Who should attend
This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
- Cleanroom staff
- Cleanroom cleaners
- Production staff
- Production Managers
- People who handle product and/or components
- People who handle raw materials
Book onto this course
- 9th March 2012 - Full
- 19th July 2012 – CGMP01/07/12
Course Outline
This useful and engaging course focuses on cleanroom Good Manufacturing Practices (GMPs) and is suitable for all staff who work in a controlled environment and for staff who don’t, but need an understanding of what it involves. The course covers basic information as to what is a cleanroom to how people working in a cleanroom can assist with maintaining its cleanliness.
Covering the dos and don’ts when in a cleanroom, this course also educates staff in basic microbiology so they can appreciate the impact of their habits on contamination in a cleanroom and of the products they are working with. Evidence shows that by understanding the impact of their actions, people take greater care in what they do. Contamination is not just from people, so using real life examples discover even more sources of contamination and items that you should not have in your cleanroom.
Cleanrooms require monitoring; discover what this means, how it is achieved, the tests that are carried out and how to interpret results. Learn what action can be taken if levels increase and what happens to your medical devices if your levels go over an action limit. Cleanrooms also require cleaning; understand the different chemicals that can be used, how often and what is a good cleaning regime.
The GMPs when applied correctly are a wonderful tool in maintaining a state of control over the cleanroom environment. This course gives delegates a full understanding of GMP in the medical device industry and is lead by microbiologists who have managed and worked in cleanrooms within the sector.
Topics covered include
- Cleanroom design & construction
- ISO 14644-1 cleanroom classification
- Contamination sources
- Basic Microbiology
- Cleaning
- Monitoring & Testing
- Pros and cons of ISO 14698-1 and 14698-2
- Movement of people and equipment
Outcomes
At the end of the seminar, delegates will gain an insight into:
- Medical device clean room environments functionality
- Controls practices required for a cleanroom
- Basic microbiology
- Risk to the cleanroom
- Cleanroom behaviour of visitors and operators
