ISO 11137 Training
Our training program comprehensively addresses Gamma sterilization, focusing on meeting international standards such as ISO 11137 Part 1, Part 2, Part 3, and Part 4. These standards encompass validation, process control, and documentation to guarantee product safety and effectiveness. Adhering to these standards is essential for ensuring sterility assurance, reducing contamination risks, and preserving product integrity. This is critical for both patient safety and compliance with healthcare sector regulations.
Course Objectives
At the end of the program participants should be able to do the following:
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Understand the philosophy and principles of sterilization.
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Aware of validation and routine control of the gamma radiation sterilization method and requirement.
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Understand the key factors for sterilization process development.
Course Outline
Set the State- Overview:
• Ice breaker- “Recognizing and identifying STERILE product.
• Objectives of the workshop.
• Agenda.
• Administrative arrangement.
Overview of Sterilization
• Introduction.
• Validation.
• Process control & releasing.
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Key Factor of Sterilization Process Development.
• Contamination control.
• Microbiological testing.
• Maintaining sterilization effectiveness