Terminal Sterilization for Medtech Industry

This module is designed to give learners a clear understanding of the role sterilization plays in the medical device and healthcare sector. It will provide learners with the fundamentals on sterilization technologies and methods, sterilization standards, regulatory requirements and product release criteria. The learner will be able to determine how to select and implement an appropriate sterilisation process and how to identify the elements of a successful sterilisation validation. Learners will participate in the design of process validations for EO, Irradiation and other modalities. Learners will have gained sufficient knowledge of  sterilisation pertaining to medical device and healthcare products to enable them to take up responsible positions in Sterility Assurance, Quality Assurance, Quality Control, Regulatory Affairs  and other related functions within the Medtech Industry.

1. Systematic understanding of EO sterilisation, irradiation sterilization and other sterilization modalities such as moist heat, and aseptic processing.

2. Detailed knowledge of sterilisation process development, process definition, validation, re-qualification, change management, and routine control.

3. Illustrate an in-depth knowledge of sterilization product validation, change management/control.

4. Critical awareness of regulatory/standard requirements pertaining to sterilization validation and routine processing.

5. Critically evaluate the advantages and limitations with each sterilisation modality.

6. Apply advanced methods to assess and evaluate out of specification results.