cell-2.jpg

You are here: Home > Tech•Knowledge > Publications
 
Publications
 

Comparative Air Sampling in Isolators Using RCS-Highflow with TCI-gamma Against M-Air Tester With Antiperoxide Cassettes and the MD8 Air Scan With Gelatine Filters
2002 PDA Annual Meeting (New Orleans, Louisiana)

TCI-gamma agar strips that are used with the RCS-Highflow System demonstrated a higher hydrogen peroxide neutralization capacity when compared to media containing 1% Pyruvate, such as used in anti-Peroxide Cassette Systems. The MD8 Air Scan was able to recover bacterial spores in isolators, but only at extremely low residual hydrogen peroxide levels.
 

Performance Comparison of Biotest Sterile Gamma-Irradiated Contact Slides DE-Gamma with Non-Irradiated D/E-Agar
Fifth International Conference of the Hospital Infection Society, 2002 (Edinburgh, Scotland)


Gamma-irradiation sterilized, modified DE Agar was compared with standard non-irradiated D/E-Agar for recovery of organisms and capacity for neutralizing disinfecting agents. The neutralizing capacity was tested using 4 microorganisms (gram positive coccus, gram positive rod, gram negative rod) with a wide range of disinfecting agents neutralized by D/E-Agar including aldehydes, phenol, quaternary agents, chlorine compounds, and hydrogen peroxide. The radiation-sterilized medium neutralized each disinfectant as well as the non-irradiated medium and fertility was equal or better on radiation sterilized DE Agar compared with standard D/E-Agar.
 
_______________
Industry Survey on Sterility Testing Isolators: Current Status and Trends
Pharmaceutical Engineering, March/April 2001

This article presents the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.
 
_______________
Chemical and Biological Aspects of Hydrogen Peroxide Gas
ISPE Barrier Isolation Technology Conference, Arlington, VA, June 5-6, 2000.

The interactions of hydrogen peroxide concentrations and surface temperatures are studied in an isolator using chemical and microbiological techniques. These tests verify commonly accepted theories of the gaseous properties of flash vaporized hydrogen peroxide that have recently been challenged.
 
_______________
Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems
Journal of Validation Technology, 5:61-71, 1998.

The purpose of this paper is 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.
 
_______________
Hydrogen Peroxide Vapor Sterilization: Applications in the Production Enviroment
Aseptic Pharmaceutical Manufacturing II: Applications for the 1990’s, 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.
 
_______________
Hydrogen Peroxide Gas Sterilization Trials Performed on A Prototype Enclosed Vial Filler
PDA/ISPE Conference, 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.
 
_______________
Case Study: Physical and Microbiological Testing of a Locally Controlled Environment Filling System at Merck Manufacturing Division
PDA/ISPE Conference, 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.
 
_______________
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.
 
_______________
Hydrogen Peroxide Gas Sterilization: A Review of Validation Test Methods
PDA Annual Meeting, 1992.

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.
 
_______________
Resistance of Various Microorganisms to Vaporized Hydrogen Peroxide in a Table Top Sterilizer
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.
 
 

Administration