Sterilization Vaporized Hydrogen Peroxides

Other Sterilants. Sterilization methods, developed in response to the requirements of a low temperature, noncorrosive stedlant and rapid turnaround time required by most hospitals, include use of hydrogen peroxide vapor, hydrogen peroxide plasma, and peroxy acetic acid. Acceptance of these methods was not universal as of this writing (ca 1996). 

Cleaning Installations, Sterilization by Steam and Vaporized Hydrogen Peroxide (VHP )... 

Sterilization by steam is a standard procedure, but can be replaced by the VHP (Vaporized Hydrogen Peroxides) process, which works at ambient temperature and without pressure. Nakahira [2.11] described the development of applicable sterilization cycles, the necessary changes in the freeze-drying plant and the sterility test necessary to validate the process. Sterilization by VHP requires certain conditions which result from the nature of the H2Oz vapor ... 

Isolator technology is required especially when processing toxic or anti-cancer products and where the operator and his environment must be protected. An automatic loading and unloading system installed in an isolator system can be CIP cleaned and can be sterilized with vaporized hydrogen peroxide (VHP) (Figure 2.74.1). 

Steam sterilization can be avoided by using the Vaporized Hydrogen Peroxide (VHP) process. VHP operates at ambient pressure and temperature. Nakahari [35] describes the development of the necessary steps in this process, the changes... 

Johnson, J.W., Arnold, J.F., Nail, S.L. et al. Vaporized hydrogen peroxide sterilization of freeze dryers. Journal of Parenteral Science and Technology 46 215-225. 

Nakahira, K. Validation of deep vacuum vapor phase hydrogen peroxide sterilizer retrofit to a production lyophilizer. PDA Asian Symposium, p. 1/6-6/6, Tokyo 1994... 

VII. VALIDATION OF VAPOR PHASE HYDROGEN PEROXIDE STERILIZATION PROCESS... 

Vapor phase hydrogen peroxide equipment and process are described elsewhere [36]. The basic steps in the process are dehumidification, conditioning, sterilization, and aeration. More specifically, there are five steps that must be part of the validation protocol [36]. 

Edwards, L. M., Childers, R. W. Hydrogen peroxide vapor sterilization Applications in the production environment. In. M. J. Groves and R. Murty, eds. Aseptic Pharmaceutical Manufacturing II Applications for the 1990s. Buffalo Grove, IL Interpharm Press, pp. 415-466 (1995). 

Freeze dryers are usually steam sterilized or sterilized using VPHP (vapor phase hydrogen peroxide). Trays used in a freeze dryer are usually cleaned and sterilized separately. 

Sterilized poly(ether imide)/PPE sulfone articles can be obtained in a hydrogen peroxide plasma or in hydrogen peroxide vapor [103]. Alternatively and previously, steam autoclaving was proposed [104]. 

Klapes, N.A. and Vesley, D. Vapor-phase hydrogen peroxide as a surface decontaminant and sterilant. Applied Environmental Microbiology 56 503-506,1990. 

Graham, G.S. (1992) Sterilization of isolators and lyophilizers with hydrogen peroxide in vapor phase. International Congress on Advances Technologies for Manufacturing of Aseptic and Therminally Sterilized Pharmaceuticals and Biopharmaceuticals, Basel, Switzerland. 

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