Cleanroom Technology, GMP & Water Systems

This module introduces learners to the use of cleanroom technology in the medical technologies industry. Learners will explore standards and guidelines and how they pertain to cleanrooms of different classification in industry. Cleanroom technology, design materials, HEPA systems and filtration, cleanroom practices and day-to-day operation, validation, control and monitoring, maintenance, cleaning, and housekeeping of cleanrooms will be examined to ensure adherence to these regulatory and GMP guidelines. Learners will also gain sufficient knowledge of GMP and water systems to enable them to take up responsible positions in sterility assurance within Industry.

1. Demonstrate detailed knowledge and systematic understanding of the design, classification, operation and management of cleanrooms and controlled environments.

2. Detailed knowledge of the defining concepts for validation, requalification and routine control requirements of a Cleanroom.

3. Critical awareness of current good manufacturing practices required for medical device manufacturing.

4. Critically evaluate and interpret the microbial quality of water purification and distribution loop systems within the medical device and healthcare setting.