Sterile Manufacturing: Aseptic Processing Course

A practical GMP training course on sterile manufacturing and aseptic processing.

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Course Content

Module 1: Introduction to Sterile Manufacturing and Aseptic Processing
  • 1. Lesson 1: What is Sterile Manufacturing
  • 2. Lesson 2: Types of Sterile Products
  • 3. Lesson 3: Terminal Sterilization vs Aseptic Processing
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Module 2: Sterile Facility Design
  • 1. Lesson 1: Cleanroom Concepts
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  • 2. Lesson 2: Cleanroom Classification (ISO & EU GMP)
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  • 3. Lesson 3: Airflow Design in Sterile Facilities
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Module 3: Sterilization Methods
  • 1. Lesson 1: Steam Sterilization
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  • 2. Lesson 2: Dry Heat Sterilization
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  • 3. Lesson 3: Filtration Sterilization
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Module 4: Aseptic Processing Operations
  • 1. Lesson 1: Aseptic Processing Principles
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  • 2. Lesson 2: Filling Operations
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  • 3. Lesson 3: Lyophilization (Freeze Drying)
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Module 5: Environmental Monitoring
  • 1. Lesson 1: Environmental Monitoring Program
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  • 2. Lesson 2: Viable Monitoring
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  • 3. Lesson 3: Non-Viable Particle Monitoring
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Module 6: Personnel & Contamination Control
  • 1. Lesson 1: Gowning Procedures
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  • 2. Lesson 2: Operator Behavior
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  • 3. Lesson 3: Contamination Sources
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Module 7: Validation & Qualification
  • 1. Lesson 1: Media Fill Simulation
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  • 2. Lesson 2: Sterilization Validation
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  • 3. Lesson 3: Filter Integrity Testing
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Module 8: Regulatory Compliance
  • 1. Lesson 1: EU GMP Annex 1
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  • 2. Lesson 2: FDA Sterile Drug Guidance
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  • 3. Lesson 3: Data Integrity in Sterile Manufacturing
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Module 9: Quality Systems
  • 1. Lesson 1: Deviation Management
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  • 2. Lesson 2: CAPA in Sterile Manufacturing
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  • 3. Lesson 3: Change Control
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Module 10: Advanced Sterile Technologies
  • 1. Lesson 1: Isolator Technology
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  • 2. Lesson 2: RABS Systems
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  • 3. Lesson 3: Future of Sterile Manufacturing
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Final Assessment
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