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A custom-designed ISO 7 cleanroom project for the client's process.

Medical device cleanroom, amplitude 1

A custom-designed cleanroom project for the client's process

Leveraging an in-depth study phase and a highly innovative proposal, VÊPRES executed this cleanroom project for AMPLITUDE, a manufacturer of implantable orthopedic medical devices (prostheses and instrumentation).

The project, spanning five months, was delivered on schedule and met the client's industrial requirements. From conception to completion, our teams provided an ISO 7 class cleanroom of 130 m², an unclassified cleaning room of 180 m², and a technical room of 115 m².

The works encompassed infrastructure, HVAC, flooring, high and low voltage systems, process fluids, automation/control, metal framework, refrigeration production, cleaning, and qualification.

Another distinctive feature is that, in close collaboration with AMPLITUDE, VÊPRES successfully integrated the process equipment and developed the complete enclosure of workstations to achieve an ISO 5 classification on the product packaging lines.

VÊPRES thanks AMPLITUDE for its trust and for the excellent reception provided to our teams throughout the duration of the work on the cleanroom and its ancillary facilities.

www.amplitude-ortho.com
Article in DeviceMed on the project

cleanroom ISO 5 for Amplitude

« More than a partnership, a genuine collaboration! »

Brune ALBARES, Technical Director at AMPLITUDE

Construction of cleanrooms with workstations achieving ISO 5 classification

Medical device cleanroom, amplitude 2

Cleanroom ISO 7

7 ISO 5 workstations with access to conveyors

Medical device cleanroom, amplitude 3

Cleaning room (grey room)

Awaiting process equipment

Medical device cleanroom, amplitude 4

ISO 7 Cleanroom Personnel Airlock Entry

Ventilated pass-through and self-breaking panels for evacuation

Medical device cleanroom, amplitude 5

Main cleanroom entrance

Control screen and interlocked door

Medical device cleanroom, amplitude 6

Main production area entrance

Medical device cleanroom, amplitude 7

Observation Corridor

Serving the cleanrooms and technical areas

Medical device cleanroom, amplitude 1

Cleanroom ISO 7

ISO 5 workstation awaiting equipment

A custom-designed project

VÊPRES designed a cleanroom for AMPLITUDE, a specialist in orthopedic medical devices. The project, completed within five months, adhered to the schedule. It includes a 130 m² ISO 7 cleanroom, a 180 m² cleaning room, and a 115 m² technical room. In collaboration with AMPLITUDE, VÊPRES integrated the process equipment and designed the ISO 5 workstation enclosures.

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