对照;和（4）Celcon粉末可用作灭菌甲醛的来源和包装中过量CH 2 O的缓慢吸收剂，导致灭菌包装中残留少量CH 2 O。第II阶段的目标是：（1）优化RC-S条件，以在小于或等于5 kGy的剂量下实现器械和孢子条无菌，同时在包装中实现几乎无CH 2 O的气体环境;（2）开发RC-S过程，与包装开发一致，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器械;及（3）进行研究，以支持在第三期安装独立（或共用）的合约垃圾收集及收集设施。II期计划包括：（1）优化RC-S过程，以在小于或等于5 kGy的剂量下与可吸收缝线和相关器械配合使用，从而选择Celcon砝码和器械夹持器的实际组合;（2）将RC-S应用扩展到可吸收骨科器械;（3）确认典型商业和选定实验缝线、骨科和相关产品的RC-S过程;及（4）与辐射技术合作伙伴制定计划，以建造一个独立（或共用）的RC-S设施，为第三阶段的预先包装产品精确提供小于或等于5 kGy的辐射。拟议的商业应用：第II阶段的结果将提供关键数据，以最终确定建造（或共享）多客户RC-S设施的计划，用于可吸收缝线和骨科内固定器械以及第III阶段的其他辐射敏感医疗器械的低剂量伽马辐照灭菌。