Cleanroom Good Manufacturing Practice (GMP)

Course Content                                                                                                     
Module 1:

Introduction to Cleanrooms

What are we trying to control and why

Module 2:

Cleanroom Design – floors, walls, ceiling, Air Handling unit, transit rooms, pressure differentials

Module 3:

ISO 14644-1 cleanroom classification

Module 4:

Contamination sources

Module 5:

Basic Microbiology

Module 6:

Cleaning of air and surfaces

Module 7

Monitoring & Testing

Module 8

ISO 14698-1 and 14698-2

Module 9

People and equipment movement in cleanroom

Overview /Outcomes

All personnel that work or enter a cleanroom, need to be absolutely sure that they are fully aware of the strict controls that are necessary to ensure contamination within this environment is very tightly controlled.

Personnel that work within a cleanroom for long periods of time, can often become complacent in their working practices of entry and exiting cleanrooms and how they carry out particular tasks within this environment. This can be greatly improved by providing personnel with a better understanding of the sources of contamination, how it can enter a cleanroom and its impact on the process and products. This up-skilling/re-skilling of personnel with the relevant skills, awareness and knowledge will greatly help them to take ownership of their role within the cleanroom and the products they produce, with a specific focus on controlling and minimising the risk of contamination.

The aim of this programme is to give cleanroom personnel a better understanding and heightened awareness as to how they and the various cleanroom processes they perform, can significantly contribute to elevated contamination levels