Medical Device

Cleanetics has been assisting facilities in renovating an existing space into cleanroom certified medical device facilities.

Products that we see in the medical profession, on our shelf at the local pharmacy store, or equipment for surgery are made and/or packaged in a cleanroom facility.

For example, medical grade masks, gloves, medical PPE, sterile gauze packets, containers for medicine, knee replacement material, medical tubing, and the list could go on.  If your facility is considering becoming a part of the Medical Device Community, it is best to consult with Cleanetics to ensure your facility is compliant with industry specific regulations.

Medical Device Cleanrooms are typically built with an ISO classification of 7 or 8. The main purpose of this industry is to ensure that products are free from viable and particulate contamination.  Technicians working in these environments must also follow an SOP and don the appropriate PPE to protect the products being made or packaged.  Humans are the biggest contaminants and must adhere to the guidelines of cGMP.  Cleanetics can assist your group in becoming proficient in your SOP.  We are not just contractors that build and walk away.  Cleanetics Cleanroom Consultants become an extension of your facility and will guide you to success.

In March of 2020, Cleanetics had a request from an automotive production facility to design, build, and certify a medical device facility for mask production. In light of the Covid pandemic, mask production became a vital product for our country to manufacture.  By April, Cleanetics had furnished a fully certified and functioning medical device cleanroom to assist our nation in PPE production.

Cleanetics offers our clients preventative maintenance packages to extend the life of the cleanroom

  • Monthly, quarterly, or semi-annual packages
  • Certification to ISO Standard 14644-1
  • BSC/LAFW equipment certification
  • Aerosol filter scan
  • Inspect all equipment for proper operation
  • HVAC inspection and cleaning; Clean/replace FFU/HEPA pre-filters; Clean/replace FFU/HEPA pre-filters
  • Return air risers and wall cleaning
  • Pressure, Temperature, and Humidity Monitoring
  • Review cleaning procedures for compliance
  • Return air risers and wall cleaning
  • Microbial Viable Testing (Air and Surface)

Our turnkey design/build cleanroom was completed in three weeks

  • 1,000 sq/ft Medical Device Facility
  • ISO 8 Certified Cleanroom
  • Bio-Gard Wall Laminated System
  • Existing Space was an automotive production facility renovated into a Medical Device Manufacturing Facility
need help? call us!
CONTACT US
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+1 (412) 405-8374

If you are in need of a cleanroom or have questions about our adaptable isolation units, please use our form or call us today. National and International inquiries welcome.

CLEANETICS

6850 N. Haggerty Road
Canton, Michigan
48187, U.S.A.

Phone:  +1 (412) 405-8374

© Copyright 2020 Cleanetics, LLC. All Rights Reserved
Oryan Agency
© Copyright 2020 Cleanetics, LLC. All Rights Reserved
Oryan Agency