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浅谈过氧化氢蒸汽灭菌与验证的相关问题

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摘要 近年来,过氧化氢蒸汽灭菌技术越来越受无菌制药界的重视。但是,统观国内绝大多数的过氧化氢蒸汽灭菌技术应用案例,不难发现众多过氧化氢蒸汽灭菌技术开发商或者使用者对过氧化氢灭菌技术及过氧化氢的灭菌验证的认识存在一定的误区。本文将对过氧化氢蒸汽灭菌及验证所面对的相关问题进行探讨。
作者 曾长金
出处 《流程工业》 2014年第20期40-42,44,共4页
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  • 1ISO 11135-1Sterilization of health care products---Ethylene oxide---Part l: Requirements for development, validation and routine control of a sterilization process for medical devices.
  • 2Parenteral Drug Association.PDA TR No.34- -Design and Validation of isolator systvms for the manutacturing and tcsting of health care products[R]. USA: PDA J Phann Sci- Tvchnol, 2001.
  • 3Center for Drug Evaluation and Research (CDER) and Center tbr Biologics Evaluation and Research (CBER ),Guidance lot Industry, sterile Drug Products, Produced by Aseptic Processing-Current Good Manufacturing Practice [M].Rockvillc; MD." U.S. Department of Health and Human Services, Food and Drug Administration, 2004.
  • 4James R, Rickloff Hydrogen peroxide gas decontamination [M].Advanced Aseptic Processing Technology, No.25,2010: 289- 308.
  • 5James Agalloco, James Akers. Decontamination of advanced aseptic processing environments. [M] Advanced Aseptic Processing Technology, No.24,2010: 277-288.
  • 6Chung, S et al. Vapor hydrogen peroxide as alternative to dry heat microbial reduction [J] Advances in Space Research, Vol.42, No.6, September 2008: 1150- 1160.
  • 7Unger, Bet al. Suitability of different construction tnaterials lbr use in aseptic processing environments decontaminated with gaseous hydrogen peroxide [J]. The PDA Journal of Pharmaceutical Science and Technology, Vol.61, No.4, 2007: 255-275.
  • 8Friedman RL. Aseptic Processing, Isolators [C]. Proceedings of the ISPE Barrier Isolation Technology Conference, 2001, Arlington, VA.

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