Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not represent a standard or regulatory guidance.
It is organized by topics related to what to consider in designing and managing isolator systems, followed by relevant points to consider. Each point begins with a problem statement in the form of a question, representing issues or points needing clarification on the specific topic. Recommendations from subject matter experts are presented in response to each question, along with the rationale for the recommendations and references where available.
Learn about best practices and considerations and encourage further dialogue with industry, health authorities, and suppliers of technology and materials while taking into account the changes and needs of the modern, global, sterile healthcare product manufacturing industry.
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Table of Contents:
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Topic 1: Isolator Design
Topic 2: Physical Environment
Topic 3: Personnel
Topic 4: Integrity Testing of Isolator and Gloves
Topic 5: Environmental Monitoring
Topic 6: Material Transport and Loading of Isolators
Topic 7: Cleaning, Disinfection, Decontamination: Cycle Development and Validation
Topic 8: Aseptic Process Simulations (APS)
Topic 9: Best Practices in Aseptic Operations