Cleanroom Design


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All our courses continue to evolve as standards and best practice change, and as we get feeedback from previous delegates. A general outline of the curriculum for the day wil include….

  • Cleanroom Introduction
  • Cleanroom Fundamentals
  • Validation Testing to ISO 14644-3:2019
  • Monitoring Plan for Continued Compliance
  • Practical Validation Testing for Compliance
  • IQ/OQ Documentation
  • Practical – Design a Cleanroom Grade A vs Grade C
  • Q&A

This will be an in-depth training course with an “open book” style exam.  Greater than 90% must be achieved to be awarded a Pass Certificate.  Any delegate not sitting the exam or not meeting the required standard will be awarded a Certificate of Attendance.


For those involved in the industry in either designing, commissioning, validating or servicing cleanrooms. This course gives an insight into the relevant ISO standards on contamination control related to cleanroom design, including selection of filters, building fabric and recommended cleaning regimes. When cleanrooms are built, typically the customer does not know what they need and they look to the ‘experts’ for guidance. Having an in-depth knowledge of why you do what you do always provides reassurance to your customer.

Instructor – Tom Hyland

Tom has been working in the medical device manufacturing and collagen processing field since 1981 and graduated in Chemistry/Chemical Engineering with Honours. Tom spent much of his early career with Johnston & Johnston and rose to Senior Operations, before working at SMT level for a number of pharmaceutical companies including Microsulis, Life Technologies and a Directorship at Collagen Solutions. He set up his consultancy, Hyland Enterprises, in 2011, where he has overseen projects in the UK, US and Australia.


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