Industrial Microbiology for Medtech

This module is designed to give learners a clear understanding of the role of microbiological Quality Assurance (QA) and Quality Control (QC), particularly as applied to the medical device sector. It will provide learners with the information and skills to enable them to recognise the role of microbiology in the production of medical device products and to participate effectively as part of QA teams in the Medtech industry. It will equip learners with the skills necessary to design appropriate Quality Control (QC) testing protocols for raw materials, fluids as well as both in-process and finished products. Learners should be able to adopt an advisory role in situations relating to Microbiological Quality Control by recommending suitable materials, equipment and procedures. Learners will have gained sufficient knowledge of the microbiology of medical device healthcare products to enable them to take up responsible positions in QA and QC within Industry.

1. Describe and illustrate the relevance of microbiology in terms of sterility assurance, cleanrooms, microbiological contamination control, risk assessments and cleaning.

2. Design appropriate microbiological QC testing protocols for bioburden, sterility testing, pyroburden and environmental monitoring.

3. Design, develop and establish environmental monitoring programmes for cleanroom validation and routine monitoring to include active microbial airborne testing, surface and contact testing, air particulate testing, humidity, temperature, compressed air and air moisture.

4. Critically review potential microbial contamination problems which would compromise the safety of medical device products and evaluate the effects of microorganism presence on products for patients.

5. Demonstrate the ability to analyse, trend, track and interpret laboratory test results and data to help identify potential drifts or seasonal excursions and utilise such data to determine suitable action and alert levels.