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Mask Manufacturing Cleanrooms

In order to meet FDA sterility requirements for medical usage, masks must be manufactured and packaged in a cleanroom.

Mask Cleanroom Design Options

  • American Cleanroom Systems® modular cleanroom walls to allow regular cleaning. Most commonly FRP, melamine, or vinyl
  • Gown room/airlock to change into and store cleanroom garment
  • HEPA fan filter units for ISO rated cleanroom classification
  • Recirculating design to maximize filtration effectiveness
  • Magnehelic gauge to monitor cleanroom pressure
  • Dedicated AC to create a controlled T environment
  • Cleanroom compatible flooring
N95 masks in blue package, surgical masks in blue package

Masks made in American Cleanroom Systems cleanroom installed in Texas.

Fast Delivery!

5/1/2020: American Cleanroom Systems® delivers a 2,208 SF ISO-8 modular cleanroom for CV-19 mask manufacturer in 2 weeks.

9/2/2020: American Cleanroom Systems® delivers a 2,677 SF ISO-8 modular cleanroom for CV-19 mask cleanroom in 2.5 weeks.

11/12/2020: American Cleanroom Systems® completes manufacturing for 1,500 SF ISO-8 modular cleanroom for mask manufacturing in 2 weeks.

Customer Testimonials

We purchased our current clean-room system from American Cleanroom Systems. Their level of professionalism and ease to work with made the task of building a custom cleanroom a breeze. We highly recommend them.

Chris 2,208 SF ISO-8 Mask Manufacturing Cleanroom

FAQs About Mask Manufacturing Cleanrooms

Q: Why do I need a cleanroom for mask manufacturing?
A: Since the masks are often used in hospitals, surgical rooms, pharmaceutical manufacturing, and medical device manufacturing they need to be sterile. This means manufacturing in a sterile cleanroom.
Q: What types of masks are manufactured in cleanrooms?
A: Surgical masks, N95 masks are most commonly masks manufactured in cleanrooms.
Q: Do I need AC for my mask manufacturing cleanroom?
A: Personnel working in cleanroom wear cleanroom jackets, cleanroom booties, gloves, and cleanroom hoods or bouffant hats. These additional garments make workers warm so cleanroom air conditioning is a requirement.
Q: What kind of floor do I need for my mask manufacturing cleanroom?
A: Most warehouses where cleanrooms are installed have concrete floors. Concrete is very porous and a major cause of particulates. It is necessary to cover the concrete with VCT tile, epoxy or heat welded vinyl cleanroom flooring to maintain the cleanroom class.
Q: Does mask manufacturing cleanrooms have special gown room needs?
A: Typically, there are large number of personnel working inside mask manufacturing cleanrooms. It is important to have a large gown room so personnel do not have to wait to enter and exit the cleanroom.
Q: What type of machines go into mask manufacturing cleanrooms?
A: Most common machines are for molding N95 masks, cutting surgical mask cloth, sewing ear bands on the masks. The mask cutting machines are long and narrow. It is important to plan for their footprint.
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