Cleanroom equipment sourcing for Ireland
LIFA coordinated cleanroom equipment testing and validation for an Irish facility, which passed particle-classification testing on its first attempt.
- The buyer
- A Cork, Ireland pharmaceutical manufacturer building a new aseptic suite.
- The product scope
- Cleanroom equipment; HVAC, filtration, and monitoring systems. Program value $5.7M.
What needed to change?
The cleanroom project required validated particle-count performance; the prior build had failed particle counts twice.
How LIFA managed the work
We qualified 2 manufacturers with cleanroom validation experience.
We managed FAT/SAT and performance validation.
We coordinated ISO 14644-1 particle-classification testing.
We provided calibration and maintenance packages.
The cleanroom passed its particle-classification testing on the first attempt; the facility became operational 2 weeks early, and the program was extended for a second suite at $4.1M.
From our company project database, with the work, approvals and results shown together.
What this project shows
Acceptance had to reflect measured particle performance. Factory tests, site tests, calibration and maintenance information formed one validation sequence.
Client identities, supplier contacts and confidential commercial terms are withheld from this public company record.