01
无菌灌装洁净室
|
02
清洁策略
03
清洁材料
04
液体清洁剂
05
清洁方法
06
清洁效果检查
07
总结
参考文献
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[2]Association for the Advancement of Medical Instrumentation, AAMI Standards and Recommended Practices: Vol. 1: Sterilization, AAMI, Arlington, VA, 1992.
[3]D.M. Carlberg, Cleanroom Microbiology for the Non-Microbiologist (Interpharm,Buffalo Grove, IL, 1995). Cleaning Aseptic Fill Areas-10 -
[4]Instituteof Environmental Sciences, Microorganisms in Cleanrooms, IESRP- CC023.1(IES, Mount Prospect, IL, 1993).
[5]D.W. Cooper, “Sterility Assurance for Cleanroom Wipers,” presentation at theannual technical meeting of the Institute of Environmental Sciences, Anaheim,CA, April 1995.
[6]D.W. Cooper, “Cleaning Surfaces with Sterile Wipers,” presentation at Medical Design and Manufacturing East, New York, June 1995.
[7]K. Hiraoka, “Particle Control in Form/Fill/Seal Systems,” in Proceedings of theInternational Conference on Particle Detection, Metrology, and Control (Instituteof Environmental Sciences and the Parenteral Drug Association, Arlington,VA, 1990), pp. 626–635.
[8]G. Van Gestel, “Clean Room Design and Operation,” in Sterilization of MedicalProducts, Vol. IV, E.R.L. Gaughran, R.L.Morrisey, and Y. Wang, Eds.(Polyscience, Montreal, 1986).
[9]J.F.Gallelli and M.J. Groves, “USP Perspectives on Particle Contamination
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[10]C.L. Thompson, “Cleanroom Cleaning,” presentation at Clean-Rooms ‘94 East,Philadelphia, March 1994.
[11]M.S. Favero and W.W. Bond, “The Use of Liquid Chemical Germicides,” in SterilizationTechnology: A Practical Guide for Manufacturers and Users of HealthCare Products, R.L. Morrisey and G.B.Phillips, Eds. (Van Nostrand Reinhold,New York, 1993).
[12]G.K. Bass, “Methods of Testing Disinfectants” in Disinfection,Sterilization, and Preservation, S.S. Block, Ed. (Lea&Febiger, Philadelphia, 1977).
[13]T.H. Leahy, “Microbiology of SterilizationProcesses,” in Validation of Aseptic PharmaceuticalProcesses, F.J. Carleton and J.P. Agalloco, Eds. (Marcel Dekker, New York, 1986).
[14] J.D. Wilson, “Validation of Sanitizers,” in Validationof Aseptic Pharmaceutical Processes, F.J. Carleton and J.P. Agalloco, Eds. (Marcel Dekker, New York, 1986).
[15]Institute of Environmental Sciences, CleanroomHousekeeping—Operating and MonitoringProcedures, IES-RP-CC018.2 (IES, Mount Prospect, IL, 1992).
[16] J. Hansen et al., “Investigating AAMIRadiation Audit Results,” MDDI 16 (5), 218–222(1994).
撰稿人 | TEXWIPE
责任编辑 | 胡静
审核人 | 何发
2024-07-16
2024-06-24
2024-06-27
2024-07-13
2024-06-27
2024-07-22
2024-07-18
本文的目的是为了探讨不同清洗方法对分装器具的清洗效果。通过选取合适的污染物,以人工模拟污染的方式来污染各种直接接触产品的分装器具,然后对手工清洗、机械清洗的清洗流程以及清洗后取样检测总有机碳 (TOC)、电导率、细菌内毒素和微生物限度这 4 项指标进行比较分析。得出的结论为机械清洗的方法更具优越性,不仅提高了分装器具灭菌的质量,也降低了分装器具发生污染及交叉污染的风险。
作者:程露露 李欣
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