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Grignol, G., Eddington, D., Karle, D., and Rickloff, J., "Chemical and Biological Aspects of Hydrogen Peroxide Gas"
Proceedings of ISPE Barrier Isolation Technology Conference, Arlington, VA, June 5-6, 2000.

The interactions of hydrogen peroxide concentrations and surface temperatures were studied in an isolator using chemical and microbiological techniques. These tests verified commonly accepted theories of the gaseous properties of flash vaporized hydrogen peroxide which have recently been challenged.


 
 
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Rickloff, J.R., "Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems"
Journal of Validation Technology, 5:61-71, 1998.

The purpose of this paper was to revisit some essential validation aspects of sanitizing isolators with hydrogen peroxide gas in order to assist the industry in demonstrating reproducibility of the process under worst-case conditions.


 
 
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Edwards, L.M. and R.W. Childers, "Hydrogen Peroxide Vapor Sterilization: Applications in the Production Environment"
Chapter in Aseptic Pharmaceutical Manufacturing II: Applications for the 1990ís, edited by Michael J. Groves and Ram Murty, Interpharm Press, 1995.

The foundation of the theory and application of hydrogen peroxide gas sterilization is discussed, including examples of filling line sanitization and lyophilizer chamber deep vacuum sterilization. Click on the link to the Interpharm Press website to order this book.


 
 
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Rickloff, J.R. and Eddington, D.L., "Hydrogen Peroxide Gas Sterilization Trials Performed on a Prototype Enclosed Vial Filler"
Proceedings of the PDA/ISPE Joint Meeting on Advanced Barrier Technology, Atlanta, GA, January 17-18, 1995.

Testing was performed on a prototype vial filler isolator at TL Systems Corp. in Minneapolis, MN to determine the feasibility of incorporating hydrogen peroxide gas sterilization into the system. Carrier sterilization, isolator aeration, and water fill residual data was presented


 
 
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Edwards, L.M. and M.E. Porter, "Case Study: Physical and Microbiological Testing of a Locally Controlled Environment Filling System"
Proceedings of the PDA/ISPE Joint Meeting on Advanced Barrier Technology, Atlanta, GA, January 17-18, 1995.

Physical limit testing is discussed, including a study of the relationship between particulate ingress through a mousehole at various operating pressure. A long-term (7-day) simulated media fill data (including environmental monitoring) reveals a very robust system for contamination control.


 
 
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Edwards, L.M., "Hydrogen Peroxide Gas Sterilization of an Enclosed Vial Filling Line"
Pharmaceutical Engineering, March/April 1993.

An initial case study for the application of hydrogen peroxide gas to an isolated filling line is reviewed in the initial design phase, denoting general principles and requirements for the system specifications.
Click on the link to the ISPE website to order this article


 
 
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Rickloff, J.R., J.P. Dalmasso, and L.W. Lyhte, "Hydrogen Peroxide Gas Sterilization: A Review of Validation Test Methods"
Proceedings of the 1992 PDA Annual Meeting.

The importance of performing temperature distribution studies, the use of chemical and biological indicators in optimizing and verifying proper gas distribution, a technique to easily perform square-wave D-value determinations, and a means to quantitatively monitor aeration efficiency when using a prototype VHP1000 was reviewed.


 
 
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Rickloff, J.R., and P.A. Orelski, "Resistance of Various Microorganisms to Vapor Phase Hydrogen Peroxide in a Prototype Dental Handpiec"
Proceedings of the ASM Annual Meeting, 1989.

A great deal of information is available in the literature on the relative resistance of microorganisms to aqueous hydrogen peroxide; however, the same cannot be said for hydrogen peroxide in the gaseous state. Bacillus stearothermophilus spores were found to be the most resistant to the sterilant and the presence of organic soil did not affect the ability of hydrogen peroxide gas to sterilize stainless surfaces.


 
 
 
 
 

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