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 ofmicrobiology in terms of sterility assurance, cleanrooms, microbiological contamination control, risk assessments and cleaning.

2. Designappropriate microbiological QC testing protocols for bioburden, sterility testing, pyroburdenand environmental monitoring.

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

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

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

The module is designed to give learners a clear understanding of the roles of Quality Management, Regulatory Affairs and Biocompatibility, particularly as applied to the medical device and healthcare sector It will provide learners with the skills and information to enable them to interpret and understand the regulations and their associated standards in relation to sterilisation and biocompatibility practises for medical devices in Europe and the US with reference to other markets and to apply this knowledge to real world scenarios. It will also provide learners with the information and skills to enable them to recognise the roles quality, regulatory affairs and biocompatibility play in the production of medical device products and to participate effectively as part of QA, RA and product development teams in the medical device Industry. Learners will have gained sufficient knowledge of the quality, regulatory and biocompatibility of medical device healthcare products to enable them to take up responsible positions in Product Development, QA, QC and RA within Industry.

1. Evaluate legislation and regulations as well as the roles of the various regulatory agencies ingoverning theuse ofmedical devices in theUS, EU and other major markets.

2. Analyse the way in which the regulations feed into the Quality Management System with respect to sterilisation, microbiological control,biocompatibility & clean-rooms.

3. Examine the ISO13485 and21 CFR Part 820Quality System requirements for medical devices with specific attention to patient safety,product quality andsterility.

4. Evaluate how to achieve and maintain Quality System compliancevia risk management, validation, calibrationandchange control methodologies.

5. Critically review the driving principles behind European and international biocompatibility quality and regulatory requirements and demonstrate improvedmaterial selection, process characterisation and toxicological risk assessment in medical device design and change management.

This module is designed to give learners an understanding of the global trends in sterilisation, particularly as applied to the medical device sector. It will provide learners with the information and skills to enable them to recognise emerging diverse novel & less frequently used sterilisation technologies (e.g., VHP, X-ray, chlorine dioxide, nitrogen dioxide, liquid chemical & dry heat) plus innovation and sustainability concerning these technologies. The leaner will thus be able to participate effectively as part of sterility assurance teams in the medical devices and healthcare industries. Learners will have gained sufficient knowledge of new and novel modalities for the sterilisation of medical devices and healthcare products to enable them to take up responsible positions in sterility assurance within Industry.

1. Evualateand critique new and novel technologies for the sterilisation of medical devices and healthcare products.

2. Formulate and design the validation and routine control of novel sterilisation technologies, the advantages of each method and their performance qualification.

3. Critically evaluate and compare global sterilisation technologies, innovation and alternatives to the standard sterilisation processing techniques.

4. Critically appraise the role of sustainability, environmental health and safety and environmental considerations for all sterility modalities.

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 requiredfor 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.

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 ofEO sterilisation, irradiation sterilization and other sterilization modalities such as moist heat, and aseptic processing.

2. Detailed knowledge ofsterilisation 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 evaluatethe advantages and limitations with each sterilisation modality.

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