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PIC/S Sterile Manufacturing & Contamination Control

PIC/S sterile manufacturing principles covering contamination control, cleanrooms, barrier technology, personnel, utilities, sterilization, aseptic processing, monitoring and sterility assurance.

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Course Content

Module 1: Sterile Manufacturing Fundamentals
  • 1. Introduction to Sterile Manufacturing
    Locked
  • 2. PIC/S Annex 1 Overview
    Locked
Module 2: Contamination Control Strategy
  • 1. Understanding the CCS
    Locked
  • 2. Sources and Control of Contamination
    Locked
Module 3: Cleanrooms & Barrier Technology
  • 1. Cleanroom Fundamentals
    Locked
  • 2. RABS and Isolators
    Locked
Module 4: Personnel, Gowning & Utilities
  • 1. Personnel in Sterile Manufacturing
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  • 2. Utilities in Sterile Manufacturing
    Locked
Module 5: Sterilization & Aseptic Processing
  • 1. Sterilization
    Locked
  • 2. Aseptic Processing
    Locked
Module 6: Monitoring & Sterility Assurance
  • 1. Environmental & Process Monitoring
    Locked
  • 2. Aseptic Process Simulation & Sterility Assurance
    Locked
Final Assessment
Complete all modules to unlock final exam
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