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Medical Devices

Cleanetics Assists in Transforming Existing Spaces into Cleanroom Certified Medical Device Facilities


Cleanroom Facilities for Medical-Grade Equipment | Cleanetics - med4

Cleanrooms are Utilized for Making and Packaging Medical Grade Equipment Nationwide

Products that we see in the medical profession, whether on a shelf at the local pharmacy or used 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, etc., are all packaged in a sterile environment. 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.

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Cleanroom Facilities for Medical-Grade Equipment | Cleanetics - Roseplastics(1)

Cleanetics Ensures Your Cleanroom is as Sterile and Safe as Possible

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. Once we have designed and constructed your medical device cleanroom facility, we will ensure that your cleanroom is certified to operate under all compliance regulations on both a state and federal level.

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Cleanroom Facilities for Medical-Grade Equipment | Cleanetics - med2

Today’s Health Climate has Resulted in an Increased Demand for Cleanrooms and Cleanroom Technology

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.

We are capable of turning around your cleanroom quickly to ensure that you can produce much needed medical equipment in a timely manner. Contact us today to discuss your medical device cleanroom needs and get started with the customized designing process.

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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

We Service Our Clients With:

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

Consult with Cleanetics to build and/or renovate your medical device manufacturing or packaging facility that is guaranteed to pass State, DOH, and Federal Standards.

 

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Cleanrooms in Action