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USP797 & USP800

USP797 & 800 to be Enforced November 1, 2023.  Is your Cleanroom Pharmacy Ready?

lab worker filling test tubes

Partner with Cleanetics to Ensure Your Cleanroom is Compliant. 

Is your facility ready for November 1, 2023?  Are you prepared for the updated regulations? Are you worried about State, JCAHO inspectors?  Do you have current issues with temperature, humidity, pressure differentials, viable or non viable particles?  Or is your cleanroom functioning within the USP797 guidelines?  Cleanetics will assess, advise, and rectify any issues you may be experiencing or maintain the already compliant cleanroom pharmacy.     

Cleanroom Consulting, Designing, Building, Certifying, & Maintaining

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, DOH, and JCAHO regulations.  Having built cleanroom facilities for top hospitals around the nation and globe, Cleanetics ensures compliancy. 

Let Cleanetics Worry about Certification and Compliance Issues

Are you a functioning USP797 Cleanroom and need to have your room certified or maintained? Our team will work around your demanding schedule to ensure your facility maintains State/DOH/Federal Regulations. When you align your cleanroom with Cleanetics, we alert you regarding certification deadlines and schedule services to keep you compliant.  We believe the pharmacy industry should concentrate on patient CSP's and we concentrate on the cleanroom.  We truly partner with your hospital facility and eliminate the cleanroom stress.

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

The difference between USP797 and USP800 is very important to understand.  Both mandates are regulating the use of cleanroom environments.   USP797 concentrates on the physical environment and USP800 concentrates on protecting the workers in the hazardous cleanroom environment.  Being up to date on both regulations is key to producing sterile compounds safe for patients and safe for the compounding technicians.


Contact Us for USP 797/800 Cleanroom Solutions

USP797 Cleanroom with a custom manufactured Material Pass Thru.

Building USP797 Cleanrooms 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.


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See Our Finished
Cleanrooms in Action