Isolation Technology Fundamentals

Learn the "basics" of sterilization fundamentals and isolation-related terminology, and review some key decision processes for bringing isolators into your facility.

Validation Issues

Review various technical topics on the approaches to validating isolator systems, including sterilization, BIs, CIs, D-Value determination, and time-saving strategies for multi-isolator systems.

Regulatory Issues

Sort through isolator-related regulations with topic papers on surrounding room classification, sterilization claims, and discussions of the similarities and differences between major US and European regulatory bodies and key industry groups such as the PDA and ISPE.

Equipment Design Issues

Understand key isolator design principles and provide effective design specifications to equipment vendors.

End User/Operational Experience

Learn helpful hints from project and operational experience on isolator systems used in sterility testing labs, clinical manufacturing, and large-scale production operations

Publications

Download industry-sponsored publications related to isolation technology.

Presentations

Download industry-sponsored presentations related to isolation technology.

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