Date: 1 day a week/over 3 weeks, September 2020
Participant Profile and Programme Objective
The Introduction to Cleanroom Operations and Maintenance course has been specifically designed to introduce trainees, with no prior Cleanroom experience, to the fundamental principles of operating in and maintaining a Cleanroom environment. Topics covered include: Gowning, Asceptic practice, HVACS and HEPA systems, Particle Monitoring, Sanitisation.
- This is an interactive 3-day course, run over 3 weeks.
- No previous Cleanroom experience or training is required.
- The course will deliver an understanding of how a Cleanroom works, introducing them to the fundamental concepts, equipment and processes they can expect to encounter.
- Trainees will receive a course manual, remote support, 3 one-day tutorials and a project to be completed as a self-directed learning element.
- The course consists of both theory and practical elements.
- All trainees will receive a certificate of attendance after course completion, with a graded mark for their project work.
Programme Objectives & Learning Outcomes
On completion of this course, trainees will be able to:
- Explain the fundamentals of micro-organisms and how a Cleanroom controls microbial growth.
- Identify micro-organisms and their habitats using a range of techniques including isolation, colony morphology, gram staining and biochemical testing
- Identify the major sources of product and process contamination.
- Demonstrate an understanding of the Gowning process, following Quality Assurances protocols.
- Have a working knowledge of heating, ventilation, and air-conditioning systems (HVACS) including area classification and HEPA filters.
- Understand the classification levels of a Cleanroom and their duties to same.
- Understand the purpose of viable and non-viable Particulate monitoring, using a Particle counter.
- Demonstrate how to sanitise a Cleanroom operating environment.
- Understand Bio-Contamination and be able to practice good aseptic techniques.
- Define the key microbiology terms and concepts in relation to cleanroom environments in the life sciences manufacturing sector
- Perform common tasks in a Cleanroom environment in compliance with standard operating procedures.
- Control cleanroom contamination using a range of corrective action and preventative actions (CAPA), including room and equipment cleansing and sanitisation, sterilisation using equipment such as an autoclave, and viable and non-viable particulate monitoring.
- Introduction to Quality Assurance (QA) of cleanroom practice using reflections on own performance and that of others.
The course will be carried out using the ESS Training Manual (supplied to each trainee) and approved gowning and PPE (supplied onsite).
Trainees should have a basic knowledge of electrical systems/mechanical equipment/facilities management.
Trainees should bring a scientific calculator and multi-meter.
For a detailed description of each section, please email firstname.lastname@example.org