微生物實驗室

PE ZD

微生物實驗室

A microbiology lab in Hsinchu County for a marketed small-molecule topical. Turnkey from concept, URS, and risk assessment through construction, testing, and qualification, aimed at PIC/S GMP.

Confidential

微生物實驗室

Area—
Contract value—
Construction—
Class—
OutcomePIC/S GMP
微生物實驗室

Challenge and approach

The product was already on the market, a topical liquid, and the lab still had to be rebuilt to PIC/S GMP.

The site is in Hsinchu County. PE ZD’s turnkey scope covered concept design, URS, risk assessment, design review, consulting and review of commissioning and qualification, construction, and test qualification. The facility stage includes detail design, construction, validation, and qualification.

Scope

  • HVAC
  • Cleanroom

Request an interview

Related projects