Presentations & Publications

Hydrogen Peroxide Gas Decontamination

This chapter provided an overview on the basics of H2O2 gas decontamination and on how the sterilant should be applied to isolator systems. In addition, the latest in validation techniques and sterilant monitoring requirements were discussed from a user and regulatory perspective.

Chemical and Biological Aspects of Hydrogen Peroxide Gas

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

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 Gas Sterilization Trials Performed on A Prototype Enclosed Vial Filler

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.

”Modern Trends in Sterilization of Enclosures”

”Engineering and Project Management Issues for a Hydrogen Peroxide Sterilized Filling System”

Hydrogen Peroxide Gas Sterilization: A Review of Validation Test Methods

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

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.

The Use of Nitrogen Dioxide Gas for Isolator Decontamination Applications

A new decontamination technology is being developed and a review of preliminary breadboard testing on an isolator was presented.

Historical Perspective on the Decontamination of Isolators Using Hydrogen Peroxide Gas

A 15-year look back at how hydrogen peroxide gas generators were developed and implemented into isolator systems was provided along with a synopsis on how to properly validate the decontamination process and how variable BI resistance can affect the revalidation of such systems.

The Use of Abbreviated Decontamination Cycles to Prevent False Negative Sterility Test Results

Reviewed the current methods and past data involved in the validation of sterility testing isolators and discussed the value of using abbreviated decontamination for some product containers to prevent sterilant penetration.

Implementing Validation Strategies for Isolator-Based Systems

This workshop thoroughly reviewed the overall strategies and basic validation methodologies for isolator system validation utilizing gaseous decontamination methods. Facility design and qualification, equipment qualification, performance qualification, and process simulation testing was reviewed, with practical examples and demonstrations of key methods and techniques.

H2O2 Gas Decontamination Cycle Comparisons Between Rigid and Flexible Wall Isolators

This presentation provided an overview on the decontamination cycle and regulatory expectations for the process. Past flexible wall data and its’ implications are reviewed and how new trends in validation techniques are implemented to reduce them. The benefits of rigid wall isolator construction are also discussed.

Microbiological Monitoring in Isolators

This presentation reviewed the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon.

Practical Validation Strategies for Isolated Sterility Testing Labs – Part I

This workshop thoroughly reviewed the overall design process and equipment qualification methodology for isolator systems utilizing gaseous decontamination methods. Key learning objectives included determining your capacity requirements, developing a validation master plan, facility classification requirements, and qualifying your isolators and related process equipment.

Practical Validation Strategies for Isolated Sterility Testing Labs – Part II

The second part of the Workshop focused on the Performance Qualification studies that are needed to properly validate the gaseous decontamination method in sterility test isolator systems. Practical examples, a discussion of acceptance criteria, and the demonstration of test methods were included. Key learning objectives included determining a D-value for your BIs, developing and qualifying decontamination cycles, isolator aeration, sterilant ingress methods, and creating a meaningful process simulation (no false negative) study.

Current Trends in Controlled Environments

An overview of conventional aseptic processing was presented, and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas.

Isolator Sterilants: Common Issues and Differences

This presentation discussed the similarities and differences of the current chemical germicides used for isolator decontamination in the pharmaceutical industry with emphasis placed on validation issues and safety considerations.

Current Trends and Concepts in Validating Sterility Testing Isolators

Past practices & current trends in validating sterility testing isolators were reviewed with an emphasis on productivity. Although the key validation criteria remain the same, i.e. no false negatives, improvements to the overall system design have permitted the optimization of the decontamination cycle.