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Publications
 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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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.
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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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