Specialist

Cleanroom & Pharmaceutical Cleaning in Ireland

Elite Cleaning & FM cleans classified cleanrooms and pharmaceutical manufacturing environments across Ireland to documented, repeatable methods. Cleanrooms are classified under ISO 14644 (ISO Class 1 to 9) and, in pharma, to EU GMP Annex 1 grades A to D — each grade sets limits on airborne particles that cleaning must not compromise. Every wipe direction, disinfectant, contact time and gowning step is defined in the method and recorded, so the work is auditable by a regulator.

Controlled environments we service

  • ISO 14644 classified cleanrooms (Class 5 through Class 8)
  • EU GMP grade A–D pharmaceutical manufacturing areas
  • Sterile fill-finish and aseptic processing suites
  • Medical device manufacturing and assembly areas
  • Laboratories, QC areas and stability suites
  • Changing rooms, airlocks and material transfer zones

Why cleanroom cleaning has to be validated

In a classified environment the cleaning process is part of the contamination control strategy, which means it is subject to the same scrutiny as any other GMP process. It is not enough for a room to look clean — you have to be able to demonstrate that a defined method was followed, by trained operatives, using approved materials.

That means low-linting wipes and mop systems rated for the class, sporicidal and disinfectant rotation to prevent resistance, unidirectional wiping from clean to less clean, defined contact times, and controlled entry of every consumable through the airlock. Each clean is signed off against the method.

Gowning, training and behaviour

People are the largest single source of particulate and microbial contamination in a cleanroom. Operatives are trained in gowning sequence, movement discipline and material transfer before they enter classified space, and are re-qualified on the same basis as your own production staff where the site requires it.

Cleanroom & Pharma

Cleanroom & Pharma questions

What is the difference between ISO 14644 classes and GMP grades A–D?

ISO 14644 is the international standard that classifies cleanrooms by the maximum number of airborne particles permitted per cubic metre, from ISO Class 1 (cleanest) to Class 9. EU GMP Annex 1 grades A to D apply specifically to sterile medicinal product manufacture and add microbial limits and requirements for the operational state of the room. A pharma cleanroom is often described in both systems.

What makes cleanroom cleaning different from deep cleaning?

Deep cleaning is about removing accumulated soil. Cleanroom cleaning is about maintaining a classified state — it uses low-linting materials rated for the room class, a defined wipe direction and sequence, controlled disinfectant rotation with measured contact times, and full documentation of every clean. The process itself is validated, not just the result.

Do you provide documentation for regulatory audits?

Yes. Cleaning is carried out against a written method statement and each clean is recorded — area, operative, materials, contact times and sign-off. That record is what an inspector asks for, and it is available to your quality team rather than held only by us.

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Get a quote for cleanroom & pharma

We survey the site before quoting, so the price reflects your building rather than an average. Teams across Ireland, based in Waterford and Cork.

kr@elitefm.ie