In this blog post, Joanne Bassett, our Territory Account Manager in the South-East, discusses the influence GMP Guidelines have on the design and build of cleanrooms and the ongoing relationship between service provider and the facility.
Design considerations from GMP annex 1
As the draft guidelines are set to supersede GMP Annex 1, the material construct of cleanrooms looking to achieve this accreditation should be in line with the draft revision.
Part 5.4 of the draft states that “in clean areas, all exposed surfaces should be smooth, impervious and unbroken in order to minimize the shedding or accumulation of particles or micro-organisms and to permit the repeated application of cleaning agents, and disinfectants, where used.”
To achieve this we use UltraTech Precision panels to create a fully-flush system. It comes with a range of fully-flush accessories, such as doors (to comply with part 5.5) and service conduits (to comply with part 7.6).
As part 5.7 states “false ceilings should be designed and sealed to prevent contamination from the space above them,” we wouldn’t recommend a grid ceiling as changes in pressure during ingress may disturb ceiling tiles. Instead a false ceiling with apertures for filtration and lighting creates a sealed ceiling to protect the clean environment.
Organisations should choose their supplier carefully as the relationship does not end with the completion of their facility. Successful MHRA audits will depend on your chosen supplier being able to stand up to audits on quality management in order to be able to provide ongoing support such as qualification testing.
GMP qualification testing
Cleanroom validation and qualification is very different for ISO 14644-1:2015 and GMP. ISO tests will be centred around air changes and airborne particle counts; whereas GMP facilities will need to consider filter integrity testing, smoke visualisation and room recovery rates, to name but a few. The full scope of testing will be driven by individual process risk and what the MHRA will need to see upon inspection.
We’d love to talk to you about where we can support your specific cleanroom requirements. Contact us, to start discussing your project today!
Thanks for reading,