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USP 797/800

USP 797 & USP 800 Cleanroom Consulting, Design, Construction, & Maintenance Services 

lab worker filling test tubes

Is Your Hospital or Pharmacy in Need of a USP797/ USP800 Cleanroom Facility or Upgrade? New regulations to be enforced November 2023.  Is your cleanroom Pharmacy ready? 

Since 2003, Cleanetics has been a leader in the USP797 cleanrooms in design, build, and certify industry.  Our team of experts stay up to date on all USP, State, and DOH regulations.  Having built cleanroom facilities for top hospitals around the nation and globe, Cleanetics ensures compliancy.   

Are you in need of renovating your existing facility, or do you need to relocate the cleanroom?  Our initial phase is assessing the current conditions, discussing the ergonomic flow of your cleanroom pharmacy, and designing based on discoveries. The second phase is to construct your cleanroom to adhere to ISO regulations: air changes per hour, pressure, temperature, humidity, and non-porous/seamless wall system guidelines.  Utilizing Bio-Gard Wall Laminate or Modular construction, our crew completes your facility and meets the ISO certification standards.  

Our mission is to ensure that you are satisfied with a state-of-the-art USP797 Cleanroom & USP800 Cleanroom. 

 

Contact Us for USP 797/800 Cleanroom Solutions

USP797 Pharmacy
USP797 IV Compounding Room
IS0 7 Anteroom
Line of Demarcation
USP797 Cleanroom
USP797 Cleanroom Cart Pass Through
USP797 Cleanroom Anteroom
External Controls/Alarms for USP797/ USP800 Cleanroom
Material Pass Throughs
Fan Filter Wall Unit
Bio-Gard Wall Laminate
ISO5 Open Architecture Compounding Zone
USP797 Compounding Pharmacy
USP797 Compounding Cleanroom
USP797 Cleanroom
USP800 Cleanroom
USP797 Cleanroom Compounding Pharmacy
USP800 Cleanroom
USP797 Cleanroom & USP800 Cleanroom

USP797 Cleanroom with a custom manufactured Material Pass Thru.

Cleanetics Has Been Building USP 797 & USP800 Hospital Pharmacies Since 2003

Since 2003, our team has been providing USP797 & USP800 cleanrooms to top hospitals across the nation. Our team began consulting, designing, building, and certifying USP797 and USP800 cleanrooms working closely with Directors of Pharmacy to create the ideal Sterile Compounding Cleanroom. With the ever-changing regulations since 2003, the Cleanetics team stays up to date on all the USP and FDA regulations to ensure our clients are in full compliance. We are not just a construction company; we are an extension of our client’s team and have your best interest in mind.

Does your facility have any questions on the recent USP797/800 regulations update?  The revisions are in and will  be enforced by Nov 2023.  Ask us how we can help.

 

Contact Our Cleanroom Experts
USP797 Cleanroom with auto slider doors from the anteroom to the IV compounding cleanroom.

We Will Design a Cleanroom That Fits Your Specific Needs

If your facility is renovating an existing space or building a new pharmacy, Cleanetics has the capabilities to complete your cleanroom project. Our specialty is in the design phase to ensure your room will meet all air changes, temperature, relative humidity, and particle count specifications.

Working with top hospitals around the globe, we have created state of the art USP797 cleanrooms & USP800 cleanrooms that follow all guidelines and ensure passing all state inspections. One of our past turn-key design build cleanroom construction projects included a 2,000sq/ft USP 797 & 800 hospital pharmacy. Cleanetics is your one-stop-shop for cleanroom design, construction, and installation, but we can also certify your cleanroom with all necessary organizations so you can confidently operate your facility in compliance with all applicable regulations.

Hire the USP797/800 Experts

Cleanetics Can Renovate Any Existing Location to meet the following regulations:

  • ISO7 Anteroom/Buffer Zone (ISO8 if the facility does not have a shared hazardous and non-hazardous cleanroom)
  • ISO 7 Negative Hazardous Compounding Room
  • ISO 7 Positive Pressure Compounding Room
  • Bio-Gard Wall Laminate
    • Non-porous, homogenous, heat welded, and durable
  • Custom Manufactured Material Pass Throughs; Hazardous Air-shower Pass Throughs
  • ISO certification guaranteed
  • Passed State, DOH, and Federal Inspections

We Service Our Clients With:

  • Monthly, quarterly, or semi-annual certification packages
    • Certification to ISO Standard 14644-1
    • BSC/LAFW equipment certification
    • Aerosol filter scan/Smoke Challenge Testing
    • Inspection of all equipment to ensure 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 Impaction and Surface)

Consult with Cleanetics to build and/or renovate your USP 797 Cleanroom & USP800 cleanroom pharmacy that is guaranteed to pass State, DOH, and Federal Standards.

 

Schedule a Consultation Now

See Our Finished
Cleanrooms in Action

Explore Our Completed Projects

Get Started with Cleanetics Today!

Call Us:
(412) 405-8692
Hours of Operation:
Mon-Fri: 7:30 AM - 4:30 PM
Sat-Sun: CLOSED
Design and Build Office:
110 5th Street
West Elizabeth, PA 15088
Headquarters:
6850 N. Haggerty Road
Canton, MI 48187
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