LIFA client project

Cleanroom equipment sourcing for Ireland Performance validated before operation

LIFA coordinated cleanroom equipment testing and validation for an Irish facility, which passed particle-classification testing on its first attempt.

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Proven client project

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

  1. We qualified 2 manufacturers with cleanroom validation experience.

  2. We managed FAT/SAT and performance validation.

  3. We coordinated ISO 14644-1 particle-classification testing.

  4. We provided calibration and maintenance packages.

Project results

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.

Proven LIFA project

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.

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