Can't Touch This! The Three W's of Barrier Isolator Technology

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$High-Temperature Stability | Do the Math for Shelf Life - Sterile ...$

Qualification of “critical” Design Features Isolators require a high level of qualification and validation with focus on: • Airflow Investigation Near Mouseholes • Isolator Integrity • Vaporised Hydrogen Peroxid (VHP) Sterilization 18
Inspectional Findings: Isolator Qualification (R. Friedmann & J. Agalloco*) • Dynamic filling line conditions not evaluated. Filling line was not in operation during smoke studies. • Smoke studies did not evaluate the pressure changes caused by introducing a glove into the isolator, or retrieving the glove from the isolator. • There was no data documenting isolator airflow parameters, such as air pressurization and velocities, during smoke studies. The acceptability of the lower air pressure limit was not evaluated. * Presentation by R. Friedman & J. Agalloco; Agallaco & Ass., NJ 2004 19
Page 1 and 2: ISOLATOR TECHNOLOGY MANUFACTURING D
Page 3 and 4: Topics Isolator Design Criteria - D
Page 5 and 6: Different Isolator Applications •
Page 7 and 8: Different Isolator Applications Con
Page 9 and 10: Different Isolator Applications „
Page 11 and 12: Different Isolator Applications „
Page 13 and 14: Different Isolator Applications Exa
Page 15 and 16: Mock-Up and Risk Analysis Cleaning
Page 17: Qualification of an Isolator 17
Page 21 and 22: Isolator Integrity Leak-Testing •
Page 23 and 24: VHP Sterilization Examples of Inspe
Page 25 and 26: VHP Sterilization VHP Cycle Develop
Page 27 and 28: VHP Sterilization Biological Indica
Page 29 and 30: VHP Sterilization Determination of
Page 31 and 32: VHP Sterilization Lessons learned E
Page 33 and 34: Isolator Technology vs Conventional
Page 39: Summary … …after five years exp

Can't Touch This! The Three W's of Barrier Isolator Technology

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