fertitech_glasspet-01

Vitromed SA – Cleanroom

fertitech_glasspet-01

Vitromed SA – Cleanroom

Life Science

Athens, Greece

2022

Design and Construction of a Cleanroom of 70sq.m. area with an Airlock of 10 sq.m. for the manufacturing of Glass Medical Devices. Production Area will be GMP Class C (ISO 7 at the “at rest” occupational state). Air lock will be Class D (ISO 8).

More specifically :
  • Cleanroom Design & Construction (wall panels, false ceiling, lighting,  Electrical Installation, doors, windows)
  • Procurement & Installation of 8 HEPA Fan Filter Units 1200×600 cm for the manufacturing area.
  • Procurement & installation of Air Conditioning Unit above the false ceiling
  • Cleanroom Certification
Testing, commissioning and Cleanroom certification ISO 14644 & EU GMP Volume 4 Annex 1:
  • Air Volumes measurement with Flow Hood and nano micrometre
  • Differential Pressures Qualification
  • Temperature / RH measurements
  • Smoke Test
  • Recovery Test
  • Particles Counting in the “At Rest” Occupational State
  • Preparation and submission of Cleanroom “Operating Qualification” Protocol
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