ISO 7 cleanroom in a 30-year building

PE ZD

ISO 7 cleanroom in a 30-year building

The Xizhi plant of 台康生技: a 30-year building turned into 600 m² of ISO 7. Construction took 5 months, design to validation 12, with HVAC split across FCU, AHU, and EFU.

台康生技股份有限公司

ISO 7 cleanroom in a 30-year building

Area600 m²
Contract value—
Construction5 months
ClassISO 7
OutcomePIC/S GMP
ISO 7 cleanroom in a 30-year building

Challenge and approach

Headroom was low, there was no shaft, and there were no original as-built drawings. The process was sensitive to cleanliness, temperature, and humidity, and there was no spare space for supply and exhaust.

PE ZD split the HVAC across FCU, AHU, and EFU, controlled it by zone, and qualified only the rooms that needed it. Scope covered HVAC, the cleanroom, process gas, and C&Q. The area is 600 m². Construction took 5 months, and design to validation took 12. Design, construction, and qualification finished on that schedule. The target is PIC/S GMP.

Scope

  • HVAC
  • Cleanroom
  • Bulk Gas
  • C&Q

Duration

Construction 5 / Design to validation 12 months

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