Cleanroom design and certification

Cleanroom contamination has a wide range of sources but by far the most common is people, both what they carry into the cleanroom with them and the way they behave when they're inside.

Risks that aren't immediately obvious such as skin flakes, cosmetics, clothing debris and spittle must be considered as contaminants, along with common behaviours such as touching and rapid movements.

Here sterility expert Dr Tim Sandle runs through strategies that can help minimise these risks along with training to ensure the chances of contamination from people remains as small as possible.

Topic areas we cover include:

• The essentials of cleanroom design to achieve contamination control and compliance, including filtration, air exchanges, air movement, pressure differentials and construction
• The certification to cleanrooms according to ISO 14644 and EU GMP best practices, including assessments of particles, microorganisms, and appropriate physical parameters

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorial boards and he has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.