Adaptive Sterile Modular ISO Class 7 Manufacturing Biomedical Cleanroom

NAU Mechanical Engineering Capstone 2023-2024

Project Description

Medical devices for stroke treatment must be assembled in a clean room environment (particle free and sterile). The scope of this project is to design, build, and test a modular curtained clean room area to help establish sterile manufacturing capabilities while converting the current clean room into a gowning room. The clean room area must be modular and able to be easily disassembled and reassembled. ​

Importance of the project

Construct a space where faculty and students can learn and develop new ways to contribute to the human healthcare system.

Deliverables

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Modularity

Can be assembled or disassembled in a buisness day with a small crew of people.

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Safe

Ceiling configuration can support the weight of 4 FFUs (Fan Filter Units).

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ISO Class 7 Compliant

Aligns with the FDAs ISO CLass 7 Standards.

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Particle Count/Size

< 0μg particles, < 0.5μm particle size.

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Airflow

≥ 90 ft/min, ≥ 60 air changes per hour.

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Deflection

0in of deflection on ceiling configuration.

Project Clients/Sponsors

Now, a word from our sponsors.....

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Aneuvas Technologies,Inc

Aneuvas Technologies Inc's mission is to improve health care by developing novel microcatheter-based medical devices for minimally invasive delivery to the blood vessels in the brain, for the treatment of aneurysms and other vascular defects.

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NAU Bioengineering Club

The Bioengineering Club is focused on learning about what goes into medical equipment by competing against each other to see whose team can come up with the most creative, reliable, and impactful solution for a given challenge. This club aims to have fun while learning how to use state-of-the-art test equipment and advanced manufacturing tools all while promoting a safe place where everyone is welcome.

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Red Rock Manufacturing

Founded in 2022 by two mechanical engineers in the mountains of Flagstaff, Arizona; we are a machine shop proudly serving several industries and individuals across the country. Our goal is to provide parts that exceed customer quality and delivery requirements.

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Gore LLC

Founded in 1958, Gore is a global materials science company with more than 13,000 Associates spanning five continents and thousands of products across industries — from high-performance fabrics to implantable medical devices and products that reduce emissions, explore space and solve other complex challenges.

What we have achieved

From August 2023 to May 2024

Particle Count (μg)

Manufactured Parts

Hours Of work

Hard Workers

Gallery

  • Manufacturing
  • Testing
  • CAD

Band Saw Cutting

@ Machine Shop

Drilling holes into support truss

@ ROTC Lab

Drilling holes to attach walls to frame

@ ROTC Lab

Vertical drill press into gowning room ceiling

@ ROTC Lab

Milling holes into cleanroom frame

@ Machine Shop

Hand Saw Cutiing Aluminum

@ ROTC Lab

Hand saw trimming polycarbonate walls

@ ROTC Lab

Airflow testing with anemometer

@ ROTC Lab

Area testing

@ ROTC Lab

Particle count testing

@ ROTC Lab

First design iteration

@ 12' x 8'

Second design iteration

@ 12' x 16' no supports

Final design iteration

@ 12' x 16' with supports including gowning room

Manufacturing and Testing Videos

Our Team

Michelle Borzick

Project Manager, Internal Communications
mrb364@nau.edu

Gia Neve

Financial Manager, External Communications, Web Developer
gnn23@nau.edu

Aaron Reynoza

CAD Engineer, Manufacturing Engineer
aer448@nau.edu

Logan Bennett

Test Manager, Manufacturing Engineer
lrb275@nau.edu