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